S-1

As filed with the Securities and Exchange Commission on May 28, 2021.

Registration No. 333-​

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933

Miromatrix Medical Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization) 2836 (Primary Standard Industrial
Classification Code Number) 27-1285782 (I.R.S. Employer
Identification Number)

10399 West 70th Street
Eden Prairie, MN 55344
(952) 942-6000

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Jeff Ross
Chief Executive Officer
Miromatrix Medical Inc.
10399 West 70th Street
Eden Prairie, MN 55344
(952) 942-6000
(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Steven Kennedy
Jonathan Zimmerman
Faegre Drinker Biddle & Reath LLP
2200 Wells Fargo Center
90 S. Seventh Street
Minneapolis, Minnesota 55402
(612) 776-7000 Ryan Brauer
Joseph Schauer
Fredrikson & Byron, P.A.
200 S. Sixth Street
Suite 4000
Minneapolis, Minnesota 55402
(612) 492-7000

Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

CALCULATION OF REGISTRATION FEE

Title of each class of securities to be registered	Proposed Maximum Aggregate Offering Price(1)(2)	Amount of registration fee(2)
Common stock, $0.00001 par value per share	$20,000,000	​	$	2,182.00

(1)

Includes shares of common stock that the underwriter has the option to purchase.

(2)

Estimated solely for the purpose of computing the amount of registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED MAY 28, 2021

PRELIMINARY PROSPECTUS

Shares

Miromatrix Medical Inc.

Common Stock

We are offering           shares of our common stock. This is our initial public offering and no public market currently exists for our common stock. We expect the initial public offering price to be between $      and $      per share. We have applied to list our common stock on the Nasdaq Capital Market under the symbol “MIRO”.

Investing in our common stock involves a high degree of risk. Please read “Risk Factors” beginning on page 12 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

We are an “emerging growth company” under the federal securities laws and will be subject to reduced public company reporting requirements for this prospectus and future filings.

​	PER SHARE			TOTAL
Initial public offering price	​	$		​	$
Underwriting discounts and commissions(1)	​	$		​	$
Proceeds, before expenses, to us	​	$		​	$

(1)

We refer you to “Underwriting” beginning on page 148 for additional information regarding underwriter compensation.

We have granted the underwriter an option for a period of 30 days to purchase an additional                 shares of our common stock at the initial public offering price, less discounts and commissions. If the underwriter exercises the option in full, the total underwriting discounts and commissions payable by us will be $      , and the total proceeds to us, before expenses, will be $      .

Delivery of the shares of common stock is expected to be made on or about                 , 2021.

Craig-Hallum

Prospectus dated                 , 2021

Table of Contents

​	Page
PROSPECTUS SUMMARY	​	1
RISK FACTORS	​	12
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	​	53
MARKET AND INDUSTRY DATA	​	54
USE OF PROCEEDS	​	55
DIVIDEND POLICY	​	56
CAPITALIZATION	​	57
DILUTION	​	59
SELECTED FINANCIAL DATA	​	61
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	​	63
BUSINESS	​	79
MANAGEMENT	​	118
EXECUTIVE AND DIRECTOR COMPENSATION	​	124
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	​	139
PRINCIPAL STOCKHOLDERS	​	142
DESCRIPTION OF CAPITAL STOCK	​	144
SHARES ELIGIBLE FOR FUTURE SALE	​	148
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS	​	151
UNDERWRITING	​	155
LEGAL MATTERS	​	163
EXPERTS	​	163
WHERE YOU CAN FIND ADDITIONAL INFORMATION	​	163
INDEX TO FINANCIAL STATEMENTS	​	F-1

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Neither we nor the underwriter have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and the underwriter take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.

Neither we nor the underwriter have done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free writing prospectus outside of the United States.

TRADEMARKS

“Miromatrix,” the Miromatrix logo and other trademarks, trade names or service marks of Miromatrix Medical Inc. appearing in this prospectus are the property of Miromatrix Medical Inc. All other trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor to these trademarks and tradenames.

INVESTORS OUTSIDE THE UNITED STATES

For investors outside of the United States: neither we nor the underwriter have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.

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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary is not complete and does not contain all of the information you should consider in making your investment decision. Before investing in our common stock, you should carefully read this entire prospectus, especially the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus. Unless the context otherwise requires, the terms “Miromatrix,” “the Company,” “we,” “us,” “our” and similar references in this prospectus refer to Miromatrix Medical Inc.

Overview

Our mission: Eliminate the organ transplant waiting list

We are a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients’ lives. Organ disease is a major public health issue. According to the American Transplant Foundation there are an estimated 114,000 people in the United States waiting for a lifesaving organ transplant, and on average 20 people die daily due to lack of available organs. We have developed a proprietary perfusion technology platform for bioengineering organs that we believe will efficiently scale to address the shortage of available human organs. Our initial development focus is on human livers and kidneys, and we have demonstrated the ability to bioengineer these organs with functional vasculature and important organ function in preclinical studies. In addition, we believe our technology platform will be able to develop other organs, including lungs, pancreas, and hearts. We have collaborations with the Mayo Clinic, Mount Sinai and the Texas Heart Institute, and our strategic investors include DaVita, Baxter and CareDx.

Our proprietary perfusion decellularization and recellulariziation technology harnesses the powerful evolutionary forces shaping complex organ development and the regenerative capabilities of living human cells. We believe the organs we are developing could have significant functional and immunological advantages compared to other organ development techniques which rely on the genetic modification of animals cells, such as xenotransplantation. Our perfusion decellularization and recellularization technology platform includes 118 issued and 35 pending patent applications, with protection in the United States and major markets worldwide.

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Decellularization.   The anatomical structure of organs is highly complex and enormously challenging to reproduce synthetically. We utilize porcine organs as the scaffold for creating human organs because significant anatomical and vascular similarities exist between the two species’ scaffolding. Using our proprietary perfusion decellularization process we remove the porcine cells from harvested porcine organs leaving behind a scaffold of extracellular matrix (“ECM”) that retains the architecture, mechanical properties, and vascular network of the original organ structure. Porcine ECM is estimated to be over 93% homologous to human ECM which significantly reduces potential for antibody formation and adverse reaction. In addition, we have generated human clinical data demonstrating the safety of our decellularized porcine liver scaffold in clinical trials of two products we previously developed, commercialized and spun out, Miromesh® and Miroderm®.

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Recellularization.   Recellularization is the process of growing new functional organs starting with the ECM that remains after the decellularization process is completed. We currently use living human cells harvested from organ donors to re-seed the ECM, and in the future intend to develop new techniques using patient-derived stem cells. Living human cells are adaptive, and when introduced into the decellularized ECM display unique regenerative, plasticity, and adhesion properties. The process of recellularization occurs in a bioreactor where media and living human cells are perfused into the ECM in the appropriate sequence in order to facilitate cellular regeneration and organ functionality.

We hope to initiate our first Phase 1 clinical trial in late 2022 with our External Liver Assist Product (“ELAP System”), which we believe will be the first-ever study to assess the function of a bioengineered liver in humans. This study will utilize external liver assist devices in combination with our bioengineered

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livers to provide external temporary liver support to human participants with acute liver failure. We hope to report interim results in early 2023. We plan to engage the Food and Drug Administration (“FDA”) to open separate Investigational New Drug Applications (“IND”) for bioengineered livers and kidneys. We would then proceed with additional Phase 1 clinical studies with full transplants of our bioengineered livers and kidneys to treat participants with liver failure and end-stage renal disease, respectively. We could potentially begin these additional studies in late 2023 or early 2024.

We previously developed and commercialized two medical device products using our proprietary perfusion decellularization technology: Miromesh®, primarily utilized for hernia repair applications, and, Miroderm®, indicated for a variety of advanced wound care applications. Miromesh and Miroderm received 510(k) clearances in 2014 with Miroderm receiving an additional 510(k) clearance in 2015. In order to focus all of our efforts on bioengineered human organs, which we believe is a much larger opportunity, we spun out the commercial acellular business as Reprise Biomedical, Inc. (“Reprise”) in June 2019 and subsequently divested our minority ownership stake in March 2021. We are entitled to a 6.5% royalty for sales of acellular products by Reprise through 2028. Thousands of patients have been implanted with Miromesh and Miroderm, demonstrating the safety of the base porcine liver scaffold and our perfusion decellularization technology. We believe this real-world use helps de-risk the development of our bioengineered organs and will accelerate our clinical development timetable.

Our Market Opportunity — Lead Liver and Kidney Programs

We estimate the price of our bioengineered livers and kidneys to be between $350,000 – $750,000 based on our expectations for (i) high transplant success rates, (ii) significantly improved patient outcomes and quality of life over a period of many years, and (iii) substantial healthcare economic benefits. Transplantation is the only potentially curative therapy for end-stage liver disease (“ESLD”) and end‑stage renal disease (“ESRD”), as patients with total liver failure die and the only treatment for renal failure is dialysis.

Implantable Bioengineered Liver

According to 2018 data from the Centers for Disease Control (“CDC”), in the U.S. there are approximately 4.5 million adults diagnosed with chronic liver disease and the primary causes are alcohol, nonalcoholic steatohepatitis, and viral hepatitis. Liver disease is the 12th leading cause of death in the U.S. with 44,358 deaths in 2019, according to the CDC. There are only approximately 8,000 livers available for transplant in the U.S. annually.

We estimate an initial $8.8 billion annual market for our bioengineered livers in the U.S. based on a $350,000 selling price (low end of our estimated price range) and an initial addressable population of 25,000 patients annually with severe forms of liver disease that can be treated with a bioengineered liver, and that are not otherwise able to be treated with a transplant given the limited supply of livers available for transplant. Over time we believe that our bioengineered livers will expand into less severe forms of chronic liver disease that are progressing and potentially causing comorbidities but are not yet life threatening.

Implantable Bioengineered Kidney

ESRD, which is the final stage of chronic kidney disease and 9th leading cause of death in the United States, affects an estimated 100,000 people each year in the U.S. These patients join the over 550,000 patients in the U.S. that either require chronic dialysis or dialysis while waiting for a kidney transplant. In 2018, there were more than 100,000 patients on the kidney transplant waitlist in the U.S. but only 21,000 received a transplant.

Medicare spending for both chronic kidney disease and ESRD was over $114 billion in 2018, representing approximately 23% of total Medicare spending. A commercially available bioengineered kidney could save the healthcare system billions of dollars annually.

We estimate an initial $26.3 billion annual market in the U.S. for our bioengineered kidneys based on a $350,000 selling price (low end of our estimated price range) and an initial addressable population

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of 75,000 patients annually. Our initial addressable population is based on the current shortfall of waitlist kidneys, but we believe over time that we will expand into the broader dialysis population to improve patient quality of life. We believe this population of dialysis patients who opt for early transplant could be significant because the risk/benefit associated with our bioengineered kidney is potentially favorable. This is because our bioengineered kidneys are heterotopically implanted, and if the new graft is not successful the patient still has their existing organs and can continue dialysis for therapy.

Our Strengths

Our novel technology is supported by the following strengths, and driven by the expertise and vision of our experienced management team:

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Our Decellularization Technology is Used for Two FDA-Cleared Medical Device Tissue Products.   We previously commercialized and spun out two FDA 510(k) medical device tissue products using our perfusion decellularization technology, which we believe are informative as to the safety risks associated with our base organ scaffold. Thousands of patients have been implanted with these medical device products to date, some with implants now exceeding five years in duration. We believe this real-word safety evidence will benefit the development of our bioengineered organ programs, but since we are pursuing a marketing approval pathway that is different than a medical device we cannot be assured that the FDA will deem our organ scaffold to be safe and effective in a bioengineered organ with living cells.

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Our Recellularized Grafts Have Demonstrated Critical Organ Function.   Our preclinical studies have demonstrated patency and hepatocyte survival in heterotopic implants of our bioengineered livers in animal models and early function of our bioengineered kidneys in bench testing. In late 2020, we completed what we believe is the final major scientific milestone that was necessary to advance our first human study when we bioengineered livers with greater than 10 billion hepatocytes.

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Our Technology Harnesses the Powerful Evolutionary Biology Shaping Complex Organ Development.   We use a hybrid approach for bioengineering organs that we believe is superior to competing technologies and will yield organs with high functionality and similar immunogenicity comparable to the current standard of care in human organ transplantation. We leverage the similarities between porcine and human organs to create a decellularized scaffold from a porcine organ and repopulate it with organ-specific human cells. We believe living human cells are functionally superior to cells produced by extensively modifying the pig genome, and significantly reduce the risk of severe immune reactions and organ rejection.

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Scalable, Multi-Organ Technology.   Our processes and technology are modular, and we believe scalable with increased square footage and additional qualified manufacturing technicians. In addition to livers and kidneys, we also believe our technology platform can be utilized to bioengineer lungs, pancreas, hearts, and potentially other internal organs or vascularized tissues.

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Pursuing an Efficient Regulatory Pathway.   The regulatory process associated with xenotransplantation requires extensive preclinical testing, safety studies, and long-term patient monitoring and follow-up. We do not believe our bioengineered organs will be classified as xenotransplants and believe they will be classified as biologics or potentially combination products, and we believe that either classification will lead to a more efficient regulatory pathway than if they were to be classified as xenotransplants. The FDA defines xenotransplantation as any procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. The guidance also specifically states that xenotransplantation does not include transplantation, implantation, or other use of acellular animal tissues. During our decellularization process we remove all animal cells and the acellular scaffold is recellularized with living human cells, which we believe will lead regulators to determine that our bioengineered organs are not xenotransplants. However, neither the FDA nor any other regulator has provided us with feedback indicating what classification our product candicates will be classified as. Further, as

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part of our regulatory pathway we will need to seek an exemption from the FDA for the cGTP prohibition against pooling cells from two or more donors during manufacturing.

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We Are Targeting an Established Market in Need of More Organs.   The organ transplant market is mature and the infrastructure today for transporting organs, transplanting organs, and caring for transplant patients can support more procedures, but the limiting factor is the availability of donor organs. This year there are over 110,000 patients on the organ transplant waiting list, and by the end of the year, as many as 70,000 patients in the U.S. who were prescreened and listed for an organ, will still not have received one.

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Potential Cost-Savings to Healthcare Systems.   We believe our bioengineered organs will eventually help the healthcare system realize billions of cost savings annually. For example, according to the American Journal of Transplantation, an estimated $1.5 million dollars is saved by the health care system for each kidney transplant compared to hemodialysis therapy.

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Collaborations with World-Class Medical Institutions.   We have active collaboration and pre-clinical research programs with the Mayo Clinic, Mount Sinai and the Texas Heart Institute. These organizations are highly regarded in the field of transplantation and regenerative medicine with significant resources.

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Robust IP Portfolio Including Foundational Patents.   We have 118 issued patents worldwide, with seven issued patents in the U.S. market covering our core technology and applications, which are expected to expire from about 2026 through about 2036 without taking into account any possible extensions. In addition, we have over 35 patent applications at various stages.

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Experienced Leaders and Talented Workforce.   Our management includes experienced leaders with demonstrated records of success at Miromatrix and other highly regarded industry participants. We believe the quality of our team positions us well to execute on our mission and commercialize our bioengineered organs.

Our Growth Strategy

Our goal is to develop high-quality bioengineered organs and be first to market with an alternative to organ donation. The key elements of our strategy include:

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Build upon our strong technology position

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Advance clinical development of our lead bioengineered kidney and liver products

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Expand our organ development pipeline

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Form and grow our collaborations and partnerships

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Maintain excellence in manufacturing and quality control

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Scale our teams and facilities to meet future demands

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Expand our IP portfolio

Clinical Development Strategy

We believe that our bioengineered organs have the potential for significant functional and immunological advantages compared to other emerging technologies for bioengineering organs. Importantly, we believe regulators will likely determine that our bioengineered organs will not be considered xenotransplants because all animal cells are removed and the organ is re-seeded with living human cells, and we believe this will shorten our regulatory pathway and overall development timetable.

We have approached our clinical development in a stepwise manner and are building towards our first human study with our implanted bioengineered human organ:

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Our first step was to demonstrate our decellularization technology and the ability to reproducibly create acellular organ matrices devoid of cellular and other unwanted biologic materials, which was completed when we launched Miromesh and Miroderm;

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Our next step is to demonstrate function of our bioengineered organs in humans. We believe it is important to first demonstrate this function outside of the patient’s body, and if successful it will expedite our clinical pathway to full organ transplantation. We are intending to file an IND submission in late 2022 for the use of our ELAP System to treat acute liver failure. Currently there are no approved device or pharmacological interventions for acute liver failure and approximately 30% of adults with this disease die within seven days of presenting. We are hopeful that the FDA will agree to a pathway for our ELAP System that will result in us being able to begin this study soon given the great unmet medical need and because our bioengineered livers will be used outside the body (potentially lowers risk to the patient);

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We intend to use the data from our first human study using the ELAP System, as well as additional preclinical data we intend to generate, to file INDs and begin Phase 1 studies for transplant of our bioengineered livers and kidneys in humans, which could potentially begin in late 2023 or early 2024.

We believe FDA registrational trials for conditional marketing approval of our bioengineered organs will be manageable in size with 100 patients or less and for ethical reasons will not include a control group. In the case of an orthotopic liver transplant, the clinical efficacy endpoint will be measured based on the survival of patients, who will be in the advanced stages of liver disease and will need a functioning liver to survive. Similarly, the endpoint in a heterotopic kidney implant will be measured by whether or not the patient requires continued hemodialysis, and as such, results will be known soon after the procedures.

Risks Associated with Our Business

Our business is subject to numerous risks, as more fully described in the section titled “Risk Factors” immediately following this prospectus summary. You should read these risks before you invest in our common stock. In particular, risks associated with our business include, but are not limited to, the following:

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we have incurred significant net losses since inception and we expect to incur net losses in the future;

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the development and commercialization of biopharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the FDA are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis if at all, our business will be substantially harmed;

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we currently do not have, and may never develop, any FDA-approved, licensed or commercialized products and we may never be able to commercialize our technology. Our business depends entirely on the successful development of our product candidates, which are still in the pre-clinical phase of development and have never been tested on humans, with our recellularized kidney product candidate having only been subject to bench testing;

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we may experience delays in commencing and successfully completing our clinical trials;

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if we are able to commercialize any of our product candidates, their commercial success will largely depend upon attaining significant market acceptance;

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our current product candidates utilize biological components obtained from animals that could prevent or restrict the development and commercialization of those product candidates;

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our product candidates may be considered combination products, which may result in additional regulatory and other risks;

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if we are unable to obtain and maintain patent and other intellectual property protection for any of our new organ candidates we develop, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop may be adversely affected;

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current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain;

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even if we are able to commercialize any product candidate, coverage and adequate reimbursement may not be available or such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business;

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we may not be able to scale our manufacturing to support our future plans;

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the sizes of the markets for our future products may be smaller than we estimate. Our results of operations could be materially harmed if we are unable to accurately forecast addressable markets for our product candidates and manage our inventory;

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we have limited cash resources and will likely require additional financing to achieve commercialization of our products;

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we currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate future product revenue; and

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our business may be adversely affected by global health epidemics, including the COVID-19 pandemic.

Recent Developments

On May 3, 2021, we entered into a stock purchase agreement with certain investors (together, the “Investors”), under which we agreed to sell an aggregate of 2,666,667 shares of Series C Convertible Preferred Stock to the Investors, at a price per share of $7.50, for an aggregate purchase price, before fees and expenses, of $20.0 million (the “Private Placement”). The Private Placement closed on May 21, 2021. As part of the Private Placement, we sold 2,000,000 shares of Series C Preferred Stock to Baxter Healthcare Corporation, an affiliate of Baxter International Inc. (“Baxter”), for an aggregate purchase price of $15.0 million and 666,667 shares of Series C Preferred Stock to CareDx, Inc. (“CareDx”) for an aggregate purchase price of approximately $5.0 million. In connection with the Private Placement, we also entered into a side letter with each of the Investors, which provide customary piggyback and demand registration rights. See “Description of Capital Stock — Registration Rights” for a further description of such registration rights.

On May 21, 2021, we agreed with CareDx to collaborate on certain research and development activities using CareDx technology.

Baxter is a leading global medical products company that specializes in the treatment of kidney disease, among other chronic and acute medical conditions. CareDx is a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

Corporate Information

We were incorporated in Delaware in 2009. Our principal executive offices are located at 10399 West 70th Street, Eden Prairie, MN 55344, and our telephone number is (952) 942-6000. Our website address is www.miromatrix.com. The information contained on, or accessible through, our website is not incorporated by reference into this prospectus, and you should not consider any information contained in, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our common stock.

Implications of Being an Emerging Growth Company

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, as amended. We will remain an emerging growth company until the earliest to occur of: the last

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day of the fiscal year in which we have more than $1.07 billion in annual revenue; the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; the issuance, in any three-year period, by us of more than $1 billion in non-convertible debt securities; and the last day of the fiscal year ending after the fifth anniversary of our initial public offering. We refer to the Jumpstart Our Business Startups Act of 2012 herein as the “JOBS Act,” and any reference herein to “emerging growth company” has the meaning ascribed to it in the JOBS Act.

As an emerging growth company, we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

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being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

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not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended;

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reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We have elected to take advantage of certain of the reduced disclosure obligations in this prospectus and may elect to take advantage of other reduced reporting requirements in our future filings with the U.S. Securities and Exchange Commission, (the “SEC”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have elected to avail ourselves of this exemption. As a result of these elections the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

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THE OFFERING

Common stock offered by us

       shares

Common stock to be outstanding immediately after this offering

       shares (        shares if the underwriter exercises its option to purchase additional shares)

Underwriter’s option to purchase additional shares

       shares

Use of proceeds

We estimate that the net proceeds from this offering will be approximately $      million (or approximately $      million if the underwriter exercises in full its option to purchase up to          additional shares of common stock), based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We currently intend to use the net proceeds from this offering for: (i) research and development activities, which may include clinical trials for our bioengineered organs, (ii) expenditures related to a new facility, (iii) repayment of the Cheshire Note to the extent not converted prior to the completion of this offering and (iv) the remaining funds, if any, for working capital and general corporate purposes.

See “Use of Proceeds” for additional information.

Risk factors

You should read the section titled “Risk Factors” for a discussion of factors to consider carefully, together with all the other information included in this prospectus, before deciding to invest in our common stock.

Proposed Nasdaq Capital Market
symbol

“MIRO”

The number of shares of our common stock to be outstanding immediately after this offering is based on 10,605,358 shares of common stock outstanding as of March 31, 2021, after giving effect to the automatic conversion of all our convertible preferred stock into an aggregate of 8,314,536 shares of our common stock immediately prior to the completion of this offering and excludes:

•

3,552,505 shares of our common stock issuable upon the exercise of stock options as of March 31, 2021, at a weighted-average exercise price of $3.21 per share;

•

564,191 shares of our common stock issuable upon the exercise of warrants as of March 31, 2021; and

•

559,500 shares of our common stock that remain available for issuance as of March 31, 2021 under our 2019 Plan.

Unless otherwise indicated, all information contained in this prospectus assumes or gives effect to:

•

the automatic conversion of all our preferred stock outstanding into an aggregate of       shares of our common stock immediately prior to the completion based on an assumed initial offering price of $      per share, which is the midpoint of the price range shown on the cover page of this prospectus;

•

such automatic conversion includes       shares of common stock our Series C Preferred stockholders (“Series C Holders”) will receive upon the automatic conversion, based on an

8

assumed initial offering price of $     per share, which is the midpoint of the price range shown on the cover page of this prospectus. The number of shares such Series C Holders will receive upon automatic conversion is calculated by multiplying the assumed initial offering price by 80% and dividing such price by $20.0 million, which is the aggregate price the issued and outstanding Series C Preferred Stock were purchased for. A $1.00 increase in the assumed initial public offering price would decrease the number of shares of common stock the Series C Holders would receive     by and a $1.00 decrease in the assumed initial public offering price would increase the number of shares of common stock the Series C Holders would receive by       ;    

•

such automatic conversion also includes       shares of common stock our Series A, B and B-2 Preferred stockholders (“Non-Series C Holders”) will receive upon the automatic conversion, based on an assumed initial offering price of $     per share, which is the midpoint of the price range shown on the cover page of this prospectus. The number of shares such Non-Series C Holders will receive is based upon a 1:1 conversion ratio. A $1.00 increase or decrease in the assumed initial public offering price would not effect on the number of shares that Non-Series C Holders would receive;

•

no exercise of the outstanding options or warrants described above; and

•

no exercise by the underwriter of its (i) option to purchase up to                 additional shares of our common stock or (ii) the warrants to purchase shares of our common stock at an exercise price per share equal to 110% of the initial public offering price per share or $      , based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, that will be issued to the underwriter in connection with this offering (the “Underwriter’s Warrants”).

9

SUMMARY FINANCIAL DATA

The following tables set forth our summary statements of operations data for the years ended December 31, 2020 and 2019, which we have derived from the financial data from our audited financial statements included elsewhere in this prospectus. The summary statements of operations data for the three months ended March 31, 2021 and 2020 and the summary balance sheet data as of March 31, 2021 are derived from our unaudited interim financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. The following summary financial data should be read with the sections titled “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus.

​

Year ended December 31,

Three Months Ended March 31,

​

2019

2020

2020

2021

Statement of Operations:

​

​

​

​

​

​

​

​

​

​

​

​

Licensing revenue

​

$

250,000

​

$

46,530

​

$

11,088

​

$

6,108

Cost of goods sold

​

​

250,000

​

​

500,000

​

​

125,000

​

​

125,000

Gross margin

​

​

—

​

​

(453,470)

​

​

(113,912)

​

​

(118,892)

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

Research and development

​

​

6,266,670

​

​

7,280,798

​

​

1,801,378

​

​

1,868,001

Regulatory and clinical

​

​

289,020

​

​

265,885

​

​

73,106

​

​

83,705

Quality

​

​

—

​

​

149,199

​

​

—

​

​

85,787

General and administrative

​

​

2,435,974

​

​

2,109,196

​

​

465,663

​

​

562,874

Total operating expenses

​

​

8,991,664

​

​

9,805,078

​

​

2,340,147

​

​

2,600,367

Operating loss from continuing operations

​

​

(8,991,664)

​

​

(10,258,548)

​

​

(2,454,059)

​

​

(2,719,259)

Other income (expense):

​

​

​

​

​

​

​

​

​

​

​

​

Interest income

​

​

106,428

​

​

8,733

​

​

5,863

​

​

40

Interest expense

​

​

(48,385)

​

​

(656,552)

​

​

(37,175)

​

​

(305,374)

Amortization of discount on note

​

​

—

​

​

(108,620)

​

​

(10,862)

​

​

(32,586)

Change in fair value of derivative

​

​

—

​

​

(51,446)

​

​

—

​

​

193,971

Research grants

​

​

431,880

​

​

992,144

​

​

180,000

​

​

150,537

Loss from continuing operations

​

​

(8,501,741)

​

​

(10,074,289)

​

​

(2,316,233)

​

​

(2,712,671)

Gain on equity investment

​

​

4,495,500

​

​

—

​

​

—

​

​

—

Equity loss in affiliate

​

​

(1,025,000)

​

​

(2,358,392)

​

​

(640,000)

​

​

(223,633)

Gain on sale of equity investment

​

​

—

​

​

2,123,113

​

​

—

​

​

1,983,912

Gain on debt extinguishment

​

​

—

​

​

—

​

​

—

​

​

518,050

Gain on disposal of discontinued operations

​

​

1,802,555

​

​

—

​

​

—

​

​

—

Loss from discontinued operations

​

​

(818,113)

​

​

—

​

​

—

​

​

—

Net loss

​

$

(4,046,799)

​

$

(10,309,568)

​

$

(2,956,233)

​

$

(434,342)

Net loss per common share

​

​

​

​

​

​

​

​

​

​

​

​

Basic and diluted

​

$

(1.98)

​

$

(4.76)

​

$

(1.40)

​

$

(0.19)

Weighted average common shares outstanding, basic and diluted

​

​

2,043,356

​

​

2,165,105

​

​

2,108,981

​

​

2,255,378

Pro forma net loss per common share basic and diluted (unaudited)

​

​

​

​

$

(0.98)

​

​

​

​

$

(0.04)

10

​	Year ended December 31,			Three Months Ended March 31,
​	2019	2020		2020	2021
Pro forma weighted average shares outstanding, basic and diluted (unaudited)	​	​	10,479,641	​	​	10,569,914

​	As of March 31, 2021
​	Actual			Pro Forma(2)	Pro Forma As Adjusted(3)(4)
Balance Sheet Data:	​	​	​	​	​
Cash and cash equivalents	​	$	4,263,528	​	​
Working capital (deficit)(1)	​	​	(3,538,077)	​	​
Total assets	​	​	5,364,528	​	​
Total liabilities	​	​	10,009,372	​	​
Convertible preferred stock	​	​	46,661,490	​	​
Total stockholders’ deficit	​	​	(51,306,334)	​	​

(1)

Working capital is calculated as current assets minus current liabilities.

(2)

The pro forma balance sheet gives effect to the automatic conversion of all our preferred stock outstanding into an aggregate of         shares of our common stock immediately prior to the completion of this offering based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

(3)

Reflects the pro forma adjustments set forth above and the issuance and sale of shares of                 shares of common stock in this offering at an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(4)

Each $1.00 increase (decrease) in the assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) each of cash and cash equivalents, working capital, total assets and total stockholders’ (deficit) equity, by $      million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1,000,000 shares in the number of shares of common stock offered by us would increase (decrease) each of cash and cash equivalents, working capital, total assets and total stockholders’ (deficit) equity, by $      million, assuming the assumed initial public offering price of $      per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

11

RISK FACTORS

Investing in our common stock involves a high degree of risk. These risks include, but are not limited to, those described below, each of which may be relevant to an investment decision. You should carefully consider the risks described below, together with all of the other information in this prospectus, including our financial statements and related notes, before investing in our common stock. While we believe that the risks and uncertainties described below are the material risks facing our business, additional risks that we do not know of or that we currently think are immaterial may also arise and materially affect our business. The realization of any of these risks could have a material adverse effect on our business, financial condition, results of operations, and our ability to accomplish our strategic objectives. In that event, the trading price of our common stock could decline, and you may lose part or all of your investment.

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

We have incurred significant net losses since inception and we expect to incur net losses in the future.

We have incurred significant net losses since our incorporation and expect to incur losses for the foreseeable future. We continue to incur significant research and development and other expenses related to our ongoing operations. For the years ended December 31, 2019 and 2020, we had net losses of $4.0 million and $10.3 million, respectively, and $3.0 million and $0.4 million for the three months ended March 31, 2020 and 2021, respectively. As of March 31, 2021, we had an accumulated deficit of $59.8 million. We have devoted substantially all of our resources and efforts to research and development and we expect that it will be many years before we generate revenue from product sales from our whole organ program, and we may never generate revenue. Even if we receive marketing approval for and commercialize one or more of our whole organ product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to develop and market additional potential product candidates, and as a result, we may never achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on an ongoing basis. If we do achieve or sustain profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives, either of which would have a material adverse effect on our business, financial condition and results of operations and may cause the market price of our common stock to decline.

We have a limited operating history, which may make it difficult to evaluate our prospects.

We are a life science company with a limited operating history. Although we previously commercialized the Miromesh and Miroderm products in 2014 and 2015, respectively, we do not have a long history as a company with commercialized products. We are now focusing our research and development efforts on our whole organ programs. We have not yet submitted a Biologics License Application (“BLA”) for approval, nor an IND to begin investigational studies on humans, and further we have not yet achieved approval for commercial sale for any whole organ product candidate. As a result, we have no meaningful history of operations upon which to evaluate our business, and predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing products that are comparable to our historical product candidates. Investing in biologic product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate an adequate safety, purity and potency profile, gain regulatory approval and become commercially viable. We do not know whether we will be able to achieve approval for or commercialize any of our whole organ or other product candidates. All of our current and future product candidates, if any, will require substantial additional development, clinical research time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales, if we are able to generate revenue at all. As a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage life science companies in rapidly evolving fields.

12

We have limited cash resources and will likely require additional financing to achieve commercialization of our products.

We believe that in order to be successful, we must grow and expand our operations. We will likely require substantial additional capital in the future to further our research and development efforts and other operating activities to develop products that can be commercialized to generate revenue. Delays in obtaining additional funding could adversely affect our ability to move forward with additional studies.

We have historically relied upon proceeds from the private placements of our equity securities to fund our business and operations. In the future, we may seek additional capital through a combination of private and public equity offerings, debt financings and strategic collaborations. If we raise additional funds through the issuance of equity or debt securities, the percentage ownership of our stockholders could be significantly diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us.

Our ability to obtain additional financing will be subject to many factors, including market conditions, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates, restrict our operations or obtain funds by entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, financial condition, results of operations and may cause the market price of our common stock to decline.

The report of our independent registered public accounting firm includes a “going concern” explanatory paragraph.

The report of our independent registered public accounting firm on our consolidated financial statements as of and for the year ended December 31, 2020 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern. If we are unable to raise sufficient capital in this offering or otherwise when needed, our business, financial condition and results of operations will be materially and adversely affected, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our consolidated financial statements. The inclusion of a going concern explanatory paragraph by our auditors, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties.

Risks Related to the Development and Commercialization of our Products

We currently do not have, and may never develop, any FDA-approved, licensed or commercialized products and we may never be able to commercialize our technology. Our business depends entirely on the successful development of our product candidates, which are still in the pre-clinical phase of development and have never been tested on humans, with our recellularized kidney product candidates having only been subject to bench testing.

We do not currently have any FDA-approved, licensed or commercialized products. We have not yet sought regulatory approvals for any of our whole organ product candidates in the United States or in any foreign market. Our lead product candidates are still in pre-clinical development and have never been tested in humans, with our recellularized kidney product candidate having only been subject to bench testing. Our interpretation of data and results from the studies we have completed to date do not

13

ensure that we will be able to initiate human clinical trials or achieve positive results in future clinical trials. In addition, pre-clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in pre-clinical studies have nonetheless failed to replicate results in clinical trials. Significant additional research and development activity and clinical testing are required before we will have a chance to achieve a viable product for commercialization from such candidates. Our research and development efforts remain subject to all the risks associated with the development of new biopharmaceutical products and treatments, including but not limited to unanticipated technical or other problems and the possible insufficiency of funds needed in order to complete development of these product candidates. As further described below, safety, regulatory and efficacy issues, clinical hurdles or other challenges may result in delays and cause us to incur additional expenses that would increase our losses. If we cannot complete, or if we experience significant delays in developing, our products for use in potential commercial applications, particularly after incurring significant expenditures, our business may fail, and investors may lose the entirety of their investment.

Moreover, our business currently depends entirely on the successful development, regulatory approval, and licensing or commercialization of our product candidates, which is subject to various risks more fully described below, and may never occur. To develop any products that might be licensed or commercialized in the future, we will have to invest further time and capital in research and product development, regulatory compliance and market development, and we may never develop any additional products that can be approved, licensed or commercialized. Further, although we have achieved significant milestones with regards to our bioengineered kidney and liver, we still need to complete additional research and development in order to have products that are ready to be used as organ transplants in human clinical trials. Most biologic candidates never reach the clinical development stage and even those that do commence clinical development have only a small chance of successfully completing clinical development and gaining regulatory approval.

The successful discovery, development, manufacturing, and sale of biologics is a long, expensive, and uncertain process and carries unique risks and uncertainties.

The successful development, manufacturing, and sale of biologics is a long, expensive, and uncertain process and the process has unique risks and uncertainties. We are not permitted to market our product candidates in the United States until we receive approval of a BLA from the FDA, or in any foreign countries until we receive the requisite approval from such countries. Biological products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. For example, access to and supply of necessary biological materials, such as cell lines, may be limited and governmental regulations restrict access to and govern the transport and use of such materials. In addition, the testing, development, approval, manufacturing, distribution, and sale of biologics is subject to applicable provisions of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), the Public Health Service Act (“PHSA”) and regulations issued thereunder that are often more complex and extensive than the regulations applicable to other pharmaceutical products or to medical devices. Manufacturing biologics, especially in large quantities, is often complicated and may require the use of innovative technologies. Such manufacturing also requires specifically designed and validated facilities and sophisticated quality assurance and quality control procedures. Biologics are also frequently costly to manufacture because production inputs are derived from living animal or plant material, and some biologics cannot be made synthetically. Failure to successfully discover, develop, manufacture, and sell biologics could adversely impact our business, operating results, and financial condition.

Further, to successfully commercialize our product candidates, we also will be required to expand, train and manage our employee base, particularly skilled technical, management and marketing personnel within a short time period. We will also be required to scale our manufacturing capabilities, and eventually, once our product candidates are cleared for commercial use, our sales and marketing capabilities. Rapid growth also would require an increase in the level of responsibility for both existing and new management and would require us to implement and improve operational, financial and management information procedures and controls. Our inability to adequately manage growth could have a material adverse effect on our business and prospects.

14

We may experience delays in commencing and successfully completing our clinical trials.

We may experience delays in initiating our clinical trials, which could significantly increase our product development costs and delay product commercialization. The commencement of clinical trials may be delayed for a variety of reasons, including the delays in:

•

demonstrating sufficient safety, purity and potency to be permitted to commence a clinical trial;

•

developing a stable formulation of a product candidate;

•

manufacturing sufficient quantities of a product candidate;

•

securing and maintaining relationships with third parties for preclinical and clinical development studies;

•

our or third-party compliance with good clinical practices (“GCPs”) and current Good Tissue Practices (“cGTPs”);

•

obtaining institutional review board approval to conduct a clinical trial at a prospective site;

•

being permitted by the FDA or other regulatory authorities to initiate our clinical trials due to questions regarding the scope or design of our clinical trials,

•

imposition of a clinical hold as a result of inspection of the clinical operations or study sites or nonclinical or clinical safety operations; and

•

funding shortages or other disruptions within the FDA and other regulatory agencies that affect their ability to perform routine functions and review biologics.

In addition, because our bioengineered liver will contain human cells from more than one donor, if we are unable to obtain an exemption from the FDA for the cGTP prohibition against pooling cells from two or more donors during manufacturing, we would be unable to initiate clinical trials of our bioengineered liver. Further, given that our clinical trials will be conducted with patients in advanced disease states, there is a risk that unexpected deaths could halt the clinical trial process. Even if we are able to commence clinical trials and our initial clinical trials are successful, we are required to conduct additional clinical trials to establish our product candidates’ safety, purity and potency before submitting a BLA. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates. Moreover, there is no guarantee that our clinical trials will be successful or that we will continue clinical development in support of such approvals.

Our current product candidates utilize biological components obtained from animals that could prevent or restrict the development and commercialization of those product candidates.

Our current product candidates use biological components obtained from animals, including our decellularized porcine scaffold. As a result, our product candidates could be deemed to involve xenotransplantation (transplantation from animals to humans). No xenotransplantation clinical trials have occurred to date and based on FDA guidance as of the date of this prospectus, we believe the regulatory approval process for xenotransplantation would be extremely complex and difficult. There are also regulatory and safety concerns surrounding the risk of infectious agents and possible transmission to the general population through xenotransplantation. Although we believe our technology overcomes the primary challenges associated with genetically modified xenotransplants, mainly because our product candidates are revascularized using living human cells as opposed to genetically modifying the genome of a pig, the FDA and other regulatory authorities may find our product candidates are xenotransplants and are thus subject to regulations and other laws regarding xenotransplantation. The additional regulations governing xenotransplantation could delay or prevent our ability to receive regulatory approval or commercialize our product candidates.

15

Our product candidates may be considered combination products, which may result in additional regulatory and other risks.

The FDA may view a bioengineered organ as a combination product comprised of a human cell, tissue, and cellular and tissue-based product (“HCT/P”) and a medical device. In this case, each component of the product candidate would be subject to FDA requirements for that type of component. As a result, FDA approval of a product candidate classified as a combination product may require multiple marketing applications, such application determination determined on a case-by-case basis. Although a single marketing application may be sufficient for the approval of a combination product, the FDA may determine that separate marketing applications are necessary. If we are required to submit multiple marketing applications, we could experience delays due to regulatory timing constraints and uncertainties in the product development and approval process, as well as coordination between two different centers within the FDA responsible for review of the different components of the combination product.

If we encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Even if we are permitted to begin clinical trials, we may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols will depend, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:

•

the patient eligibility and exclusion criteria defined in the protocol;

•

the willingness or availability (including legality under applicable COVID-19 regulations, if applicable) of patients to participate in our trials;

•

the size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients;

•

the proximity of patients to trial sites;

•

our ability to recruit clinical trial investigators with the appropriate competencies and experience;

•

the design of the trial;

•

clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating;

•

the availability of competing commercially available therapies and other competing product candidates’ clinical trials; and

•

the risk that patients enrolled in clinical trials will drop out of the trials before completion whether due to medical complications from advance disease states or otherwise.

We may encounter difficulties enrolling subjects in our future clinical trials due, in part, to defined inclusion and exclusion criteria, effect on their transplant list status, and reluctance to try an unproven therapy, among others. Additionally, any future clinical trials for our organ program will necessarily involve major surgeries, which some members of the relevant patient populations may be hesitant to undertake.

If we are unable to enroll patients in any clinical trials we conduct in the future, in accordance with our planned timelines, it could constitute a significant setback to our product development and path to commercializing our product candidates.

We may be unable to process organ products in quantities sufficient for clinical trials or a commercial launch.

We may encounter difficulties in producing our organ products. Processing of tissue and organs involves strict adherence to complex manufacturing and storage protocols and procedures. Future difficulties may arise which limit our production capability and delay progress in our clinical trials.

16

Moreover, we have no current experience in manufacturing our fully recellularized whole organs for human patients and we are not aware of any party that manufactures products similar to ours. As a result, if we are not able to successfully manufacture our products, it would have a material adverse effect on our business and cause us to cease operations.

Our supply of raw materials for use in preclinical activities and manufacturing our product candidates may be vulnerable to disruption.

Our process includes cellular and acellular components. Disruptions from suppliers for the starting porcine materials, decellularization chemicals, cell culture media, cell culture supplies, laboratory supplies, cell culture media components, release testing analytical components or other raw materials utilized in our development and manufacturing could constitute a significant setback to our product development and path to commercializing our product candidates.

Even if we obtain approval of our product candidates, our biologic products may be subject to competition from biosimilars. Further, we may be unable to compete successfully with larger competitors in our highly competitive industries.

Even if we are able to successfully develop biologics in the future, the Biologics Price Competition and Innovation Act, (“BPCIA”), created a framework for the approval of biosimilars in the United States that could allow competitors to reference data from any future biologic products for which we receive marketing approvals and otherwise increase the risk that any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

In addition, there is a risk that any of our product candidates regulated as a biologic and licensed under a full BLA, would not qualify for FDA exclusivity or that such exclusivity could be shortened due to congressional action or otherwise, potentially creating the opportunity for competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

In Europe, the European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In addition, companies are developing biosimilars in other countries that could compete with any biologic products that we develop. If competitors are able to obtain marketing approval for biosimilars referencing any biologic products that we develop, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

While we are not aware of any other company developing bioengineered whole organs based on perfusion decellularization and recellularization, we believe our technology will compete with other technologies including xenografts, immersion decellularization, 3D printing and direct implantation of animal organs, as well as other therapeutic (i.e., non-transplant) options for the indications which we attempt to address. Certain companies with these products and technologies are significantly larger than us and have much greater financial, marketing and other resources than we do. Accordingly, we may not be able to compete successfully against existing or new competitors which would have a material adverse effect on our business.

Our competitors with greater financial resources could also acquire other companies to gain enhanced name recognition and market share, as well as new technologies or products that could effectively compete with our future products, which may harm our business. Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, our product candidates. Because of the complex and technical nature of our product candidates and the dynamic markets in which we will compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our ability to develop and commercialize our products, which would have a material adverse effect on our business, financial condition and results of operations. See “Business — Competition.”

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While we are not aware of any other company developing bioengineered whole organs based on perfusion decellularization and recellularization, we believe our technology will compete with other technologies including xenografts, immersion decellularization, 3D printing and direct implantation of animal organs, as well as other therapeutic (i.e., non-transplant) options for the indications which we attempt to address. See “Business — Competition.” If we are unable to compete successfully with these alternative companies or technologies, our results will suffer.

Moreover, the biologics industry is characterized by rapid and significant change. There can be no assurance that other companies will not succeed in developing or marketing devices and products that are more effective than any products that we may offer in the future or that would render any such products obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our future products. Accordingly, our success will depend in part on our ability to respond quickly to medical and other changes through the development and introduction of new products. Product development involves a high degree of risk, and there can be no assurance that our new product development efforts will result in any commercially successful products.

If we are able to commercialize any of our product candidates, their commercial success will largely depend upon attaining significant market acceptance.

Even if we are able to receive regulatory approval for one or more of our product candidates, our ability to execute our growth strategy, achieve commercial success and become profitable will depend upon the adoption by hospitals, surgeons and patients of our bioengineered organs. We cannot predict how quickly, if at all, our products will be accepted or, if accepted, how frequently they will be used. Our bioengineered organs may never gain broad market acceptance among the medical community for some or all of our indications. The market for regenerative medicine technology is relatively new, subject to rapid innovation and remains uncertain. Further, our perfusion technology is a new approach for processing and developing organs. The degree of market acceptance of any of our products will depend on a number of factors, including:

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the prevalence and severity of any complications associated with our products;

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the competitive pricing of our products;

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the quality of our products meeting patient and surgeon expectations;

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the results of clinical trials and post-market clinical studies relating to the use of our products; and

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our ability to provide incremental clinical and economic data that show the safety, clinical efficacy and cost effectiveness, and patient benefits from, our products.

Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations. Further, if we cannot build and maintain strong working relationships with these professionals and seek their advice and input on our product candidates, the development and marketing of our future products could suffer, which could have a material adverse effect on our business, financial condition and results of operations.

We rely on third parties to conduct certain preclinical development activities and will rely on third parties for certain clinical development activities.

We rely on third parties to conduct certain preclinical development activities and we intend, in the future, to rely on third parties to conduct any clinical trials we undertake. We may not be able to secure and maintain relationships with these third parties for preclinical and clinical development studies on acceptable terms and our reliance on these third parties reduces our control over these activities. We are responsible for ensuring that each of our preclinical development activities and our clinical trials are conducted in accordance with the applicable U.S. federal and state laws and foreign regulations, general investigational plan and protocols. However, other than any contracts with these third parties, we have no direct control over these researchers or contractors, as they are not our employees. Moreover, the FDA

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requires us to comply with standards, commonly referred to as GCP, for conducting, recording and reporting the results of our preclinical and clinical trials to assure that data and reported results are credible and accurate and that the rights, safety and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. These third parties also may have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical development activities or our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our products and will not be able to, or may be delayed in our efforts to, successfully commercialize our products. These third parties may be subject to various types of sanctions by the FDA or other government or regulatory authorities for failing to meet the applicable requirements imposed on such third parties. As a result, the third parties may not be able to fulfill their contractual obligations, and the results obtained from such third parties regarding preclinical and clinical research may not be accepted by the FDA to support the marketing approval of our product candidates. If the third parties or their employees become debarred by the FDA, we cannot use the research data derived from their services to support the marketing approval of our products. Finally, these third parties may be acquired by other entities, change their business plans or strategies or go out of business, thereby preventing them from meeting their contractual obligations to us. Our success depends on conducting preclinical and clinical trials successfully through commercialization, and therefore, any failure by a third party in this regard would have a material adverse effect on our business.

Risks Related to Intellectual Property and Information Technology Matters

If we are unable to obtain and maintain patent and other intellectual property protection for any of our new organ candidates we develop, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop may be adversely affected.

Our commercial success will depend in large part on our ability to obtain and maintain patent, trademark, trade secret and other intellectual property protection of our new organ candidates and other technology, methods used to manufacture them and methods of treatment, as well as successfully defending our patent and other intellectual property rights against third-party challenges. It is difficult and costly to protect and enforce intellectual property rights, and we may not be able to ensure the same for every product. Our ability to stop unauthorized third parties from making, using, selling, offering to sell, importing or otherwise commercializing our new organ candidates is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

We seek to protect our proprietary position by developing a comprehensive intellectual property portfolio including filing patent applications and obtaining granted patents in the United States and abroad related to our new organ candidates that are important to our business. If we are unable to obtain or maintain patent protection with respect to a product candidate we may develop, or if the scope of the patent protection secured is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours and our ability to commercialize that product candidate may be adversely affected.

The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior

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art allow our inventions to be patentable over the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent position of biotechnology companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are uncertain and we may become involved in complex and costly litigation. Our pending and future patent applications may not result in patents being issued which protect new organ candidates or effectively prevent others from commercializing competitive technologies and new organ candidates.

We also cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will be valid and enforceable and provide sufficient protection from competitors. Any patents that we own or in-license may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether any new organ candidates we may develop will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.

In addition, given the amount of time required for the development, testing, and regulatory review of new organ candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Moreover, some of our owned patents and patent applications may in the future be, co-owned by us with third parties. If we are unable to obtain an exclusive license to such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

Our patents and patent applications contain claims directed to new organ candidates, as well as methods directed to making new organ candidates, intermediates in the making of new organ candidates, the use of such new organ candidates, and other technologies. Method-of-use patents do not prevent a competitor or other third party from developing or marketing an identical product for an indication that is outside the scope of the patented method. Moreover, with respect to method-of-use patents, even if competitors or other third parties do not actively promote their product for our eventual targeted indications or uses for which we may obtain patents, providers may recommend that patients use these products off-label, or patients may do so themselves.

The strength of patents in the biotechnology field involves complex legal and scientific questions and can be uncertain. The patent applications that we own may fail to result in issued patents with claims that cover our new organ candidates or uses thereof in the United States or in other foreign countries. For example, while our patent applications are pending, we may be subject to a third-party pre-issuance submission of prior art to the United States Patent and Trademark Office, or USPTO, or become involved in interference or derivation proceedings, or equivalent proceedings in foreign jurisdictions. Even if patents do successfully issue, third parties may challenge their inventorship, validity, enforceability or scope, including through opposition, revocation, reexamination, post-grant and inter partes review proceedings. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable certain patent rights, allow third parties to commercialize our technology or new organ candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as

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oppositions in a foreign patent office, that challenge features of patentability with respect to one or more patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and new organ candidates. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. If the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, our new organ candidates. Further, if we encounter delays in development, testing, and regulatory review of new organ candidates, the period of time during which we could market our new organ candidates under patent protection would be reduced.

Given that patent applications in the United States and other countries are confidential for a period of time after filing, at any moment in time, we cannot be certain that we were in the past or will be in the future the first to file any patent application related to our new organ candidates. In addition, some patent applications in the United States may be maintained in secrecy until the patents are issued. As a result, there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim, and we may be subject to priority disputes. We may in the future become a party to proceedings or priority disputes in Europe or other foreign jurisdictions. The loss of priority for, or the loss of, these patents could have a material adverse effect on the conduct of our business.

We may be required to disclaim part or all of the term of certain patents or patent applications. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we or potential future licensors are aware, but which we or those licensors do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. No assurance can be given that, if challenged, our patents would be declared by a court, patent office or other governmental authority to be valid or enforceable or that even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents. We may analyze patents or patent applications of our competitors that we believe are relevant to our activities, and consider that we are free to operate in relation to our new organ candidates or if applicable challenge the validity of any issued patents, but our competitors may achieve issued claims, including in patents we consider to be unrelated, that block our efforts or potentially result in our new organ candidates or our activities infringing such claims. It is possible that our competitors may have filed, and may in the future file, patent applications covering our products or technology similar to ours. Those patent applications may have priority over our patent applications or patents, which could require us to obtain rights to issued patents covering such technologies. The possibility also exists that others will develop products that have the same effect as our new organ candidates on an independent basis that do not infringe our patents or other intellectual property rights, or will design around the claims of our patent applications or our in-licensed patents or patent applications that cover our new organ candidates.

Likewise, our current patents in the US are expected to expire from about 2026 through about 2036 without taking into account any possible extensions. We have in-force patents and pending patent applications in the US and foreign jurisdictions. Our patents may expire before, or soon after, our first new organ candidate is licensed in the United States or foreign jurisdictions. Additionally, no assurance can be given that the USPTO or relevant foreign patent offices will grant any of the pending patent applications we own or in-license currently or in the future. Upon the expiration of our current patents, we may lose the right to exclude others from practicing these inventions. The expiration of these patents could also have a similar material adverse effect on our business, financial condition, results of operations and prospects.

We may also be subject to claims that former employees, collaborators, or other third parties have an interest in our patents or patent applications or other intellectual property as an inventor or co-inventor. If we are unable to obtain an exclusive license to any such third party co-owners’ interest in such patent applications, such co-owners may be able to license their rights to other third parties, including

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our competitors. In addition, we may need the cooperation of any such co-owners to enforce any patents that issue from such patent applications against third parties, and such cooperation may not be provided to us.

If we are unsuccessful in any interference proceedings or other priority, validity (including any patent oppositions), or inventorship disputes to which we maybe subject, we may lose valuable intellectual property rights through the loss of one or more of our owned, licensed, or optioned patents, or such patent claims may be narrowed, invalidated, or held unenforceable, or through loss of exclusive ownership of or the exclusive right to use our patents. In the event of loss of patent rights as a result of any of these disputes, we may be required to obtain and maintain licenses from third parties, including parties involved in any such interference proceedings or other priority or inventorship disputes. Such licenses may not be available on commercially reasonable terms or at all, or may be non-exclusive. If we are unable to obtain and maintain such licenses, we may need to cease the development, manufacture, and commercialization of one or more of the new organ candidates we may develop. The loss of exclusivity or the narrowing of our patent claims could limit our ability to stop others from using or commercializing similar or identical technology and new organ candidates. Even if we are successful in an interference proceeding or other similar priority or inventorship disputes, it could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could result in a material adverse effect on our business, financial condition, results of operations, or prospects.

We have intellectual property coverage for our new organ candidates in the United States, Europe, and other territories, but our foreign intellectual property rights are not exhaustive.

We have intellectual property for our new organ candidates in many key markets such as the United States and Europe. However, we do not have intellectual property rights in every country throughout the world. Filing, prosecuting, and defending patents on new organ candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States, and Europe can be less extensive than those in the United States. In addition, the laws of foreign countries do not protect intellectual property rights to the same extent as federal and state laws of the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as that in the United States. These products may compete with our new organ candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products against third parties in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our patents and intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Moreover, the initiation of proceedings by third parties to challenge the scope or validity of our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business and / or the limitation or loss of key patent rights. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against

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government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.

We may enter into license agreements for intellectual property rights in the future and if we fail to comply with our obligations in such agreements or otherwise experience disruptions to our business relationships with our licensors or research and development partners, we could lose license rights that are important to our business.

We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant. It is possible that our ability to commercialize some new organ candidates in the United States and abroad may be adversely affected if we cannot obtain a license to any potentially relevant third-party patents on commercially-reasonable terms that would allow us to make an appropriate return on our investment. In addition, the licensing or acquisition of third-party intellectual property rights is a highly competitive area, and other, potentially more established companies may pursue strategies to license or acquire third party intellectual property rights that we may, in the future, consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Further, even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability, or priority. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. As such, we could be forced, including by court order, to cease developing, manufacturing, and commercializing the infringing technology or new organ candidates. In addition, we could be found liable for significant monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right. Thus, we may be required to expend significant time and resources to redesign our technology, new organ candidates, or the methods for manufacturing them or to develop or license replacement technology, or we may need to abandon development of the relevant program or product candidate, all of which may not be feasible on a technical or commercial basis and could have a material adverse effect on our business, financial condition, results of operations, and prospects. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations, and prospects.

The intellectual property landscape pertaining to live new organs is in constant flux.

The field of new organs is still in its infancy. Due to the intense research and development that is taking place by several companies, including us and our competitors, in this field, the intellectual property landscape is evolving and in flux, and it may remain uncertain for the coming years. There may be significant intellectual property related litigation and proceedings relating to intellectual property and proprietary rights in the future.

Our commercial success depends upon our ability and the ability of future collaborators to develop, manufacture, market, and sell any new organ candidates that we may develop and use our proprietary technologies without infringing, misappropriating, or otherwise violating the intellectual property and proprietary rights of third parties. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights as well as

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administrative proceedings for challenging patents, including interference, derivation, inter partes review, post grant review, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. We may in future be subject to and may in the future become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights including interference proceedings, post-grant review, inter partes review, and derivation proceedings before the USPTO and similar proceedings in foreign jurisdictions such as oppositions before the EPO. Numerous U.S. and foreign issued patents and pending patent applications that are owned by third parties may exist in the fields in which we are developing our new organ candidates and they may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.

As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our new organ candidates may give rise to claims of infringement of the patent rights of others. Moreover, it is not always clear to industry participants, including us, which patents cover various types of new organ therapies, products or their methods of use or manufacture. There may be third-party patents or patent application with claims to technologies, methods of manufacture or methods for treatment related to the use or manufacture of our new organ candidates. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our new organ candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

Defense of third-party claims of infringement of misappropriation, or violation of intellectual property rights involves substantial litigation expense and would be a substantial diversion of management and employee time and resources from our business. Some third-parties may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, financial condition, results of operations and prospects. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming, and unsuccessful and could result in a finding that such patents are unenforceable or invalid.

Competitors may infringe our patents, or we may be required to defend against claims of infringement. In addition, our patents may in the future become involved in inventorship, priority, validity or enforceability disputes. Countering or defending against such claims can be expensive and time consuming. In possible future infringement proceedings, a court may decide that a patent owned by us is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our owned or any in-licensed patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly.

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. These types of mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). These types of proceedings could result in revocation or amendment to our patents such that they no longer cover our new organ candidates. The outcome for any particular patent following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent

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examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and perhaps all, of the patent protection on our technology and/or new organ candidates. Defense of these types of claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

Conversely, we may choose to challenge the patentability of claims in a third party’s U.S. patent by requesting that the USPTO review the patent claims in re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). If we challenge and subsequently fail to obtain a favorable result at the USPTO, EPO or other patent office then we may be exposed to litigation by a third party alleging that the patent may be infringed by our new organ candidates or other proprietary technologies.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation in the US and certain other jurisdictions, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications are due to be paid to the USPTO and foreign patent agencies outside of the United States over the lifetime of our patents and applications. The USPTO and foreign patent agencies require compliance with several procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can ordinarily be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations, however, in which non-compliance can result a partial or complete loss of patent rights in the relevant jurisdiction. Were a noncompliance event to occur, our competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Changes in patent law in the United States and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our new organ candidates.

Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.

Changes in either the patent laws or interpretation of the patent laws could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of our issued patents. For example, in March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, the United States transitioned from a “first to invent” to a “first-to-file” patent system. Under a “first-to-file” system, assuming that other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on an invention regardless of whether another inventor had made the invention earlier. A third party that files a patent

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application in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either file any patent application related to our technology or new organ candidates or invent any of the inventions claimed in our or our licensor’s patents or patent applications. The America Invents Act also includes a number of other significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted, allowing third party submission of prior art and establish a new post-grant review system including post-grant review, inter partes review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. The effects of these changes are currently unclear as the USPTO continues to promulgate new regulations and procedures in connection with the America Invents Act and many of the substantive changes to patent law, including the “first-to-file” provisions, only became effective in March 2013. In addition, the courts have yet to address many of these provisions and the applicability of the act and new regulations on the specific patents discussed in this filing have not been determined and would need to be reviewed. Thus, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

In addition, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. These cases include Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 12-398 (2013) or Myriad; Alice Corp. v. CLS Bank International, 573 U.S. 13-298 (2014); and Collaborative Services v. Prometheus Laboratories, Inc., or Prometheus, 566 U.S. 10-1150 (2012). In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, in the case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to DNA molecules are not patentable, but claims to complementary DNA, or cDNA, molecules, which are not genomic sequences, may be patent eligible because they are not a natural product. The effect of the decision on patents for other isolated natural products is uncertain. However, on March 4, 2014, the USPTO issued a memorandum to patent examiners providing guidance for examining claims that recite laws of nature, natural phenomena or natural products under the Myriad and Prometheus decisions. The guidance did not limit the application of Myriad to DNA but, rather, applied the decision broadly to other natural products, which may include our new organ candidates. The March 4, 2014 memorandum and the USPTO’s subsequent interpretation of the cases and announced examination rubric received widespread criticism from stakeholders during a public comment period and was superseded by interim guidance published on December 15, 2014. Subsequently, the USPTO has issued further guidance on patent subject matter eligibility. We cannot predict how this and future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Any similar adverse changes in the patent laws of other jurisdictions could also have a material adverse effect on our business, financial condition, results of operations and prospects.

Patent terms may be inadequate to protect our competitive position on our new organ candidates for an adequate amount of time.

Patents have a limited lifespan. The terms of individual patents depends upon the legal term for patents in the countries in which they are granted. In most countries, including the United States, if all

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maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest non-provisional filing date in the applicable country. However, the actual protection afforded by a patent varies from country to country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent. Various extensions including patent term extensions (“PTE”) and patent term adjustments, may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our new organ candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics. Given the amount of time required for the development, testing and regulatory review of new organ candidates, patents protecting our new organ candidates might expire before or shortly after we or our partners commercialize those candidates. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

If we do not obtain a PTE for a patent, our business may be materially harmed.

Depending upon the timing, duration and specifics of any FDA licensing of any new organ candidates we may develop, one or more of our U.S. patents may be eligible for limited PTE. Analogous extensions of patent term may be available upon marketing approval in other jurisdictions. The PTE term of up to five years is awarded as compensation for patent term lost during the FDA regulatory review process. A PTE cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent per product may be extended and only those claims covering the licensed new organ, a method for using it, or a method for manufacturing it may be extended. However, even if we were to seek a PTE or corresponding extension of patent term in other jurisdictions, it may not be granted because of, for example, the failure to exercise due diligence during the testing phase or regulatory review process, the failure to apply within applicable deadlines, the failure to apply prior to expiration of relevant patents, or any other failure to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain PTE or a corresponding extension of patent term in other jurisdictions, or the term of any such extension is less than we request, our competitors may be able to launch competing products earlier than anticipated following our patent expiration, and our business, financial condition, results of operations, and prospects could be materially harmed.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for our technology and new organ candidates, we also rely on know-how and trade secret protection, as well as confidentiality agreements, non-disclosure agreements and invention assignment agreements with our employees, consultants and third-parties, to protect our confidential and proprietary information, especially where we do not believe patent protection is appropriate or obtainable.

It is our policy to require our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors, and other third parties to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed by or made known to the individual or entity during the course of the party’s relationship with us is to be kept confidential and not disclosed to third parties, except in certain specified circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. In the case of consultants and other third parties, the agreements provide that all inventions conceived in connection with the services provided are our exclusive property. However, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. Additionally, the assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring

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against us, to determine the ownership of what we regard as our intellectual property. Any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable.

In addition to contractual measures, we try to protect the confidential nature of our proprietary information through other appropriate precautions, such as physical and technological security measures. However, trade secrets and know-how can be difficult to protect. These measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and any recourse we might take against this type of misconduct may not provide an adequate remedy to protect our interests fully. In addition, trade secrets may be independently developed by others in a manner that could prevent us from receiving legal recourse. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any of that information was independently developed by a competitor, our competitive position could be harmed.

In addition, some courts inside and outside the United States are sometimes less willing or unwilling to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. Even if we are successful, these types of lawsuits may consume our time and other resources. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.

As is common in the biotechnology and pharmaceutical industries, we may employ individuals that are currently or were previously employed at universities, research institutions or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants, and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Also, in the future we may be subject to claims that these individuals are violating non-compete agreements with their former employers. We may then have to pursue litigation to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, that perception could have a substantial adverse effect on the price of our common stock. This type of litigation or proceeding could substantially increase our operating losses and reduce our resources available for development activities, and we may not have sufficient financial or other resources to adequately conduct this type of litigation or proceedings. For example, some of our competitors may be able to sustain the costs of this type of litigation or proceedings more effectively than we can because of their substantially greater financial resources. In any case, uncertainties resulting from the initiation and continuation of intellectual property litigation or other intellectual property related proceedings could adversely affect our ability to compete in the marketplace.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition

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among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

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any new organ candidates we may develop will likely eventually become commercially available in biosimilar product forms;

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others may be able to make new organ products that are similar to any new organ candidates we may develop but that are not covered by the claims of the patents that we own or may own in the future;

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we, or our current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or may own in the future;

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we, or our current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

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we, or our current or future collaborators, may fail to meet our obligations to the U.S. government regarding any patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights;

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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

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it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;

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it is possible that there are prior public disclosures that could invalidate our patents, or parts of our patents;

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it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our new organ candidates or technology similar to ours

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it is possible that our patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable;

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issued patents that we hold rights to may be held invalid, unenforceable, or narrowed in scope, including as a result of legal challenges by our competitors;

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the claims of our issued patents or patent applications, if and when issued, may not cover our new organ candidates;

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the laws of foreign countries may not protect our proprietary rights or the proprietary rights of current or future collaborators to the same extent as the laws of the United States;

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the inventors of our patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to us or the patents or patent applications on which they are named as inventors;

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our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

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we have engaged in scientific collaborations in the past and will continue to do so in the future and our collaborators may develop adjacent or competing products that are outside the scope of our patents;

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we may not develop additional proprietary technologies that are patentable;

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any new organ candidates we develop may be covered by third parties’ patents or other exclusive rights;

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the patents of others may harm our business; or

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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Risks Related to Government Regulation

The development and commercialization of biopharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the FDA are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis if at all, our business will be substantially harmed.

The clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing, distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other possible activities relating to our product candidates are subject to extensive regulation. In the United States, marketing approval of biologics requires the submission of a BLA to the FDA, and we are not permitted to market any product candidate in the United States until we obtain approval from the FDA of the BLA for that product candidate. A BLA must be supported by extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing, and controls. Outside the United States, many comparable foreign regulatory authorities employ similar approval processes.

We have not previously submitted a BLA to the FDA or similar regulatory approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that any of our product candidates will receive regulatory approval. We are not permitted to market our product candidates in the United States or in other countries until we receive approval of a BLA from the FDA or marketing approval from applicable regulatory authorities outside the United States. Obtaining approval of a BLA can be a lengthy, expensive, and uncertain process, and we have no experience with the preparation of a BLA submission for marketing approval. Further, the FDA has not yet granted approval for any whole organ using our perfusion technology or any whole organ biologic, and to our knowledge, a clinical trial has never been conducted using a bioengineered organ in humans before, which we believe may increase the complexity, uncertainty and length of the regulatory approval process. Further, if the FDA was to categorize our bioengineered organ products as xenotransplants, the length of the regulatory approval process could be extended. In addition, the FDA has the authority to require a risk evaluation and mitigation strategies, ("REMS"), plan as part of a BLA or after approval, which may impose further requirements or restrictions on the distribution or use of an approved biologic, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry.

Our product candidates could fail to receive regulatory approval for many reasons, including the following:

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, and might therefore not allow an IND to proceed;

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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe, pure and potent for its proposed indication;

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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

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the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere, or regulatory authorities may not accept a submission due to, among other reasons, the content or formatting of the submission;

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the FDA or comparable foreign regulatory authorities may fail to approve our manufacturing processes or facilities or those of third-party manufacturers with which we contract for clinical and commercial supplies; and

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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations, and prospects. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process, and determining when or whether regulatory approval will be obtained for any of our product candidates. As a result, we may be required to conduct additional preclinical studies, alter our proposed clinical trial designs, or conduct additional clinical trials to satisfy the regulatory authorities in each of the jurisdictions in which we hope to conduct clinical trials and develop and market our products, if approved. Further, even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA or any comparable foreign regulatory authority.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, testing, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion, and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current Good Manufacturing Practices (“cGMPs”), current Good Tissue Practices (“cGTPs”) and GCPs for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such products. In addition, any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate.

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Manufacturers and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations, as well as, for the manufacture of certain of our product candidates, the FDA’s cGTPs for the use of human cellular and tissue products to prevent the introduction, transmission or spread of communicable diseases. As such, we and our contract suppliers and manufacturers, if any, will be subject to continual review and inspections to assess compliance with cGMPs, cGTPs and adherence to commitments made in any approved marketing application. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, quality control, and distribution.

If there are changes in the application of legislation or regulatory policies, or if problems are discovered with a product or our manufacture of a product, or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include issuing warning letters or untitled letters, imposing fines on us, imposing restrictions on the product or its manufacture, and requiring us to recall or remove the product from the market. The regulators could also suspend or withdraw our marketing authorizations, requiring us to conduct additional clinical trials, change our product labeling, or submit additional applications for marketing authorization. If any of these events occurs, our ability to sell such product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect our business, financial condition, and results of operations.

In addition, if we have any product candidate approved, our product labeling, advertising, and promotion will be subject to regulatory requirements and continuing regulatory review. In the United States, the FDA and the Federal Trade Commission, (“FTC”), strictly regulate the promotional claims that may be made about pharmaceutical products to ensure that any claims about such products are consistent with regulatory approvals, not misleading or false in any particular, and adequately substantiated by clinical data. The promotion of a drug product in a manner that is false, misleading, unsubstantiated, or for unapproved (or off-label) uses may result in enforcement letters, inquiries and investigations, and civil and criminal sanctions by the FDA or the FTC. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant sanctions and may result in false claims litigation under federal and state statutes, which can lead to consent decrees, civil monetary penalties, restitution, criminal fines and imprisonment, and exclusion from participation in Medicare, Medicaid, and other federal and state healthcare programs. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

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issue warning or untitled letters;

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issue, or require us to issue, safety-related communications, such as safety alerts, field alerts, “Dear Doctor” letters to healthcare professionals, or import alerts;

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impose civil or criminal penalties;

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suspend, limit, or withdraw regulatory approval;

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suspend any of our preclinical studies and clinical trials;

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refuse to approve pending applications or supplements to approved applications submitted by us;

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impose restrictions on our operations, including closing our and our contract manufacturers’ facilities; or

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seize or detain products, refuse to permit the import or export of products, or require us to conduct a product recall.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products, if approved. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

Moreover, the policies of the FDA and of comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new biologics or modifications to licensed biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately, in response to the COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most inspections of foreign manufacturing facilities, and on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities. Subsequently, on July 10, 2020, the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within a given geographic area, ranging from mission critical inspections to resumption of all regulatory activities. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or comparable foreign regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or comparable foreign regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Compliance with current and future governmental regulations regarding the treatment of animals used in research could increase our operating costs or impact the commercialization of our technology.

Certain laws and regulations require us to test our product candidates on animals before initiating clinical trials involving humans. In addition, we are subject to federal law that covers the treatment of

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certain animals used in research. Currently, federal law imposes a wide variety of specific regulations that govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most notably relating to personnel, facilities, sanitation, cage size, feeding, watering and shipping conditions. Third parties with whom we contract are subject to registration, inspections and reporting requirements. Furthermore, some states have their own regulations, including general anti-cruelty legislation, which establish certain standards in handling animals. If we or any of our contractors fail to comply with regulations concerning the treatment of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations could be adversely affected.

Moreover, animal testing activities have been the subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through protests and other means. To the extent the activities of these groups are successful, our research and development activities may be interrupted, delayed, or become more expensive.

Our business operations and current and future relationships with healthcare professionals, principal investigators, consultants, vendors, customers, and third-party payors in the United States and elsewhere are subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, and other healthcare laws and regulations, which could expose us to substantial penalties, contractual damages, reputation harm, administrative burdens, and diminished profits.

Healthcare providers, healthcare facilities and institutions, physicians, and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, healthcare facilities and institutions, principal investigators, consultants, customers, and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, that may constrain the business or financial arrangements and relationships through which we research, sell, market, and distribute any product candidates for which we obtain marketing approval. In addition, we may be subject to physician payment transparency laws and regulation by the federal government and by the states and foreign jurisdictions in which we conduct our business. The applicable federal, state, and foreign healthcare laws that affect our ability to operate include, but are not limited to, the following:

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the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under any U.S. federal healthcare program, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value, including stock options. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between biologics manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Any arrangements with prescribers must be for bona fide services and compensated at fair market value. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

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the U.S. federal civil and criminal false claims laws, including without limitation, the civil False Claims Act, which can be enforced by private citizens on behalf of the U.S. federal government through civil whistleblower or qui tam actions, and the federal civil monetary penalties law which

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prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease, or conceal an obligation to pay money to the U.S. federal government. Pharmaceutical manufacturers can cause false claims to be presented to the U.S. federal government by, among other things, engaging in impermissible marketing practices, such as the off-label promotion of a product for an indication for which it has not received FDA approval. Further, pharmaceutical manufacturers can be held liable under the civil False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

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the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items, or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation;

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the FFDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics, and medical devices;

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the PHSA, which prohibits, among other things, the introduction into interstate commerce of a biological product unless a biologics license is in effect for that product;

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the U.S. Physician Payments Sunshine Act and its implementing regulations, which requires, among other things, certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare and Medicaid Services, or CMS, information related to certain payments and other transfers of value to physicians, as defined by statute, and teaching hospitals, as well as ownership and investment interests held by such physicians and their immediate family members. Beginning in 2022, such obligations will include the reporting of payments and other transfers of value provided in the previous year to certain other healthcare professionals, including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants, and certified nurse-midwives;

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analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements, and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring the registration of biologics sales representatives; and

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similar healthcare laws and regulations in foreign jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers.

Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is not always possible to identify and deter employee misconduct or business noncompliance, and the precautions we take to

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detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. We have entered into consulting and scientific advisory board arrangements with physicians and other healthcare providers, including some who could influence the use of our product candidates, if approved. Compensation under some of these arrangements includes the provision of stock or stock options in addition to cash consideration. Because of the complex and far-reaching nature of these laws, it is possible that governmental authorities could conclude that our payments to physicians may not be fair market value for bona fide services or that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including civil, criminal, and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations to resolve allegations of noncompliance, disgorgement, imprisonment, contractual damages, reputational harm, diminished profits, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Our employees, independent contractors, principal investigators, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other misconduct. We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the laws or regulations of the jurisdictions in which we operate, including, without limitation, employment, foreign corrupt practices, trade restrictions and sanctions, environmental, competition, and patient privacy and other privacy laws and regulations. Misconduct by employees could include failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately, or disclose unauthorized activities to us. In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, labeling, marketing and promotion, sales commission, customer incentive programs, and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material and adverse effect on our business, financial condition, results of operations and prospects, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, individual imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to

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resolve allegations of noncompliance with the law, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy.

Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.

In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private payors. Among the provisions of the ACA of importance to the pharmaceutical and biotechnology industries, which includes biologics, are the following:

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manufacturers and importers of certain biologics with annual sales of more than $5 million made to or covered by specified federal healthcare programs are required to pay an annual, nondeductible fee according to their market share of all such sales;

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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% of the average manufacturer price for most branded drugs, biologics, and biosimilars and to 13.0% for generic drug, and cap of the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;

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a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted, or injected;

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extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

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expansion of the entities eligible for discounts under the Public Health program, commonly referred to as the “340B Program;”

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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians, also known as the “Physician Payments Sunshine Act;”

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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

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establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending; and

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a licensure framework for follow-on biologic products.

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. For example, legislation enacted in 2017 informally titled the Tax Cuts and Jobs Act of 2017, repealed the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage that is commonly referred to as the “individual mandate.” In December 2019, a U.S. District Court upheld a ruling that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. In November 2020, the Supreme Court of the United States heard oral arguments in the appeal of this case, but it is uncertain when the Supreme Court will rule on this case. It is unclear how this and other efforts to challenge, repeal, or replace the ACA will impact the ACA or our business.

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In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted which, among other things, have reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers. These new laws or any other similar laws introduced in the future, as well as regulatory actions that may be taken by CMS, may result in additional reductions in Medicare and other healthcare funding, which could negatively affect our customers and accordingly, our financial operations. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. Additionally, individual states in the United States have passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing and costs. Similar developments have occurred outside of the United States, including in the European Union where healthcare budgetary constraints have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. To obtain reimbursement or pricing approval in some European Union member states, we may be required to conduct studies that compare the cost-effectiveness of our product candidates to other therapies that are considered the local standard of care.

It is also possible that additional governmental action is taken in response to address the COVID-19 pandemic. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States, particularly as a result of the recent presidential election, or any other jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

Even if we are able to commercialize any product candidate, coverage and adequate reimbursement may not be available or such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.

The regulations that govern regulatory approvals, pricing, and reimbursement for biologics such as our product candidates vary widely from country to country. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing approval is granted. In some foreign markets, product pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain regulatory approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain regulatory approval.

Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors, such as government authorities, private health insurers, and other organizations. Even if we succeed in bringing one or more products to the market, these products may not be considered cost-effective, and the amount reimbursed for any products may be insufficient to allow us to sell our products on a competitive basis. Because our programs are in the early stages of development, and in particular due to the novel nature of our technology, we are unable at this time to determine their cost effectiveness or the likely level or method of coverage and reimbursement. Increasingly, the third-party payors who reimburse patients or healthcare providers are requiring that companies provide them with predetermined discounts from list prices, and are seeking to reduce the prices charged or the amounts reimbursed for drug products. If the price we are able to charge for any products we develop, or the coverage and reimbursement provided for such products, is inadequate in light of our development and other costs, our return on investment could be affected adversely.

Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor. Third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. As a result, the

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coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis. One payor’s determination to provide coverage for a biologic does not assure that other payors will also provide coverage and adequate reimbursement for the biologic. Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal, and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, including repeal, replacement, or significant revisions to the Affordable Care Act. The continuing efforts of the government, insurance companies, managed care organizations, and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

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the demand for our product candidates, if we obtain regulatory approval;

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our ability to set a price that we believe is fair for our products;

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our ability to obtain coverage and reimbursement approval for a product;

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our ability to generate revenue and achieve or maintain profitability;

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the level of taxes that we are required to pay; and

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the availability of capital.

Our inability to promptly obtain coverage and adequate reimbursement from both third-party payors for the product candidates that we may develop and for which we obtain regulatory approval could have a material and adverse effect on our business, financial condition, results of operations, and prospects.

We face potential liability related to the privacy of personal information, including health information we utilize in the development of our product candidates.

We and our partners and vendors are subject to various federal, state, and foreign data protection laws and regulations. If we fail to comply with these laws and regulations, we may be subject to litigation, regulatory investigations, enforcement notices, enforcement actions, fines, and criminal or civil penalties, as well as negative publicity, reputational harm, and a potential loss of business.

In the United States, numerous federal and state laws and regulations, including state data breach notification laws and federal and state data privacy laws and regulations that govern the collection, use, disclosure, and protection of health information and other personal information apply to our operations and the operations of our partners. For example, most healthcare providers, including research institutions from which we obtain patient health information, are subject to data privacy and security regulations promulgated under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH). Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA. For example, under HIPAA, we could potentially face substantial criminal or civil penalties if we knowingly receive protected health information from a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of such health information, or otherwise violate applicable HIPAA requirements related to the protection of such information. Even when HIPAA does not apply, failing to take appropriate steps to keep consumers’ personal information secure may constitute a violation of the Federal Trade Commission Act.

Certain of the research materials we use in our research and development efforts are derived from human sources, which potentially contain sensitive identifiable personal information regarding the donor. In addition, once we commence clinical trials, we may maintain sensitive identifiable personal information, including health information, that we receive throughout the clinical trial process, in the course of our research collaborations, and directly from individuals (or their healthcare providers) who

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enroll in our patient assistance programs. As such, we may become subject to further obligations under HIPAA. In addition, our collection of personal information generally (e.g., of employees currently and/or of patients in the future) may subject us to state data privacy laws governing the processing of personal information and requiring notification of affected individuals and state regulators in the event of a breach of such personal information. Numerous laws relating to data privacy and security have been proposed at the state and federal level, and if passed, such laws may have potentially conflicting requirements that would make compliance challenging, require us to expend significant resources to come into compliance, and restrict our ability to process certain personal information. New legislation proposed or enacted in various other states will continue to shape the data privacy environment nationally. Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to confidential, sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which may complicate compliance efforts.

Any clinical trial programs and research collaborations that we engage in outside the United States may implicate international data protection laws, including, in Europe, the General Data Protection Regulation (GDPR). The GDPR imposes stringent operational requirements for data processors and controllers of personal data. Among other things, the GDPR requires detailed notices for clinical trial subjects and investigators, as well as the security of personal data, and notification of data processing obligations or security incidents to appropriate data protection authorities or data subjects. Further, following the United Kingdom’s withdrawal from the European Union effective as of December 31, 2020, we will have to comply with the GDPR and the GDPR as incorporated into United Kingdom national law, which may have differing requirements.

One particularly sensitive issue under these European Union data privacy laws involves European Economic Area (EEA) laws on data export if we begin to transfer personal data from the EEA to other jurisdictions. Recent legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States. For example, on July 16, 2020, the Court of Justice of the European Union, or CJEU, invalidated the EU-US Privacy Shield Framework, or Privacy Shield, under which personal data could previously be transferred from the EEA to United States entities who had self-certified under the Privacy Shield scheme. The CJEU decision also created additional obligations and uncertainty around the ability to use standard contractual clauses for such data transfers. As government authorities issue further guidance on personal data export mechanisms or start aggressively taking enforcement action based on such guidance or the CJEU decision, we could suffer additional costs, complaints, and/or regulatory investigations or fines. If we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and adversely affect our financial results. These international laws and regulations may apply not only to us, but also to vendors that store or otherwise process personal data on our behalf, such as information technology vendors. If our data privacy and/or security measures fail to comply with European Union and United Kingdom data privacy laws, or if a vendor misuses data we have provided to it or fails to safeguard such data, we may be subject to litigation, regulatory investigations, enforcement notices, and/or enforcement actions imposing fines and/or requiring us to change the way we use personal data, as well as negative publicity, reputational harm, and a potential loss of business.

We are likely to be required to expend significant capital and other resources to ensure ongoing compliance with applicable data privacy and security laws. Claims that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend, and could result in adverse publicity that could harm our business. Moreover, even if we take all necessary action to comply with legal and regulatory requirements, we could be subject to a data breach or other unauthorized access of personal information, which could subject us to fines and penalties, as well as litigation and reputational damage.

If we fail to keep apprised of and comply with applicable international, federal, state, or local regulatory requirements, we could be subject to a range of regulatory actions that could affect our or any collaborators’ ability to seek to commercialize our clinical candidates. Any threatened or actual government enforcement action or litigation where private rights of action are available could also

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generate adverse publicity, damage our reputation, result in liabilities, fines and loss of business, and require that we devote substantial resources that could otherwise be used in other aspects of our business.

Our business involves the use of hazardous materials and we must comply with environmental laws and regulations, which may be expensive and restrict how we do business.

Our manufacturing activities may involve the controlled storage, use and disposal of hazardous materials and, on that basis, we may be subject to federal, state, local and non-U.S. laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these hazardous materials. We currently carry no insurance specifically covering environmental claims relating to the use of hazardous materials.

Although we believe that our safety procedures for handling and disposing of these materials and waste products comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of hazardous materials. In the event of an accident, federal, state or other applicable authorities may curtail our use of these materials and interrupt their business operations which could adversely affect our business.

Compliance with environmental laws and regulations may be expensive and non-compliance could result in substantial liabilities, fines and penalties, personal injury and third-party property damage claims and substantial investigation and remediation costs. Environmental laws and regulations could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We cannot assure you that violations of these laws and regulations will not occur in the future or have not occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense associated with environmental regulation and remediation could harm our financial condition and results of operations.

Risks Related to Our Business

We may not be able to scale our manufacturing to support our future plans.

Although we believe our manufacturing capabilities are sufficient for our current purposes, we will need to build a new facility to support our human clinical trials, which we expect to begin as early as late 2022. We have designed this new facility, but we will need to obtain additional financing to build and equip the facility. Any new facility will also be required to conform to cGMP regulations. If we are not able to raise the funds to build this new facility, or if the development or construction of this facility experiences delays or cost overruns, we will not have the capacity to conduct our clinical activities in line with our business plans and our business and prospects will suffer.

Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our business.

Our quarterly and annual results of operations may vary significantly in the future, and period-to-period comparisons of our operating results may not be meaningful. Accordingly, the results of any one quarter or period should not be relied upon as an indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside our control.

Factors that may cause fluctuations in our quarterly and annual results include:

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our ability to obtain and maintain regulatory clearance or approval for any products in development or for any additional indications or in additional jurisdictions;

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timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;

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surgeon and patient adoption of our future products;

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changes in coverage policies by third-party payors;

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unanticipated pricing pressures;

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results of clinical research and trials on our products in development;

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delays in, or failure of, component and raw material deliveries by our suppliers; and

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positive or negative coverage in the media or clinical publications of our future products or products of our competitors or our industry.

Because our quarterly and annual results may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of our business. These fluctuations may also increase the likelihood that we will not meet our forecasted performance, which could negatively affect the market price for our common stock.

All of our operations are currently conducted at one location and any disruption at this facility could materially and adversely affect our businesses.

Because of the level of precision and quality required for our operations, we currently conduct and intend to conduct all of our manufacturing and preclinical work in-house at our own facility for the foreseeable future. Our facility and equipment would be costly to replace and could require substantial lead time to repair or replace. The facility may be harmed or rendered inoperable by natural or man-made disasters, including, but not limited to, tornadoes, flooding, fire and power outages, which may render it difficult or impossible for us to perform our research, development and commercialization activities for some period of time. The inability to perform those activities may result in the loss of certain opportunities or harm to our reputation. Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all.

We may in the future face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business.

Our business exposes us to the risk of product liability claims that are inherent in the testing, manufacturing and marketing of products in the industry in which we operate. This risk exists even if a product is cleared or approved for commercial sale by the FDA or another regulator, and manufactured in facilities licensed and regulated by such regulator(s). Any side effects, manufacturing defects or misuse associated with our product candidates could result in patient injury or death, in particular because our product candidates are designed to be permanently placed in the human body. Further, given that our products deal with biological material, there is a product liability risk related to disease transmission from the bioengineered organ to the patient. We could also become subject to liability caused by any adverse events caused by technology that we license out, including Miroderm and Miromesh. The industry in which we operate has historically been subject to extensive litigation over product liability claims, and we cannot offer any assurance that we will not face product liability suits. We may be subject to product liability claims if our future products cause, or merely appear to have caused, patient injury or death. Such claims may be brought against us by patients, healthcare providers or others selling or otherwise coming into contact with our products. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability claims may result in substantial litigation costs, product recalls or market withdrawals, decreased sales and demand for our future products and damage to our reputation.

While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market any defective products, any recall or market withdrawal of our products may delay the supply of those products to our customers and may impact our reputation. We can provide no assurance that we will be successful in initiating appropriate market recall or market withdrawal efforts that may be required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying product liability that may result. Such recalls and withdrawals may also be used by our competitors to harm our reputation for safety or be perceived by patients as a safety risk when considering the use of our products, either of which could have a material adverse effect on our business, financial condition and results of operations.

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Although we plan on obtaining product liability insurance that we believe will be appropriate, this insurance will be subject to deductibles and coverage limitations and coverage may not be adequate to protect us against any future product liability claims. We do not have nor do we expect to obtain insurance covering our costs and losses as the result of any recall of our products due to alleged defects, whether such a recall is instituted by us or required by a regulatory agency. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition and results of operations.

We anticipate that, if we receive regulatory clearance or approval for any of our product candidates, those clearances or approvals will be for specific indications. We would not, however, be able to prevent a surgeon or medical professional from using any products we may commercialize in the future for off-label uses. In such a case, the FDA or another regulatory authority could conclude that we have engaged in off-label promotion. If the FDA determines that our promotional or training materials constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions. It is also possible that other federal, state or non-U.S. enforcement authorities might take action under other regulatory authority if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations. In those possible events, our reputation could be damaged, and adoption of the products would be impaired.

The sizes of the markets for our future products may be smaller than we estimate. Our results of operations could be materially harmed if we are unable to accurately forecast addressable markets for our product candidates and manage our inventory.

Our estimates of the annual total addressable markets for our products under development are based on a number of internal and third-party estimates, as well as assumed prices at which we can sell our future products. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, our estimates of the annual total addressable market for our product candidates may prove to be incorrect. If the price at which we can sell future products, or the annual total addressable market for our product candidates is smaller than we have estimated, it could have an adverse impact on our business. Moreover, our product candidates have a limited shelf life and will expire if not timely used. To ensure adequate inventory supply once commercialized, we will need to forecast inventory needs based on forecasted markets, which could be negatively affected by many factors, including:

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product introductions by competitors;

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an increase or decrease in surgeon demand for our products or for products of our competitors;

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our failure to accurately manage our growth strategy;

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our failure to accurately forecast surgeon acceptance of new products; and

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unanticipated changes in general market conditions or regulatory matters.

Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely affected and could impair the strength of our brand. Additionally, we are subject to the risk that a portion of our inventory will expire, which could have a material adverse effect on our earnings and cash flows due to the resulting costs associated with the inventory impairment charges and costs required to replace such inventory. Conversely, if we underestimate customer demand for our future products, we may not be able to deliver, and this could result in damage to our reputation and customer relationships. In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, which could have an adverse effect on our ability to meet customer demand and our results of operations.

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Our ability to maintain our competitive position depends on our ability to attract and retain senior management and other highly qualified personnel.

We are highly dependent on our senior management and other key personnel. Our success depends in part on our continued ability to attract, retain and motivate highly qualified senior management and attract, retain and motivate qualified employees, including sales and marketing professionals, clinical specialists and other highly skilled personnel. Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, or at all. If we are not successful in attracting and retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition and results of operations. The loss of highly qualified employees could result in delays in product development and commercialization and harm our business

Although we have entered into an employment agreement with our chief executive officer, he may terminate his employment with us at any time. The replacement of any of our key personnel likely would involve significant time and costs and may significantly delay or prevent the achievement of our business objectives and could therefore have an adverse effect on our business. We also do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees.

We currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate future product revenue.

We have no internal sales, marketing or distribution capabilities. If any of our product candidates ultimately receives regulatory approval, we expect to establish a direct marketing and sales force with technical expertise and supporting distribution capabilities to commercialize each such product in major markets, which will be expensive and time consuming. There are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. We may also choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing and distribution functions on acceptable financial terms, or at all. In addition, our product revenues and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute any products that we develop ourselves. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we are not successful in commercializing our products, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and our business would be harmed.

Economic conditions may adversely affect our business.

Adverse worldwide economic conditions may negatively impact our business. Our general business strategy may be adversely affected by such economic conditions or the presence of a volatile business environment or unpredictable and unstable market conditions. Challenging global economic conditions may impact the availability to or affordability of health insurance or may impact patient decisions to have a medical procedure performed. Accordingly, a pronounced and sustained economic downturn, including the current economic challenges associated with the COVID-19 pandemic, could have a material adverse effect on our business, financial condition and prospects. Furthermore, challenging economic conditions could also cause a delay or disruption in the performance or satisfaction of commitments to us by our distribution partners, contract clinical providers, suppliers or other third parties, which would have a material adverse effect on our business.

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Our business may be adversely affected by global health epidemics, including the COVID-19 pandemic.

The outbreak of COVID-19 and government measures taken in response to the pandemic have had a significant impact, both direct and indirect, on businesses and commerce, including our company, and may continue to significantly impact our business in the future. In particular, worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. As a result of the COVID-19 pandemic, we have experienced disruptions and may continue to experience disruptions that could severely impact our preclinical studies and business development plan, including:

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interruption of our preclinical trial activities, due to restricted or limited operations at our manufacturing facility, limitations on travel, or interruption of study procedures that are deemed non-essential, which may impact the integrity of subject data and study endpoints;

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interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

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interruption of, or delays in receiving, supplies of raw materials or other components for our preclinical activities; and

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limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies, including because of sickness of employees or their families;

The COVID-19 pandemic continues to rapidly evolve. The extent to which the outbreak impacts our business, preclinical studies and future plans will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the pandemic, timeline and success of the vaccine rollout, travel restrictions, new safety requirements or regulations imposed on us, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. We continue to monitor our operations and governmental recommendations and have made modifications for an indefinite period to our normal operations because of the COVID-19 pandemic. Additionally, while the potential economic impact brought by and the duration of the COVID-19 pandemic are difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively affect our short- and long-term liquidity. In addition, the impact of the COVID-19 pandemic could exacerbate other risks we face, including those described elsewhere in “Risk Factors.”

Changes in U.S. tax law could adversely affect our financial condition and results of operations.

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Future changes in U.S. tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations. We urge investors to consult with their legal and tax advisors regarding the implications of potential changes in U.S. tax laws on an investment in our common stock.

If we become profitable, our ability to use our net operating loss carryforwards and other tax attributes to offset future taxable income or taxes may be subject to limitations.

As described under “— Risks Related to Our Limited Operating History, Financial Position and Capital Requirements,” we have incurred net losses since our inception, and expect to continue to incur operating losses for the foreseeable future. If we become profitable in the future, our ability to use net operating loss carryforwards, or NOLs, and other tax attributes to offset future taxable income or reduce taxes may be subject to limitations. In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” ​(generally defined as a greater than 50% cumulative change by value in its equity ownership of certain

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stockholders over a rolling three-year period) is subject to an annual limitation on its ability to utilize its pre-change NOLs and other tax attributes (including any research and development credit carryforwards). Similar provisions of state tax law may also apply to limit the use of our state NOLs and other tax attributes.

We have not performed an analysis to determine whether our past issuances of stock and other changes in our stock ownership may have resulted in one or more ownership changes within the meaning of Sections 382 and 383 of the Code. In addition, we may experience an ownership change in connection with this offering or in the future as a result of subsequent changes in our stock ownership, some of which are outside our control ;and we are not intending to take any steps to prohibit any subsequent changes in our stock ownership in order to avoid such an ownership change. If an ownership change has occurred in the past or occurs in the future, we may not be able to use a material portion of our NOLs and other tax attributes to offset future taxable income or taxes if we attain profitability.

In addition to any limitation imposed by Section 382 of Code, the use of NOLs arising after December 31, 2017 generally is limited to a deduction of 80% of taxable income for the corresponding taxable year. NOLs arising after December 31, 2017, with certain exceptions that do not apply at the time of this offering, may not be carried back to previous taxable years, but may be carried forward indefinitely.

Risks Related to Our Common Stock and this Offering

In connection with the audit of our financial statements as of and for the years ended December 31, 2020 and 2019, a significant deficiency in our internal control over financial reporting was identified and we may identify additional significant deficiencies in the future.

In connection with the preparation and audits of our financial statements as of and for the years ended December 31, 2020 and 2019, a significant deficiency (as defined under the Exchange Act and by the auditing standards of the U.S. Public Company Accounting Oversight Board, or “PCAOB”), was identified in our internal control over financial reporting. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention by those responsible for oversight of the company's financial reporting.

Specifically, we have determined that we have not maintained sufficient staffing or written policies and procedures for accounting and financial reporting, which contributed to the lack of a formalized process or controls for management’s timely review and approval of financial information.

More specifically, we have determined that our financial statement close process includes significant control gaps mainly driven by the small size of our accounting and finance staff and, as a result, a significant lack of appropriate segregation of duties. We also determined that we have not maintained sufficient staffing or written policies and procedures for accounting and financial reporting, which contributed to the lack of a formalized process or controls for management’s timely review and approval of financial information.

The process of designing and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate and take actions to improve our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine to modify certain of the remediation measures described above. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to remediate the significant deficiency we have identified or avoid potential future significant deficiencies.

If we are unable to successfully remediate our existing or any future significant deficiencies in our internal control over financial reporting, or if we identify any additional material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to

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applicable stock exchange listing requirements, investors may lose confidence in our financial reporting, and our share price may decline as a result. We also could become subject to investigations by Nasdaq, the SEC, or other regulatory authorities.

There has been no prior public market for our common stock and an active trading market may never develop or be sustained.

Prior to this offering, there has been no public market for our common stock. Although we have applied to list our common stock on the Nasdaq Capital Market, or Nasdaq, an active trading market for our common stock may never develop following completion of this offering or, if developed, may not be sustained. The lack of an active trading market may impair the value of your shares and your ability to sell your shares at the time you wish to sell them. An inactive trading market may also impair our ability to raise capital by selling shares of our common stock and enter into strategic partnerships or acquire other complementary products, technologies or businesses by using shares of our common stock as consideration. Furthermore, even if approved for listing there can be no guarantee that we will continue to satisfy the continued listing standards of Nasdaq. If we fail to satisfy the continued listing standards, we could be de-listed, which would have a negative effect on the price of our common stock.

The price of our common stock may be volatile and you may lose all or part of your investment.

The initial public offering price for the shares of our common stock sold in this offering is determined by negotiation between the underwriter and us. This price may not reflect the market price of our common stock following this offering. In addition, the market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors, including:

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results of our clinical trials;

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the introduction of new products or product enhancements by us or others in our industry;

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the timing of regulatory clearances of our product candidates or those of our competitors;

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disputes or other developments with respect to our or others’ intellectual property rights;

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product liability claims or other litigation;

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quarterly variations in our results of operations or those of others in our industry;

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media exposure of our product candidates or of those of others in our industry;

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changes in governmental regulations or in reimbursement;

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changes in earnings estimates or recommendations by securities analysts; and

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general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.

In recent years, the stock markets generally have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors may significantly affect the market price of our common stock, regardless of our actual operating performance. These fluctuations may be even more pronounced in the trading market for our common stock shortly following this offering. If the market price of shares of our common stock after this offering does not ever exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment.

In addition, in the past, class action litigation has often been instituted against companies whose securities have experienced periods of volatility in market price. Securities litigation brought against us following volatility in our stock price, regardless of the merit or ultimate results of such litigation, could result in substantial costs, which would hurt our financial condition and operating results and divert management’s attention and resources from our business.

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We do not intend to pay dividends on our common stock, so any returns will be limited to increases, if any, in our stock’s value. Your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the agreement governing our credit facility precludes, and any future debt agreements may preclude, us from paying cash dividends. Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant. Any return to stockholders will therefore be limited to the appreciation in the value of their stock, if any.

A significant portion of our outstanding shares of common stock are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that these sales may occur, could result in a decrease in the market price of our common stock. Immediately after this offering, we will have outstanding           shares of common stock, based on the number of shares of common stock outstanding as of                 , 2021, (after giving effect to the automatic conversion of all shares of our preferred stock into shares of our common stock immediately prior to the closing of this offering). This includes the shares that we are selling in this offering, which may be resold in the public market immediately without restriction, unless purchased by our affiliates or existing stockholders who have entered into lock-up agreements. Of the remaining shares,           shares are currently restricted as a result of securities laws or 180-day lock-up agreements (which may be waived, with or without notice, by the underwriter) but will be able to be sold beginning 180 days after this offering, unless held by one of our affiliates, in which case the resale of those securities will be subject to volume limitations under Rule 144 of the Securities Act of 1933, as amended, or the Securities Act. See “Shares Eligible for Future Sale.” Moreover, holders of an aggregate of up to           shares of our common stock, (including shares of our common stock issuable upon the automatic conversion of all shares of our preferred stock into shares of our common stock immediately prior to the closing of this offering), have rights, subject to certain conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders as described in the section of this prospectus entitled “Description of Capital Stock — Registration Rights.” We also intend to register all shares of common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market, subject to volume limitations applicable to affiliates and the lockup agreements referred to above and described in the section of this prospectus entitled “Underwriting.”

We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions and relief from various reporting requirements that are applicable to other public companies that are not “emerging growth companies.” In particular, while we are an “emerging growth company” ​(i) we will not be required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, (ii) we will be exempt from any rules that could be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotations or a supplement to the auditor’s report on financial statements, (iii) we will be subject to reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and (iv) we will not be required to hold nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments not previously approved.

We may remain an emerging growth company until as late as December 31, 2026, the fiscal year-end following the fifth anniversary of the completion of this initial public offering, though we may

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cease to be an “emerging growth company” earlier under certain circumstances, including if (i) we have more than $1.07 billion in annual revenue in any fiscal year, (ii) the market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30 or (iii) we issue more than $1.0 billion of non-convertible debt over a three-year period.

The exact implications of the JOBS Act are still subject to interpretations and guidance by the SEC and other regulatory agencies, and we cannot assure you that we will be able to take advantage of all of the benefits of the JOBS Act. In addition, investors may find our common stock less attractive to the extent we rely on the exemptions and relief granted by the JOBS Act. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may decline or become more volatile.

If you purchase shares of our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares.

Investors purchasing shares of our common stock in this offering will pay a price per share that substantially exceeds the pro forma as adjusted net tangible book value per share of our common stock. As a result, investors purchasing common stock in this offering will incur immediate dilution of $      per share, representing the difference between our assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and our pro forma as adjusted net tangible book value per share as of December 31, 2020. To the extent outstanding options to purchase shares of our common stock are exercised, new investors may incur further dilution. For more information on the dilution you may experience as a result of investing in this offering, see the section of this prospectus entitled “Dilution.”

We will have broad discretion in the use of proceeds of this offering designated for working capital and general corporate purposes.

We intend to use the net proceeds from this offering for: (i) research and development activities, which may include clinical trials for our bioengineered organs, (ii) expenditures related to a new facility, (iii) repayment of the Cheshire Note to the extent not converted prior to the completion of this offering and (iv) the remaining funds, if any, for working capital and general corporate purposes. Our management will have broad discretion over the use and investment of the net proceeds of this offering. Accordingly, investors in this offering have only limited information concerning our management’s specific intentions and will need to rely upon the judgment of our management with respect to the use of proceeds.

We expect to incur significant additional costs as a result of being a public company.

Upon completion of this offering, we expect to incur costs associated with corporate governance requirements that will become applicable to us as a public company, including rules and regulations of the SEC, under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, as well as the rules of Nasdaq. These rules and regulations are expected to significantly increase our accounting, legal and financial compliance costs and make some activities more time-consuming. We also expect these rules and regulations to make it more expensive for us to maintain directors’ and officers’ liability insurance. As a result, it may be more difficult for us to attract and retain qualified persons to serve on our board of directors or as executive officers. Accordingly, increases in costs incurred as a result of becoming a publicly traded company may adversely affect our business, financial condition and results of operations.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Upon the closing of this offering, we will become subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to provide reasonable assurance that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and

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procedures, no matter how well those controls and procedures are conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

We are at risk of securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because life science companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

If a trading market for our common stock develops, the trading market will be influenced to some extent by the research and reports that industry or financial analysts publish about us and our business. We do not control these analysts. As a newly public company, we may be slow to attract research coverage and the analysts who publish information about our common stock will have had relatively little experience with us or our business and products, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us provide inaccurate or unfavorable research or issue an adverse opinion regarding our stock price, our stock price could decline. If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline and result in the loss of all or a part of your investment in us.

Provisions in our corporate charter documents and under Delaware law could discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws that will become effective upon the closing of this offering may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. As our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions provide, among other things, that:

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our board of directors has the exclusive right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;

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our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

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our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

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a special meeting of stockholders may be called only by the chair of our board of directors, our chief executive officer (or president, in the absence of a chief executive officer) or a majority of our board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;

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our amended and restated certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

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our board of directors may alter certain provisions of our amended and restated bylaws without obtaining stockholder approval;

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the approval of the holders of at least two-thirds of our shares entitled to vote at an election of our board of directors is required to adopt, amend or repeal our amended and restated bylaws or repeal the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors;

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stockholders must provide advance notice and additional disclosures to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain voting control of our shares; and

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our board of directors is authorized to issue shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, or DGCL, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation that will become effective upon the completion of this offering provides that the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United State District Court for the District of Delaware) is the exclusive forum, to the fullest extent permitted by law, for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, employees or agents to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation or amended and restated bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, except, in each case, (A) any claim as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination), (B) which is vested in the exclusive jurisdiction of a court or forum other than such court, or (C) for which such court does not have subject matter jurisdiction, in all cases subject to the courts having jurisdiction over indispensable parties named as defendants. This provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees. For example, stockholders who do bring a claim in the Court of Chancery could face additional litigations costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than

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to our stockholders. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in such action. Alternatively, if a court were to find the choice of forum provision contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions. This provision will not apply to actions arising under the Securities Act or Exchange Act. Our amended and restated certificate of incorporation and amended and restated bylaws further provide that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. Section 22 of the Securities Act, however, creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements concerning our business, operations and financial performance and conditions, as well as our plans, objectives and expectations for our business operations and financial performance and condition. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. In addition, statements that “we believe” or similar statements reflect our beliefs and opinions on the relevant subject. These forward-looking statements, which are subject to risks, uncertainties and assumptions about us, may include projections of our future financial performance, our anticipated growth strategies and anticipated trends in our business. These forward-looking statements include, but are not limited to, statements regarding:

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estimates regarding future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing;

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our expectations with respect to the regulatory pathway of our product candidates, our ability to obtain regulatory approvals for such product candidates, and the anticipated effect of delays in obtaining any such regulatory approvals;

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our expectations with respect to pre-clinical and clinical trial plans for our product candidates, the results of such activities and the safety and efficacy of our product candidates;

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our plans with respect to collaborating with third parties on product development and other matters;

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our ability to commercialize our product candidates

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our expectations regarding our manufacturing capabilities;

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our ability to compete successfully with larger competitors in our highly competitive industry;

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our ability to achieve and maintain adequate levels of coverage or reimbursement for any future products we may seek to commercialize;

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our beliefs with respect to the development, regulatory approval, efficacy and commercialization of competing products;

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our business model and strategic plans for our product candidates, technologies and business, including our implementation thereof;

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the size of the markets for our product candidates and our expectations about market trends;

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our ability to attract and retain senior management and key scientific personnel;

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our ability to obtain additional capital to finance our planned operations;

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regulatory developments in the United States and internationally;

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our ability to establish and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others;

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our expectations regarding the use of proceeds from this offering; and

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other risks and uncertainties, including those listed under the caption “Risk Factors.”

These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe the expectations reflected in the forward-looking statements are reasonable, the future results, levels of activity, performance or

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events and circumstances reflected in the forward-looking statements may not be achieved or occur at all. You should refer to the section titled “Risk Factors” and elsewhere in this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements speak only as of the date of this prospectus. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

MARKET AND INDUSTRY DATA

We obtained the industry, market and competitive position data used throughout this prospectus from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties. The market and industry data used in this prospectus involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those described in the section titled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties or by us.

54

USE OF PROCEEDS

We estimate that the net proceeds to us from this offering will be approximately $      million (or approximately $      million if the underwriter exercises in full its option to purchase up to         additional shares of common stock), based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by $      million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million in the number of shares of common stock offered by us, as set forth on the cover of this prospectus, would increase (decrease) the net proceeds to us by $      million, assuming an initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We currently intend to use the net proceeds from this offering, together with our existing cash and cash equivalents as follows:

•

between approximately $      million to $      million to fund our research and development activities, which we expect will be sufficient to fund such activities through       , including, but not limited to, our Phase 1 trial for ELAP and certain pre-clinical trials for our bioengineered organs;

•

between approximately $      million to $      million to fund the full cost of constructing a new facility;

•

approximately $        for repayment of the Cheshire Note to the extent not converted prior to the completion of this offering; and

•

The remaining funds, if any, for working capital and general corporate purposes.

This expected use of the net proceeds from this offering, and the sufficiency of such net proceeds to fund certain of our operations, represents our intentions based on our current plans and business conditions, which could change in the future as our plans and business conditions evolve. Our management will have broad discretion over the use of the net proceeds from this offering, and our investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering.

On March 6, 2020, we entered into a note and warrant purchase agreement (the “Cheshire Purchase Agreement”) with Cheshire MD Holdings, LLC (“Cheshire”), an affiliate of DaVita Inc., under which we received a bridge financing of $6,000,000. In connection with the Cheshire Purchase Agreement, we issued a $6,000,000 convertible promissory note (the “Cheshire Note”) to Cheshire and issued Cheshire a warrant to purchase up to $750,000 of shares of our preferred stock. The Cheshire Note is unsecured and has a maturity date of September 6, 2021. If we complete a preferred stock offering of at least $34,000,000 prior to the maturity date, the Cheshire Note and all accrued interest will automatically convert into preferred shares of such offering at the offering price. The Cheshire Note bore interest at 5% per annum through and until May 1, 2020, at which time the interest rate increased to 7%. The interest rate increased by an additional 2% on the first day of each subsequent month (beginning on June 2, 2020) prior to the maturity date, provided that the interest rate shall not exceed 20%. As of December 1, 2020, the interest rate reached the maximum of 20%.

Pending the use of the net proceeds from this offering as described above, we intend to invest the net proceeds in a variety of capital preservation instruments, including short-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States government.

55

DIVIDEND POLICY

We currently intend to retain all available funds and any future earnings to fund the development and growth of our business and, therefore, we do not anticipate paying any cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors, subject to various factors, including applicable laws, our results of operations, financial condition, future prospects and any other factors deemed relevant by our board of directors. Investors should not purchase our common stock with the expectation of receiving cash dividends.

56

CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of March 31, 2021, as follows:

•

an actual basis;

•

on a pro forma basis to give effect to the automatic conversion of all our preferred stock outstanding, into an aggregate of       shares of our common stock immediately prior to the completion of this offering based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

•

a pro forma as adjusted basis, giving effect to the pro forma adjustments discussed above, and giving further effect to the issuance and sale of                 shares of common stock in this offering at an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma and pro forma as adjusted information below is illustrative only, and our capitalization following the completion of this offering will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this table together with the sections titled “Selected Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus.

​	As of March 31, 2021
​	Actual			Pro Forma			Pro Forma As Adjusted(1)
​	​	​	​	(unaudited)
Cash and cash equivalents	​	$	4,263,528	​	$		​	$
Total liabilities	​	$	10,009,372	​	$		​	$
Series B-2 Convertible Preferred Stock, $.00001 par value; 2,500,000 shares authorized; 2,095,874 shares issued and outstanding, actual and as adjusted	​	​	15,670,097	​	​	​	​	​	​
Series B Convertible Preferred Stock, $.00001 par value; 4,000,000 shares authorized; 3,218,282 shares issued and outstanding, actual and as adjusted	​	​	23,865,732	​	​	​	​	​	​
Series A Convertible Preferred Stock, $.00001 par value; 3,300,000 shares authorized; 3,000,380 shares issued and outstanding, actual and as adjusted	​	​	7,125,661	​	​	​	​	​	​
Stockholders’ deficit:	​	​	​	​	​	​	​	​	​
Common Stock, $.00001 par value; 30,000,000 shares authorized; 2,290,822 shares issued and outstanding, actual and as adjusted	​	​	23	​	​	​	​	​	​
Additional paid-in capital	​	​	8,509,143	​	​	​	​	​	​
Accumulated deficit	​	​	(59,815,500)	​	​	​	​	​	​
Total stockholders’ deficit	​	$	(51,306,334)	​	$		​	$
Total capitalization	​	$	5,364,528	​	$		​	$	​

(1)

Each $1.00 increase (decrease) in the assumed initial public offering price of $      per share (which is the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) each of our pro forma as adjusted cash and cash equivalents, additional paid-in capital and total stockholders’ deficit by $      million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by

57

us. Similarly, each increase (decrease) of 1.0 million shares of common stock offered by us would increase (decrease) the pro forma as adjusted cash and cash equivalents, additional paid-in capital and stockholders’ deficit by $      million, assuming the assumed initial public offering price of $      per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The foregoing discussion and tables are based on are based on 10,605,358 shares of common stock outstanding as of March 31, 2021, which gives effect to the pro forma transactions described above, and excludes:

•

3,552,505 shares of our common stock issuable upon the exercise of stock options as of March 31, 2021, at a weighted-average exercise price of $3.25 per share;

•

564,191 shares of our common stock issuable upon the exercise of warrants as of March 31, 2021; and

•

559,500 shares of our common stock that remain available for issuance as of March 31, 2021 under the 2019 Plan.

58

DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock after this offering.

Our historical net tangible book deficit as of March 31, 2021 was $(4,644,844), or $(2.03) per share of common stock based on 2,290,822 shares of common stock outstanding as of such date. Our historical net tangible book deficit represents our total tangible assets less total liabilities divided by the number of shares of our common stock outstanding as of March 31, 2021.

Our pro forma net tangible book value (deficit) as of March 31, 2021 was $      million, or $      per share of our common stock. Pro forma net tangible book value (deficit) represents the amount of our total tangible assets less our total liabilities after giving effect to (i) the automatic conversion of all our preferred stock outstanding, into an aggregate of                 shares of our common stock immediately prior to the completion of this offering based on an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus. Pro forma net tangible book value (deficit) per share is our pro forma net tangible book value (deficit) divided by the number of shares of our common stock deemed to be outstanding as of March 31, 2021.

After giving effect to the issuance and sale of                 shares of common stock in this offering at an assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value (deficit) as of March 31, 2021 would have been $      million, or $      per share. This represents an immediate increase (decrease) in pro forma as adjusted net tangible book value (deficit) of $      per share to our existing stockholders and an immediate dilution of $      per share to new investors purchasing shares of our common stock in this offering. We determine dilution per share to new investors by subtracting our pro forma as adjusted net tangible book value per share after this offering from the assumed public offering price per share paid by new investors in this offering.

The following table illustrates this dilution on a per share basis:

Assumed initial public offering price per share	​	​	$
Historical net tangible book deficit per share as of March 31, 2021	$	(2.03)	​	​
Decrease in historical net tangible book deficit per share attributable to pro forma transactions and other adjustments described above	​	​	​	​
Pro forma net tangible book value (deficit) per share as of March 31, 2021	​	​	​	​
Increase in pro forma net tangible book value per share attributable to new investors participating in this offering	​	​	​	​
Pro forma as adjusted net tangible book value per share after this offering	​	​	​	​
Dilution per share to new investors participating in this offering	​	​	$

Each $1.00 increase (decrease) in the assumed initial public offering price of $      (which is the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) our pro forma as adjusted net tangible book value (deficit) per share after this offering by $      per share and the dilution per share to new investors participating in this offering by $      per share, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million in the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted net tangible book value (deficit) per share after this offering by $      per share and increase (decrease) the dilution per share to new investors participating in this offering by $      per share, assuming that the assumed initial public offering price remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

59

If the underwriter exercises in full its option to purchase additional shares of common stock, the pro forma as adjusted net tangible book value (deficit) per share after giving effect to this offering would be $      per share, representing an immediate increase to existing stockholders of $      per share and immediate dilution to new investors participating in this offering of $      per share assuming that the assumed initial public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The following table shows, as of March 31, 2021, on a pro forma as adjusted basis as described above, the number of shares of common stock purchased from us, the total consideration paid to us and the average price per share paid, or to be paid, by existing stockholders and by new investors purchasing common stock in this offering at the assumed initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us:

​	Shares Purchased			Total Consideration					​	​	​
​	Number	Percent		Amount			Percent		Average Price Per Share
Existing stockholders before this offering		​	%	​	$		​	%	​	$
New investors participating in this offering	​	​	​	​	​	​	​	​	​	​	​
Total	​	​	100%	​	​	​	​	100%	​	​	​

Each $1.00 increase (decrease) in the assumed initial public offering price of $      per share (which is the midpoint of the price range set forth on the cover page of this prospectus), would increase (decrease) the total consideration paid by new investors participating in this offering and total consideration paid by all stockholders by $      million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The above table assumes no exercise of the underwriter’s option to purchase additional shares. If the underwriter exercises its option to purchase additional shares in full, our existing stockholders before this offering would own    % and our new investors participating in this offering would own    % of the total number of shares of our common stock outstanding immediately prior to the completion of this offering. Additionally, the consideration paid to us by existing stockholders before this offering would be $      million, or approximately    % of the total consideration, and the consideration paid to us by new investors participating in this offering would be $      million, or approximately    % of the total consideration.

The foregoing discussion and tables are based on (other than the historical net tangible book value calculation) are based on 10,605,358 shares of common stock outstanding as of March 31, 2021, which gives effect to the pro forma transactions described above, and excludes:

•

3,552,505 shares of our common stock issuable upon the exercise of stock options as of March 31, 2021, at a weighted-average exercise price of $3.25 per share;

•

564,191 shares of our common stock issuable upon the exercise of warrants as of March 31, 2021; and

•

559,500 shares of our common stock that remain available for issuance as of March 31, 2021 under our 2019 Plan.

To the extent that stock options or warrants are exercised, new stock options are issued under our stock incentive plans, or we issue additional shares of common stock in the future, there will be further dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

60

SELECTED FINANCIAL DATA

You should read the following selected financial data together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus. The selected financial data included in this section are not intended to replace the financial statements and are qualified in their entirety by the financial statements and the related notes included elsewhere in this prospectus.

We derived the selected statement of operations data for the years ended December 31, 2020 and 2019 and the selected balance sheet data as of December 31, 2020 and 2019 from our audited financial statements and accompanying notes appearing elsewhere in this prospectus. The summary statements of operations data for the three months ended March 31, 2021 and 2020 and the summary balance sheet data as of March 31, 2021 are derived from our unaudited interim financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

​

Year ended December 31,

Three Months Ended March 31,

​

2019

2020

2020

2021

Statement of Operations:

​

​

​

​

​

​

​

​

​

​

​

​

Licensing revenue

​

$

250,000

​

$

46,530

​

$

11,088

​

$

6,108

Cost of goods sold

​

​

250,000

​

​

500,000

​

​

125,000

​

​

125,000

Gross margin

​

​

—

​

​

(453,470)

​

​

(113,912)

​

​

(118,892)

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

Research and development

​

​

6,266,670

​

​

7,280,798

​

​

1,801,378

​

​

1,868,001

Regulatory and clinical

​

​

289,020

​

​

265,885

​

​

73,106

​

​

83,705

Quality

​

​

—

​

​

149,199

​

​

—

​

​

85,787

General and administrative

​

​

2,435,974

​

​

2,109,196

​

​

465,663

​

​

562,874

Total operating expenses

​

​

8,991,664

​

​

9,805,078

​

​

2,340,147

​

​

2,600,367

Operating loss from continuing operations

​

​

(8,991,664)

​

​

(10,258,548)

​

​

(2,454,059)

​

​

(2,719,259)

Other income (expense):

​

​

​

​

​

​

​

​

​

​

​

​

Interest income

​

​

106,428

​

​

8,733

​

​

5,863

​

​

40

Interest expense

​

​

(48,385)

​

​

(656,552)

​

​

(37,175)

​

​

(305,374)

Amortization of discount on note

​

​

—

​

​

(108,620)

​

​

(10,862)

​

​

(32,586)

Change in fair value of derivative

​

​

—

​

​

(51,446)

​

​

—

​

​

193,971

Research grants

​

​

431,880

​

​

992,144

​

​

180,000

​

​

150,537

Loss from continuing operations

​

​

(8,501,741)

​

​

(10,074,289)

​

​

(2,316,233)

​

​

(2,712,671)

Gain on equity investment

​

​

4,495,500

​

​

—

​

​

—

​

​

—

Equity loss in affiliate

​

​

(1,025,000)

​

​

(2,358,392)

​

​

(640,000)

​

​

(223,633)

Gain on sale of equity investment

​

​

—

​

​

2,123,113

​

​

—

​

​

1,983,912

Gain on debt extinguishment

​

​

—

​

​

—

​

​

—

​

​

518,050

Gain on disposal of discontinued operations

​

​

1,802,555

​

​

—

​

​

—

​

​

—

Loss from discontinued operations

​

​

(818,113)

​

​

—

​

​

—

​

​

—

Net loss

​

$

(4,046,799)

​

$

(10,309,568)

​

$

(2,956,233)

​

$

(434,342)

Net loss per common share

​

​

​

​

​

​

​

​

​

​

​

​

Basic and diluted

​

$

(1.98)

​

$

(4.76)

​

$

(1.40)

​

$

(0.19)

Weighted average common shares outstanding, basic and diluted

​

​

2,043,356

​

​

2,165,105

​

​

2,108,981

​

​

2,255,378

61

​	Year ended December 31,				Three Months Ended March 31,
​	2019	2020			2020	2021
Pro forma net loss per common share basic and diluted (unaudited)	​	​	$	(0.98)		​	$	(0.04)
Pro forma weighted average shares outstanding, basic and diluted (unaudited)		​	​	10,479,641	​	​	​	10,569,914

​	As of December 31,						As of March 31, 2021
​	2020			2019
Balance Sheet Data:	​	​	​	​	​	​	​	​	​
Cash and cash equivalents	​	$	4,444,395	​	$	3,250,014	​	$	4,263,528
Working capital (deficit)(1)	​	​	(3,474,276)	​	​	2,249,556	​	​	(3,538,077)
Total assets	​	​	5,254,428	​	​	7,745,811	​	​	5,364,528
Total liabilities	​	​	9,627,131	​	​	2,517,700	​	​	10,009,372
Convertible preferred stock	​	​	46,661,490	​	​	46,661,490	​	​	46,661,490
Total stockholders’ deficit	​	$	(51,034,193)	​	$	(41,433,379)	​	$	(51,306,334)

(1)

We define working capital as current assets minus current liabilities.

62

MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with the section titled “Selected Financial Data” and the financial statements and the related notes included elsewhere in this prospectus. In addition to historical financial information, the following discussion contains forward-looking statements based upon our current plans, expectations and beliefs that involve risks, uncertainties and assumptions. Our actual results may differ materially from those described in or implied by these forward-looking statements as a result of many factors, including those set forth under the section titled “Risk Factors” and in other parts of this prospectus.

Overview

We are a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients’ lives. Organ disease is a major public health issue. According to the American Transplant Foundation, there are an estimated 114,000 people in the U.S. waiting for a lifesaving organ transplant, and on average 20 people die daily due to lack of available organs. We have developed a proprietary perfusion technology platform for bioengineering organs that we believe will efficiently scale to address the shortage of available human organs. Our initial development focus is on human livers and kidneys, and we have demonstrated the ability to bioengineer these organs with functional vasculature and important organ function in preclinical studies. In addition, we believe our technology platform will be able to develop other organs, including lungs, pancreas, and hearts. We have collaborations with the Mayo Clinic, Mount Sinai and the Texas Heart Institute, and our strategic investors include DaVita, Baxter and CareDx.

Substantially all of our revenue to date has been generated by royalties we received from the sale of our biologic surgical products Miromesh and Miroderm which we spun out as Reprise effective June 30, 2019 and subsequently divested our minority ownership stake in March 2021. We continue to receive a royalty on the sales of these products by Reprise. This prior acellular business is accounted for as discontinued operations in our financial statements. See ““Related Party Transactions — Reprise.”

Our revenue for the years ended December 31, 2020 and 2019 was $46,530 and $250,000, respectively, consisting entirely of licensing revenue. Our net loss for the years ended December 31, 2020 and 2019 was $10.3 million and $4.0 million, respectively. We have not been profitable since inception and as of December 31, 2020, we had an accumulated deficit of $59.4 million.

Components of Our Results of Operations

Revenue

For the periods presented, all of our revenue consists of licensing revenue pursuant to the license agreement with Reprise. Revenue pursuant to this agreement is recognized at the later of (i) when the related sales occur after the minimum guarantee is satisfied, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Cost of Goods Sold

Cost of goods sold for continuing operations relates to our license agreement with the University of Minnesota, pursuant to which we owe the University of Minnesota royalties on our revenues, which are subject to annual minimum payments.

Gross Margin

Our gross margin is calculated by subtracting our cost of goods sold from our revenue.

Research and Development Expenses

Research and development expenses consist primarily of engineering, product development, consulting services, materials, depreciation and other costs associated with products and technologies

63

in development. These expenses include payroll and related expenses, consulting expenses, laboratory supplies, and amounts incurred under certain collaborative agreements. Expenditures for research and development activities are charged to operations as incurred.

We expect research and development expenses in absolute dollars to increase in the future as we develop our lead product candidates and expand into other programs. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of new product development initiatives.

Regulatory and Clinical Expenses

Regulatory and clinical expenses include costs for developing our regulatory and clinical study strategies for our products. These expenses include payroll and related expenses and consulting expenses.

Over time we expect our regulatory and clinical expenses to increase in absolute dollars as we continue to expand our product offerings and move through various regulatory processes. We expect our regulatory and clinical expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.

Quality Expenses

Quality expenses relate to costs of systems and procedures to develop a cGMP manufacturing facility. These expenses include payroll and related expenses. We expect our quality expenses to increase in future years as we continue to develop the process and systems need to produce our products.

General and Administrative Expenses

General and administrative expenses include costs for our executive, accounting and human resources functions. Costs consist primarily of payroll and related expenses, professional service fees related to accounting, legal and other contract and administrative services and related infrastructure expenses.

We expect that our general and administrative expenses will increase in absolute dollars as we expand our headcount to support our growth and incur additional expenses related to operating as a public company, including director and officer insurance coverage, legal costs, accounting costs, costs related to exchange listing and costs related to SEC compliance and investor relations. We expect our general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, we generate revenue and our revenue grows.

Interest Income

Interest income consists of interest earned on our cash and cash equivalents.

Interest Expense

Interest expense consists of interest under our loan agreements. See “— Liquidity and Capital Resources.”

64

Results of Operations

Comparison of the Years Ended December 31, 2020 and 2019 and the Three Months Ended March 31, 2020 and 2021

​

Year ended December 31,

Change

Three Months Ended March 31,

Change

​

2019

2020

Dollar

Percentage

2020

2021

Dollar

Percentage

​

​

​

​

​

​

​

​

​

​

​

​

​

​

(unaudited)

​

​

(unaudited)

​

​

(unaudited)

​

(unaudited)

(in thousands)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Statement of Operations:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Licensing revenue

​

$

250

​

$

47

​

$

(203)

​

(81.2)%

​

$

11

​

$

6

​

$

(5)

​

(44.5)%

Cost of goods sold

​

​

250

​

​

500

​

​

250

​

100.0

​

​

125

​

​

125

​

​

—

​

0%

Gross margin

​

​

—

​

​

(453)

​

​

(453)

​

—

​

​

(114)

​

​

(119)

​

​

(5)

​

4.4

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Research and development

​

​

6,267

​

​

7,281

​

​

1,014

​

16.2

​

​

1,801

​

​

1,868

​

​

67

​

3.7

Regulatory and clinical

​

​

289

​

​

266

​

​

(23)

​

(8.0)

​

​

73

​

​

83

​

​

10

​

13.7

Quality

​

​

—

​

​

149

​

​

149

​

—

​

​

—

​

​

86

​

​

86

​

—

General and administrative

​

​

2,436

​

​

2,109

​

​

(327)

​

(13.4)

​

​

466

​

​

563

​

​

97

​

20.8

Total operating expenses

​

​

8,992

​

​

9,805

​

​

813

​

9.0

​

​

2,340

​

​

2,600

​

​

260

​

11.1

Operating loss from continuing operations

​

​

(8,992)

​

​

(10,258)

​

​

(1,266)

​

14.1

​

​

(2,454)

​

​

(2,719)

​

​

(265)

​

10.8

Other income (expense):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Interest income

​

​

106

​

​

9

​

​

(97)

​

(91.5)

​

​

6

​

​

—

​

​

(6)

​

(100.0)

Interest expense

​

​

(48)

​

​

(657)

​

​

(609)

​

1,268.8

​

​

(37)

​

​

(305)

​

​

(268)

​

724.3

Amortization of discount on note

​

​

—

​

​

(109)

​

​

(109)

​

(100.0)

​

​

(11)

​

​

(33)

​

​

(22)

​

(200.0)

Change in fair value of derivative

​

​

—

​

​

(51)

​

​

(51)

​

(100.0)

​

​

—

​

​

194

​

​

194

​

100.0

Research grants

​

​

432

​

​

992

​

​

560

​

129.6

​

​

180

​

​

150

​

​

(30)

​

(16.7)

Loss from continuing operations

​

​

(8,502)

​

​

(10,074)

​

​

(1,572)

​

18.5

​

​

(2,316)

​

​

(2,713)

​

​

(397)

​

17.1

Gain on equity investment

​

​

4,495

​

​

—

​

​

(4,495)

​

(100.0)

​

​

—

​

​

—

​

​

—

​

—

Equity loss in affiliate

​

​

(1,025)

​

​

(2,358)

​

​

(1,333)

​

(130.0)

​

​

(640)

​

​

(223)

​

​

417

​

65.2

Gain on sale of equity investment

​

​

—

​

​

2,123

​

​

2,123

​

100.0

​

​

—

​

​

1,984

​

​

1,984

​

100

Gain on debt extinguishment

​

​

—

​

​

—

​

​

—

​

—

​

​

—

​

​

518

​

​

518

​

100.0

Gain on disposal of discontinued operations

​

​

1,803

​

​

—

​

​

(1,803)

​

(100.0)

​

​

—

​

​

—

​

​

—

​

—

Loss from discontinued operations

​

​

(818)

​

​

—

​

​

818

​

100.0

​

​

—

​

​

—

​

​

—

​

—

Net loss

​

$

(4,047)

​

$

(10,309)

​

$

(6,262)

​

154.7%

​

$

(2,956)

​

$

(434)

​

$

2,522

​

(85.3)%

Revenue

Licensing revenue decreased by $203,000, or 81.2%, from $250,000 for the year ended December 31, 2019, to $47,000 for the year ended December 31, 2020. The decrease in licensing revenue was due to the minimum royalty due from Reprise for 2020 being deferred until 2022. Due to uncertainty regarding the collectability of this minimum royalty from Reprise in 2022, the Company has set up an allowance to offset the full year receivable amount.

Licensing revenue decreased by $5,000, or 44.5%, from $11,000 for the three months ended March 31, 2020, to $6,000 for the three months ended March 31, 2021. The decrease in licensing revenue was due to lower royalties on the licensing agreement with Reprise.

65

Cost of Goods Sold

Cost of goods sold increased by $250,000, or 100%, from $250,000 for the year ended December 31, 2019 to $500,000 for the year ended December 31, 2020. The cost of goods sold relates to the minimum royalties due to the University of Minnesota under our licensing agreement. The increase is a result of the minimum royalty for the first half of 2019 being recorded in discontinued operations as a result of the spin-out of the acellular business to Reprise.

Cost of goods sold was $125,000 for both the three months ended March 31, 2020 and 2021 and is a result of the minimum royalty due to the University of Minnesota under our licensing agreement.

Gross Margin

Gross margin was $(453,000) and $0 for the years ended December 31, 2020 and 2019, respectively. For the year ended December 31, 2020, the Company recorded the minimum royalty due to the University of Minnesota under our licensing agreement. In the year ended December 31, 2019, licensing revenue equaled the cost of goods sold for each of those periods.

Gross margin decreased by $5,000 from $(114,000) for the three months ended March 31, 2020, to $(119,000) for the three months ended March 31, 2021. The gross margin was negative for the three months ended March 31, 2021 and 2020 due to the uncertainty of collecting the deferred minimum royalty from Reprise.

Research and Development

Research and development expenses increased by $1.0 million, or 16.2%, from $6.3 million for the year ended December 31, 2019, to $7.3 million for the year ended December 31, 2020. The increase was due primarily to increases of $0.5 million for salary and benefits resulting from increased headcount and $0.4 million related to an increase in lab supplies.

Research and development expenses increased by $67,000, or 3.7%, from $1,801,000 for the three months ended March 31, 2020, to $1,868,000 for the three months ended March 31, 2021. The increase in research and development expenses was primarily due to increases in employee costs and lab supplies partially offset by a decrease in contract pre-clinical costs.

Regulatory and Clinical

Regulatory and clinical expenses remained largely flat at $266,000 and $289,000 for the years ended December 31, 2020 and 2019, respectively. The slight decrease was due primarily to a decrease in consulting expenses.

Regulatory and clinical expenses increased by $10,000, or 13.7%, from $73,000 for the three months ended March 31, 2020, to $83,000 for the three months ended March 31, 2021. The increase in regulatory and clinical expenses was due to increases in employee costs.

Quality Expenses

Quality expenses were $0 and $149,000 for the years ended December 31, 2019 and 2020, respectively. The increase was due to an increase in salary and benefits resulting from increased headcount.

Quality expenses increased by $86,000, from $0 for the three months ended March 31, 2020, to $86,000 for the three months ended March 31, 2021. The increase was due to an increase in salary and benefits resulting from increased headcount.

General and Administrative

General and administrative expenses decreased by $0.3 million, or 13.4%, from $2.4 million for the year ended December 31, 2019, to $2.1 million for the year ended December 31, 2020. The $0.3 million

66

decrease was primarily due to a $0.4 million decrease in salary and benefits resulting from lower stock option expense and reduced headcount.

General and administrative expenses increased by $97,000, or 20.8%, from $466,000 for the three months ended March 31, 2020, to $563,000 for the three months ended March 31, 2021. The increase in general and administrative expenses was primarily due to an increase in expenses relate to the Company’s audit.

Interest Income

Interest income increased approximately $97,000, or 1,077.8%, from $9,000 for the year ended December 31, 2019 to $106,000 for the year ended December 31, 2020. The decrease was due to a lower average cash on hand balance and lower interest rates on those balances in 2020 as compared with 2019.

Interest income decreased by $6,000, or 100%, from $6,000 for the three months ended March 31, 2020, to $0 for the three months ended March 31, 2021. The decrease in interest income was due to a lower average cash on hand balance and lower interest rates on those balances in 2021 as compared with 2020.

Interest Expense

Interest expense increased by approximately $600,000, or 1,268.8%, from $48,000 for the year ended December 31, 2019 to $657,000 for the year ended December 31, 2020. The increase was primarily the result of interest expense on the March 2020 note with one of our shareholders as well as interest on the paycheck protection program loan we received in 2020.

Interest expense increased by $268,000, or 724.3%, from $37,000 for the three months ended March 31, 2020, to $305,000 for the three months ended March 31, 2021. The increase was primarily the result of interest expense on the March 2020 note with one of our shareholders.

Amortization of Discount on Note

During the year ended December 31, 2020 the Company recognized amortization expense related to a promissory note issued in March 2020.

Amortization expense related to the promissory note issued in March 2020 increased by $22,000, or 200%, from $11,000 for the three months ended March 31, 2020, to $33,000 for the three months ended March 31, 2021. The increase in amortization expense was due to there only being one month of amortization expense in the three months ended March 31, 2020 versus three months in the comparable period in 2021.

Change in Fair Value of Derivative

During the year ended December 31, 2020 the Company recorded a change in the fair value of an embedded derivative related to a promissory note issued in 2020.

The Change in fair value of the embedded derivative related to the promissory note issued in 2020 decreased by $194,000, or 100%, from $0 for the three months ended March 31, 2020, to $194,000 for the three months ended March 31, 2021. The decrease in the change in fair value of the embedded derivative was due to a re-valuation of the the liability as of March 31, 2021.

Research Grants

Research grants increased by approximately $560,000, or 129.6%, from $432,000 for the year ended December 31, 2019 to $992,000 for the year ended December 31, 2020. The increase was the result of increased grant funds received under an NIH grant related to the Miroliver program.

Research grants decreased by $30,000, or 16.7%, from $180,000 for the three months ended March 31, 2020, to $150,000 for the three months ended March 31, 2021. The decrease in research

67

grants was primarily due to a decrease in the expenditures for pre-clinical contracting, resulting in lower grant funds, during the three months ended March 31, 2021 as compared to the three months ended March 31, 2020.

Gain on Equity Investment

For the year ended December 31, 2019 we had a gain on equity investment of $4.4 million. The gain on equity investment in Reprise resulted from recording the fair value of the Company’s investment in Reprise upon losing a controlling interest in the Company on June 30, 2019.

Equity Loss in Affiliate

Equity loss in affiliate was $1.0 million and $2.4 million for the years ended December 31, 2019 and 2020, respectively. In the year ended December 31, 2019 we recorded our equity method losses in Reprise from the date of the spinout, June 30, 2019, to December 31, 2019 and in the year ended December 31, 2020 we recorded our equity method losses in Reprise from January 1, 2020 through December 31, 2020.

Equity loss in affiliate decreased by $416,000, or 65.0%, from $640,000 for the three months ended March 31, 2020, to $224,000 for the three months ended March 31, 2021. The decrease in equity loss in affiliate was due to the Company owning a smaller percentage of Reprise Biomedical, Inc. in the three months ended March 31, 2021 as compared to the comparable period in the prior year as well as the Company selling all of its ownership in Reprise on March 15, 2021.

Gain on Debt Extinguishment

During the three months ended March 31, 2021 the Company had a gain on the extinguishment of debt of $518,000 related to the forgiveness of a loan under the Small Business Administration’s Paycheck Protection Program.

Gain on Sale of Equity Investment

For the year ended December 31, 2020 we recognized a gain of $2.1 million related to the sale of 2.7 million shares in Reprise.

For the three months ended March 31, 2021 we recognized a gain of $2.0 million related to the sale of 1.8 million shares in Reprise.

Gain on Disposal of Discontinued Operations

For the year ended December 31, 2019 we had a gain on disposal of discontinued operations of $1.8 million. This is the result of the difference between the $2.5 million payment we received upon spinning out Reprise and the carrying value of the assets transferred to Reprise.

Loss from Discontinued Operations

In the year ended December 31, 2019 we had a loss from discontinued operations of $0.8 million. This represents the loss on our acellular business from January 1, 2019 to the day the acellular business was spun-out to Reprise, June 30, 2019.

Liquidity and Capital Resources

We have incurred net losses since our inception. We incurred net losses of $10.3 million and $4.0 million for the years ended December 31, 2020 and 2019, respectively. As of December 31, 2020, we had an accumulated deficit of $59.4 million. For the three months ended March 31, 2021 and 2020, we incurred net losses of $434,000 and $2,956,000, respectively. As of March 31, 2021, we had an accumulated deficit of $59.8 million.

We expect to incur additional losses in the near future, and we expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue to develop our

68

bioengineered organs, as we conduct clinical trials and other studies for our bioengineered organs, seek regulatory clearances or approvals for Miroliver and Mirokidney, continue preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and to invest in our infrastructure to support our future manufacturing and other activities. In addition, upon the completion of this offering, we expect to incur additional costs associated with operating as a public company in the United States. The timing and amount of our operating expenditures will depend largely on our ability to, among other things:

•

advance clinical development of our product candidates;

•

manufacture, or have manufactured on our behalf, our preclinical and clinical materials and develop processes for commercial manufacturing of any product candidates that may receive regulatory approval;

•

seek regulatory approvals for any product candidates that successfully complete clinical trials;

•

establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own;

•

establish collaborations to commercialize any product candidates for which we may obtain marketing approval but do not intend to commercialize on our own;

•

expand our operational, financial and management systems and hire additional personnel, including personnel to support our clinical development, quality control, research and development, manufacturing and commercialization efforts, our general and administrative activities and our operations as a public company; and

•

obtain new intellectual property and maintain, expand and protect our intellectual property portfolio.

To date, we have primarily financed our operations through equity and debt financings as well as research grants. We believe that the anticipated net proceeds from this offering, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements through            . As of December 31, 2020, we had cash and cash equivalents of $4.4 million. As of March 31, 2021, we had cash and cash equivalents of $4.3 million. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

Until such time, if ever, as we can generate substantial revenue from sales of our bioengineered organs, we expect to finance our cash needs through a combination of securities offerings and debt financings. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our shareholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Additional capital may not be available when needed, on reasonable terms, or at all, and our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, curtail or discontinue our product development or future commercialization efforts, or grant rights to develop and market products that we would otherwise prefer to develop and market ourselves.

In December 2010, we entered into a loan and security agreement with the Minnesota Agricultural and Economic Development Board under which we borrowed $250,000. The loan was secured by our accounts receivable and bore an interest rate of 6% per annum. This loan matured on November 1, 2020.

In January 2012, we signed a promissory note with the Regents of the University of Minnesota for $405,559. The promissory note bears interest at 3% per annum, compounded monthly. The note matures

69

on December 31, 2022 and is unsecured. We are required to make monthly principal and interest payments of $7,737 until the note is paid in full. In connection with the promissory note, we issued the Regents of the University of Minnesota warrants to purchase 80,000 shares of our common stock at an exercise price of $1.69. As of December 31, 2020 and 2019, the principal outstanding on this loan was $172,731 and $258,990, respectively.

In May 2015, we entered into a loan agreement with the Minnesota Department of Employment & Economic Development under which we borrowed $250,000. The loan is unsecured and does not bear interest. The loan is due in a lump sum payment on April 1, 2022. As of both December 31, 2020 and 2019, the balance outstanding on this loan was $250,000.

In October 2018, we entered into a lease agreement for certain lab equipment, which is being accounted for as a capitalized lease. The total cost of the equipment was $102,026. The lease bears interest at 7.2% per annum and we will make 60 payments in total of $2,003 until the lease is paid in full. As of December 31, 2020 and 2019, the amount outstanding on the lease was $57,127 and $74,674, respectively. The lease is secured by the lab equipment.

In January 2019, we issued the University of Minnesota a promissory note in the amount of $385,997 in satisfaction of our minimum royalty obligation under the University of Minnesota License Agreement for the year ended December 31, 2018. The note bears interest at 6% per annum and is due on January 31, 2025. In addition, we issued the University a 10-year warrant to purchase 20,587 shares of our common stock at an exercise price of $3.75 per share.

On March 6, 2020, we entered into a note and warrant purchase agreement (the “Cheshire Purchase Agreement”) with Cheshire MD Holdings, LLC (“Cheshire”), an affiliate of DaVita Inc., under which we received a bridge financing of $6,000,000. In connection with the Cheshire Purchase Agreement, we issued a $6,000,000 convertible promissory note (the “Cheshire Note”) to Cheshire and issued Cheshire a warrant to purchase up to $750,000 of shares of our preferred stock. The Cheshire Note is unsecured and has a maturity date of September 6, 2021. If we complete a preferred stock offering of at least $34,000,000 prior to the maturity date, the Cheshire Note and all accrued interest will automatically convert into preferred shares of such offering at the offering price. The Cheshire Note bore interest at 5% per annum through and until May 1, 2020, at which time the interest rate increased to 7%. The interest rate increased by an additional 2% on the first day of each subsequent month (beginning on June 2, 2020) prior to the maturity date, provided that the interest rate shall not exceed 20%. As of December 1, 2020, the interest rate reached the maximum of 20%. Under the Cheshire Purchase Agreement, as long as the Cheshire Note remains outstanding, the Company is required to issue to Cheshire additional warrants, on the first date of each month beginning on May 1, 2020, to purchase up to $75,000 of shares of our preferred stock. As of May 1, 2021, Cheshire holds warrants to purchase up to $1,725,000 of shares of our preferred stock.

On April 16, 2020, we issued a promissory note for $563,397 under the Paycheck Protection Program through the U.S. Small Business Administration (“SBA”), as part of the Coronavirus Aid, Relief and Economic Security Act. The promissory note is unsecured and is fully guaranteed by the SBA. The promissory note bears interest at 1% per annum and is due on April 16, 2022. Under the terms of the note, some or all of the debt may be forgiven based upon our use of the funds. We received notification from the bank in March 2021 that $513,520 had been forgiven and are working to have the remaining amount forgiven.

Following the completion of this offering, we will incur additional costs of operating as a public company. Based on our current business plan, we believe that our existing cash resources and estimated net proceeds from this offering will be sufficient to meet our capital requirements and fund our operations for at least the next 12 months. If these sources are insufficient to satisfy our liquidity requirements, we may seek to sell additional common equity or debt securities, or enter into a new credit facility. If we raise additional funds by issuing equity securities, our stockholders would experience dilution and any new equity securities could have rights, preferences and privileges superior to those of holders of our common stock, including the shares of common stock sold in this offering. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. We cannot be assured that additional equity or debt financing will be available on terms favorable

70

to us or our stockholders, or at all. If we are unable to obtain adequate financing we may be required to delay the development, commercialization and marketing of our product candidates.

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:

​

Year Ended December 31,

Three Months Ended March 31,

(in thousands)

2019

2020

2020

2021

Net cash provided by (used in):

​

​

​

​

​

​

​

​

​

​

​

​

Operating activities

​

$

(8,325)

​

$

(8,038)

​

$

(2,071)

​

$

(2,177)

Investing activities

​

​

10,361

​

​

2,877

​

​

(7)

​

​

1,994

Financing activities

​

​

313

​

​

6,355

​

​

6,030

​

​

2

Net increase in cash and cash equivalents

​

$

2,349

​

$

1,194

​

$

3,952

​

$

(181)

Operating Activities

Net cash used in operating activities consisted of net losses adjusted for certain non-cash items and changes in operating assets and liabilities.

During the year ended December 31, 2020 net cash used in operating activities was $8.0 million and reflected (i) the net loss of $10.3 million, (ii) net non-cash items of $1.2 million, including $0.6 million of stock-based compensation, depreciation and amortization of $0.2 million, $2.4 million in equity loss in affiliate, offset by a gain on sale of stock of $2.1 million, and (iii) a net cash inflow from changes in balances of operating assets and liabilities of $1.1 million. The most significant item comprising the changes in balances of operating assets and liabilities was a higher balance of accrued interest of $0.6 million.

During the year ended December 31, 2019 net cash used in operating activities was $8.3 million and reflected (i) the net loss of $4.0 million, (ii) net non-cash items usage of $4.0 million, including gain on disposal of discontinued operations of $1.8 million and gain on equity investment of $4.5 million offset by $0.9 million of stock-based compensation, depreciation and amortization of $0.3 million, $1.0 million in equity loss in affiliate, and (iii) a net cash outflow from changes in balances of operating assets and liabilities of $0.3 million. The most significant items comprising the changes in balances of operating assets and liabilities was a $0.2 million receivable from Reprise, a $0.3 million grant receivable, a decrease in accounts payable and accrued expenses of $0.1 million offset by a $0.2 million decrease in accounts receivable and a $0.1 million decrease in inventories.

During the three months ended March 31, 2021 net cash used in operating activities was $2,177,000 and reflected (i) the net loss of $434,000, (ii) net non-cash usage items of $2,276,000, including a gain on sale of equity investment of $1,984,000, $518,000 related to the forgiveness of a paycheck protection program loan and $194,000 related to the change in fair value of embedded derivative, partially offset by $133,000 of stock-based compensation and $224,000 in equity loss in affiliate, and (iii) a net cash inflow from changes in balances of operating assets and liabilities of $533,000.

During the three months ended March 31, 2020 net cash used in operating activities was $2,071,000 and reflected (i) the net loss of $2,956,000, (ii) net non-cash items of $876,000, including $157,000 of stock-based compensation and $640,000 in equity loss in affiliate, and (iii) net cash inflows from changes in balances of operating assets and liabilities of $9,000. The most significant items comprising the changes in balance of operating assets and liabilities was a lower balance of receivable from Reprise of $217,000 and a lower balance of grant receivable of $257,000, partially offset by a lower balance of accounts payable and accrued expenses of $440,000.

Investing Activities

For the year ended December 31, 2020 investing activities provided $2.9 million of cash. The sale of reprise stock provided $3.0 million of cash offset by $0.1 million of capital equipment purchases.

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For the year ended December 31, 2019 investing activities provided $10.3 million of cash. Sales of short-term investments provided $8.0 million of cash and proceeds from the sale of the acellular business provided $2.5 million. These were offset by $0.1 million of capital equipment purchases.

During the three months ended March 31, 2021, net cash provided by investing activities was $1,994,000 and reflected $2,000,000 from the sale of Reprise stock and $6,000 used to purchase equipment.

During the three months ended March 31, 2020, net cash used in investing activities was $7,000 to purchase equipment.

Financing Activities

For the years ended December 31, 2020 and 2019 financing activities provided $6.4 million and $0.3 million of cash, respectively, primarily from the net proceeds of long-term debt.

During the three months ended March 31, 2021, net cash provided by financing activities was $2,000 primarily related to proceeds from stock option exercises partially offset by payments on long term debt.

During the three months ended March 31, 2020, net cash provided by financing activities was $6,030,000 primarily related to proceeds from a promissory note with one our our shareholders.

Contractual Obligations and Commitments

The following table summarizes our contractual obligations as of March 31, 2021 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:

​

Payments due by Period

​

Total

Less than 1 year

1 to 3 years

3 to 5 years

More than 5 years

Principal payments on long—term debt

​

$

7,372,125

​

$

6,481,774

​

$

504,354

​

$

385,997

​

$

—

Interest on long—term debt(1)

​

​

1,598,435

​

​

1,434,896

​

​

1,822

​

​

161,717

​

​

—

Capitalized lease

​

​

63,342

​

​

22,356

​

​

40,986

​

​

—

​

​

—

Operating leases

​

​

240,386

​

​

240,386

​

​

—

​

​

—

​

​

—

Total

​

$

9,274,288

​

$

8,179,412

​

$

547,162

​

$

547,714

​

$

—

(1)

Interest payable reflects the rate in effect as of March 31, 2021.

Quantitative and Qualitative Disclosures about Market Risk

We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate risks, foreign currency exchange risks and inflation risks. Periodically, we maintain deposits in accredited financial institutions in excess of federally insured limits. We deposit our cash in financial institutions that we believe have high credit quality and have not experienced any losses on such accounts and do not believe we are exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Interest Rate Risk

Our cash consists of cash in readily-available checking accounts and short-term money market fund investments. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant.

Foreign Currency Exchange Risk

All of our employees and our operations are currently located in the United States. We have, from time-to-time, engaged in contracts with contractors or other vendors in a currency other than the U.S.

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dollar. To date, we have had minimal exposure to fluctuations in foreign currency exchange rates as the time period between the date that transactions are initiated and the date of payment or receipt of payment is generally of short duration. Accordingly, we believe we do not have a material exposure to foreign currency risk.

Inflation Risk

Inflation generally affects us by increasing our cost of labor and research and development costs. We do not believe inflation has had a material effect on our results of operations during the periods presented.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operation is based on our financial statements, which have been prepared in accordance with United States generally accepted accounting principles or U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Items subject to estimates based on judgments include, but are not limited to: the valuation of options and warrants to purchase common stock and the determination of the valuation allowance associated with deferred tax assets. Actual results could differ from these estimates and such differences could affect the results of operations in future periods.

Our significant accounting policies are described in Note 1 to our audited financial statements included elsewhere in this prospectus. Some of these accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. We believe that the following critical accounting policies reflect the more significant estimates and assumptions used in the preparation of our financial statements.

Stock-Based Compensation

We recognize compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant, net of estimated forfeitures. We estimate the grant date fair value, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model. The grant date fair value of the stock-based awards is expensed on a straight-line basis over the vesting period of the respective award.

Information regarding our stock option grants, along with the estimated fair value per share of the underlying common stock for stock options granted from January 1, 2019 to December 31, 2020 is summarized below:

Grant Date	Number of Shares Granted		Exercise Price Per Share			Estimated Fair Value Per Share of Common Stock
January 24, 2019	​	38,000	​	$	3.75	​	$	3.23
February 18, 2019	​	8,000	​	$	3.75	​	$	3.23
May 1, 2019	​	30,000	​	$	3.75	​	$	3.23
July 25, 2019	​	242,000	​	$	3.75	​	$	3.23
July 31, 2019	​	8,000	​	$	3.75	​	$	3.23
August 31, 2019	​	5,000	​	$	3.75	​	$	3.23
October 28, 2019	​	36,000	​	$	3.75	​	$	3.23
February 4, 2020	​	54,000	​	$	3.75	​	$	3.23
April 21, 2020	​	17,000	​	$	3.75	​	$	3.23

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Grant Date	Number of Shares Granted		Exercise Price Per Share			Estimated Fair Value Per Share of Common Stock
July 14, 2020	​	113,000	​	$	3.75	​	$	3.23
July 16, 2020	​	80,000	​	$	3.75	​	$	3.23
November 17, 2020	​	54,000	​	$	3.75	​	$	3.23
December 17, 2020	​	20,000	​	$	3.75	​	$	3.23

As a result of our Black-Scholes option fair value calculations, we recognized stock-based compensation expense of $930,000 and $655,000 during the years ended December 31, 2019 and 2020, respectively. As of December 31, 2020, total compensation cost related to unvested stock options not yet recognized in the financial statements was approximately $562,000 which will be recognized over the next four years. We expect to continue to grant stock options in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase. Following the consummation of this offering, stock option award values will be determined based on the quoted market price of our common stock.

The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which help us determine the estimated fair value of stock-based awards, including the expected term and the price volatility of the underlying stock. These assumptions include:

•

Expected Term:   The expected term represents the period for which our stock-based awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the options and the holders’ historical exercise patterns and termination behavior.

•

Volatility:   We used an average historical stock price volatility of comparable public companies that were deemed to be representative of future stock price trends as we do not have any trading history for our common stock.

•

Risk-Free Interest Rate:   We base the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant.

•

Expected Dividends:   We have not paid and do not anticipate paying any dividends in the near future.

In addition to the assumptions used in the Black Scholes option-pricing model, we must also estimate a forfeiture rate to calculate the stock-based compensation for our awards. We will continue to use judgment in evaluating the expected volatility, expected terms and forfeiture rates utilized for our stock-based compensation calculations on a prospective basis.

The estimated grant date fair values of the employee and non-employee stock options were based on the following weighted-average assumptions:

​	2020	2019
Expected life in years	5.7 years	6.1 years
Risk—free interest rate	0.63%	2.04%
Expected dividend yield	0	0
Expected volatility	35.0%	44.6%

We are also required to estimate the fair value of the common stock underlying our stock-based awards when performing the fair value award calculations using the Black-Scholes option-pricing model. The estimated fair value of the common stock underlying our stock-based awards was determined on each grant date by our board of directors, with input from management. Our board of directors is comprised of a majority of non-employee directors with significant experience investing in and operating companies in the Company’s industry. As such, we believe that our board of directors has the relevant experience to determine a fair value of our common stock on each respective grant date.

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Given the absence of a public trading market of our common stock, and in accordance with the American Institute of Certified Public Accountants, or AICPA, Practice Aid, Valuation of Privately-held-Company Equity Securities issued as Compensation (the AICPA Practice Aid) our board of directors exercised reasonable judgment and considered numerous objective and subjective factors to determine the best estimate of the fair value of our common stock.

Significant Factors, Assumptions and Methodologies Used in Determining the Estimated Fair Value of Our Common Stock

The exercise price of our stock options and the estimated fair value of the common stock underlying the options was determined by our board of directors with input from management, after taking into account the relevant valuations from an independent third-party valuation specialist. The board of directors utilized the fair values of the common stock derived in the third-party valuations as a factor to set the exercise prices for options granted, however management and our board of directors assume full responsibility for the estimates. Our board of directors determined the estimated fair value of our common stock on the date of each grant based on a number of objective and subjective factors, including:

•

the superior rights and preferences of the convertible preferred stock relative to those of our common stock, including the liquidation preferences of the convertible preferred stock;

•

our operating results and financial condition, including our levels of available capital resources;

•

material risks related to our business;

•

the lack of liquidity of our common stock as a private company and the state of the initial public offering market for similarly situated private companies;

•

the estimated likelihood of achieving a liquidity event such as an initial public offering and valuation conditions on our ability to go public;

•

the results of research and development activities;

•

external market conditions affecting the life sciences industry sector;

•

the valuation of publicly traded companies in the life sciences sector;

•

valuations performed by an independent third party; and

•

general U.S. economic conditions, including stock volatility and interest rates.

Our board of directors intended all options granted to be exercisable at a price per share not less than fair market value of the shares of our stock underlying those options on their respective dates of grant.

There are significant judgments and estimates inherent in the determination of the estimated fair value of our common stock. These judgments and estimates include assumptions regarding our future operating performance, the time to a liquidity event, such as an initial public offering, or other event and the determination of the appropriate valuation methods. If we had made different assumptions, our stock-based compensation expense, net loss and net loss per share could have been significantly different.

Following the completion of this offering, the fair value of our common stock will be based on the closing price as reported on the date of grant on the primary stock exchange on which our common stock is traded.

Research and Development Expenses

Our research and development expenses consist primarily of engineering, product development, consulting services, materials, depreciation and other costs associated with products and technologies in development. These expenses include employee and non-employee compensation, including stock-based compensation, supplies, materials, consulting, related travel expenses and facility costs. We charge expenditures for research and development activities to operations as they are incurred.

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Equity Method Investment

We account for our equity investments in 20% to 50%-owned companies under the equity method as the Company can exercise significant influence, but not control, over such investments. The equity method requires that gains (losses) are recognized in other income (expense), net in the statements of operations. Our gain on equity investment in Reprise resulted from recording the fair value of the Company’s investment in Reprise upon losing a controlling interest in the Company on June 30, 2019. The Company recorded its equity method share of losses in Reprise from July 1, 2019 through December 31, 2019 and from January 1, 2020 to December 31, 2020 in the statements of operations. Even though the Company’s ownership dropped to 18% on November 15, 2020, the Company still had significant influence over the activities of Reprise due to common board members.

License Revenue

We recognize revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (ASC 606).

In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps: (i) identify the contract with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) each performance obligation is satisfied.

Our agreements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur after the minimum guarantee is satisfied, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). We assess the collectability of the consideration and only recognize revenue when the collectability of the consideration is deemed probable. We re-assess the collectability of the consideration on a periodic basis, typically quarterly, and recognize revenue deemed probable of being collected.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Recently Issued and Adopted Accounting Pronouncements

There are no new accounting pronouncements issued that are expected to significantly impact our financial statements or results of operations.

Internal Controls over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP. As a result of becoming a public company, we will be required, under Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting beginning with our second annual report due to be filed with the SEC after becoming a public company. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. The SEC defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be detected or prevented on a timely basis.

In preparation for our initial public offering, we identified a significant deficiency in our internal control over financial reporting related to our control environment. Specifically, we have determined that we have not maintained sufficient staffing or written policies and procedures for accounting and

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financial reporting, which contributed to the lack of a formalized process or controls for management’s timely review and approval of financial information. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention by those responsible for oversight of the company's financial reporting.

More specifically, we have determined that our financial statement close process includes significant control gaps mainly driven by the small size of our accounting and finance staff and, as a result, a significant lack of appropriate segregation of duties. We also determined that we have not maintained sufficient staffing or written policies and procedures for accounting and financial reporting, which contributed to the lack of a formalized process or controls for management’s timely review and approval of financial information.

The process of designing and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate and take actions to improve our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine to modify certain of the remediation measures described above. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to remediate the significant deficiency we have identified or avoid potential future material weaknesses.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards.

We will remain an emerging growth company until the earlier of (1) following the fifth anniversary of the completion of this offering, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.07 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

•

we may present only two years of audited financial statements, plus unaudited condensed financial statements for any interim period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

•

we may avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;

•

we may provide reduced disclosure about our executive compensation arrangements; and

•

we may not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering

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is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company after this offering if either (1) the market value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

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BUSINESS

Overview

Our mission: Eliminate the organ transplant waiting list

We are a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients’ lives. Organ disease is a major public health issue. According to the American Transplant Foundation there are an estimated 114,000 people in the United States waiting for a lifesaving organ transplant, and on average 20 people die daily due to lack of available organs. We have developed a proprietary perfusion technology platform for bioengineering organs that we believe will efficiently scale to address the shortage of available human organs. Our initial development focus is on human livers and kidneys, and we have demonstrated the ability to bioengineer these organs with functional vasculature and important organ function in preclinical studies. In addition, we believe our technology platform will be able to develop other organs including, lungs, pancreas, and hearts. We have collaborations with the Mayo Clinic, Mount Sinai and the Texas Heart Institute, and our strategic investors include DaVita, Baxter and CareDx.

Our proprietary perfusion decellularization and recellularization technology harnesses the powerful evolutionary forces shaping complex organ development and the regenerative capabilities of living human cells. We believe the organs we are developing could have significant functional and immunological advantages compared to other organ development techniques which rely on the genetic modification of animal cells, such as xenotransplantation. Our perfusion decellularization and recellularization technology platform includes 118 issued and 35 pending patent applications with protection in the U.S. and major markets worldwide.

•

Decellularization.   The anatomical structure of organs is highly complex and enormously challenging to reproduce synthetically. We utilize porcine organs as the scaffold for creating human organs because significant anatomical and vascular similarities exist between the two species’ scaffolding. Using our proprietary perfusion decellularization process we remove the porcine cells from harvested porcine organs leaving behind a scaffold of extracellular matrix (“ECM”) that retains the architecture, mechanical properties, and vascular network of the original organ structure. Porcine ECM is estimated to be over 93% homologous to human ECM which significantly reduces potential for antibody formation and adverse reaction. In addition, we have generated human clinical data demonstrating the safety of our decellularized porcine liver scaffold in clinical trials of two products that we previously developed, commercialized and spun out, Miromesh and Miroderm.

•

Recellularization.   Recellularization is the process of growing new functional organs starting with the ECM that remains after the decellularization process is completed. We currently use living human cells harvested from organ donors to re-seed the ECM, and in the future intend to develop new techniques using patient-derived stem cells. Living human cells are adaptive, and when introduced into the decellularized ECM display unique regenerative, plasticity, and adhesion properties. The process of recellularization occurs in a bioreactor where media and living human cells are perfused into the ECM in the appropriate sequence in order to facilitate cellular regeneration and organ functionality.

We hope to initiate our first Phase 1 clinical trial in late 2022 with our External Liver Assist Product (“ELAP System”), which we believe will be the first-ever study to assess the function of a bioengineered liver in humans. This study will utilize external liver assist devices in combination with our bioengineered livers to provide external temporary liver support to human participants with acute liver failure. We hope to report interim results in early 2023. We plan to engage the FDA to open separate INDs for bioengineered livers and kidneys. We would then proceed with additional Phase 1 clinical studies with full transplants of our bioengineered livers and kidneys to treat participants with liver failure and end-stage renal disease (“ESRD”), respectively. We could potentially begin these additional studies in late 2023 or early 2024.

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Our History

We were formed in 2009 and entered into an exclusive license agreement with the University of Minnesota in 2010. To obtain human clinical data on the safety of our base acellular porcine liver-derived scaffold, we developed and commercialized two medical device products using our proprietary perfusion decellularization technology: Miromesh, primarily utilized for hernia repair applications, and, Miroderm, indicated for a variety of advanced wound care applications. Miromesh and Miroderm received 510(k) clearances in 2014 with Miroderm receiving an additional 510(k) clearance in 2015. We completed three post-market clinical studies on Miromesh and Miroderm with implants now exceeding five years. Since the commercial launches of Miromesh and Miroderm, thousands of patients have been treated with decellularized liver medical device products derived from our technology. Commercialization of our base acellular liver-derived scaffold demonstrated our ability to source, manufacture and scale our technology in accordance with FDA requirements for medical devices. We believe that having already demonstrated the safety of the base porcine liver scaffold and perfusion decellularization technology, including the implantation of these products in patients, partially de-risks the development of our lead product candidates.

In order to focus all of our efforts on bioengineered human organs, we spun out the commercial acellular business as Reprise in June 2019, and subsequently divested our minority ownership stake in March 2021. Reprise is now manufacturing and selling the Miromesh and Miroderm products as well as developing additional acellular products. We are entitled to a 6.5% royalty for sales of these products by Reprise through 2028. See “Related Party Transactions — Reprise.”

Our Lead Programs

We believe that our lead bioengineered human organ transplant programs in liver disease and kidney failure represent a significant unmet market opportunity.

Miroliver Program:   We are developing a bioengineered liver for the treatment of acute and chronic liver failure. By implanting tissue-engineered liver grafts in pigs, we have demonstrated that these organs have a vascular function similar to a normal donor liver. This research was published in Nature Biomedical Engineering. We also completed a preclinical study that demonstrated patency and hepatocyte survival in a heterotopic implant.

We are intending to submit an IND to the FDA in late 2022 and anticipate reporting interim first in human data in early 2023 for the use of our ELAP System to treat acute liver failure. The ELAP System consists of an external perfusion system and our bioengineered liver that will reside outside of the human body to provide temporary liver support. We believe we will be the first company to report data from a bioengineered human liver, which is intended to demonstrate our ability to provide critical liver function in a human. We believe we have successfully completed the most challenging scientific milestones associated with bioengineering livers in a scalable model, and in late 2020 we bioengineered livers with greater than 10 billion hepatocytes, a cell count we believe is adequate to provide the required function.

In late 2019, we had a productive INTERACT meeting with the FDA regarding our planned regulatory pathway for our implantable liver program. This program is an orthotopic transplantation where the native liver is completely removed and replaced with our bioengineered liver. We believe it is important to first demonstrate function of our bioengineered livers using the ELAP System outside of the patient’s body, and intend to use this data to expedite development efforts in our implantable liver program. Assuming we are able to proceed with the study of the ELAP System and proceed with an IND for the implantable liver product, we hope to initiate a Phase 1 clinical study in late 2023 or early 2024 for our fully transplantable liver for the treatment of liver failure.

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Figure: This is an image of a fully decellularized kidney, and is not a prototype of the BEK we plan to commercialize.

Mirokidney Program:   We are also simultaneously developing a bioengineered transplantable kidney. We have demonstrated key functional aspects including long-term patency of a revascularized kidney after implantation in a large animal model. We also recellularized our bioengineered kidneys, which then demonstrated early kidney function in bench testing, including creatinine clearance. We are currently focusing on optimizing the recellularization to increase the level of functionality to potentially support an IND submission.

Our goal is to initiate first-in-human clinical trials in late 2023 or early 2024 for our implantable kidney. Our kidney program is a heterotopic transplant where the native organs are left in place and a single bioengineered kidney is grafted into the vasculature. Heterotopic implants generally pose less safety risks to patients than orthotopic implants.

In 2019, we were awarded the Kidney X prize from the Department of Health and Human Services (“HHS”) and the American Society of Nephrology (“ASN”) to redesign dialysis.

Overview of the Decellularization and Recellularization Processes

Our technology encompasses a method to decellularize and recellularize whole or partial organs and tissues. The technology is based on our proprietary method of removing all cells and other unwanted biological material while maintaining a non-cellular (called extracellular) matrix or scaffold with its original architecture, mechanical properties, and a vascular network capable of maintaining the requisite physiological pressures. In the regenerative medicine field, thin patches and coverings using porcine, bovine, and human donor material have achieved success using immersion decellularization, but this technology is not suitable for the development of thicker tissues, including whole organs, due to the degradation that occurs while the tissue is soaked and agitated in a vat of chemicals over a lengthy period of time.

Our patented decellularization technology overcomes the limitations of immersion decellularization by facilitating rapid access to the whole organ through cannulation of the native vasculature and perfusion of a mild detergent solution through the canulated blood vessels. This allows us to rapidly remove cellular material within organs without damaging the non-cellular scaffold.

Our perfusion decellularization technology is highly efficient because organs are dense with vascular capillaries and most cells in an organ are located in close proximity to capillaries. By cannulating the native vasculature, our technology exponentially increases the capillary surface area exposed to detergent, resulting in decreased time required to dissolve unwanted cellular material. Our entire decellularization phase typically takes less than 24 hours. Following decellularization, we then go through a series of washes to remove the detergent and disinfect the organ scaffold over a period of two to three days. The end result is a completely preserved native scaffold, typically produced in approximately three to four days, containing the appropriate microenvironment required for the introduction of organ-specific cells, along with an intact vascular network to reconnect to the patient’s blood supply and outer capsule capable of maintaining physiological pressures. Based on bench testing results to date, we believe our decellularized organs can be stored for up to 12 months adding increased flexibility to our bioengineering process.

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Figure: These images show: (i) a porcine liver prior to being decellularized, (ii) a porcine liver eight hours into the decellularization process and (iii) a porcine liver twenty-four hours into the decellularization process. These images have been provided to demonstrate the decellularization process, and are not protypes for our BEL product candidate, and do not represent results from a clinical trial.

To complete a bioengineered organ we then use our perfusion technology to recellularize the organ scaffold with human vascular and organ specific cells. Living human cells are adaptative and when introduce into the ECM scaffold, which includes the appropriate composition of collagen, proteoglycans and cytokines throughout the different organ structures, biochemical and biomechanical cues are initiated which are required for cellular morphogenesis, differentiation, growth, and homeostasis. We obtain living cells from human organ donors and have developed techniques for rapidly culturing donor cells to increase the number of new organs we can revascularize. The organ is grown and matured in bioreactors where it is continuously perfused with nutrient media and oxygenated under normal physiological conditions. Our entire recellularization process can be completed quickly, typically taking between two to four weeks depending on the organ type and its specific characteristics. Our finished bioengineered organs can be transplanted utilizing the same techniques and equipment as current organ transplantation, which we believe will speed the adoption of our products.

Since the landmark publication by Nature Medicine, describing perfusion decellularization as a technique to generate acellular whole organ matrices, the technology has been the basis for over 500 publications. These publications have reported the use of the Miromatrix technology to advance regenerative medicine to levels not previously obtainable. The studies presented in these publications demonstrate the perfusion decellularization of whole animal organ matrices from hearts as was shown in a study published by Nature Medicine, lungs as was shown in a study published by Nature Biotechnology, livers as was shown in a study published by the Journal of Hepatology, pancreas as was shown in a study published by Transplant Proceedings, kidneys as was shown in a study published by Nature Medicine, and others. More importantly, these animal organ matrices have been recellularized (repopulated) using perfusion with various cells, including human cells, resulting in functional cellular phenotypes and increased cellular viability which is critical to bioengineering an organ. These studies completed by third parties (none of whom have any commercialization rights to our technology) confirm the ability to remove the cellular content, leaving a pristine organ matrix with the appropriate physiological and mechanical properties and matrix composition to bioengineer new organs using recellularization. We believe the large body of evidence generated from their publications validates the importance and efficacy of our technology.

Market Opportunity

Bioengineered Organ Pricing

We estimate the price of our bioengineered livers and kidneys to be between $350,000 – $750,000 based on our expectations for (i) high transplant success rates, (ii) significantly improved patient outcomes and quality of life over a period of many years, and (iii) substantial healthcare economic benefits. Our pricing estimate is partially informed by other one-time potentially curative biologic therapies, the cost of

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hemodialysis over the life of a patient and the three- to five-year cost of orphan CKD therapies intended for long-term administration.

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Recent CAR-T therapies such as Novartis’ KYMRIAH®, Bristol Myers Squibbs’ Breyanzi®, and Gilead’s Tecartus™ have list prices of $475,000, $410,300, and $373,000, respectively;

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The estimated average cost of hemodialysis over the life of a dialysis patient ranges from $450,000 – $900,000 assuming an annual Medicare cost for hemodialysis of $93,000 and an average patient life expectancy on dialysis of five to ten years, according to the National Kidney Foundation; and

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Jarnique® received FDA approval in 2018 and is the first and only approved treatment for autosomal dominant polycystic kidney disease (rare form of CKD) and it is intended for long-term administration. Jarnique® has an annual price of $156,000, which over the course of three to five years totals $468,000 to $780,000.

Liver

Significant progress has been made in the last 30 years in the treatment and management of liver disease, yet transplantation remains the only effective therapy for liver failure. Unlike kidney failure patients who undergo dialysis, liver failure without the availability of an organ for transplant results in death, and neither pharmaceuticals nor medical devices can effectively prevent this. According to 2018 data from the CDC, in the U.S. there are approximately 4.5 million adults diagnosed with chronic liver disease and the primary causes are alcohol, nonalcoholic steatohepatitis, and viral hepatitis. Liver disease is the 12th leading cause of death in the U.S. with 44,358 deaths in 2019, according to the CDC. There are only approximately 8,000 livers available for transplant in the U.S. annually.

Acute Liver Failure

Each year over 80,000 patients are hospitalized in the U.S. for acute of liver failure (2,000), acute on chronic liver failure (28,000), or severe acute alcoholic hepatitis (56,000). The condition is challenging with high mortality rates and the current standard of care is management of complications. In the U.S. spontaneous survival occurs in approximately 45%, liver transplantation in 25% and death without transplantation in approximately 30% of adult patients. The mortality rate is lower in children at approximately 13%. Impatient mortality rates for acute on chronic liver failure are approximately 53% and approximately 7% for severe acute alcoholic hepatitis. The mortality rate is lower in children at approximately 13%. Patients who do spontaneously recover may still suffer significant liver damage and in the future may require a liver transplant.

We estimate an initial $8.8 billion annual market for our bioengineered livers in the U.S. based on a $350,000 selling price (low end of our estimated price range) and an initial addressable population of 25,000 patients annually with severe forms of liver disease that can be treated with a bioengineered liver, and that are not otherwise able to be treated with a transplant given the limited supply of livers available for transplant. Over time we believe that our bioengineered livers will expand into less severe forms of chronic liver disease that are progressing and potentially causing comorbidities but are not yet life threatening.

Kidney

Chronic kidney disease (“CKD”) is the slow, progressive loss of kidney function over time resulting from multiple causes, with diabetes and hypertension as the leading causes. End-stage renal disease is the final stage of CKD, characterized by near-total kidney failure is fatal if not treated. Each year over 100,000 people in the U.S. are diagnosed with ESRD, which is the 9th leading cause of death in the U.S. with approximately 48,000 deaths annually. These patients join the over 550,000 patients in the U.S. that either require chronic dialysis or dialysis while waiting for a kidney transplant. Dialysis, which involves passing a patient’s blood through an external circuit for filtration before being returned back to the patient’s body, is a short-term and costly treatment and does not cure ESRD. Additionally, dialysis is time consuming, lasting three to five hours and often being required three times per week, and often results in poor quality of life for many patients.

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Kidney transplantation is the most effective therapy for ESRD and the only potentially curative option. To highlight this, kidney transplantation is associated with a consistently higher 5-year survival rate — approximately 84.1% for living donor transplants and 76.8% for deceased donor transplants, compared to 52.1% for peritoneal dialysis and 42.0% for hemodialysis. Despite its superior clinical outcomes, kidney transplantation is limited by an ongoing and severe shortage of donor kidney grafts for transplantation. In 2018, there were more than 100,000 patients in the U.S. on the waiting list, which is growing at approximately 8% per year, but only 21,000 received a transplant. Worldwide, there are approximately 2.1 million patients undergoing dialysis treatment. Under 80,000 kidney transplants are performed worldwide each year, making the kidney the most sought-after organ in the world. Due to limited supply, current kidney transplants represent only 10% of the existing need.

Medicare spending for CKD exceeded $81 billion in 2018, and Medicare spending on both CKD and ESRD was over $114 billion, representing approximately 23% of total Medicare spending. The 750,000-plus people who live with ESRD are 1% of the U.S. Medicare population, but account for roughly 7% of the Medicare budget. Hemodialysis treatment costs an average of $93,000 per patient annually in the U.S. and according to one estimate, and according to the American Journal of Transplantation, each transplant could save the health care system over $1.5 million per patient not factoring in the total economic savings with over 90% of dialysis patients also being disabled. A commercially available bioengineered kidney could save the healthcare system billions of dollars annually.

We estimate an initial $26.3 billion annual market in the U.S. for our bioengineered kidneys based on a $350,000 selling price (low end of our estimated price range) and an initial addressable population of 75,000 patients annually. Our initial addressable population is based on the current shortfall of waitlist kidneys, but we believe over time that we will expand into the broader dialysis population to improve their quality of life. We believe this population of dialysis patients who opt for early transplant could be significant because the risk/benefit associated with our bioengineered kidney is potentially favorable. This is because our bioengineered kidneys are heterotopically implanted, and if the new graft is not successful the patient still has their existing organs and can continue dialysis.

Our Strengths

Our novel technology is supported by the following strengths, and driven by the expertise and vision of our experienced management team:

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Our Decellularization Technology is Used for Two FDA-Cleared Medical Device Tissue Products.   We previously commercialized and spun out two FDA 510(k) medical device tissue products using our perfusion decellularization technology, which we believe are informative as to the safety risks associated with our base organ scaffold. Thousands of patients have been implanted with these medical device products to date, some with implants now exceeding five years in duration. We believe this real-word safety evidence will benefit the development of our bioengineered organ programs, but since we are pursuing a marketing approval pathway that is different than a medical device we cannot be assured that the FDA will deem our organ scaffold to be safe and effective in a bioengineered organ with living cells.

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Our Recellularized Grafts Have Demonstrated Critical Organ Function.   Our preclinical studies have demonstrated the potential promise of our recellularization technology, including patency and hepatocyte survival in heterotopic implants of our bioengineered livers in animal models and early function of our bioengineered kidneys in bench testing. In late 2020, we completed what we believe is the final major scientific milestone which was necessary to advance our first human study when we bioengineered livers with greater than 10 billion hepatocytes.

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Our Technology Harnesses the Powerful Evolutionary Biology Shaping Complex Organ Development.   We use a hybrid approach for bioengineering organs that we believe is superior to competing technologies and will yield organs with high functionality and immunogenicity comparable to the current standard of care in human organ transplantation. The anatomical structure and ECM composition of porcine organs is similar to humans. Our decellularization technology leverages these similarities and creates human-like organ scaffolds by removing cellular and other unwanted biological material from porcine organs. The integrity of the organ

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scaffold is key to initiate certain biochemical and biomechanical cues during the process of recellularization. We utilize organ-specific human cells during the process of recellularization to harness the innate adaptability of living cells and their affinity for adhesion, plasticity, and proliferation when introduced into our scaffolds. We believe living human cells are functionally superior to cells produced by extensively modifying the pig genome, and significantly reduce the risk of severe immune reactions and organ rejection

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Scalable, Multi-Organ Technology.   Our processes and technology are modular and we believe scalable with increased square footage and additional qualified laboratory technicians. We have demonstrated the ability to bioengineer livers and kidneys with functional vasculature and early organ function, and we believe our technology can also be utilized to bioengineer lungs, pancreas, hearts, and potentially other internal organs. In addition, we believe we can readily obtain porcine organs, bioreactors, media, living human cells (through tissue donor networks), and other materials we utilize in our process to address the shortage of available human organs for transplant.

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Pursuing an Efficient Regulatory Pathway.   The regulatory process associated with xenotransplantation requires extensive preclinical testing, safety studies, and long-term patient monitoring and follow-up. We do not believe our bioengineered organs will be classified as xenotransplants and believe they will be classified as biologics or potentially combination products, and we believe that either classification will lead to a more efficient regulatory pathway than if they were to be classified as xenotransplants. The FDA defines xenotransplantation as any procedure that involves the transplantation, implantation or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. The guidance also specifically states that xenotransplantation does not include transplantation, implantation, or other use of acellular animal tissues. During our decellularization process we remove all animal cells and the acellular scaffold is recellularized with living human cells, which we believe will lead regulators to determine that our bioengineered organs are not xenotransplants. However, neither the FDA nor any other regulator has provided us with feedback indicating what classification our product candicates will be classified as. Further, as part of our regulatory pathway we will need to seek an exemption from the FDA for the cGTP prohibition against pooling cells from two or more donors during manufacturing.

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We Are Targeting an Established Market in Need of More Organs.   The first human organ was transplanted more than 50 years ago, and since then major medical advances and improvements in technology have led to a highly developed market for organ transplantation. The infrastructure today for transporting organs, transplanting organs, and caring for transplant patients can support more procedures, but the limiting factor is the availability of donor organs. This year there are over 110,000 patients on the organ transplant waiting list, by the end of the year, as many as 70,000 patients in the U.S. who were prescreened and listed for an organ, will still not have received one. In addition, our finished bioengineered organs can be transplanted utilizing the same techniques and equipment as current organ transplantation, which we believe will speed the adoption of our products if approved.

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Potential Cost-Savings to Healthcare Systems.   We believe our bioengineered organs will eventually help the healthcare system realize significant cost savings by timely providing an additional source of much needed transplantable organs. For example, according to the American Journal of Transplantation, an estimated $1.5 million dollars is saved by the health care system for each kidney transplant compared to hemodialysis therapy. Given the CMS budget expense of nearly $114 billion per year on kidney disease, we believe a commercially available bioengineered kidney could save the healthcare system billions of dollars annually.

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Collaborations with World-Class Medical Institutions.   We have active collaboration and pre-clinical research programs with The Mayo Clinic, Mount Sinai and The Texas Heart Institute. These organizations are highly regarded with significant resources and state-of-the-art equipment and provide unique opportunities to collaborate with thought leaders in the field of transplantation and regenerative medicine.

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Robust IP Portfolio Including Foundational Patents.   We have 118 issued patents worldwide, with seven issued patents in the US market covering our core technology and applications, which are expected to expire from about 2026 through about 2036 without taking into account any possible extensions. Our leading patents on perfusion decellularization and recellularization are broad encompassing both method and composition of matter claims. They also include key aspects of revascularizing the organs. In addition, we have over 35 patent applications at various stages. Our IP portfolio is also reinforced by the 12 years of biologics exclusivity we would expect to receive if our products are approved by the FDA.

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Experienced Leaders and Talented Workforce.   Our management includes experienced leaders with demonstrated records of success at Miromatrix and other highly regarded industry participants. As of March 31, 2021, approximately 30% of our employees hold doctoral or other advanced degrees. We believe the quality of our team positions us well to execute on our mission and commercialize our bioengineered organs.

Our Growth Strategy

Our goal is to develop high-quality bioengineered organs and be first to market with an alternative to organ donation. The key elements of our strategy include:

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Build upon our strong technology position.   We believe we have strong technological differential for bioengineering organs that will yield outstanding functionality and have significant immunological advantages. We intend to maintain our technology position in the industry by further improving organ functionality through additional research and development and increasing the efficiency and scalability of our processes including, for instance, our ability to culture greater quantities of living human cells for recellularization. In the future, we also intend to develop new techniques to introduce patient-derived stem cells into various renal and liver cells types, which we will use to recellularize our decellularized organs. We believe use of stem cells could reduce or possibly eliminate the need for immunosuppressants.

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Advance clinical development of our lead bioengineered kidney and liver products.    We anticipate efficient clinical access for our liver products given the lack of any alternative therapies for both acute and chronic liver failure outside of transplantation. We also anticipate efficient clinical access for our bioengineered kidney given the large number of patients on the kidney transplant waiting list and the number of patients on dialysis.

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Expand our organ development pipeline.   Our decellularization and recellularization technology is applicable to the development of lungs, pancreas, hearts, and other whole organs. These are areas we plan to develop in the future, following our initial success.

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Form and grow our collaborations and partnerships.   To date, significant investments have been made by independent third parties advancing the Miromatrix technology, including the functional transplantation of perfusion decellularized and recellularized livers, lungs and kidneys back into animals. While these groups are unable to commercialize products due to our intellectual property protection, they continue development efforts in furtherance of clinical and scientific advancements. We have had, and continue to have, discussions with a variety of academic institutions that have utilized our technology. To date, we have agreements in place with The Mayo Clinic (liver), The Texas Heart Institute (“THI”) (total heart) and Mount Sinai Hospital (kidney). We plan to further grow and support these relationships, which we believe will result into clinical research opportunities which will advance the development of our medical device products.

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Maintain excellence in manufacturing and quality control.   Our core technology requires consistency and excellence and, for that reason, we constructed our own cGMP manufacturing facility, where we decellularize all organs and tissues. We will continue to perform all manufacturing operations internally as we focus on transplantable livers and kidneys in order to assure the highest level of quality.

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Scale our teams and facilities to meet future demands.   We will use a portion of the proceeds of this offering to expand our facilities and scale capacity of bioengineered organs we

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can produce. We intend to increase our footprint from 15,000 square feet to 40,000 square feet, as well as invest in additional cellular manufacturing capabilities. We will also increase the size of our workforce to support our expanded bioengineering capacity and our research and development initiatives.

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Expand our IP portfolio.   We continue to file and expand our IP portfolio to include aspects of decellularization, recellularization, transportation, and other aspects associated with bioengineering organs.

Product Pipeline

Research and Development

Liver Function Restoration

We have been developing Miroliver, in collaboration with the cellular scientists at the Mayo Clinic, since 2011. Starting in late 2018, our development efforts accelerated when we began large animal transplants using liver transplant surgeons at The Mayo Clinic that included hepatocyte seeded grafts. The Miroliver is bioengineered by recellularizing a decellularized porcine liver with human endothelial

cells (vascular), hepatocytes and accessory cells (liver cells), and cholangiocytes (bile duct cells), which can be anastomosed directly into the host’s circulatory system. We have approached our research in a stepwise manner, and we believe we successfully completed the most challenging scientific milestones associated with bioengineering livers in a scalable model. In late 2020, we completed what we believe is the key major scientific milestone which was necessary to proceed with our first product (external assist liver) and move towards our IND enabling study when we bioengineered livers with greater than 10 billion hepatocytes, a cell count we believe is adequate to provide the required function.

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Surgical Implantation of a Revascularized Liver Graft in a Large Animal

Figure: The surgical implantation and perfusion of our revascularized bioengineered liver into a pig model demonstrating the ability to surgically implant the graft and achieve active perfusion by the recipient. This study was performed at the Mayo Clinic. These images have been provided to demonstrate the process of surgically implanting a BEL and are not prototypes of the BEL that we expect to use for human clinical trials.

A key liver-based milestone was achieved in 2019, when we published our findings on the successful revascularization of a decellularized porcine liver graft with human endothelial cells in Nature Biomedical Engineering. The study highlighted three key milestones which we’ve achieved. First was the demonstration of sustained patency, which has been a significant vascular challenge inhibiting bioengineering of organs. Second was the ability to non-destructively monitor the revascularization process, an important step in manufacturing and quality control. This was achieved through monitoring metabolic function during the bioreactor phase — more specifically, monitoring the glucose consumption rate (“GCR”). Third, we demonstrated the ability of the introduced endothelial cells to upregulate the expression of liver specific endothelial cell markers and detection of fenestrations, a hallmark attribute of liver sinusoidal endothelium, demonstrating the potential ability of the decellularized matrix to provide the appropriate cellular signals or cues.

Non-Destructive Measurement of Growth	Upregulation of Sinusoidal Endothelial Market LYVE-1 and STAB2

Figure: The revascularization process of the bioengineered liver is monitored through the metabolic consumption of glucose and defined by low, mid and high phases. Transcript levels of liver sinusoidal endothelial cell-associated markers measured by quantitative PCR with reverse transcription (qRT−PCR) in the high GCR phase demonstrated an upregulation of LYVE1 (7.2-fold ± 1.8-fold, mean ± s.d.) and STAB2 (4.8-fold ± 3.31-fold) compared to human vascular endothelial cells (HUVEC) cultured in standard two dimensional culture flasks, as well as a significant increase from low to high phases (P < 0.05) for LYVE1, while CD31 was not significantly changed (1.9-fold ± 1.8-fold).

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Fenestration Development Demonstrates Cellular Plasticity

Figure: Detection of fenestration structures within our revascularized bioengineered livers. Tunneling Electron Microscopy of images from native liver (q) and our revascularized bioengineered liver (r–t). Red arrows indicate fenestra-like structures within the endothelial cells.

The next significant milestone was the functional demonstration of the liver following the addition of liver hepatocytes. During bench testing, we demonstrated the ability of the recellularized grafts to perform key liver functions, including albumin production, urea synthesis and an important liver function, ammonia clearance. These studies have been completed with porcine and human hepatocytes. Over the last 12 months, our optimization efforts have led to a fivefold increase in hepatocytes seeded into the livers to over 10 billion, which we consider to be a key clinical threshold.

Demonstrated Ex Vivo Liver Function

Figure: Bioengineered livers seeded and cultured with endothelial cells and primary hepatocytes demonstrate liver specific function through the production of Albumin and Urea, and the clearance of ammonia in a challenge assay during bench testing.

We reached another major milestone in 2019 by demonstrating the ability of a recellularized liver graft (endothelial and hepatocyte cells) to remain patent in a heterotopic transplant model receiving native portal blood flow. In this study, the vasculature of the native liver was ligated and controls were performed to create a portal-caval shunt enabling blood that is normally supplied to the liver to be recirculated. These animals quickly developed acute liver failure with the hallmark signature of increased ammonia blood concentration. Our recellularized liver grafts were orthotopically transplanted with direct portal vein and inferior vena cava anastomosis to allow normal blood circulation through our recellularized bioengineered liver. Over the course of the two-day study, we demonstrated the ability of the Miroliver to sustain perfusion, survival of the hepatocytes and an early trend of decreased blood ammonia levels emerged. The work is currently under review for publication.

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Our most recent preclinical data provides the foundation for our bioengineered liver application in an external liver assist application to treat acute liver failure, where high blood ammonia levels are present. To move these studies into an IND submission we remain focused on additional bench testing including the deployment of our 6-hour blood perfusion loop and key functional challenge assays. We are creating the large animal model to induce acute liver failure and provide external liver support with our bioengineered liver. These pre-clinical studies are ongoing, and we plan to initiate further IND enabling studies later in 2021 or early 2022 to support our first clinical application.

Implantation of Bioengineered Liver in Acute Liver Failure Preclinical Model

Figure: 3D-reconstruction from CT imaging demonstrating the continuous perfusion of our bioengineered liver and lack of perfusion to the native liver (no liver seen) in our acute liver failure model over the two-day study. Blood ammonia levels were lower in the rescue group receiving a bioengineer liver compared to the control group that received a portal/cava shunt.

While completing the final external liver assist product stages, we continue the development of our fully transplantable liver that includes the recellularization of the biliary system. This is achieved through the seeding of bile duct cells (cholangiocytes) directly into the bile duct. We have demonstrated the ability to isolate, culture, expand and seed cholangiocytes. We achieved a key milestone by demonstrating site specific localization and the appropriate phenotypic expression within our bioengineered liver grafts. Seeded cholangiocytes were identified within the biliary tree with high level of expression of the general cholangiocyte marker, Cytokeratin 19 (CK19), along with the appropriate cuboidal morphology and polarization. Cytokeratin 7 (CK7), which is localized to larger bile ducts was present in the larger ducts but absent in smaller ones. Most impressively, alpha-tubulin, which stains the presences of a key cholangiocyte feature, the central cilia, was localized in the lumen. Lastly, Gamma-glutamyltransferase (“GGT”) was localized to the luminal surface of the bile ducts. Collectively, the positive staining and site-specific localization of key markers confirm our ability to recellularize the biliary tree. Additional development is ongoing for the full integration into the recellularized liver and functional demonstration.

Successful Bile Duct Seeding and Staining

Figure: Localization and cell specific expression of key cholangiocyte markers following their seeding into bioengineered liver grafts. Cells were detected with the following markers: EpCam, a general epithelial marker, Cytokeratin 19 (CK19)- a general cholangiocyte marker, Cytokeratin 7 (CK7)-a cholangiocyte marker localized to larger bile ducts, Alpha-tubulin which stains the presences of a key cholangiocyte feature and Gamma-glutamyltransferase (GGT)- a transmembrane glycoprotein localized to the luminal surface. All sections were counterstained with DAPI a nuclear stain.

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Kidney

Our Mirokidney is bioengineered through the recellularization of a decellularized porcine kidney with human endothelial cells (vascular) and human renal specific cells, including key cells of the glomerulus (mesangial cells and podocytes) and nephron (proximal and distal tubule cells, thin and thick limb Loop of Henle cells, and collecting duct cells). The bioengineered kidney can be anastomosed directly into the host’s circulatory system in a procedure similar to current kidney transplantation. The development of Mirokidney has an advantage of building on the success of our Miroliver program potentially reducing key development timelines. Significant milestones have been achieved to demonstrate the initial success and path forward. While continued development is required to initiate clinical trials, the program has achieved numerous milestones.

Characterized Revascularization and Vascular Patency in Bioengineered Kidneys

Figure: The revascularization process of the bioengineered kidney (BEK) is monitored through the metabolic consumption of glucose and defined by low, mid and high phases. Patency was evaluated in an ex vivo model through direct flow into and out of the kidney. A flow meter was used to monitor volumetric flow rate of blood leading into the renal artery of the organ. Decellularized kidneys (no cells) and endothelialized bioengineered kidney with low GCRs did not maintain blood flow beyond several minutes, while endothelialized bioengineered kidneys with high GCRs maintained consistent perfusion throughout the entire study period.

To systematically demonstrate the potential of our Mirokidney, we applied a similar stepwise approach to our bioengineered kidney that we utilized for our bioengineered liver program. Starting with demonstrating our ability to revascularize a decellularized porcine kidney, we have achieved multiple milestones. First, we confirmed the ability to utilize the metabolic marker of glucose consumption rate as a predictor of revascularization, which will serve as an important manufacturing control. The GCR is directly correlated to the ability of the bioengineered kidney to remain patent. Second, revascularized bioengineered kidneys, based on predictive GCR rates, were heterotopically transplanted into our large animal model with direct renal artery and vein anastomosis, highlighting the similarities to normal kidney transplantation. Our transplanted revascularized kidneys maintained whole kidney perfusion over 14 days as measured by angiograms and demonstrated the ability to withstand physiological pressures and flow. Maintaining perfusion in our transplanted revascularized kidneys in a normal transplant model was a key milestone and solves an issue which has inhibited the advancement of bioengineering organs and complex tissues. Mount Sinai Hospital and their transplant surgeons were instrumental to achieving this milestone. This study has been submitted for publication.

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Demonstrated Kidney Vascular Patency in Preclinical Models

Figure: Orthotopic transplantation of human endothelialized BEK grafts in a pig model. Adult pigs underwent unilateral nephrectomy followed by orthotopic transplantation of endothelialized kidney grafts. An anastomosed BEK graft is shown before and after reperfusion. Compilation of follow-up angiographies performed on a kidney graft through Day 14 demonstrate continuous perfusion of the implant revascularized BEK. These images have been provided to demonstrate the process of transplanting BEK grafts, and the corresponding results in follow-up angiograms, and are not prototypes of our BEK.

Following the successful revascularization of the kidney, we focused on the recellularization of the glomerular and nephron structures within the kidney. We achieved this milestone by demonstrating our ability to procure, isolate, and seed revascularized bioengineered kidneys with both human and porcine kidney cells, human renal specific cells for the glomerulus (Mesangial Cells and Podocytes) and nephron (proximal and distal tubule cells, thin and thick limb Loop of Henle cells, and collecting duct cells). Isolated tubule epithelial cells were seeded into decellularized localized to nephron tubules and collecting ducts and demonstrated a >50% matrix coverage after 14 days. This heterogenous mixture of kidney parenchymal cells proliferated, expressed E-cadherin with a tubular epithelial morphology and more importantly, acquired a ciliated brush border, a key hallmark of mature and functioning proximal tubules.

Demonstrated Nephron Recellularization

Figure: Tubule epithelial cells were seeded localized to nephron tubules and collecting ducts as detected by positive E-cadherin staining. Total coverage increased from ~10% to ~50% after 14 days of continuous perfusion within the bioengineered kidney with active proliferation as characterized by positive Ki67+ staining. Electron microscopy of the tubules demonstrated the presence of ciliated brush border, a key hallmark of mature and functioning proximal tubules cilia formation (arrows).

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Non-transplantable human kidneys are received through our established agreements with numerous Organ Procurement Organizations (“OPOs”) and we have successfully demonstrated the ability to isolate the required kidney cells from even highly compromised kidneys. Isolated human kidney cells seeded into the decellularized matrix with expression of EpCAM indicative of a distal tubule or collecting duct phenotype and expression of the proximal tubule markers aquaporin-1 (“AQP1”) and type I gamma-glutamyltransferase (“GGT1”) with positive Ki67 co-expression of the latter indicating proliferation of primary proximal tubule cells in recellularized bioengineered kidneys (“BEKs”). Additional studies have demonstrated the ability to localize endothelial and epithelial cells to the glomerulus with site specific orientation.

Demonstrated Kidney Recellularization

Figure: Primary kidney cells seeded and cultured in decellularized kidneys for 18 days demonstrate localization and expression of the proximal tubule markers aquaporin-1 (AQP1) and type I gamma-glutamyltransferase (GGT1) with positive Ki67 co-expression of the latter indicating proliferation of primary proximal tubule cells in recellularized BEKs. Positive staining of EpCAM, a distal tubule or collecting duct marker, display the polarization of the recellularized tubule. Additional studies have demonstrated the ability to localize endothelial and glomerular cells to the glomerulus with site specific orientation.

Recently, we achieved another key milestone with the demonstration of the ability to maintain vascular patency and produce effluent at the appropriate rate in an acute transplant model. The current research and development focus is on further scaling the human kidney isolation population to support high volume recellularization and production. This will allow for further advancements in functional assessments leading to large animal studies to support IND enabling studies and clinical trials.

Demonstrated Early Kidney Function in Preclinical Models

Figure: The evaluation of filtration in our bioengineered kidneys that received endothelial (HUVEC) and glomerulus seeding in an ex vivo blood loop. The effluent from these BEKs were collected and analyzed. The addition of glomerular outgrowths reduced hematocrit concentrations to an undetectable level in comparison to the pig’s blood compared to no selection in the HUVEC-only BEKs. Quantification of the ureter effluent demonstrated the addition of glomerular outgrowths in our BEK restored physiological flow rates of ureter effluent.

Next Generation Miroliver and Mirokidney

Future development of our bioengineered livers and kidneys includes the use of stem cells to fully recellularize our decellularized organs. The target population of stem cells includes pluripotent stem cells (“iPCSs”) that would be either patient derived or derived from a universal donor. We aim to eliminate or significantly reduce the need for immune suppression therapies by using these cells during our recellularization processes. While our current focus is on speed to market with our primary cell approach, we plan to initiate stem cell related work in late 2021 through internal development and future external collaborations. The field of gene and cell therapy has dramatically increased over the last 10 years and the therapeutic advancements in gene therapy, CRISPR, CAR T, and general cell therapy are providing a strong regulatory foundation to help accelerate our work.

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We believe our proprietary decellularized porcine scaffold and perfusion recellularization technology already support the development of our next generation organs with stem cells. An adequate scaffold is necessary to initiate the biochemical and biomechanical cues which are required for cellular morphogenesis, adhesion, differentiation, growth, and homeostasis. Our technology can produce a scaffold that is anatomically similar to native human organs with the appropriate composition of proteins throughout the different structures, which we believe yields optimal growth and function of our bioengineered organs. Our perfusion recellularization technology enables this hand-in-glove relationship between living cells and the organ scaffold by facilitating rapid access to the surface area of the scaffold and by providing a nutrient-rich environment optimal for cellular growth.

Potential Future Programs

We believe that our patented technology has a myriad of potential applications. While we are currently focused on our liver and kidney programs, in the future we intend to develop programs aimed at the creation of other organs including, lung, pancreas and heart. Beyond whole organs, our patented technology also includes the ability to develop future programs for parts of organs. We may also seek to engineer recellularized bone or develop transplantable tissue capable of being seeded with genetically modified cells to deliver therapy, which we also believe would be covered by our existing intellectual property. Finally, we may also seek to use our products for advanced drug testing and potentially enter into third-party relationships for other applications of our technology, although we do not have any current plans with respect to these relationships.

Lung

Nearly 25 million people live with chronic obstructive pulmonary disease and approximately 120,000 patients die from end-stage lung disease annually in the U.S. Lung transplantation remains the only definitive treatment for end-stage lung disease. As with other organs, the supply of donor lungs is extremely limited with only 2,500 lung transplants occurring in 2019. A new therapeutic solution is needed to treat not only the patients on the lung transplant waiting list, but also the thousands of patients who are unable to get on the list. We believe that the creation of a bioengineered lung would eliminate the current availability constraints and enable thousands of patients in need of treatment. Several previous approaches have been undertaken to engineer functional lung tissue using polymers and other natural materials to mimic the architecture and function of the lung. These technologies, however, all failed to create lung tissue that had the structure and function to be ventilated, support oxygen exchange and be perfused with the patient’s blood.

We believe that our perfusion decellularization and recellularization technology could provide a solution for this critical issue by maintaining the native lung architecture and vasculature, thereby enabling ventilation and perfusion. We have demonstrated the successful decellularization of porcine lungs.

Pancreas / Diabetes Treatment

We may also seek to develop a biologic, vascularized, implantable Miropancreas which, if successful could provide normal insulin regulation for type I diabetic patients.

The major hurdle to creating a biological pancreas has, to a large extent, been the lack of a vascularized substrate to support islet cells, allowing for sustained function. Our perfusion decellularization offers a direct solution to this hurdle due to its ability to decellularize whole or partial organs while preserving the extracellular matrix with its original architecture, native microenvironment, mechanical properties and vascular network, thereby allowing for recellularization to create a functional replacement organ.

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A critical step toward curing diabetes is the development of a non-immunogenic, non-fibrogenic implantable islet support device (Miropancreas) which provides immediate vascular support and the appropriate microenvironment for islet cell survival, expansion, and sustained physiologic function. Our significant progress in re-endothelializing a porcine liver matrix with human endothelial cells is helpful in this context. The high vascular density of the liver makes the re-endothelialized liver matrix an ideal substrate from which to engineer a biologic Miropancreas that maintains a suitable microenvironment and vascular supply to support islet function and long-term survival while being self-contained, implantable and removable.

We believe that a Miropancreas could offer advantages over islet type support devices currently being developed by others. These advantages include the ability to be implanted in a readily accessible location and anastomosed directly to patient vasculature (thereby providing immediate vascular support); the flexibility to be seeded with beta cell precursors, beta cells, islets, or encapsulated beta cells; the ability to condition the constructs ex-vivo prior to implantation with strict functional release criteria; the potential to improve islet maturation within the re-endothelialized matrix; and the ability to remove the Miropancreas if needed.

Heart

Cardiovascular disease (“CVD”) remains the leading cause of death in the U.S., with over 630,000 cardiac deaths in 2016 and approximately 6.2 million American adults living with heart failure. The annual total cost of CVD in the U.S. was estimated at $351.2 billion in 2014 – 2015, with $213.8 billion in direct cost, including 46% for inpatient care. Approximately every 40 seconds, an American will have a myocardial infarction (“MI”). The average age of first myocardial infarction is 65.6 years old for men and 72.0 years old for women. Heart transplantation is a viable therapy for patients with end stage heart failure, however in 2019 there were only 3,597 heart transplants performed in United States due to the limited supply with over 4,000 patients on the waiting list. We have agreed to collaborate with the Texas Heart Institute (“THI”) and have made progress in developing a bioengineered heart for human implant.

Partial Organs and Tissues Products

In addition to our bioengineered whole organs, we have the technology, IP and potential to develop portions of organs that could include heart valves, cardiac patches, glands, revascularized tissues or skin products, and vascular grafts.

Collaborations and Partnerships

Mayo Clinic

On January 1, 2011, we entered into a license agreement with the Mayo Clinic, and have thereafter entered into subsequent amendments (as amended, the “Mayo Agreement”), pursuant to which we and the Mayo Clinic have agreed to collaborate to test and evaluate the viability of the transplantation of a recellularized liver. Specifically, the collaboration aims to evaluate the effectiveness of a transplanted recellularized liver in a recipient large animal, along with determining the most effective conditions and techniques for re-seeding the liver. We are responsible for delivering the recellularized liver to the Mayo Clinic, whose surgeons are responsible for the transplantation and evaluation of the recellularized liver. The Mayo Clinic will own all rights to any inventions or discoveries solely developed pursuant to the Mayo Agreement, however, we have the exclusive right to license any such inventions or discoveries. To date, we have completed hepatocyte isolations, created surgical transplant models, generated transplant data from the bioengineered liver published in Nature Biomedical Engineering, and submitted the data pertaining to initial liver function, which is for publication.

Over the course of the Mayo Agreement, the Mayo Clinic has provided $400,000, in consideration of which we provided them with 83,333 shares of Series A Preferred Stock and 26,667 shares of

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Series B Preferred Stock and warrants to purchase 24,000 shares of Series A Convertible Preferred Stock at $2.50 per share, which have since expired. We have funded the balance of the cost of the project, which as of May 1, 2021, constituted $1,650,727. Under our latest amendment to the Mayo Agreement, we have agreed to provide $317,600 in funding through the remaining term of the Mayo Agreement, which is set to expire on December 31, 2021, however, we anticipate further extending the Mayo Agreement and providing the Mayo Clinic with ongoing funding, as is necessary. Neither party is subject to any royalty or milestone obligations, and the Mayo Agreement may be terminated by either party for a breach of the Mayo Agreement. Please note that this is just a brief summary of the Mayo Agreement, for complete terms, please see the agreements attached as exhibits to the registration statement of which this prospectus forms a part.

Mount Sinai

On October 19, 2015, we entered into a collaboration agreement with Mount Sinai Hospital, whereby we have developed a large animal kidney transplantation model to demonstrate continuous blood flow through a perfusion decellularized and recellularized transplanted kidney. Utilizing this model, we have achieved transplantation of numerous revascularized kidneys by the surgeons at Mount Sinai. Neither party is subject to any royalty or milestone obligations. The agreement may be terminated by either party upon thirty days written notice to the other party, and is set to expire in March of 2023.

Texas Heart Institute

On October 1, 2013, we entered into a sub-license agreement with THI, and have thereafter entered into subsequent amendments thereto (as amended, the “THI License Agreement”), pursuant to which we have granted THI an exclusive sub-license to our intellectual property related to the transplantation of the heart organ in human beings, whereby perfusion decellularization and/or perfusion recellularization has been utilized in any portion of the creation or manufacture of such whole heart organ. Under this agreement, THI is required to achieve certain milestones by certain dates, and the failure to do as much provides us with the right to terminate the THI License Agreement. These milestones require THI to, among other things: (i) develop the cardiac decellularization and recellularization process, resulting in a functional recellularized heart, (ii) complete preclinical studies demonstrating the efficacy and safety of a whole heart transplantation in large animals using perfusion technology and (iii) to file an IND submission for a Phase 1 trial and complete a first-in-human clinical trial. Once the first-in-human clinical trial is completed, all licensing rights will revert from THI back to us and THI will receive a 5.0% royalty on all of our commercial sales of products related to the transplantation of the heart organ in human beings using the perfusion decellularization and recellularization process. Further, to the extent we fail to meet any of our milestones after the licensing rights have reverted from THI back to us, and are provided written notice by THI of such failure, and fail to cure such failure in 60 days, the sub-license will revert back to THI, subject to a 10.0% royalty due to us on all of THI’s commercial sales of products related to the transplantation of the heart organ in human beings using the perfusion decellularization and recellularization process. The THI License Agreement may be terminated upon a breach of the agreement or our or THI’s bankruptcy, and shall have no further effect on a patent-by-patent basis, once the applicable patent term has expired. Additionally, if THI fails to meet any milestone, we may terminate their sub-license rights, however, to the extent we are granted FDA approval within three years of such termination, THI will retain their 5.0% royalty right. If we do not obtain such approval within three years, all licenses, sublicenses and royalty obligations under the agreement shall immediately terminate. To date, progress has been achieved on the initial recellularization of the bioengineered heart. Please note that this is just a brief summary of the THI License Agreement, for complete terms, please see the agreements attached as exhibits to the registration statement of which this prospectus forms a part.

University of Minnesota

On February 4, 2010, we entered into an exclusive patent license agreement with the University of Minnesota (“the University”), and have thereafter entered into subsequent amendments thereto (as amended, the “EPLA”). The EPLA grants us an exclusive license over the decellularization and recellularization of organs and tissues, among other processes and products, and such patents provide

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us with exclusivity in numerous jurisdictions, including, but limited to, the United States, throughout Europe, China, Australia and Japan. We entered into an amendment to the EPLA on September 15, 2016, which transferred the ownership, right, title and interest in all of the licensed patents under the EPLA to us. Under the EPLA, the Company is required to make minimum royalty payments to the University of the greater of $500,000 per year and 6.5% of net sales of any licensed products. Further, to the extent we license any products developed under the EPLA to an assignee, we shall provide payment in the amount of 25% of such royalties received by such assignee to the University. We also pay the University an annual maintenance fee of $5,000. There are no milestone payments due under the EPLA. As of May 1, 2020, we have paid the University of Minnesota $1,113,342 under the EPLA. The EPLA and the royalties due thereunder will continue in full force and effect on a product-by-product and country-by-country basis until the licensed patents are no longer valid. Further, the EPLA does not have any termination provisions. As discussed in further detail in Note 6 to the financial statements, we entered into an amendment to the EPLA on February 21, 2021, which allows us to defer the payment of any difference between the $500,000 minimum annual payment and what was actually provided to the University for each of calendar years 2020 and 2021 and such difference shall be added to the minimum sum required for calendar years 2022 and 2023, respectively.

Reprise

Concurrently with the spin-out of Reprise Biomedical, Inc. (“Reprise”) on June 30, 2019, we entered into a patent and know-how license agreement with Reprise, and have thereafter entered into subsequent amendments thereto (as amended, the “Reprise License Agreement”), which entitles us to a 6.5% royalty and a minimum annual royalty of the greater of $500,000 per year or 6.5% of all sales of products utilizing our decellularization technology, including, but not limited to, Miromesh and Miroderm, and which grants them an exclusive license over any acellular products derived from our perfusion decellularization technology, which does not include: (i) decellularized whole organs, (ii) all non-clinical applications or (iii) use in 3D printing applications. There are no milestone or other payments due under the Reprise License Agreement. Reprise provided us with total royalty payments of $250,000 during the year ended December 31, 2019 and total royalty payments of $46,530 during the year ended December 31, 2020 under the Reprise License Agreement. We also recorded a long-term receivable of $453,470 related to the minimum royalty due from Reprise for the year ended December 31, 2020, but due to the uncertainty regarding collectability, we fully reserved against the receivable. The Reprise License Agreement and the royalties due thereunder will continue in full force and effect on a product-by-product and country-by-country basis until the licensed patents are no longer valid or unless we terminate the agreement. We may terminate the Reprise License Agreement, (i) in the event of a breach, (ii) if Reprise fails to make any payment due under the agreement and does not cure such non-payment within the applicable time period and (iii) in the event of Reprise’s bankruptcy. Further, we entered into an amendment to the Reprise License Agreement on February 21, 2021, which allows Reprise to defer the payment of any difference between the $500,000 minimum annual payment and what was actually provided to us for each of calendar years 2020 and 2021 and such difference shall be added to the minimum sum required for calendar years 2022 and 2023, respectively.

Competitive Organ Bioengineering Technologies in Development

Due to the depth and breadth of our patent protection, we are not aware of any competing companies offering whole transplantable organs using perfusion decellularization. Certain other technologies, described below, are being developed, but we believe our technology is superior to these alternatives. These technologies are being developed by United Therapeutics, eGenesis Bio, Prellis Bio, and other companies.

The field of xenotransplantation has been active for decades and recent advances of CRISPR technology have reinvigorated the field. Xenotransplantation is being investigated in the genetic engineering of pigs to essentially remove the immunogenic protein to enable direct transplant of porcine organs into humans. No xenotransplantation clinical trials have commenced, and we do not anticipate any clinical trials will commence in 2021. Significant hurdles remain to demonstrate long-term cross-species organ functionality and immune tolerance of organs created through the xenotransplantation process. Based on FDA guidance to date, we believe the regulatory oversight (Source Animal, Product,

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Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans) will be onerous and limiting even if promising evidence emerges that enough genes can be altered to enable the initial implantations. In addition, the FDA has raised concerns around the risk of infectious agents and possible transmission to the general population through xenotransplantation, including retroviruses which may be latent and lead to disease years after infection.

Normothermic perfusion has been emerging as a method to help maintain organ function and in some cases, recondition marginal organs to increase the quality of the organ for transplantation. The field was initiated with the reconditioning of lungs in a process called ex-vivo lung perfusion. Companies are attempting to develop methods to apply this process to livers and kidneys as potential options. While the approach has resulted in favorable data for lungs, the number of marginal organs that qualify for this approach are very limited.

3D printing is also being explored in the development of bioengineered organs, but to date has shown limited success. Organs are highly complex, integrated, multilayered-layered structures with fine-tuned mechanical properties. Organ ECM is heterogenous and the composition of collagen, proteoglycans and cytokines varies throughout the different organ structures. Organ ECM provides not only an essential scaffold for cellular constituents, but it also initiates biochemical and biomechanical cues that are required for cellular morphogenesis, differentiation, growth, and homeostasis. Overall we believe the complexity and heterogeneity of the ECM scaffold will limit the effectiveness of 3D printing in organs, and that the technology is better suited for larger structure including bones and vascular conduits

We believe our technology overcomes the primary challenges associated with 3D printing and genetically modified xenografts, and that normothermic perfusion is not a scalable approach. Our decellularized porcine scaffold closely resembles the anatomical structure of a human organ and includes the appropriate ratios of ECM proteins throughout the various organ structures which are necessary for successful cellular adhesion, differentiation, and regeneration during the process of organ growth. We believe this level of complexity cannot be achieved using current 3D printing technologies. We also believe our bioengineered organs could have significant functional and immunological advantages compared to genetically modified xenografts. Our bioengineered organs are recellularized using living human cells as opposed to genetically modifying the genome of a pig, and therefore we believe we have a clear advantage of known immune and rejection risks. In addition, humans last shared a common ancestor with pigs 80 million years ago and on a cellular level we do not believe the pig genome can be modified to the point where pig cells are functionally equivalent to human cells.

Another significant advantage of our technology is that, because we envision being able to seed our ECM with the stem cells in the future, we hope to be able to alleviate the long-term requirement of immunosuppression that is standard following organ transplantation.

Intellectual Property

We strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business, including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and in jurisdictions outside of the United States related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business. We intend to rely on data exclusivity, market exclusivity and patent term extensions when available, including any relevant exclusivity through supplementary protection certificates.

Patents

We own numerous patents and/or patent applications which relate to our material products, including patents and/or patent applications with respect to Miroliver, Mirokidney, Mirolung, Miroheart, Miropancreas, perfusion decellularization, perfusion recellularization, revascularization, acellular matrix and the use of stem cells. Although in the aggregate our intellectual property is of material importance to our business, we do not believe that any single patent is of material importance to our product portfolio.

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As of March 11, 2021, we wholly own or exclusively license 7 issued U.S. patents and 11 pending U.S. patent applications relating to our products and process. The U.S. patents are expected to expire between 2026 and 2036. We also wholly own or exclusively license 111 foreign patents and 24 pending foreign patent applications relating to our products and process. The foreign patents are expected to expire between 2026 and 2036. Our issued patents and selected patent applications as of March 11, 2021 directed to products and process are summarized in the table below.

The pending patent applications, if issued, are expected to expire between 2026 and 2040, without accounting for potential patent term extensions and adjustments.

We expect to seek 5-year patent term extension (“PTE”) under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (the “ACT”). The Act allows the extension of the term of a patent claiming a product that requires regulatory approval prior to being sold. The determination as to whether PTE should be granted is made by the U.S. Patent and Trademark Office (“PTO”), in consultation with the regulatory agency responsible for approval of the product. See “Government Regulation — U.S. Patent Term Restoration and Marketing Exclusivity” for more details related to the limitations and guidelines surrounding PTEs under the ACT.

Additional protection may be sought through FDA exclusivity under the Orphan Drug Exclusivity of 7 years or under the Patient Protection and Affordable Care Act of 2010 of 12 years.

Country	Application Number	Filing Date	Patent Number	Status	Expected Expiration Date	Description
US	12/064613	Oct-08	8470520	GRANTED	8/28/2026	Method and composition of matter covering perfusion decellularization of whole organs
EP	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	An ex vivo method of decellularizing a mammalian organ or a mammalian vascularized tissue
FR	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
GB	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
DE	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
BE	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
CH	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
ES	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
IT	50201500-	8/28/2006	2431063	GRANTED	8/28/2026	​
​	0052004	​	​	​	​	​
NL	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
PL	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
SE	11181797.90	8/28/2006	2431063	GRANTED	8/28/2026	​
IN	1741/DELNP/2008	8/28/2006	263193	GRANTED	8/28/2026	​
AU	2006282783.00	8/28/2006	2006282783	GRANTED	8/28/2026	​
CN	200680030925.40	8/28/2006	ZL200680030925.4	GRANTED	8/28/2026	​
IL	189418.00	8/28/2006	189418	GRANTED	8/28/2026	​
KR	10-2008-7007151	8/28/2006	10-1376013	GRANTED	8/28/2026	​
MX	MX/A/2008/00258 9	8/28/2006	320910	GRANTED	8/28/2026	​
TR	6790024.10	8/28/2006	TR201203945T4	GRANTED	8/28/2026	​
RU	2008111503.00	8/28/2006	2463081	GRANTED	8/28/2026	​
US	13/725030	12/21/2012	10441609	GRANTED	8/28/2026	Recellularization of decellularized organs including stem cells
EP	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
FR	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
GB	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
DE	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
BE	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​

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Country	Application Number	Filing Date	Patent Number	Status	Expected Expiration Date	Description
CH	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
ES	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
IT	5020129-	8/28/2006	1928519	GRANTED	8/28/2026	​
​	02039720	​	​	​	​	​
NL	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
PL	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
JP	2015-094591	8/28/2006	6089062	GRANTED	8/28/2026	​
SE	6790024.10	8/28/2006	1928519	GRANTED	8/28/2026	​
AU	2013224686.00	8/28/2006	2013224686	GRANTED	8/28/2026	​
HK	12109340.40	8/28/2006	HK1168565	GRANTED	8/28/2026	​
CN	201210287455.70	8/28/2006	ZL201210287455.7	GRANTED	8/28/2026	​
IL	233821.00	8/28/2006	233821	GRANTED	8/28/2026	​
KR	10-2013-7028378	8/28/2006	10-1420585	GRANTED	8/28/2026	​
MX	MX/A/2014/00677 8	8/28/2006	350338	GRANTED	8/28/2026	​
RU	2012122055.00	8/28/2006	2635478	GRANTED	8/28/2026	​
SG	201101898-3	8/28/2006	170731	GRANTED	8/28/2026	​
TR	11181797.90	8/28/2006	2015/11093	GRANTED	8/28/2026	​
US	13/913974	6/10/2013	10220056	GRANTED	8/28/2026	Perfusion decellularization of portions, includes the recellularization and use of stem cells
EP	15170077.00	8/28/2006	2965769	GRANTED	8/28/2026	An ex vivo method of making an organ, or a vascularized portion of an organ or tissue
FR	15170077.00	8/28/2006	2965769	GRANTED	8/28/2026	​
GB	15170077.00	8/28/2006	2965769	GRANTED	8/28/2026	​
DE	15170077.00	8/28/2006	2965769	GRANTED	8/28/2026	​
AU	2017272168.00	8/28/2006	2017272168	GRANTED	8/28/2026	​
HK	16108222.50	7/13/2016	1220646	GRANTED	8/28/2026	​
MX	MX/A/2017/01110 7	8/28/2006	369594	GRANTED	8/28/2026	​
SG	10201603074Q	8/28/2006	10201603074Q	GRANTED	8/28/2026	​
US	13/820079	2/28/2013	10233420	GRANTED	9/1/2031	An ex vivo method of reendothelializing a decellularized mammalian tissue or organ matrix for improved transplantability
JP	2013-527329	9/1/2011	5931878	GRANTED	9/1/2031	​
EP	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
AU	2011295779.00	9/1/2011	2011295779	GRANTED	9/1/2031	​
BE	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
CN	201180052952.20	9/1/2011	ZL201180052952.2	GRANTED	9/1/2031	​
FR	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
DE	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
NL	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
HK	14100212.60	1/8/2014	HK1187284	GRANTED	9/1/2031	​
IT	50201600-	9/1/2011	2611472	GRANTED	9/1/2031	​
​	0034676	​	​	​	​	​
PL	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
RU	2013114382.00	9/1/2011	2611361	GRANTED	9/1/2031	​
SG	201301570-6	9/1/2011	188369	GRANTED	9/1/2031	​
ES	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
SE	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
CH	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​

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Country	Application Number	Filing Date	Patent Number	Status	Expected Expiration Date	Description
TR	11776927.30	9/1/2011	2016/02464	GRANTED	9/1/2031	​
GB	11776927.30	9/1/2011	2611472	GRANTED	9/1/2031	​
KR	10-2013-7008118	9/1/2011	10-1900116	GRANTED	9/1/2031	​
MX	MX/a/2013/002372	9/1/2011	343363	GRANTED	9/1/2031	​
IL	224964.00	40787	224964	GRANTED	9/1/2031	​
US	15/079985	3/24/2016	9974814	GRANTED	3/24/2036	The ability to inflate the decellularized matrix with a gas or vapor containing a protein or other agents
DE	16730926.90	3/24/2016	3274007	GRANTED	3/24/2036	​
EP	16730926.90	3/24/2016	3274007	GRANTED	3/24/2036	​
FR	16730926.90	3/24/2016	3274007	GRANTED	3/24/2036	​
GB	16730926.90	3/24/2016	3274007	GRANTED	3/24/2036	​
US	14/777360	9/15/2015	10213525	GRANTED	5/9/2034	Use of revascularized liver to repopulate with insulin producing cells
AU	2014236952.00	3/13/2014	2014236952	GRANTED	3/13/2034	​
CH	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
DE	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
EP	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
ES	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
FR	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
GB	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
IT	502020000-	3/13/2014	2970891	GRANTED	3/13/2034	​
​	109269	​	​	​	​	​
JP	2020-035278	3/2/2020	6781352	GRANTED	3/13/2034	​
NL	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
SE	14721618.80	3/13/2014	2970891	GRANTED	3/13/2034	​
US	13/787625	3/1/2013	9290738	GRANTED	3/1/2033	Decellularization and recellularization of bone
AU	2013274322.00	6/1/2013	2013274322	GRANTED	6/1/2033	​
CA	2876648.00	6/1/2013	2876648	GRANTED	6/1/2033	​
CN	201380041965.90	6/1/2013	104937094	GRANTED	6/1/2033	​
MX	MX/A/2014/01527 0	6/1/2013	359769	GRANTED	6/1/2033	​
SG	11201408337P	6/1/2013	11201408337P	GRANTED	6/1/2033	​
BE	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	3D decellularized matrix system for the maturation of stem cells into liver or pancreas cells
CH	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
DE	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
EP	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
ES	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
FR	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
GB	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
HK	13112040.00	6/1/2011	1184813	GRANTED	6/1/2031	​
IT	502017000-	6/1/2011	2588592	GRANTED	6/1/2031	​
​	140089	​	​	GRANTED	6/1/2031	​
NL	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
PL	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
SE	11803935.30	6/1/2011	2588592	GRANTED	6/1/2031	​
TR	11803935.30	6/1/2011	2017/19561	GRANTED	3/13/2034	Use of microparticles to maintain or increase capillary lumen of revascularized organs
AU	2014251336.00	3/13/2014	2014251336	​	​	​
CN	201480024707.40	3/13/2014	ZL201480024707.4	GRANTED	3/13/2034	​

101

Country	Application Number	Filing Date	Patent Number	Status	Expected Expiration Date	Description
DE	14725270.40	3/13/2014	2968672	GRANTED	3/13/2034	​
EP	14725270.40	3/13/2014	2968672	GRANTED	3/13/2034	​
FR	14725270.40	3/13/2014	2968672	GRANTED	3/13/2034	​
GB	14725270.40	3/13/2014	2968672	GRANTED	3/13/2034	​
HK	16106912.40	6/15/2016	1218888	GRANTED	3/13/2034	​
JP	2016-502149	3/13/2014	6491187	GRANTED	3/13/2034	​
SG	11201507673W	3/13/2014	11201507673W	GRANTED	3/13/2034	​

Selected Pending Applications					​
US	16/245,435	43783	PENDING	8/28/2026	Expands decellularization coverage to include cannual
US	16/554,792	44028	PENDING	8/28/2026	Expands recellularization coverage to include bioreactors
PCT	PCT/US2019/035449	06/04/2019	PENDING	06/04/2039	Use of glucose consumption rate in livers and kidney, and endothelial fenestration.
PCT	PCT/US2020/012587	01/07/2020	PENDING	01/07/2040	ECM partilcle formation and use in gels or 3D printing applications
PCT	WO2020191374A1	03/20/2020	PENDING	03/20/2040	Selective improvements to perfusion decellularization
PCT	PCT/US2020/046963	08/19/2020	PENDING	08/19/2040	A method to decrease porosity of an outer fibrous layer of a decellularized mammalian organ or tissue
PCT	PCT/US2020/063460	12/04/2020	PENDING	12/04/2040	Kidney and liver recellularization based on function or metabolic rates

Clinical Development

Overview

We believe that our bioengineered organs have the potential for significant functional and immunological advantages compared to other emerging technologies for bioengineering organs. Importantly, we believe regulators will determine that our bioengineered organs will not be considered xenotransplants because all animal cells are removed and the organ is re-seeded with living human cells, and we believe this will shorten our regulatory pathway and overall development timetable.

We have approached our clinical development in stages to strategically to demonstrate meaningful and appropriate progress toward our first fully transplanted organ. The first step was to demonstrate our decellularization technology and the ability to reproducibly create acellular organ matrices devoid of cellular and other unwanted biologic materials. We completed this first step when we launched two FDA cleared medical devices, Miroderm and Miromesh, which we subsequently spun out to focus entirely on bioengineering whole organs. Our next step is to develop a pathway for human development of bioengineered whole organs and demonstrate human function. In order to begin studies in humans, we are preparing to engage the FDA regarding what will be necessary to open INDs. Prior to launching into human transplants, we plan to start by working with the FDA on a plan for human studies of an external assist system utilizing our bioengineered livers in acute liver failure. Currently there are no approved device or pharmacological interventions for acute liver failure and approximately 30% of adults with this disease die within 7 days of presenting. We are hopeful that the FDA will agree to a pathway for our external liver assist system that will result in us being able to begin human trials soon, since our bioengineered livers would be used outside the body. We believe that if a human study of the liver assist system provides positive results on key functional markers from our bioengineered livers that we will be well-positioned to move into submitting an IND and beginning human research on our transplantable liver product. In parallel we will be working on submitting our IND for our transplantable kidney product.

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Development Strategy to De-risk and Accelerate Human Data

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Clinical Development Plan for Bioengineered Whole Organs

Extracorporeal Liver Assist Product

We intend to propose to FDA a first-in-human (“FIH”) trial for the ELAP System which will assess the safety and physiological function of the ELAP System. We expect the FIH trial to be designed so that the ELAP System will be considered for supplementation of a native liver in patients who are experiencing acute liver failure as a bridge-to-recovery or a bridge-to-transplant for up to seven days. We are actively working with Mayo Clinic in Rochester, Minnesota on the development of ELAP System, and we hope that The Mayo Clinic will be among the first centers to participate in our Phase 1/2 trials. We anticipate requesting a pre-IND meeting in 2021 and, depending upon the feedback from the FDA at the pre-IND meeting, submitting an IND in late 2022. We are evaluating applicable designations from FDA for ELAP System, including Orphan Drug and Fast Track, and will determine whether to pursue.

The FIH ELAP System study we plan to submit to FDA in our IND is a Phase1/2 interventional, randomized, open-label trial is expected to enroll up to 30 subjects and to assess up to 3 “doses” of the bioengineered organ, including a potential group of patients randomized to a reendothelialized BEL with no hepatocytes. The other dose levels will be based on the number of hepatocytes. For instance, for a “low dose” we may propose 5 billion cells and “high dose” may be 10 billion cells. The primary endpoint proposed will likely be overall survival of subjects through day 10 following initiation of treatment with the ELAP system. A proposed secondary endpoint will likely be proportion of survivors at the end of the subject’s participation in the trial (90 days). Other global measures may include the Model for End-Stage Liver Disease Score (MELD), Maddrey’s Discriminant Function for Alcoholic Hepatitis, and West Haven Encephalopathy Stage. Because of the limited number of subjects and the nature of the pathology, it is unlikely we will identify statistically significant effects in the primary or secondary endpoints, therefore, we do not plan to control for multiplicity and plan to complete a rigorous trend analysis. The safety profile will be further evaluated by tracking related adverse events.

We expect this trial will also assess the physiological activity of the BEL by assessing numerous biomarkers of liver function over the time course of treatment and at follow-up. Major blood (serum) based biomarkers of liver function may include but are not limited to ammonia (clearance), bilirubin (conjugated, unconjugated, and total), creatinine, albumin, nitric oxide, von Willebrand factor, factor V, alkaline phosphatase, gamma glutamyl transferase (GGT), bile acids, lactate, blood urea nitrogen, glucose, sodium, potassium, oxygen, alanine aminotransferase (ALT), aspartate transaminase (AST), total protein, platelet count, compete blood count, hematocrit, interleukin-6 (IL-6), alpha-fetoprotein (AFP), international normalized ratio (INR), prothrombin time, and activated clotting time (ACT). This would allow for a comprehensive “dose” dependent characterization of therapeutic effects and the potential to speak to the minimum number of hepatocytes necessary for a therapeutically viable whole organ. Information on liver function gained during this trial will help inform the development of the transplant BEL and FIH transplant trial.

We expect the subjects will be recruited from the population of patients referred to the study site(s) for acute or acute-on-chronic liver failure. They will be screened for eligibility, invited to participate in the study and provide informed consent. The subject’s demographics, medical history, co-morbidities, liver disease diagnosis and prognosis will be documented. Extracorporeal perfusion will begin as soon as possible after identification of the need for an emergency liver transplant or poor survival prognosis consistent with the full protocol. Treatment will be initiated using a double lumen jugular catheter to connect the ELAP System to the subject’s blood supply. Treatment will be continuous until the subject’s native liver is functional, the subject undergoes the necessary orthotopic transplant, or for defined therapy duration. Subjects will receive appropriate post-operative care. We anticipate the subjects’ total time of participation will be no more than 91 days (with the critical treatment portion no more than 7 days). With the anticipated sample size, results should be available in a relative timely manner.

It is anticipated that the FDA will require additional follow-up of these subjects past the planned 90-day trial.

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Bioengineered Liver for Orthotopic Liver Transplant

In 2019 we requested and were granted an INTERACT meeting with members of FDA’s Center for Biologics Evaluation and Research (“CBER”) for the bioengineered liver used in an orthotopic transplant (“OLT”) (the Miroliver product). Interact is the acronym for INitial Targeted Engagement for Regulatory Advice on CBER producTs. INTERACT meetings are informal, non-binding consultations with CBER to enable sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase. Such meetings are intended for innovative investigational products that introduce unique challenges due to the unknown safety profiles resulting from the use of complex manufacturing technologies, development of innovative devices, or cutting-edge testing methodologies.

Based upon the feedback we received in the INTERACT meeting, we anticipate being ready to request a pre-IND meeting for the Miroliver in 2022 and, depending upon the feedback at the pre-IND, an IND for the Miroliver in late 2023 or early 2024. The research, data, and timeline for the ELAP System could also impact the timeline for the clinical development program of Miroliver. We anticipate requesting both Orphan Drug and Fast Track designations. Based upon the current criteria for these designations and the information we expect to be able to submit, we believe we could receive these designations. The FIH trial for the bioengineered liver (BEL) used in an OLT is expected to assess the safety and effectiveness of the BEL. The BEL will be considered for replacement of a diseased or malfunctioning native liver in patients who have reached the limits of other medical therapies and lack access to a transplantable liver due to, acute liver failure, complications of cirrhosis, liver-based metabolic disease, systemic complications of chronic liver disease, and chronic liver disease. We will work with FDA to identify the specific inclusion criteria. We expect the BEL will be studied for its potential to support life sustaining liver functions. The Mayo Clinic and Recanati/Miller Transplant Institute at Mount Sinai will likely be the first study sites based on our historical collaboration with them.

Our planned FIH trials are purposefully designed to occur in two stages. Subjects enrolled in the (Phase 1/2) FIH study, will have the opportunity to enroll and roll-into the second (Phase 2/3) clinical study. Because of the nature of the pathology and treatment it should be noted that, any type of comparative study would be practically and ethically untenable, assessment of effectives cannot be separated from assessment of safety, the ability of the BEL to sustain life will be apparent immediately, with the stability of that effect to be empirically determined. Thus, we believe the FDA would be willing to entertain the submission of a BLA subsequent to follow-up of a minimal number of subjects. The study conduct outlined will be the same (pending changes based on observations made during the first part of the trial) for all subjects with timing such that after 5 subjects are entered into the Phase 1/2 study, we anticipate a maximum 6 month pause before initiation of the second part of the trial. A Phase 2/3 study enrolling an additional 15-20 subjects for a total of 20-25. We anticipate that favorable results with these subjects will support a BLA.

Two stage summary:

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Part A: Initial safety and effectiveness study, total of 5 subjects enrolled. Subjects will be allowed to participate in the second stage study.

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Part B: Continued safety and effectiveness trial, likely after an FDA mandated pause. An additional 15-20 subjects will be enrolled for a total cohort of 20-25.

We intend this to be a Phase 1/2 (then 2/3) interventional, nonrandomized (single arm), open-label, study to evaluate the therapeutic effects of Miromatrix BEL in adults’ patients with end-stage liver disease. The primary objective will be to assess safety of the BEL and the BEL’s ability to sustain life for 6-12 months. The primary endpoint will be a composite of three events, biopsy-proven acute rejection, graft loss, and death at 6-12 months. Secondary objectives will be the time course of perfusion and initial effectiveness. This will also include the incidence of primary non-function (“PNF”) of the implanted BEL. The safety profile will be further characterized by tracking related adverse events. Additional global health quality of life measures will be collected such as the SF-36 Health Assessment Short Form Health Survey and EQ-5D-5L. Additionally, a comprehensive assessment of biomarkers indicative of liver function (see above) will be collected over the course of the study.

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Total patient participation will be 12 months from the day of the OLT. Subjects will be recruited from the study site’s normal population or referrals from other transplant centers. The BEL will be implanted by a proficient liver transplant surgeon in a hospital setting with medical support for transplant patients. The transplant will be consistent with standard cadaveric liver transplant. Surgical technique for BEL implantation will generally be at the discretion of the operating surgeon at the selected transplant center. We anticipate having partnered with the United Network for Organ Sharing (“UNOS”) to have the ability for an emergency allograft transplant. Subjects will receive standard post-operative care including immunosuppression. It is anticipated the subjects will be hospitalized for one-month post procedure.

It is expected that the FDA will require substantial follow-up of these subjects past the planned 12-month trial.

Bioengineered Kidney for Heterotopic Kidney Transplant

We anticipate being ready to submit a pre-IND meeting request for the bioengineered kidney (BEK) used in a heterotopic kidney transplant (“HKT”) (the Mirokidney) in late 2022 and, depending upon the feedback at the pre-IND meeting, submit an IND for the Mirokidney in late 2023 or early 2024. The research, data, and timeline for the ELAP System and Miroliver could also impact the timeline for the clinical development program of Mirokidney. We anticipate requesting Fast Track designation. Based upon the current criteria for this designation and the information we hope to be able to submit, we are hopeful we could receive this designation. The FIH trial for the BEK is expected to assess the safety and effectiveness of the BEK used in a HKT. We anticipate the BEK will be studied for supplementation of a diseased or malfunctioning native kidney(s) in adults whose estimated glomerular filtration rate is less than 15 mL/min/1.73 m2 and for whom transplant, or dialysis is necessary to sustain life. Chronic kidney disease or end-stage renal disease may be a result of diabetes, hypertension, glomerulonephritis, cystic kidney disease or other conditions. We expect the BEK will be studied for its ability to support life sustaining hemi-filtration.

This will be a Phase 1/2, interventional, nonrandomized, open-label study to evaluate the therapeutic effects of Miromatrix BEK in patients with end-stage renal disease in 5-15 subjects experiencing chronic kidney disease or end-stage renal disease. The primary endpoint will be proportion of subjects that are dialysis free at 6 months. Secondary endpoints will likely include, incidence of delayed graft function, biopsy-proven acute rejection, graft loss at 6-12 months, and glomerular filtration rate at 6-12 months. The safety profile will be characterized by tracking related adverse events. Global health and quality of life measures will be collected such as the SF-36 Health Assessment Short Form Health Survey and EQ-5D-5L. Additionally, a comprehensive assessment of biomarkers indicative of kidney function will be collected over the course of the study. These will likely include but are not limited to creatinine, cystatin C, and estimated glomerular filtration rate, sodium, potassium, chloride, blood urea nitrogen, albumin and protein, urinary albumin creatinine ratio, neutrophil gelatinase-associated lipocalin/lipocalin-2, retinol binding protein, cell free donor derived DNA, Kidney injury molecule-1, and Interleukin-18, erythropoietin and vitamin D.

Subjects will be recruited from the study site’s normal population and referrals from other transplant centers. Subjects will be screened for eligibility, invited to participate in the study and provide informed consent. The BEK will be implanted by a proficient kidney transplant surgeon in a hospital setting with medical support for transplant patients. The transplant will be consistent with standard cadaveric kidney transplantation. Surgical technique for BEK implantation will generally be at the discretion of the operating surgeon at the selected transplant center. Subjects will receive standard post-operative care including immunosuppression. It is anticipated the subjects will be hospitalized for one-week post procedure. Total patient participation will be 12 months from the day of HKT.

It is anticipated that the FDA will require substantial follow-up of these subjects past the planned 12-month trial.

Manufacturing and Suppliers

We maintain a facility in Eden Prairie, Minnesota where we decellularize all organs and tissues. This facility is maintained to the same standard as our previous cGMP manufacturing facility that

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received ISO 13485 certification for the quality management system for the design, development and manufacturing of sterile decellularized porcine matrix. A larger cGMP facility is planned to support the manufacturing of clinical product to support clinical trials. We anticipate moving our operations to this new facility in late 2021.

Our existing R&D cleanroom space was designed to support preclinical and initial clinical studies based on our manufacturing design and experience. The porcine raw materials for that facility are available to us from two alternate suppliers with which we have relationships. We plan to conduct the decellularization and recellularization processes of all products, including our transplantable organs, in a Miromatrix facility for the foreseeable future in order to maximize efficiencies, expertise and cost-savings, and ensure the highest level of quality.

The initial bioengineered kidney (“BEK”) and bioengineered liver (“BEL”) are based on primary cells from kidneys and livers unsuitable for transplant. We have established agreements with a wide group of organ procurement organizations to secure a large supply of discarded kidneys and livers. We continue to grow our network and anticipate signing over 50% of the OPOs by the inception of our first clinical trial.

Sales, Marketing and Distribution

Once we have achieved regulatory clearance for our whole organ programs, we plan to hire a direct sales force and numerous clinical specialists. Our plans are to work with key hospital systems to utilize existing priority lists and work with them as we scale and increase our manufacturing capabilities.

Government Regulation

Our research and development activities and the manufacturing and marketing of our products are subject to the laws and regulations of governmental authorities in the United States and other countries in which our products may be marketed. Specifically, in the United States, the FDA regulates drugs, biologics and medical devices and requires new product approvals or clearances to assure safety and effectiveness of these products. Governments in other countries have similar requirements for testing and marketing. In the United States, in addition to meeting FDA regulations, we are also subject to other federal laws, such as the Occupational Safety and Health Act and the Environmental Protection Act, as well as certain state laws.

Some human cell or tissue products that are intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated solely as human cell, tissue, and cellular and tissue-based products (“HCT/Ps”) and do not require the FDA’s premarket review. If these cell or tissue products do not meet the FDA’s requirements for regulation solely as an HCT/P, they likely require FDA premarket review and approval of a biologics license application (“BLA”) in order to be marketed. The regulatory classifications and corresponding pathways for ELAP System and our bioengineered organ transplant products have not yet been established. The ELAP System could be classified by the FDA as a combination biological product and medical device regulated as a biologic. We are unsure whether FDA will likewise classify our bioengineered organ transplant products as a combination biological product and medical device regulated as a biologic, or something else. It is clear that the cellular component of the ELAP System and the bioengineered organ transplant products would be considered cellular products regulated by the FDA as biological products. However, it is less clear how the FDA will regulate the extracellular matrix component, though it is possible that the FDA would view the extracellular matrix as a medical device or a xenograft. Regardless of how the FDA views the extracellular matrix, the cells would likely be viewed as providing the primary mode of action, which means that the products will require approved BLAs in order to be marketed in the U.S. Additionally, commercial production of these products needs to occur in FDA-registered facilities in compliance with cGMP requirements for biologics. Depending on how the FDA decides to regulate the extracellular matrix, we may be subject to additional requirements for medical devices, such as the quality system regulation for medical devices, or for xenografts.

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Regulatory Process

The FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and the Public Health Service Act (“PHSA”), and their implementing regulations. Obtaining approval of a BLA for a new biological product is a lengthy process leading from development of a new product through preclinical and clinical testing. This process takes a number of years and the expenditure of significant resources.

The FFDCA and other federal and state statutes and regulations govern the research, testing, manufacture, safety, labeling, storage, record-keeping, approval, distribution, use, adverse event reporting, advertising and promotion of our products. Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve our marketing applications or to allow us to enter into government supply contracts, withdrawal of previously approved applications and criminal prosecution.

Product Approval

In order to obtain an FDA license for, or approval of, a new biological product or a new combination medical device biological product regulated as a biological product, sponsors must submit proof of safety, purity and potency. In most cases, such proof entails extensive nonclinical, also known as preclinical, studies in animal models and well-controlled clinical trials in human subjects. Although not explicitly part of the statutory standard for a BLA, when FDA reviews a therapeutic biologic, it evaluates whether the application has provided substantial evidence of effectiveness. The testing, preparation of necessary applications and processing of those applications by the FDA is expensive, may take several years to complete and could have uncertain outcomes. The FDA regulatory review and approval process is complex and can result in requests for additional data, increased development cost, time to market delays, or preclude us from bringing to market new products. The FDA may also require post-marketing studies and risk evaluation and mitigation strategies (“REMS”) as conditions to approval. These requirements will add to the cost of regulatory compliance and the cost to sell our products, due to complex distribution and restricted commercial operations. Product approvals may be withdrawn if compliance with applicable regulations is not maintained or if safety issues are identified during routine safety monitoring following commercialization.

Adequate and well-controlled clinical studies are required by the FDA for approval of a BLA. To conduct a clinical trial in the U.S., the study sponsor is required to submit an Investigational New Drug (IND) application, including the study protocol, prior to commencing human clinical trials. The submission must be supported by data, typically including the results of nonclinical, manufacturing and laboratory testing. The conduct of the nonclinical tests must comply with Good Laboratory Practice. Long-term nonclinical testing, such as animal reproductive toxicity and carcinogenicity, is conducted if warranted, and its results are submitted to the IND to support a future BLA. Following the initial submission of the IND, the FDA has 30 days to review the application and raise safety and other clinical trial issues through a partial or full clinical hold. If questions or objections are not raised within that period, the clinical trial may commence according to the investigational protocol submitted to the FDA and following Institutional Review Board (IRB) approvals for each of the clinical sites where the study will be conducted. Protocol amendments need to be submitted and approved by the FDA prior to implementation. Clinical studies can also be conducted outside of the U.S. with or without a U.S. IND. However, a clinical trial application (CTA) or IND is required to be submitted to the local competent regulatory authority to begin conducting human clinical trials. The CTA has similar data requirements to those of an IND.

For products that are regulated as biologics, the FDA requires: (i) nonclinical animal testing to establish a safety profile and/or a starting dose for initiation of clinical trials in humans; (ii) submission to the FDA of an IND application, which must become effective prior to the initiation of human clinical trials; (iii) adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of the product for its intended use; (iv) submission to the FDA of a BLA; and (v) review and approval of the BLA as well as pre-approval inspections of the manufacturing facilities by the FDA.

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Human clinical trials are typically conducted in three sequential phases that may sometimes overlap:

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Phase 1-The biological product is initially tested for safety and tolerability. In the case of biological products and those for severe or life-threatening diseases, the initial human testing is generally conducted in healthy patients. These trials may also provide early evidence of effectiveness.

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Phase 2-These trials are conducted in a limited number of subjects in the target population to determine a safe and effective dosage to evaluate in Phase 3 and to identify possibly related adverse effects and safety risks. Multiple

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Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

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Phase 3-Phase 3 trials are undertaken to provide evidence of clinical efficacy and to further evaluate dosage, potency, and safety in an expanded patient population at multiple clinical trial sites. Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the product has been obtained, and are intended to establish the overall benefit-risk relationship of the investigational product, and to provide an adequate basis for product approval and labeling.

Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials may be required by the FDA as a condition of approval and are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. The FDA has express statutory authority to require post-market clinical trials . All of these trials must be conducted in accordance with good clinical practice (“GCP”) requirements in order protect the health and safety of human subjects and for the data to be considered reliable for regulatory purposes.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the IND. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events; any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects; or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

Phase 1, Phase 2, and Phase 3 clinical trials may not be completed successfully or within any specified period, or at all. Regulatory authorities, a data safety monitoring board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the participants are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients.

A drug being studied in clinical trials may be made available to individual patients in certain circumstances. Pursuant to the 21st Century Cures Act, or Cures Act, which was signed into law in December 2016, the manufacturer of an investigational drug for a serious disease or condition is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for individual patient access to such investigational drug. This requirement applies on the later of 60 calendar days after the date of enactment of the Cures Act or the first initiation of a Phase 2 or Phase 3 trial of the investigational drug.

Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents with the use of biological products, the PHSA Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently

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producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

After completion of the required clinical testing, a BLA is prepared and submitted to the FDA. FDA review and approval of the BLA is required before marketing of the product may begin in the United States. The BLA must include the results of all nonclinical, clinical, and other testing and a compilation of data relating to the quality and manufacture of the product, including, chemistry, manufacture, and controls, to demonstrate the safety, purity and potency, of the product based on these results. If the product is deemed a combination product then the agency will also review the other constituent part during the application review. The cost of preparing and submitting a BLA is substantial. Under federal law, the submission of most BLAs is subject to an application user fee, as well as an annual prescription drug product program user fee, which may total several million dollars and are increased annually.

The FDA has 60 days from its receipt of a BLA to determine whether the application will be filed based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is filed, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of BLAs, including to review 90 percent of standard BLAs within 10 months from the date the application is filed. The FDA can refer applications for novel biologics, or biologics which present difficult questions of safety or efficacy, to an advisory committee-typically a panel that includes clinicians and other experts-for review, evaluation, and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving a BLA, the FDA will typically inspect one, or more, clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the biologic is manufactured, or tested, as part of a pre-license inspection. The FDA will not approve the product unless it verifies that compliance with requirements for cGMP is satisfactory and the BLA contains data that demonstrate that the biologic is safe, pure and potent and provide substantial evidence of effectiveness for the intended use.

Based upon our expectation that the cellular component of the ELAP System and the bioengineered organ transplant products would be considered cellular products regulated by the FDA as biological products, the FDA also will not approve our products if the manufacturer is not in compliance with the current Good Tissue Practices (“cGTP”). These are FDA regulations that govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, which are human cells or tissues intended for implantation, transplant, infusion, or transfer into a human recipient. The primary intent of the cGTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease. FDA regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing. To assure cGMP, cGTP and cGCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.

After the FDA evaluates the BLA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter means that the BLA will not be approved in its present form and generally outlines the deficiencies in the submission. Complete responses may require substantial additional testing, or information, in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction, the FDA will issue an approval letter. The agency will review such resubmissions in two or six months depending on the type of information included. The FDA approval is never guaranteed, and the FDA may refuse to approve a BLA if the regulatory requirements are not satisfied.

An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications. The approval for a biologic may be significantly more limited than requested in the application, including limitations on the specific diseases and dosages or the indications for use, which could restrict the commercial value of the product. The FDA may also require that

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certain contraindications, warnings, or precautions be included in the product labeling. In addition, as a condition of BLA approval, the FDA may require a REMS to help ensure that the benefits of the biologic outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS with a biologic can materially affect the potential market and profitability of the biologic. Moreover, product approval may require, as a condition of approval, substantial post-approval testing and surveillance to monitor the biologic’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory requirements and standards is not maintained or problems are identified following initial marketing.

Under current requirements, facilities manufacturing biological products for commercial distribution must be registered with the FDA. In addition to the preclinical studies and clinical trials, the BLA includes a description of the facilities, equipment and personnel involved in the manufacturing process. A biologics license, which is the product’s approval, is granted on the basis of inspections of the applicant’s facilities in which the primary focus is on compliance with cGMP and the ability to consistently manufacture the product in the facility in accordance with the BLA. If the FDA finds the results of the inspection unsatisfactory, it may decline to approve the BLA, resulting in a delay in production and commercialization of products.

Regulation of Combination Products in the United States

Certain products may be comprised of components, or constituent parts, that would normally be regulated under different types of regulatory authorities and frequently by different centers at the FDA. These products are known as combination products. Specifically, under regulations issued by the FDA, a combination product may be:

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A product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

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Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

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A drug, or device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, or device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

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Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

Under the FFDCA, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for review of a combination product. That determination is based on the “primary mode of action” of the combination product. Thus, if the primary mode of action of a device-biologic combination product is attributable to the biologic product, the FDA center responsible for premarket review of the biologic product would have primary jurisdiction for the combination product. The FDA has also established an Office of Combination Products to address issues surrounding combination products and provide more certainty to the regulatory review process. That office serves as a focal point for combination product issues for agency reviewers and industry. It is also responsible for developing guidance and regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.

Regenerative Advanced Therapies

As part of the Cures Act, Congress amended the FFDCA to create a pathway to facilitate development and expedite review of regenerative advanced therapies, which are intended to treat,

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modify, reverse, or cure a serious or life-threatening disease or condition and include cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. Regenerative advanced therapies do not include those human cells, tissues, and cellular and tissue-based products regulated solely under section 361 of the PHSA Act and 21 CFR Part 1271. A sponsor may request that the FDA designate a product as a regenerative medicine advanced therapy concurrently with or at any time after submission of an IND. The FDA has 60 calendar days to determine whether the product meets the criteria, including whether there is preliminary clinical evidence indicating that the product has the potential to address unmet medical needs for a serious or life-threatening disease or condition. A BLA for a regenerative medicine advanced therapy may be eligible for priority review or accelerated approval through surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites. Therapies with a Regenerative Medicine Advanced Therapy (“RMAT”) designation will be eligible for accelerated approval through, as appropriate:

(i)

Surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or

(ii)

Reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

Another benefit of RMAT designation is that it creates the possibility to meet post-approval requirements beyond the standard, controlled clinical trial. Post-approval requirements can possibly be met through:

•

Clinical evidence, clinical studies, patient registries, or other sources of real-world evidence, such as electronic health records;

•

The collection of larger confirmatory data sets; or

•

Post-approval monitoring of all patients treated with such therapy prior to approval of the therapy.

Finally, the designation also includes early interactions with the FDA to discuss any potential surrogate or intermediate endpoint to be used to support accelerated approval.

FDA Post-Approval Requirements

Maintaining substantial compliance with applicable federal, state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Rigorous and extensive FDA regulation of biological products, devices and combination products continues after approval, particularly with respect to cGMP. We will rely, and expect to continue to rely, on third parties to manufacture or supply certain components, equipment, disposable devices, testing and other materials used in our manufacturing process for any products that we commercialize or may commercialize. Manufacturers of our products are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation. We cannot be certain that we or our present or future suppliers will be able to comply with the cGMP and other FDA regulatory requirements. Other post-approval requirements applicable to biological products and certain combination products include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements, monitoring and reporting of adverse effects, reporting updated safety and efficacy information, periodic reporting requirements and complying with electronic record and signature requirements. Similarly, there are a number of post-marketing requirements for devices, including medical device reporting regulations that require manufacturers to report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and corrections and removal reporting regulations that require manufacturers to report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a risk to health. Additionally, devices must comply with the cGMP requirements that are set forth in the FDA’s Quality System Regulation (“QSR”), including complaint handling and corrective and preventative actions.

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After a BLA is approved, the biological product also may be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, and potency of biological products. After approval of biologics, manufacturers must address any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval.

Further, for BLAs, changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs. Similarly, changes to approved or cleared devices may require FDA’s premarket review.

Discovery of previously unknown problems or the failure to comply with the applicable regulatory requirements, by us or our suppliers, may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions and adverse publicity. FDA sanctions could include refusal to approve pending applications or supplements, license revocation, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

Biological product and medical device manufacturers and other entities involved in the manufacture and distribution of approved biological products, devices and combination products are required to register their facilities with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval, with certain exceptions.

Pediatric Research Equity Act

Under the Pediatric Research Equity Act (“PREA”), a BLA or BLA supplement claiming a new indication must contain data to assess the safety and effectiveness of the biological product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, for a new product, new indication or dosage form. The intent of PREA is to compel sponsors whose products have pediatric applicability to study those products in pediatric populations, rather than ignoring pediatric indications for adult indications that could be more economically desirable. The FDA may grant deferrals for submission of data or full or partial waivers. By its terms, PREA does not apply to any biological product for an indication for which orphan designation has been granted, unless the FDA issues regulations saying otherwise. Because the FDA has not issued any such regulations, submission of a pediatric assessment is not required for an application to market a product for an orphan-designated indication, and waivers are not needed at this time. However, if only one indication for a product has orphan designation, a pediatric assessment may still be required for any applications to market that same product for the non-orphan indication(s).

U.S. Patent Term Restoration and Marketing Exclusivity

Depending upon the timing, duration, and specifics of the FDA approval of the use of our current or future product candidates, some of our U.S. patents may be eligible for limited patent term extension

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under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. Patent term restoration can compensate for time lost during product development and the regulatory review process by returning up to five years of patent life for a patent that covers a new product or its use. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The period of patent term restoration is generally one-half the time between the effective date of an IND (falling after issuance of the patent) and the submission date of a BLA, plus the time between the submission date of the BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved biological product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The application for patent term extension is subject to approval by the United States Patent and Trademark Office, or PTO, in consultation with the FDA.

A biological product can obtain pediatric market exclusivity in the United States. This six-month exclusivity, which runs from the end of other exclusivity protection, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study.

Biosimilars

The Patient Protection and Affordable Care Act, or the Affordable Care Act, includes the Biologics Price Competition and Innovation Act of 2009. That Act created an approval pathway authorizing the FDA to approve biosimilars and interchangeable biologics, which could allow competitors to reference future data from our product candidates for which we receive marketing approval and increase the risk that our product candidates may face competition sooner than anticipated. Biosimilars are biological products which are “highly similar” to a previously approved biologic product or “reference product” and for which there are no clinically meaningful differences between the biosimilar product and the reference product in terms of the safety, purity, and potency as shown through analytical studies, animal studies and a clinical study or studies. For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biosimilar and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. A reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product.

Advertising and Promotion

The FDA closely regulates the post-approval marketing and promotion of biologics and devices including regulating through standards and regulations for direct-to-consumer advertising and promotional activities involving the internet. The agency also prohibits the off-label promotion of biologics, devices and combination products, and provides guidance on industry-sponsored scientific and educational activities to ensure that these activities are not promotional. Any claims we make for our products in advertising or promotion must be appropriately balanced with important safety information and otherwise adequately substantiated. Failure to comply with these requirements can result in adverse publicity and significant penalties, including the issuance of untitled or warning letters directing a company to correct deviations from FDA standards, corrective advertising, a requirement that future advertising and promotional materials be pre-cleared by the FDA, injunctions, and federal and state civil and criminal investigations and prosecutions.

While doctors are free to prescribe any product approved by the FDA for use, a company can only make claims relating to safety and effectiveness of a biological product or device that are consistent with the FDA approval or clearance, and the company is allowed to actively market and promote a biological product or device only for the particular use and treatment approved or cleared by the FDA.

Orphan Drug

Under the Orphan Drug Act, the FDA may grant orphan designation to drugs or biologics intended to treat a rare disease or condition, generally a disease or condition that affects fewer than 200,000

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individuals in the United States, or affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States for such disease or condition will be recovered from sales in the United States of such drug or biologic. Orphan drug designation must be requested to and granted by the FDA before submitting a BLA. Among the benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application user fee. After the FDA grants orphan drug designation, the generic identity of the biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. However, the first applicant to receive FDA approval for a particular product to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United States for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan product to meet the needs of patients with the disease or condition for which the biologic was designated. Orphan drug exclusivity, which would most likely run concurrently with the exclusivity, if any, received from the time of first licensure of a reference product, does not prevent the FDA from approving a different biologic for the same disease or condition, or the same biologic for a different disease or condition.

Anti-Kickback and False Claims Laws

In the United States, the research, manufacturing, distribution, sale and promotion of biological products and devices are subject to regulation by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare & Medicaid Services, other divisions of the U.S. Department of Health and Human Services (e.g., the Office of Inspector General), the U.S. Department of Justice, state Attorneys General, and other federal, state and local government agencies. For example, sales, marketing and scientific/educational grant programs must comply with the FFDCA, Anti-Kickback Statute, as amended, the False Claims Act, as amended, the Patient Protection and Affordable Care Act, as amended, the privacy regulations promulgated under the Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially subject to federal and state consumer protection and unfair competition laws.

The Anti-Kickback Statute makes it illegal for any person, including a biological product manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including the purchase or order of an item for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Violations of this law are punishable by up to five years in prison, criminal fines, administrative civil money penalties, and exclusion from participation in federal healthcare programs. In addition, many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to the referral of patients for healthcare services reimbursed by any insurer, not just federal healthcare programs such as Medicare and Medicaid. Due to the breadth of these federal and state anti-kickback laws and the potential for additional legal or regulatory change in this area, it is possible that our sales and marketing practices and/or our relationships with physicians might be challenged under anti-kickback laws, which could harm us. Because we have commercialized and intend to continue to commercialize products that could be reimbursed under a federal healthcare program and other governmental healthcare programs, we have developed a comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we are subject.

The federal False Claims Act prohibits anyone from, among other things, knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including biological products, that are false or fraudulent. Although we would not submit claims directly to payers, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or

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coding information to customers or promoting a product off-label. In addition, our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, pharmaceutical companies have been prosecuted under the federal False Claims Act in connection with their off-label promotion of drugs. Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties of between $11,181 and $22,363 for each separate false claim, the potential for exclusion from participation in federal healthcare programs, and, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes. If the government were to allege that we were, or convict us of, violating these false claims laws, we could be subject to a substantial fine and may suffer a decline in our stock price. In addition, private individuals have the ability to bring actions under the federal False Claims Act and certain states have enacted laws modeled after the federal False Claims Act.

There are also an increasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. Many of these laws contain ambiguities as to what is required to comply with the laws. In addition, a provision of the Patient Protection and Affordable Care Act, referred to as the Sunshine Act, requires biological product manufacturers to track and report to the federal government certain payments or other transfers of value made to physicians and teaching hospitals in the previous calendar year. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state and federal authorities.

International Regulation

In addition to regulations in the United States, a variety of foreign regulations govern clinical trials, development, commercial sales, manufacturing, and distribution of product candidates. The marketing authorization approval process and requirements vary from country to country, as do product classifications. Particularly in the area of regenerative medicines, the regulatory pathways may be unclear. The review timelines may be longer or shorter than that required for FDA approval. As of right now, the Company is focused on product development in the United States and has not spent significant time or resources exploring product development in any country other than the United States.

Pharmaceutical Coverage, Pricing, and Reimbursement

In the United States and other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payers, including government health administrative authorities, managed care providers, private health insurers, and other organizations. Third-party payers are increasingly examining the medical necessity and cost effectiveness of medical products and services in addition to safety and efficacy and, accordingly, significant uncertainty exists as to the reimbursement status of newly approved therapeutics. Third-party reimbursement adequate to enable us to realize an appropriate return on our investment in research and product development may not be available for our products.

Employees

As of February 28, 2021, we had 36 employees worldwide. None of our employees are represented by a collective bargaining agreement and we have never experienced a work stoppage. We believe we have good relationships with our employees.

Properties

We lease our corporate headquarters in Eden Prairie, Minnesota, which houses our research and development operations and office space, and currently totals approximately 14,700 square feet.

We believe that our current facilities meet our current needs through 2021. A larger 30,000 square feet facility to support our development and early clinical trials has been designed and budgeted for $3 million. We hope the transition to the new facility will start in late 2021. We may seek to evaluate additional or alternate space for our operations in the future. We believe appropriate facilities will be readily available on commercially reasonable terms.

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Legal Proceedings

We may be subject to legal proceedings and claims in the ordinary course of business. We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and attention as well as the financial costs related to resolving such disputes.

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MANAGEMENT

The following table sets forth information regarding our executive officers and directors, including their ages as of December 31, 2020:

NAME	AGE	POSITION(S)
Executive Officers	​	​
Jeff Ross	45	Chief Executive Officer and Director
Brian Niebur	57	Chief Financial Officer
Laji Kattungal	50	Vice President of Quality
Non-Employee Directors	​	​
Paul Buckman	65	Chairman of the Board of Directors
Ronald Eibensteiner	70	Director
John Erb	71	Director
Mahesh Krishnan	50	Director
Mark Wagner	64	Director

(1)

Member of our audit committee.

(2)

Member of our compensation committee.

(3)

Member of our nominating and corporate governance committee.

Executive Officers

Jeff Ross, Ph.D.   Dr. Ross has been our Chief Executive Officer since 2017 and has served on our Board since October of 2019. Prior to serving as our Chief Executive Officer, Dr. Ross was our Vice President of Product Development from 2010 to 2017. Dr. Ross started his industry career at Guidant leading a biologics group for new cardiovascular therapies. Following Guidant, he worked at Athersys assisting with the commercialization and scale up of stem cell technologies. He then served as Director of Research and Commercial Development of Biologics at SurModics. Dr. Ross has over 30 published and issued patents along with leading publications in Nature and the Journal of Clinical Investigation. He holds a M.S. in Biomedical Engineering and a Ph.D. in Molecular, Cellular and Developmental Biology, from the University of Minnesota.

Brian Niebur.   Mr. Niebur has been our Chief Financial Officer since 2016. Prior to joining the Company, he was the chief financial officer of Entrprize Corp. from 2002 to 2016. From 2000 to 2016, he served as the vice president and controller of Wyncrest Capital, Inc., a privately-held venture capital firm, where he led the financial departments of various private and publicly-held corporations. Mr. Niebur has a B.A. in Accounting from the University of Minnesota and is a certified public accountant (inactive).

Laji Kattungal.   Mr. Kattungal joined us as our Vice President of Quality in July of 2020, with over 20 years of experience in the Biopharmaceutical industry. Prior to joining the Company, Mr. Kattungal held positions of increasing responsibilities within Quality in small and large biotech companies, including, most recently, as the leader of the Quality departments at Nuvation Bio from 2019 – 2020 and at Sanbio from 2018-2019. At Sanbio, he was part of the team that enabled key regulatory milestones, including obtaining the Sakigake, RMAT and Prime status for SB 623, a cell-based investigational product which is expected to trigger the brain’s natural regenerative ability to recover lost motor functions. Prior to his work at Sanbio, Mr. Kattungal worked in Quality at Orexigen from 2017 – 2018, Medivation from 2013 – 2017, Jazz Pharmaceuticals from 2010 – 2012, Medimmune from 2008 – 2010 and Amgen from 2003 – 2007. As a seasoned Quality professional, Mr. Kattungal has successfully built and managed wide-ranging and robust Quality organizations and programs for maintaining internal and external compliance. He has provided Quality guidance, for all phases of product development — bench to market, including, preclinical, early and late phase clinical trials and

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market launch of Biopharmaceutical products. Mr. Kattungal holds a BS in Biology from the University of Michigan in Ann Arbor.

Non-Employee Directors

Paul Buckman.   Mr. Buckman has served on our Board since April of 2017. Mr. Buckman has 41 years of medical device experience in general management, sales, marketing, finance, international and operations. In addition to LivaNova, Mr. Buckman was President of the Cardiovascular Divisions of both Boston Scientific and St. Jude Medical where he implemented significant growth strategies in both core and emerging technologies. He was also a co-founder, Chairman, and CEO of ev3 which was acquired by Covidien for $2.5B. Mr. Buckman has also had previous CEO roles with Conventus Orthopaedics, SentreHeart (sold to AtriCure), Pathway Medical (sold to Bayer Healthcare), and Devax (sold to Biosensors Intl.), in addition to executive management roles at DVI (sold to Eli Lilly) and American Hospital Supply. Presently, Paul serves as a Director on the Boards of NeuroOne (Chairman), Miromatrix (Chairman), Ablative Solutions, ActivOrtho, Inc. (Co-Founder), Shoulder Innovations, SentiAR, and Medical Device Manufacturers Association.

Ronald Eibensteiner.   Mr. Eibensteiner has served on our Board since 2010. Mr. Eibensteiner has been President of Wyncrest Capital, Inc. since 1993, an investment company for early-stage technology companies in the area of telecommunications, medical devices and software. Mr. Eibensteiner co-founded Ready Credit Corporation in 2005 and served as its Chief Executive Officer and Chairman during its formation and currently serves on the Board. Mr. Eibensteiner is a board member of Kwikbit Inc, a telecom network company. Mr. Eibensteiner also serves on the board of Reprise Biomedical. His past investment activities included: co-founder of Diametrics Medical, Inc., a manufacturer of blood gas diagnostic systems; a principal investor and Board member of OnHealth Network Company, a web-based publisher of health and wellness information which was later merged with WebMD; principal investor and Board member of BigCharts, Inc., a provider of financial internet content until its sale to Dow Jones/MarketWatch.com in June 1999; Chairman of the Board of Prodea Software Corporation, a data-warehousing software company, until its sale to Platinum Technology, Inc.; and principal investor and Board of Director member of Travanti Pharma Inc, a specialty drug delivery firm, until its sale to Teikoku Pharmaceutical in May of 2009. Mr. Eibensteiner also served as a member of the Board of Stellant Software (Nasdaq: STEL) from 1996 until 2001. In 1983, Mr. Eibensteiner co-founded Arden Medical Systems and served as its Chief Financial Officer until its sale to Johnson & Johnson in 1987. Mr. Eibensteiner holds a B.S. in Political Science from the University of Minnesota.

John Erb.   Mr. Erb has served on our Board since April of 2017. Mr. Erb is currently Chairman of the Board for CHF Solutions Inc., a global medical device company involved in the treatment of heart failure, and has been in that role since 2016. He also currently serves as Chairman of the Board of Directors for Osprey Medical, a public ASX company. Mr. Erb is co-founder of NuAx, Inc. (formerly Cardia Access, Inc.), a medical device company involved in developing new devices for the treatment of heart disease. Previously, Mr. Erb served as Chairman of the Board of Directors for Vascular Solution, Inc., a public NASDAQ company, (acquired by Teleflex Incorporated), and was a board member for CryoCath Technologies (acquired by Medtronic in 2008) and SenoRx, Inc. (acquired by CR Bard in 2010). From 2001 through 2006, Mr. Erb was Chief Executive Officer of CHF Solutions, Inc., a medical device company focused on the treatment of congestive heart failure. CHF Solutions, Inc. was acquired by Gambro. From 1997 through 2001, Mr. Erb was President and Chief Executive Officer of IntraTherapeutics, Inc., a medical device company involved in the development, manufacturing and distribution of peripheral vascular stents. IntraTherapeutics, Inc. was acquired by Sulzer Medica. Other previous executive experience includes Vice President of Operations for Schneider Worldwide, a division of Pfizer, Inc.; ten years with Johnson & Johnson’s Iolab Division; and the start of his career with American Hospital Supply Corporation. Mr. Erb has a B.S. in Business Administration from California State University, Fullerton.

Mahesh Krishnan, MD, MPH, MBA, FASN.   Mr. Krishnan has served on our Board since March of 2020. Mr. Krishnan is the clinical lead for DaVita Venture Group and focuses on establishing strategic partnerships with industry leaders, while remaining active in DaVita’s R&D efforts. Prior to taking on this role, he served as DaVita’s first international Chief Medical Officer and Group Vice President of

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Research and Development from 2015 to 2019. Before DaVita, Mr. Krishnan served as medical director for Epogen® at Amgen, and practiced nephrology in northern Virginia for nearly five years. He earned his M.D. from Jefferson Medical College at Thomas Jefferson University. He also holds an M.P.H. from Johns Hopkins University and an M.B.A. from the Johns Hopkins Carey School of Business.

Mark Wagner.   Mr. Wagner has served on our Board since April of 2017. Mr. Wagner currently is a member of the board of directors for Miromatrix, and Sonex Health, a company that has developed innovation technology to treat hand disorders, and the Chairman of Zipnosis Inc., a Healthcare Information Technology company involved in bringing the latest advances in Telemedicine. Previously Mr. Wagner served as President and CEO of Minnesota-based Celleration, a company commercializing therapeutic ultrasound platform for the treatment of acute and chronic wounds, until its acquisition by Alliqua in May 2015. Prior to Celleration, Mr. Wagner co-founded and served as board chairman for Orasi Medical, a University of Minnesota spinout that developed diagnostic tools for neurological diseases. Mr. Wagner has served as President and CEO for both Reshape Medical and ProVation Medical, and as Chairman and CEO of Survivalink. Mr. Wagner’s experience also includes a number of executive leadership positions at Nellcor Puritan Bennett. Mr. Wagner began his career at GE Healthcare where he worked in marketing, business development and finance. Mr. Wagner has served on the boards of director for 14 Life Sciences companies. In addition to completing executive leadership and corporate training programs, Mr. Wagner earned a Bachelor of Science in Business Administration from the University of Southern California.

Board Composition and Election of Directors

Our board of directors is currently composed of six members. In accordance with our amended and restated certificate of incorporation, which will be filed immediately prior to the completion of this offering, our directors will be divided into three classes serving staggered three-year terms. At each annual meeting of stockholders, our directors will be elected to succeed the class of directors whose terms have expired. Our current directors will be divided among the three classes as follows:

•

the Class I directors will consist of                 ,                 and                 , and their terms will expire at the annual meeting of stockholders to be held in 2021;

•

the Class II directors will consist of                 ,                 and                 , and their terms will expire at the annual meeting of stockholders to be held in 2022; and

•

the Class III directors will consist of                 ,                 and                 , and their terms will expire at the annual meeting of stockholders to be held in 2023.

The classification of our board of directors, together with the ability of the stockholders to remove our directors only for cause and the inability of stockholders to call special meetings, may have the effect of delaying or preventing a change in control or management. See “Description of Capital Stock — Anti-Takeover Provisions of Delaware Law and our Charter Documents” for a discussion of other anti-takeover provisions that are included in our amended and restated certificate of incorporation.

Director Independence

Under the Nasdaq Marketplace Rules, or the Nasdaq Listing Rules, each committee of our board of directors must be comprised of at least one independent member at the time of listing, a majority of independent directors no later than 90 days after such date and solely independent directors within one year after such date.

Our board of directors has undertaken a review of its composition, the composition of its committees and the independence of each director. Based upon information provided by each director, our board of directors has determined that none of our directors, with the exception of Jeff Ross, has a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and is independent under applicable Nasdaq rules. In making these determinations, our board of directors considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in

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determining their independence, including the beneficial ownership of our capital stock by each non-employee director, and the transactions involving them described in the section titled “Certain Relationships and Related Party Transactions.”

Director Compensation

Upon completion of this offering, directors who are also full-time officers or employees of our company will receive no additional compensation for serving as directors, and directors who are not full-time officers or employees of our company, or non-employee directors, will receive compensation, if any, pursuant to a compensation policy we expect to implement for our non-employee directors.

Board Committees

Audit Committee

Our audit committee consists of                 . Our board of directors has determined that each of such directors are independent under the Nasdaq Listing Rules and Rule 10A-3(b)(1) of the Securities Exchange Act of 1934, or the Exchange Act. The chair of our audit committee is                 . Our board of directors has determined that                 is an “audit committee financial expert” as such term is currently defined in Item 407(d)(5) of Regulation S-K. This designation does not impose any duties, obligations or liabilities that are greater than are generally imposed on members of our audit committee and our board of directors. Our audit committee is directly responsible for, among other things:

•

selecting a firm to serve as the independent registered public accounting firm to audit our financial statements;

•

ensuring the independence of the independent registered public accounting firm;

•

discussing the scope and results of the audit with the independent registered public accounting firm and reviewing, with management and that firm, our interim and year-end operating results;

•

establishing procedures for employees to anonymously submit concerns about questionable accounting or audit matters;

•

considering the adequacy of our internal controls and internal audit function;

•

monitoring compliance with the code of business and conduct and ethics for financial management;

•

reviewing material related party transactions or those that require disclosure; and

•

approving or, as permitted, pre-approving all audit and non-audit services to be performed by the independent registered public accounting firm.

Our audit committee will operate under a written charter, to be effective prior to the completion of this offering, that satisfies the applicable rules of the Securities and Exchange Commission, or the SEC, and the Nasdaq Listing Rules.

Compensation Committee

Our compensation committee consists of                 . Each member of this committee is a non-employee director, as defined by Rule 16b-3 promulgated under the Exchange Act and meets the requirements for independence under the current Nasdaq Listing Rules. The chair of our compensation committee is                 . The compensation committee is responsible for, among other things:

•

reviewing and approving, or recommending that our board of directors approve, the compensation of our executive officers;

•

reviewing and recommending to our board of directors the compensation of our directors;

•

administering our stock and equity incentive plans;

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•

reviewing and approving, or making recommendations to our board of directors with respect to, incentive compensation and equity plans; and

•

reviewing our overall compensation philosophy.

Our compensation committee will operate under a written charter, to be effective prior to the completion of this offering.

Nominating and Corporate Governance Committee

Our nominating and corporate governance committee consists of                 . The chair of our nominating and corporate governance committee is                 . Each member of the nominating and corporate governance committee meets the requirements for independence under the current Nasdaq Listing Rules. The nominating and corporate governance committee is responsible for, among other things:

•

identifying and recommending candidates for membership on our board of directors;

•

reviewing and recommending our corporate governance guidelines and policies;

•

reviewing proposed waivers of the code of conduct for directors and executive officers;

•

overseeing the process of evaluating the performance of our board of directors; and

•

assisting our board of directors on corporate governance matters.

Our nominating and corporate governance committee will operate under a written charter, to be effective prior to the completion of this offering.

Compensation Committee Interlocks and Insider Participation

None of the members of the compensation committee is currently, or has been at any time, one of our executive officers or employees. None of our executive officers currently serves, or has served during the last year, as a member of the board of directors or compensation committee of any entity that has one or more executive officers serving as a member of our board of directors or on our compensation committee.

Code of Business Conduct and Ethics

In connection with this offering, our board of directors will adopt a written code of business conduct and ethics that will apply to all of our directors, officers and employees. The code of business conduct and ethics will cover fundamental ethics and compliance-related principles and practices such as accurate accounting records and financial reporting, avoiding conflicts of interest, the protection and use of our property and information and compliance with legal and regulatory requirements. Our code of business conduct and ethics will be posted on the investor relations section of our website at www.miromatrix.com. We intend to disclose any amendments to our code of business conduct and ethics, or waivers of its requirements, on our website to the extent required by the applicable rules and exchange requirements.

Limitations on Liability and Indemnification Matters

Our amended and restated certificate of incorporation, which will be effective immediately prior to the completion of this offering, and our amended and restated bylaws, which will become effective immediately prior to the completion of this offering, limits our directors’ liability, and may indemnify our directors and officers to the fullest extent permitted under the DGCL. The DGCL provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except for liability for any:

•

transaction from which the director derives an improper personal benefit;

•

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

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•

unlawful payment of dividends or redemption of shares; or

•

breach of a director’s duty of loyalty to the corporation or its stockholders.

The DGCL and our amended and restated bylaws provide that we will, in certain situations, indemnify our directors and officers and may indemnify other employees and other agents, to the fullest extent permitted by law. Any indemnified person is also entitled, subject to certain limitations, to payment or reimbursement of reasonable expenses, including attorneys’ fees and disbursements, in advance of the final disposition of the proceeding.

We have entered or intend to enter into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.

We maintain a directors’ and officers’ insurance policy pursuant to which our directors and officers are insured against liability for actions taken in their capacities as directors and officers. We believe that these provisions in our amended and restated certificate of incorporation and amended and restated bylaws and these indemnification agreements are necessary to attract and retain qualified persons as directors and officers.

Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, or the Securities Act, may be permitted to directors, officers or control persons, in the opinion of the SEC, such indemnification is against public policy, as expressed in the Securities Act and is therefore unenforceable.

The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit against our directors and officers for breach of their fiduciary duty. They may also reduce the likelihood of derivative litigation against our directors and officers, even though an action, if successful, might benefit us and our stockholders. Further, a stockholder’s investment may be adversely affected to the extent that we pay the costs of settlement and damage awards against directors and officers as required by these indemnification provisions. At present, there is no pending litigation or proceeding involving any of our directors, officers or employees for which indemnification is sought and we are not aware of any threatened litigation that may result in claims for indemnification.

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EXECUTIVE AND DIRECTOR COMPENSATION

Summary Compensation Table

The following table sets forth summary compensation information for our “named executive officers” for the year ended December 31, 2020, which consists of our principal executive officer and our two other most highly compensated executive officers. The following table includes all compensation earned by the named executive officers for such period, regardless of whether such amounts were actually paid during the period:

Name and Position

Fiscal Years

Salary ($)

Stock Awards ($)

Option Awards ($)

Non-Equity Incentive Plan  Compensation ($)

All Other Compensation ($)

Total ($)

Jeff Ross

2020

​

300,989

​

—

​

—

​

22,500

​

—

​

323,489

Chief Executive Officer

​

​

​

​

​

​

​

​

​

​

​

​

​

Brian Niebur

2020

​

162,637

​

—

​

—

​

16,177

​

—

​

178,814

Chief Financial Officer

​

​

​

​

​

​

​

​

​

​

​

​

​

Laji Kattungal(1)

2020

​

110,735

​

—

​

77,275(2)

​

10,000

​

​

​

198,010

Vice President of Quality

​

​

​

​

​

​

​

​

​

​

​

​

​

(1)

Mr. Kattungal’s employment began on July 16, 2020.

(2)

Amount represents the grant date fair value of the stock option award granted to Mr. Kattungal on July 16, 2020, in connection with his commencement of employment with us, as computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718 (“ASC Topic 718”), disregarding the impact of estimated forfeitures. The assumptions used in calculating the grant date fair value of the stock options are set forth in Note 6 to the audited financial statements included in this prospectus. Note that the amounts reported in this column reflects the accounting cost for these stock-based awards and does not correspond to the actual economic value that may be received by the Named Executive Officer for these awards.

Employment Agreements

We have entered into an employment agreement with our chief executive officer, the key terms of which are described below. The following is a summary of the material terms of the agreement. For complete terms, please see the agreement attached as an exhibit to the registration statement of which this prospectus forms a part.

Mr. Ross

We entered into an employment agreement, or the Ross Employment Agreement, with Mr. Ross, dated March 3, 2017, providing for his position as Chief Executive Officer. The Ross Employment Agreement provides for (i) an initial base salary of $275,000, (ii) a stock option grant to purchase up to 100,000 shares of our common stock at an exercise price equal to the fair market value of our common stock as of the grant date, which will vest in four equal installments commencing on the one year anniversary of the Ross Employment Agreement and which will have a term of ten years and (iii) eligibility to participate in the employee benefit plans, policies or arrangements maintained by us for our senior executive employees generally. If Mr. Ross’s employment is terminated by us without “cause,” as defined in the Ross Employment Agreement, or by Mr. Ross for “good reason,” as defined in the Ross Employment Agreement, Mr. Ross will be eligible to receive, subject to Mr. Ross’s execution and nonrevocation of a general release of claims and continued compliance with his restrictive covenant obligations:

•

the greater of (i) $275,000 and (ii) his total actual compensation (including any bonus paid) for the previous 12 months;

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•

any portion of that year’s annual potential bonus that was earned but unpaid as of the termination date; and

•

12 months continued provision of group medical and/or dental insurance.

The Ross Employment Agreement reaffirms Mr. Ross’s non-competition and confidentiality obligations under the confidentiality agreement dated March 25, 2010.

Mr. Niebur and Mr. Kattungal

We have not entered into employment agreements with Mr. Niebur or Mr. Kattungal.

Annual Bonus Plan

The Company maintains an annual bonus plan under which our Named Executive Officers, together with other executives and key employees of the Company, are eligible to earn an annual bonus based on the level of achievement of corporate objectives, individual objectives, or a combination of the two. For 2020, our CEO’s bonus was determined entirely based on the level of achievement of corporate objectives, while for Mr. Niebur and Mr. Kattungal, the bonus was determined based on a combination of corporate and individual objectives. The Company’s primary focus for 2020 related to key objectives and milestones with respect to the development and testing of select protocols and products. Based on the Compensation Committee’s assessment of 2020 performance, each of our Named Executive Officers received a cash incentive payment in the amount disclosed in the Summary Compensation Table in respect of 2020 performance.

Outstanding Equity Awards at December 31, 2020

The following table shows outstanding option awards held by the named executive officers as of December 31, 2020.

​	Option awards(1)
​	Number of securities underlying unexercised options (#) exercisable		Number of securities underlying unexercised options (#) unexercisable		Equity incentive plan awards: Number of securities underlying unexercised unearned options (#)	Option exercise price ($)		Option expiration date
Jeff Ross	​	33,750 35,438 37,500 41,250 43,750 33,688 39,375 75,000 34,357	​	25,000(2) 34,357(3)	​	​	0.10 1.25 1.25 3.75 3.75 3.75 3.75 3.75 3.75	​	6/20/21 3/23/22 12/7/22 3/1/24 1/16/25 1/1/26 2/22/27 3/3/27 5/30/28
Brian Niebur	​	50,000 30,000 31,873	​	31,874(3)	​	​	3.75 3.75 3.75	​	1/1/26 2/22/27 5/30/28
Laji Kattungal	​	​	​	80,000(4)	​	​	3.75	​	7/16/30

(1)

All of the stock options listed in this table were granted under either our 2019 Stock Incentive Plan or our 2010 Stock Incentive Plan and are options to purchase our common stock, par value $0.00001 per share.

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(2)

Option grant vests in four equal installments on each of the first four anniversaries of the date of grant (March 3, 2017), subject to the executive’s continued employment with the Company. As of 12/31/20, the first three installments of the option vested and the remaining unvested installment vested on March 1, 2021.

(3)

Option grant vests in four equal installments on each of the first four anniversaries of the date of grant (May 30, 2018), subject to the executive’s continued employment with the Company. As of 12/31/20, the first two installments of the option had vested.

(4)

Option grant vests in four equal installments on each of the first four anniversaries of the date of grant (July 16, 2020), subject to the executive’s continued employment with the Company.

2021 Equity Incentive Plan

On April 28, 2021, the Board, at the recommendation of its Compensation Committee, approved the Miromatrix Medical Inc. 2021 Equity Incentive Plan (the “2021 Plan”). The purpose of the 2021 Plan is to assist the Company in attracting, retaining, motivating and rewarding key employees, officers, directors, and consultants of the Company and its affiliates, promoting the creation of long-term value for stockholders of the Company by closely aligning the interests of such individuals with those of such stockholders. The 2021 Plan was approved by our stockholders on May 20, 2021, and became effective upon its approval by our stockholders. Upon the effectiveness of the 2021 Plan, no new awards may be granted under the 2019 Plan, which is described below.

The following summarizes the material features of the 2021 Plan. This summary is qualified in its entirety by reference to the full text of the 2021 Plan, which is filed as an exhibit to the registration statement of which this prospectus is a part.

Administration

The 2021 Plan will be administered by the Board or a committee authorized by the Board to administer the 2019 Plan (the “Committee”). To the extent consistent with applicable law, the Committee may delegate its duties, power and authority under the 2021 Plan to any one or more of its members, or, with respect to awards to participants who are not themselves our directors or executive officers, to one or more of our other directors or executive officers or to a committee of the Board comprised of one or more directors. The Committee may also delegate non-discretionary administrative duties to other persons, agents or advisors.

The Committee has the authority to determine the persons to whom awards will be granted, the timing, type and number of shares covered by each award, the terms and conditions of the awards and the manner in which the awards are paid or settled. The Committee may also (i) adopt sub-plans or special provisions applicable to awards, (ii) cancel or suspend an award, accelerate the vesting or extend the exercise period of any award, or otherwise amend the terms and conditions of outstanding awards to the extent permitted under the 2021 Plan, (iii) establish, modify or rescind rules to administer the 2021 Plan, interpret the 2021 Plan and any related award agreement, reconcile any inconsistency, correct any defect or supply any omission in the 2021 Plan, (iv) grant substitute awards under the 2021 Plan, and (v) require or permit the deferral of the settlement of an award and establish the terms and conditions of any such deferral. Unless an amendment to the terms of an award is necessary to comply with applicable laws or stock exchange rules, a participant whose rights would be materially adversely impaired by such an amendment must consent to it.

Subject to certain limits in the 2021 Plan, the Committee may also establish sub-plans or modify the terms of awards under the 2021 Plan with respect to participants who reside outside of the United States or are employed by a non-U.S. subsidiary in order to comply with local legal requirements or otherwise meet the objectives of the 2021 Plan.

Except in connection with equity restructurings and other situations in which share adjustments are specifically authorized, the 2021 Plan prohibits the Committee from repricing any outstanding “underwater” option or SAR awards without the prior approval of our stockholders. For these purposes, a “repricing” includes amending the terms of an option or SAR award to lower the exercise price, canceling an option or SAR award in conjunction with granting a replacement option or SAR award with

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a lower exercise price, canceling an underwater option or SAR award in exchange for cash, other property or grant of a new full value award, or otherwise making an underwater option or SAR award subject to any action that would be treated under accounting rules as a “repricing.”

Available Shares and Share Limits

The number of shares of common stock that may be the subject of awards issued under the 2021 Plan is 1,000,000. In addition, shares of common stock that would have otherwise been available under our 2019 Plan will increase the number of shares of common stock available for issuance under our 2021 Plan. Shares of common stock subject to outstanding awards under the 2019 Plan that would otherwise return to the share reserve of the 2019 Plan upon expiration, forfeiture, retention by the Company to satisfy any exercise price or any tax withholding, repurchase by the Company at their original purchase price or settlement in cash of awards outstanding under the 2019 Plan may be added to the number of shares of common stock available for issuance under the 2021 Plan. As of April 29, 2021, 559,500 shares of common stock were available for ssuance under our 2019 Plan, and 435,500 shares of common stock were subject to awards outstanding under our 2019 Plan.

The number of shares of common stock reserved for issuance under our 2021 Plan will automatically increase on the first day of each year, commencing on January 1, 2022 and ending on (and including) January 1, 2031, in an amount equal to the lesser of (a) 4.5% of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, (b) 600,000 shares of Common Stock, or (c) such lesser number of shares as determined by the Board.

The aggregate value of awards granted under the 2021 Plan to a non-employee director in any calendar year, solely with respect to his or her service on the Board, may not exceed $500,000, determined based on the aggregate fair market value of such awards as of the date of grant. In addition, the aggregate value of awards granted under the 2021 Plan to any non-employee director in connection with their initial appointment to the Board (excluding awards described in the preceding sentence for regular service on the Board) may not exceed $500,000, determined based on the aggregate fair market value of such awards as of the date of grant.

Eligible Participants

Employees of, and consultants and advisors to, our company or any subsidiary, as well as all non-employee directors of our company, will be eligible to receive awards under the 2021 Plan. As of April 29, 2021, there were approximately 37 employees, 5 non-employee directors, and 6 consultants and advisors who would be eligible to participate in the 2021 Plan.

Share Adjustment Provisions

If certain transactions with our stockholders occur that cause the per share value of common stock to change, such as stock splits, spin-offs, stock dividends or certain recapitaalizations, the Committee will equitably adjust (i) the class of shares issuable and the maximum number and kind of shares subject to the 2021 Plan, (ii) outstanding awards as to the class, number of shares and price per share, and (iii) award limitations prescribed by the 2021 Plan. Other types of transactions may also affect the common stock, such as reorganizations, mergers or consolidations. If there is such a transaction and the Committee determines that adjustments of the type previously described in connection with equity restructurings would be appropriate to prevent any dilution or enlargement of benefits under the 2021 Plan, the Committee will make such adjustments as it may deem equitable.

Types of Awards

The 2021 Plan permits us to award stock options, stock appreciation rights or “SARs”, restricted stock awards, stock unit awards, and other stock-based awards to eligible recipients. These types of awards are described in more detail below.

Options.   Employees of our company or any subsidiary may be awarded options to purchase common stock that qualify as “incentive stock options” within the meaning of Section 422 of the Internal Revenue Code (the “Code”), and any eligible recipient may be awarded options to purchase

127

Common Stock that do not qualify as incentive stock options, referred to as “nonqualified stock options.” The exercise price to be paid by a participant at the time an option is exercised may not be less than 100% of the fair market value of one share of common stock on the date of grant, unless the option is granted as a substitute award as described earlier. “Fair market value” under the 2021 Plan as of any date means, if the shares of common stock are readily tradable on an established securities market, then fair market value will be the closing sales price for a share on the principal securities market on which it trades on the date for which it is being determined, or if no sale of shares occurred on that date, on the next preceding date on which a sale of shares occurred, as reported in The Wall Street Journal or such other source as the Committee deems reliable. If the shares of common stock are not readily tradable on an established securities market, then fair market value will be determined by the Committee as the result of a reasonable application of a reasonable valuation method that satisfies the requirements of Section 409A of the Code.

The total purchase price of the shares to be purchased upon exercise of an option will be paid by the participant in cash or in such other manner as the Committee may permit, including by payment under a broker-assisted sale and remittance program, by withholding shares otherwise issuable to the participant upon exercise of the option or by delivery to the Company of shares (by actual delivery or attestation) already owned by the participant (in either case, such shares having a fair market value as of the date the option is exercised equal to the purchase price of the shares being purchased).

An option will vest and become exercisable at such time, in such installments and subject to such conditions as may be determined by the Committee, and no option may have a term greater than 10 years from its date of grant. No dividends or dividend equivalents may be paid or credited with respect to shares subject to an option award.

The aggregate fair market value of shares of common stock with respect to which incentive stock options granted to any participant may first become exercisable during any calendar year may not exceed $100,000. Any incentive stock options that become exercisable in excess of this amount will be treated as nonqualified stock options. The maximum number of shares that may be issued upon the exercise of incentive stock option awards under the 2021 Plan is 1,000,000, subject to adjustment for changes in our corporate structure or shares, as described above.

Stock Appreciation Rights.   A SAR award provides the right to receive a payment from us, in the form of shares of common stock, cash or a combination of both, equal to the difference between (i) the fair market value of a specified number of shares of common stock on the date of exercise of the SAR, and (ii) the aggregate exercise price under the SAR of that number of shares. SARs will be subject to such terms and conditions, consistent with the other provisions of the 2021 Plan, as may be determined by the Committee. The Committee will have the sole discretion to determine the form in which payment of SARs will be made to a participant.

The exercise price per share of a SAR award will be determined by the Committee, but may not be less than 100% of the fair market value of one share of common stock on the date of grant, unless the SAR is granted as a substitute award as described earlier. A SAR award will vest and become exercisable at such time, in such installments and subject to such conditions as may be determined by the Committee, and no SAR award may have a term greater than 10 years from its date of grant. No dividends or dividend equivalents may be paid or credited with respect to shares subject to a SAR award.

Restricted Stock Awards.   A restricted stock award is an award of common stock that vests at such times and in such installments as may be determined by the Committee. Until an award vests, the shares subject to the award are subject to restrictions and the possibility of forfeiture. The Committee may impose such restrictions or conditions to the vesting of restricted stock awards as it deems appropriate, including that the participant remain continuously employed by, or in the service of, us or a subsidiary of ours for a certain period or that we, or any of our subsidiaries or business units or the participant satisfy specified performance criteria.

Any dividends or distributions payable with respect to shares that are subject to the unvested portion of a restricted stock award will be subject to the same restrictions and risk of forfeiture as the shares to which such dividends or distributions relate. Participants are entitled to vote restricted shares prior to the time they vest.

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Stock Unit Awards.   A stock unit award is a right to receive the fair market value of a specified number of shares of common stock, payable in cash, shares, or a combination of both, that vests at such times and in such installments as may be determined by the Committee. Until it vests, a stock unit award is subject to restrictions and the possibility of forfeiture. Stock unit awards will be subject to such terms and conditions, consistent with the other provisions of the 2021 Plan, as may be determined by the Committee. The Committee may provide for the payment of dividend equivalents on stock unit awards and other stock-based awards, but any such dividend equivalents will be subject to the same restrictions and risk of forfeiture as the underlying units or other share equivalents to which such dividend equivalents relate.

Other Stock-Based Awards.   The Committee may grant awards of common stock and other awards that are valued by reference to and/or payable in shares of common stock under the 2021 Plan. The Committee has discretion in determining the terms and conditions of such awards.

Term of the 2021 Plan

Unless terminated earlier, the 2021 Plan will terminate on the tenth anniversary of its effective date. Awards outstanding under the 2021 Plan at the time it is terminated will continue in accordance with their terms and the terms of the 2021 Plan unless otherwise provided in the applicable agreements. The Board may suspend or terminate the 2021 Plan at any time.

Amendment of the Plan

The Board may amend the 2021 Plan from time to time, but no amendments to the 2021 Plan will be effective without stockholder approval if such approval is required under applicable laws, regulations or stock exchange rules, including stockholder approval for any amendment that seeks to modify the prohibition on underwater option or SAR re-pricing discussed above. Termination, suspension or amendment of the 2021 Plan will not adversely affect any outstanding award without the consent of the affected participant, except for amendments necessary to comply with applicable laws or stock exchange rules.

Transferability of Awards

In general, no right or interest in any award under the 2021 Plan may be assigned, transferred, exchanged or encumbered by a participant, voluntarily or involuntarily, except by will or the laws of descent and distribution. However, the Committee may provide that an award (other than an incentive stock option) may be transferable by gift to a participant’s family member or pursuant to a domestic relations order. Any permitted transferee of such an award will remain subject to all the terms and conditions of the award applicable to the participant.

Change in Control

If a change in control of our company occurs, the Board or the Committee may, in its discretion, provide for one or more of the following with respect to awards under the 2021 Plan: (i) the continuation, assumption or replacement of outstanding awards; (ii) the acceleration of vesting and exercisability of outstanding awards; (iii) the cancellation of unvested and unexercised awards; or (iv) the cancellation of awards in exchange for payment to participants in cash equal the difference, if any, between the fair market value of the consideration that would be received in the change of control transaction for the number of shares subject to the award and the aggregate exercise price (if any) of the shares subject to the award.

For these purposes, a “change in control” generally occurs if:

(i)

any person becomes after the effective date of the 2021 Plan the “beneficial owner” of:

(A)

20% or more, but not 50% or more, of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders, unless the transaction resulting in such ownership has been approved in advance by the continuing directors; or

129

(B)

50% or more of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders (regardless of any approval by the continuing directors); or

(ii)

there is a merger or consolidation to which the Company is a party if the Company’s stockholders immediately prior to effective date of such merger or consolidation have “beneficial ownership” immediately following the effective date of such merger or consolidation, of securities of the surviving entity representing:

(A)

50% or more, but less than 80%, of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity, unless such merger or consolidation has been approved in advance by the continuing directors; or

(B)

less than 50% of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity (regardless of any approval by the continuing directors); or

(iii)

there is a sale, lease, exchange or other transfer, directly or indirectly, of substantially all of the assets of the Company (in one transaction or in a series of related transactions) to a person or entity that is not controlled by the Company; or

(iv)

there is a consummation of a complete liquidation or dissolution of the Company.

Notwithstanding the foregoing, any transaction that is fundamentally a financing transaction, as determined in good faith by the Board, shall not be deemed a change of control for the purposes of the 2021 Plan. In addition, if any repurchase or other acquisition by the Company of its outstanding equity securities causes any person to become the beneficial owner of the combined voting power of the Company’s outstanding equity securities over the threshold amounts referenced in clauses i(A) and i(B) above, then no change of control will be deemed to have occurred for the purposes of the 2021 Plan.

Effect of Termination of Employment

The effect of a termination of a participant’s service on any outstanding awards granted under the 2021 Plan will be as provided in the applicable award agreement.

Deferral of Payouts

The Committee may permit or require the deferral by a participant of the receipt of shares or cash in settlement of any full value award under the 2021 Plan, and will prescribe the terms, conditions and procedures for such deferrals, which may include effecting a deferral in accordance with eligible deferred compensation plans. Shares to effect the settlement of any such deferral will be drawn from and charged against the 2021 Plan’s share reserve.

2019 Stock Incentive Plan

On July 25, 2019, our board of directors adopted our Miromatrix Medical Inc. 2019 Stock Incentive Plan (the “2019 Plan”), which became effective on such date. The purpose of the 2019 Plan is to attract and retain the best available personnel for positions of responsibility within the Company, to provide additional incentives to them to align their interests with those of the Company’s stockholders and to thereby promote the Company’s long-term business success. The following is a summary of the material terms of the 2019 Plan, but does not include all of the provisions of such plan. For further information about the 2019 Plan, we refer you to the complete text of the 2019 Plan, which is filed as an exhibit to the registration statement of which this prospectus is a part. Effective upon the adoption of our 2021 Plan, the Company will no longer grant awards under the 2019 Plan.

Administration

The 2019 Plan is administered by our board of directors or such committee as designated by our board of directors ( the “Committee”). The Committee has complete authority to determine all provisions

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of the awards granted under the 2019 Plan (as consistent with the terms of the Plan), to interpret the 2019 Plan and to make any other determination which it believes necessary and advisable for the proper administration of the 2019 Plan. The Committee’s decisions on matters relating to the 2019 Plan will be final and binding on all parties with an interest therein.

Available Shares

The aggregate number of shares of our common stock which may be issued or transferred pursuant to awards granted under the 2019 Plan may not exceed 1,000,000 shares.

In general, if awards granted under the 2019 Stock Incentive Plan expire or are forfeited, cancelled, settled for cash, surrendered pursuant to an exchange program or otherwise are settled in a manner that does not result in the issuance of all or a portion of the shares subject to the award, then to the extent of such forfeiture, cancellation, cash settlement, surrender or non-issuance, the 2019 Plan provided that such shares would again become available for awards under the 2019 Plan. In the event that any award is exercised through the tendering of shares (either actually or by attestation) or by the withholding of shares by the Company in payment of the applicable exercise price, or any tax withholding obligation arising from an award are satisfied by the tendering of shares (either actually or by attestation) or by the withholding of shares by the Company, the 2019 Plan provided that the shares so tendered or withheld would again become available for awards under the 2019 Stock Incentive Plan. As described above in the summary of the 2021 Plan, following the adoption of our 2021 Plan, any shares of our common stock that would otherwise become available for issuance under the 2019 Plan will instead become available for issuance under the 2021 Plan.

Eligibility for Participation

The persons eligible to receive awards under the 2019 Plan were our employees, non-employee directors and any consultant or advisor who is a natural person and who provides services to the Company and its affiliates (other than in connection with a capital-raising transaction or promoting or maintaining a market in Company securities, in each case, as selected by the Committee.

Types of Awards

Under the 2019 Plan, the Committee was authorized to grant nonqualified stock options, that is, options that are not intended to qualify as “incentive stock options” within the meaning of Section 422 of the Code, to purchase shares of our common stock, “incentive stock options,” stock appreciation rights, restricted stock awards, stock unit awards and other stock-based awards. Awards granted under the 2019 Plan could be issued subject to service-based vesting requirements, time-based vesting requirements and a combination of service-based and time-based vesting requirements.

Stockholder Rights

Except as otherwise expressly specified in the 2019 Plan or in a grant agreement, no participant will have any rights as a stockholder with respect to any shares of our common stock covered by or relating to any award granted pursuant to the 2019 Plan until the date a participant becomes the registered owner of such shares of common stock.

Amendment and Termination

The board of directors may at any time terminate, suspend or amend the 2019 Plan. No termination, suspension or amendment of the 2019 Plan may materially impair the rights of any participant under a previously granted award without the participant’s consent, unless such action is necessary to comply with applicable law or stock exchange rules.

Change in Control

In the event of a change in control of the Company, the surviving or successor entity may continue, assume or replace awards outstanding as of the change in control. For purposes of the 2019 Plan, an award will be considered assumed or replaced if, in connection with the change in control, the contractual obligations represented by the award are expressly assumed by the surviving or successor entity (or

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its parent), with appropriate adjustments to reflect the transaction, or the participant has received a comparable equity-based award that preserves the intrinsic value of the award exiting at the time of the change in control and contains terms and conditions that are substantially similar to those of the award. Following a change in control, a participant’s outstanding awards will vest if the participant experiences an involuntary termination of employment other than for cause within the first year following the change in control.

If there is a change in control of the Company and the acquiring entity or successor to the Company does not assume the outstanding awards or replace them with substantially equivalent awards, then, unless otherwise determined by the Committee or set forth in an individual’s grant agreement, all outstanding options and stock appreciation rights will vest, and the restrictions on all restricted stock awards and restricted stock units will lapse. The Committee also have authority to provide for the cash-out and cancellation of awards that are not continued, assumed or replaced in the event of a change in control

Transferability

Awards granted under the 2019 Plan are generally nontransferable (other than by will or the laws of descent and distribution).

2010 Stock Incentive Plan

On February 26, 2010, our board of directors adopted our Miromatrix Medical Inc. 2010 Stock Incentive Plan the “2010 Plan”). The purpose of the 2010 Plan is to increase shareholder value and to advance the interests of the Company by furnishing a variety of economic incentives designed to attract, retain and motivate employees, directors, officers and consultants. The following is a summary of the material terms of the 2010 Plan, but does not include all of the provisions of such plan. For further information about the 2010 Plan, we refer you to the complete text of the 2010 Plan, which is filed as an exhibit to the registration statement of which this prospectus is a part. No additional awards may be issued under the 2010 plan.

Administration

The 2010 Plan is administered by our board of directors or such committee as designated by our board of directors (we’ll refer to the body administering the 2010 Plan as the “Committee”). Among the Committee’s powers under the 2010 Plan are the power to determine those persons who will be granted awards and the amount, type and other terms and conditions of awards. The Committee has complete authority to determine all provisions of the awards granted under the 2010 Plan (as consistent with the terms of the Plan), to interpret the 2010 Plan and to make any other determination which it believes necessary and advisable for the proper administration of the 2010 Plan. The Committee’s decisions on matters relating to the 2010 Plan will be final and conclusive on the participants and the Company.

Available Shares

The aggregate number of shares of our common stock which may be issued or transferred pursuant to awards granted under the 2010 Plan may not exceed 375,000 shares.

In general, if awards granted under the 2010 Plan expire or are forfeited, cancelled or terminated without the issuance of shares of our common stock, the shares covered by such awards would remain or become available for issuance under the 2010 Plan provided that Plan.

Eligibility for Participation

The persons eligible to receive awards under the 2010 Stock Incentive Plan are our employees, directors and consultants, advisors and other independent contractors and those of our subsidiaries selected by the Committee.

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Types of Awards

Under the 2010 Plan, the Committee was authorized to grant nonqualified stock options, “incentive stock options,” within the meaning of Section 422 of the Code, stock appreciation rights, stock awards and restricted stock awards and performance-share awards.

Stockholder Rights

Except as otherwise expressly specified in the 2010 Plan or in a grant agreement, no participant will have any rights as a stockholder with respect to any shares of our common stock covered by or relating to any award granted pursuant to the 2010 Plan until the date a participant becomes the registered owner of such shares of common stock.

Amendment and Termination

Notwithstanding any other provision of the 2010 Plan, our board of directors may, in its sole discretion, amend, suspend or discontinue the 2010 Plan at any time.

Change in Control

If there is a change in control of the Company and the acquiring entity or successor to the Company does not assume the outstanding awards or replace them with substantially equivalent awards, then, unless otherwise determined by the Committee or set forth in an individual’s grant agreement, all outstanding options and stock appreciation rights will vest, the restrictions on all shares of restricted stock will lapse and all performance objectives related to performance shares will be deemed met. The Committee also has authority to provide for the cash-out and cancellation of outstanding options in the event of a change in control

Transferability

Awards granted under the 2010 Plan are generally nontransferable (other than by will or the laws of descent and distribution.

U.S. Federal Income Tax Consequences of the 2021 Plan, the 2019 Plan and the 2010 Plan

The following is a summary of the principal United States federal income tax consequences to our company and to participants subject to U.S. taxation with respect to awards granted under the 2021 Plan, 2019 Plan and 2010 Plan, based on current statutes, regulations and interpretations.

Non-qualified Stock Options

If a participant is granted a non-qualified stock option, the participant will not recognize taxable income upon the grant of the option. Generally, the participant will recognize ordinary income at the time of exercise in an amount equal to the difference between the fair market value of the shares acquired at the time of exercise and the exercise price paid. The participant’s basis in the common stock for purposes of determining gain or loss on a subsequent sale or disposition of such shares generally will be the fair market value of common stock on the date the option was exercised. Any subsequent gain or loss will be taxable as a capital gain or loss. Our company will generally be entitled to a federal income tax deduction at the time and for the same amount as the participant recognizes as ordinary income.

Incentive Stock Options

If a participant is granted an incentive stock option, the participant will not recognize taxable income upon grant of the option. Additionally, if applicable holding period requirements (a minimum of two years from the date of grant and one year from the date of exercise) are met, the participant will not recognize taxable income at the time of exercise. However, the excess of the fair market value of the shares acquired at the time of exercise over the aggregate exercise price is an item of tax preference income potentially subject to the alternative minimum tax. If shares acquired upon exercise of an incentive stock option are held for the holding period described above, the gain or loss (in an amount equal to the difference between the fair market value on the date of sale and the exercise price) upon disposition

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of the shares will be treated as a long-term capital gain or loss, and our company will not be entitled to any deduction. Except in the event of death, if the holding period requirements are not met, the incentive stock option will be treated as one that does not meet the requirements of the Code for incentive stock options and the tax consequences described for nonqualified stock options will generally apply.

Other Award

The current federal income tax consequences of other awards authorized under our equity incentive plans generally follow certain basic patterns. An award of restricted stock results in income recognition by a participant in an amount equal to the fair market value of the shares received at the time the restrictions lapse and the shares vest, unless the participant elects under Code Section 83(b) to accelerate income recognition and the taxability of the award to the date of grant. Stock unit awards generally result in income recognition by a participant at the time payment of such an award is made in an amount equal to the amount paid in cash or the then-current fair market value of the shares received, as applicable. SAR awards result in income recognition by a participant at the time such an award is exercised in an amount equal to the amount paid in cash or the then-current fair market value of the shares received by the participant, as applicable. In each of the foregoing cases, the Company will generally have a corresponding deduction at the time the participant recognizes ordinary income, subject to Code Section 162(m) with respect to covered employees.

Section 162(m) of the Code

Code Section 162(m) denies a deduction to any publicly-held corporation for compensation paid to certain “covered employees” in a taxable year to the extent that compensation to the covered employee exceeds $1,000,000.

Section 409A of the Code

The foregoing discussion of tax consequences of awards assumes that the award discussed is either not considered a “deferred compensation arrangement” subject to Section 409A of the Code, or has been structured to comply with its requirements. If an award is considered a deferred compensation arrangement subject to Section 409A but fails to comply, in operation or form, with the requirements of Section 409A, the affected participant would generally be required to include in income when the award vests the amount deemed “deferred,” would be required to pay an additional 20 percent income tax on such amount, and would be required to pay interest on the tax that would have been paid but for the deferral.

Employee Stock Purchase Plan

On April 28, 2021, the Board approved the adotion of the Miromatrix Medical Inc. Employee Stock Purchase Plan (the “ESPP”). The ESPP was approved by our stockholders on May 20, 2021, and will become effective on the effective date of the Company’s registration statement on Form S-1 for the initial public offering of its common stock. The ESPP will offer eligible employees the opportunity to acquire a stock ownership interest in the Company through periodic payroll deductions that will be applied towards the purchase of common stock at a discount from the then-current market price.

The following summarizes the material features of the ESPP, but does not include all of the provisions of the ESPP. For further information about the ESPP Plan, we refer you to the complete text of the ESPP, which is filed as an exhibit to the registration statement of which this prospectus is a part.

Administration

The ESPP will be administered by the Committee. The Committee has full authority to adopt rules and procedures to administer the ESPP, to interpret the provisions of the ESPP, to determine the terms and conditions of offerings under the ESPP, to designate which of our subsidiaries may participate in the ESPP, and to adopt rules, procedures and sub-plans to permit employees of our foreign subsidiaries

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to participate in the ESPP on a basis not intended to comply with Code Section 423. All costs and expenses incurred in ESPP administration are paid by the Company.

Available Shares

The maximum number of shares that may be sold by the Company under the ESPP will be 300,000 shares, plus an automatic annual increase in such amount on January 1 of each year beginning in 2022 and ending on (and including) January 1, 2030 equal to the lesser of: (i) 1% of the total number of shares outstanding as of December 31 of the immediately preceding calendar year, or (ii) 200,000 shares, unless the Board determines that any annual increase shall be for a number of shares that is less than the number of shares determined by the application of clauses (i) and (ii). If the purchases by all participants in an offering period would otherwise cause the aggregate number of shares to be sold under the ESPP to exceed the then-applicable available shares under the ESPP, each participant in that offering period shall be allocated a ratable portion of the remaining number of shares which may be sold under the ESPP.

Eligibility and Participation

The Company expects that any individual employed by the Company or any participating parent or subsidiary corporation (including any corporation which subsequently becomes such at any time during the term of the ESPP) who is customarily expected to work at least 20 hours per week is eligible to participate in the ESPP. As of April 29, 2021, we estimate that approximately 37 employees, including our 3 executive officers, were eligible to participate in the ESPP.

Eligible employees will be able to enroll in the ESPP and begin participating at the start of any purchase period.

Purchase Periods and Purchase Dates

Shares of common stock will be offered under the ESPP through a series of offerings, each of which consists of offering periods of such duration (up to 27 months, or such longer period as may be permitted under Section 423 of the Code) as the Committee may prescribe. We currently expect that our shares will be offered under the ESPP through a series of successive six-month purchase periods that will commence on the first day of January and July each year. Purchases under the ESPP will occur on the last trading day of June and December each year.

Purchase Price

The purchase price of common stock acquired on each purchase date will be no less than 85% of the lower of (i) the closing market price per share of common stock on the first day of the applicable purchase period or (ii) the closing market price per share of common stock on the purchase date at the end of the applicable six-month purchase period.

Payroll Deductions and Stock Purchases

Each participant may authorize periodic payroll deductions in any multiple of 1% of his or her eligible earnings each purchase period (up to a maximum of 15% of eligible compensation each purchase period, or such other maximum as the Committee may determine from time to time). The accumulated deductions will automatically be applied on each purchase date to the purchase of shares of common stock at the purchase price in effect for that purchase date. For purposes of the ESPP, eligible compensation generally includes the total cash compensation (including wages, salary, commission, bonus, and overtime earnings) paid by the Company or any affiliate to a participant in accordance with the participant’s terms of employment, but excludes employer contributions to a 401(k) or other retirement plan, any expense reimbursements or allowances, or any income (whether paid in shares or cash) realized by the participant as a result of participation in any equity-based compensation plan of the Company or any affiliate.

Special Limitations

The ESPP imposes certain limitations upon a participant’s right to acquire common stock, including the following:

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•

Purchase rights may not be granted to any individual who owns stock (including stock purchasable under any outstanding purchase rights) possessing 5% or more of the total combined voting power or value of all classes of our stock or the stock of any of our subsidiaries.

•

A participant may not be granted rights to purchase more than $25,000 worth of common stock (valued at the time each purchase right is granted) for each calendar year in which such purchase rights are outstanding.

•

No participant may purchase more than 5,000 shares of common stock on any one purchase date.

Termination or Modification of Purchase Rights

A participant may withdraw from the ESPP at any time, and his or her accumulated payroll deductions will be promptly refunded. A participant’s purchase right will immediately terminate upon his or her cessation of employment for any reason. Any payroll deductions that the participant may have made for the purchase period in which such cessation of employment occurs will be refunded and will not be applied to the purchase of common stock.

Special Provisions Applicable to Employees of Foreign Subsidiaries

The ESPP authorizes the Committee to adopt rules, procedures or subplans relating to the operation and administration of the ESPP to accommodate the specific requirements of local laws and procedures outside the United States.

Stockholder Rights

No participant will have any stockholder rights with respect to the shares covered by his or her purchase rights until the shares are actually purchased on the participant’s behalf through the ESPP.

Transferability

No purchase rights will be assignable or transferable by the participant, except by will or the laws of inheritance following a participant’s death.

Corporate Transactions

If the Company is acquired by merger or through the sale of all or substantially all its assets, the Board may provide that (i) each right to acquire shares on any purchase date scheduled to occur after the date of the consummation of the acquisition transaction shall be continued or assumed or an equivalent right shall be substituted by the surviving or successor corporation or its parent or subsidiary; (ii) the ESPP shall be terminated; or (iii) the purchase period then in progress shall be shortened by setting a new purchase date.

Share Proration

Should the total number of shares of common stock to be purchased pursuant to outstanding purchase rights on any particular purchase date exceed the number of shares remaining available for issuance under the ESPP at that time, then the Committee will make a pro-rata allocation of the available shares on a uniform and nondiscriminatory basis, and the payroll deductions of each participant not used to purchase shares will be refunded.

Amendment and Termination

The ESPP may be terminated at any time by the Board, and will terminate upon the date on which all shares remaining available for issuance under the ESPP are sold pursuant to exercised purchase rights. The Board may at any time amend or suspend the ESPP. However, the Board may not, without stockholder approval, amend the ESPP to (i) increase the number of shares issuable under the ESPP or increase the rate of automatic annual increase in the number of shares reserved under the ESPP, or (ii) effect any other change in the ESPP that would require stockholder approval under applicable law or to maintain compliance with Code Section 423.

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U.S. Federal Income Tax Consequences

The following is a summary of the principal United States federal income tax consequences to the Company and to participants subject to U.S. taxation with respect to participation in the ESPP. This summary assumes the ESPP qualifies as an “employee stock purchase plan” within the meaning of Code Section 423, is not intended to be exhaustive and does not discuss the income tax laws of any city, state, or foreign jurisdiction in which a participant may reside.

Under a qualified Code Section 423 arrangement, no taxable income will be recognized by a participant, and no deductions will be allowed to the Company, upon either the grant or the exercise of the purchase rights. Taxable income will not be recognized until either there is a sale or other disposition of the shares acquired under the ESPP or in the event the participant should die while still owning the purchased shares.

If a participant sells or otherwise disposes of the purchased shares within two years after the first day of the purchase period in which such shares were acquired, or within one year after the actual purchase date of those shares, then the participant will recognize ordinary income in the year of sale or disposition equal to the amount by which the closing market price of the shares on the purchase date exceeded the purchase price paid for those shares, and the Company will be entitled to an income tax deduction, for the taxable year in which such disposition occurs, equal in amount to such excess. The participant also will recognize a capital gain to the extent the amount realized upon the sale of the shares exceeds the sum of the aggregate purchase price for those shares and the ordinary income recognized in connection with their acquisition.

If a participant sells or disposes of the purchased shares more than two years after the first day of the purchase period in which the shares were acquired and more than one year after the actual purchase date of those shares, the participant will recognize ordinary income in the year of sale or disposition equal to the lower of (i) the amount by which the selling price of the shares on the sale or disposition date exceeded the purchase price paid for those shares or (ii) 15% of the closing market price of the shares on the first day of the purchase period in which the shares were acquired. Any additional gain upon the disposition will be taxed as a long-term capital gain. The Company will not be entitled to an income tax deduction with respect to such disposition.

If a participant still owns the purchased shares at the time of death, his or her estate will recognize ordinary income in the year of death equal to the lower of (i) the amount by which the closing market price of the shares on the date of death exceeds the purchase price or (ii) 15% of the closing market price of the shares on the first day of the purchase period in which those shares were acquired.

Director Compensation

Our board of directors intends to adopt a non-management director compensation policy following the completion of this offering.

Director Compensation Table

The table below sets forth information for the fiscal year ended December 31, 2020 regarding the compensation awarded to, earned by or paid to our non-employee directors.

Name	Fees Earned or Paid in Cash ($)		Option Awards ($)(1)(2)(3)		Total ($)
Paul Buckman	​	—	​	24,164	​	24,164
Ronald Eibensteiner	​	—	​	24,164	​	24,164
John Erb	​	—	​	24,164	​	24,164
Mark Wagner	​	—	​	24,164	​	24,164

(1)

Amounts shown in this column do not reflect dollar amounts actually received by our directors. Instead, these amounts reflect the aggregate grant date fair value of each stock option granted in

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2020 computed in accordance with the provisions of FASB ASC Topic 718. Assumptions used in the calculation of these amounts are included in Note 6 to our audited consolidated financial statements included in this prospectus. Our directors will only realize compensation to the extent the trading price of our common stock is greater than the exercise price of such stock options.

(2)

For the year ended December 31, 2020, Messrs. Buckman, Eibensteiner, Erb and Wagner each were granted options to purchase 25,000 shares of our common stock, respectively. No directors other than Messrs. Buckman, Eibensteiner, Erb and Wagner were granted equity awards for the year ended December 31, 2020.

(3)

These options have exercise prices equal to $3.75, which our board of directors has determined to be the fair value of our common stock on the date of grant, and vested monthly throughout 2020, subject to the director’s continuous service with us through the relevant vesting dates.

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

We describe below transactions or series of similar transactions, since the beginning of our last fiscal year, or currently proposed, to which we were a party or will be a party, in which:

•

the amounts involved exceeded $120,000; and

•

any of our directors, executive officers or beneficial holders of more than 5% of any class of our capital stock had or will have a direct or indirect material interest.

Other than as described below, there have not been, nor are there any currently proposed, transactions or series of similar transactions meeting this criteria to which we have been or will be a party other than compensation arrangements, which are described where required under the section titled “Executive and Director Compensation.”

Reprise

Reprise License Agreement

Concurrently with the spin-out of Reprise Biomedical Inc., or Reprise, in June of 2019, we entered into a patent and know-how license agreement with Reprise, or the Reprise License Agreement, which entitles us to a 6.5% royalty and a minimum annual royalty of $500,000 in connection with all sales of Miromesh and Miroderm products. On February 22, 2021, the Company and Reprise amended the Patent and Know-How License Agreement dated June 30, 2019. Under the original agreement Reprise was obligated to pay the Company a minimum of $500,000 per year in royalties. Reprise was to pay the difference between the total amounts actually paid to the Company for each year and the minimum sum of $500,000 (the “Difference”) within 30 days following the end of such year. The amendment allows Reprise to defer the payment of such Difference for each of calendar years 2020 and 2021 and such Difference added to the minimum sum required for calendar years 2022 and 2023, respectively. Reprise provided us with a payment of $250,000 during the year ended December 31, 2019 and a $47,000 payment during the year ended December 31, 2020 under the Reprise License Agreement. We also recorded a long-term receivable of $453,470 related to the minimum royalty due from Reprise for the year ended December 31, 2020, but due to the uncertainty regarding collectability, we fully reserved against the receivable.

We retained a minority ownership in Reprise, which was fully divested in March 2021. Ronald Ebensteiner who serves on our board of directors, also serves on the board of directors at Reprise.

Reprise Stock Sale

For the year ended December 31, 2020, we recognized a gain of $2.1 million related to the sale of 2.7 million shares in Reprise. As discussed above, certain of our directors and executive officers are Reprise stockholders and serve on the board at Reprise.

See Notes 3 and 14 to our financial statements appearing elsewhere in this prospectus for further details regarding our relationship with Reprise.

University of Minnesota Promissory Note

In January 2019, we issued the University of Minnesota a promissory note in the amount of $385,997 in satisfaction of our minimum royalty obligation under the University of Minnesota License Agreement for the year ended December 31, 2018. The note bears interest at 6% per annum and is due on January 31, 2025. In addition, we issued the University a 10-year warrant to purchase 20,587 shares of our common stock at an exercise price of $3.75 per share. Our license agreement with the University of Minnesota requires us to pay a flat 6.5% royalty to the University of Minnesota with a $500,000 yearly minimum royalty payment.

The University of Minnesota Regents is the beneficial owner of approximately 5.4% of our common stock as of May 21, 2021.

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Cheshire Note

On March 6, 2020, we entered into a note and warrant purchase agreement (the “Cheshire Purchase Agreement”) with Cheshire MD Holdings, LLC (“Cheshire”), an affiliate of DaVita Inc., under which we received a bridge financing of $6,000,000. In connection with the Cheshire Purchase Agreement, we issued a $6,000,000 convertible promissory note (the “Cheshire Note”) to Cheshire and issued Cheshire a warrant to purchase up to $750,000 of shares of our preferred stock. The Cheshire Note is unsecured and has a maturity date of September 6, 2021. If we complete a preferred stock offering of at least $34,000,000 prior to the maturity date, the Cheshire Note and all accrued interest will automatically convert into preferred shares of such offering at the offering price. The Cheshire Note bore interest at 5% per annum through and until May 1, 2020, at which time the interest rate increased to 7%. The interest rate increased by an additional 2% on the first day of each subsequent month (beginning on June 2, 2020) prior to the maturity date, provided that the interest rate shall not exceed 20%. As of December 1, 2020, the interest rate reached the maximum of 20%. Under the Cheshire Purchase Agreement, as long as the Cheshire Note remains outstanding, the Company is required to issue to Cheshire additional warrants, on the first date of each month beginning on May 1, 2020, to purchase up to $75,000 of shares of our preferred stock. As of May 1, 2021, Cheshire holds warrants to purchase up to $1,725,000 of shares of our preferred stock.

Cheshire MD Holdings, LLC is the beneficial owner of approximately 14.5% of our common stock as of May 21, 2021.

Baxter

In May of 2021, we entered into a stock purchase agreement with Baxter Healthcare Corporation, an affiliate of Baxter International Inc. (“Baxter”), under which we sold an aggregate of 2,000,000 shares of Series C Convertible Preferred Stock to Baxter, at a price per share of $7.50, for an aggregate purchase price, before fees and expenses, of $15.0 million.

Baxter is the beneficial owner of approximately 15.0% of our common stock as of May 21, 2021.

CareDx

In May of 2021, we entered into a stock purchase agreement with CareDx, Inc. (“CareDx”), under which we sold an aggregate of 666,667 shares of Series C Convertible Preferred Stock to Baxter, at a price per share of $7.50, for an aggregate purchase price, before fees and expenses, of $5.0 million.

In May of 2021, we entered into a memorandum of understanding (“MoU”) with CareDx relating to (i) the development of a formal collaboration agreement and (ii) whereby we are obligated to source our requirements for donor-derived cell-free DNA, services and related technology from CareDx for a period of five years from the effective date of the agreement.

CareDx is the beneficial owner of approximately 5.0% of our common stock as of May 21, 2021.

Other Transactions

We have entered into an employment agreement with our chief executive officer that, among other things, provide for compensatory benefits. For a description of this agreements and arrangements with our chief executive officer, see the section titled “Executive and Director Compensation — Executive Officer Employment Agreements.”

We have also granted stock options to our executive officers and directors. For a description of these stock options, see the section titled “Executive and Director Compensation.”

Indemnification Agreements

We have entered or intend to enter into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement

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amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request. For more information regarding these indemnification agreements, see “Management — Limitations on Liability and Indemnification Matters.”

Policies and Procedures for Related Party Transactions

Our board of directors will adopt a written related party transaction policy, to be effective upon the completion of this offering, setting forth the policies and procedures for the review and approval or ratification of related-party transactions. This policy will cover any transaction, arrangement or relationship or any series of similar transactions, arrangements or relationships, in which we were or are to be a participant and a related party had or will have a direct or indirect material interest, as determined by the audit committee of our board of directors, who will be tasked with enforcing such policy, including, without limitation, purchases of goods or services by or from the related party or entities in which the related party has a material interest, and indebtedness, guarantees of indebtedness or employment by us of a related party. In reviewing and approving any such related party transactions, our audit committee will be tasked to consider all relevant facts and circumstances, including but not limited to whether the transaction is on terms comparable to those that could be obtained in an arm’s length transaction with an unrelated third party and the extent of the related person’s interest in the transaction.

All related party transactions described in this section occurred prior to adoption of this policy and as such, these transactions were not subject to the approval and review procedures set forth in the policy. However, these transactions were reviewed and approved by our board of directors.

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PRINCIPAL STOCKHOLDERS

The following table sets forth the beneficial ownership of our common stock as of May 21, 2021 and as adjusted to reflect the sale of the common stock offered by us in this offering, for:

•

each stockholder known by us to be the beneficial owner of more than 5% of our outstanding shares of common stock;

•

each of our directors;

•

each of our named executive officers; and

•

all of our directors and executive officers as a group.

In accordance with the rules of the SEC, beneficial ownership includes voting or investment power with respect to securities and includes the shares issuable pursuant to stock options that are exercisable within 60 days of May 21, 2021. Shares issuable pursuant to stock options are deemed outstanding for computing the percentage of the person holding such options but are not outstanding for computing the percentage of any other person. The percentage ownership information under the column titled “Before Offering” is based on shares of common stock outstanding as of May 21, 2021 and includes shares of common stock subject to repurchase by us, assuming the automatic conversion of all our preferred stock outstanding into an aggregate of shares of our common stock immediately prior to the completion of this offering. The percentage ownership information under the column titled “After Offering” is based on the sale of shares of common stock in this offering (assuming an initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus). The percentage ownership information assumes no exercise of (i) the underwriter’s option to purchase additional shares or (ii) the warrants to purchase shares of our common stock at an exercise price per share equal to 110% of the initial public offering price per share or $      ,based on an assumed initial public offering price of $       per share, which is the midpoint of the price range set forth on the cover page of this prospectus, that will be issued to the underwriter in connection with this offering.

Except as otherwise indicated in the footnotes to this table the persons or entities named have sole voting and investment power with respect to all shares of our common stock shown as beneficially owned by them, and the address for each person or entity listed in the table is c/o Miromatrix Medical Inc., 10399 West 70th Street Eden Prairie, MN 55344.

​	Before Offering				After Offering
Name of Beneficial Owner	Number of Shares Beneficially Owned		Percentage of Shares Beneficially Owned		Number of Shares Beneficially Owned	Percentage of Shares Beneficially Owned
Greater than 5% Stockholders:	​	​	​	​	​	​
Baxter Healthcare Corporation(1)	​	2,000,000	​	15.0%	​	​
Cheshire MD Holdings, LLC(2) an affiliate of DaVita, Inc.	​	2,105,756	​	14.5%	​	​
Robert Cohen(3)	​	1,490,000	​	10.6%	​	​
Regents of the University of Minnesota(4)	​	720,384	​	5.4%	​	​
Texas Heart Institute(5)	​	666,667	​	5.0%	​	​
CareDx, Inc.(6)	​	666,667	​	5.0%	​	​
Directors and Named Executive Officers:	​	​	​	​	​	​
Jeff Ross(7)	​	607,865	​	4.4%	​	​
Brian Niebur(8)	​	150,415	​	1.1%	​	​
Laji Kattungal(9)	​	80,000	​	*	​	​
Paul Buckman(10)	​	196,750	​	1.5%	​	​
Ronald Eibensteiner(11)	​	577,269	​	4.2%	​	​
John Erb(12)	​	200,417	​	1.5%	​	​
Mahesh Krishnan	​	—	​	—	​	​
Mark Wagner(13)	​	197,084	​	1.5%	​	​
Directors and executive officers as (8 persons)	​	2,009,800	​	13.5%	​	​

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*

Represents less than 1% of outstanding shares of common stock.

(1)

Consists of 2,000,000 shares of common stock issuable upon the conversion of Series C Preferred Stock. The business address of Baxter Health Corporation is One Baxter Parkway, Deerfield, IL 60015.

(2)

Consists of (i) 933,334 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock; (ii) 230,000 shares of common stock issuable upon the conversion of 230,000 shares of Series C preferred stock, which are issuable upon the exercise of warrants that are exercisable within 60 days of May 21, 2021; and (iii) 942,422 shares of common stock issuable upon the conversion of 942,422 shares of Series C preferred stock, which are issuable upon the conversion of the Cheshire Note, which is convertible within 60 days of May 21, 2021. The business address of Cheshire MD Holdings, LLC is 2000 16th St., Denver, CO 80202.

(3)

Consists of (i) 800,000 shares of common stock; and (ii) 690,000 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

(4)

Consists of (i) 619,797 shares of common stock; and (ii) 100,587 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days of May 21, 2021. The business address of the Regents of the University of Minnesota is 600 McNamara Alumni Center S.E., 200 SE Oak St., Minneapolis, MN 55455.

(5)

Consists of 666,667 shares of common stock issuable upon the conversion of Series B Preferred Stock. The business address of the Texas Heart Institute is 6770 Bertner Ave., Houston, TX 77030.

(6)

Consists of 666,667 shares of common stock issuable upon the conversion of Series C Preferred Stock. The business address of CareDx, Inc. is 1 Tower Pl 9th floor, South San Francisco, CA 94080.

(7)

Consists of (i) 203,750 shares of common stock; (ii) 4,400 shares of common stock issuable upon the conversion of Series B Preferred Stock; and (iii) 399,715 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

(8)

Consists of (i) 3,334 shares of common stock issuable upon the conversion of Series B Preferred Stock; (ii) 3,334 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock; and (iii) 143,747 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021 held in joint tenancy with his spouse.

(9)

Consists of 80,00 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

(10)

Consists of (i) 3,000 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock held by the Paul R. Buckman Revocable Trust; and (ii) 193,750 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

(11)

Consists of (i) 59,769 shares of common stock issuable upon the conversion of Series A Preferred Stock; (ii) 20,000 shares of common stock issuable upon the conversion of Series B Preferred Stock held by Laurie Ebensteiner New Direction IRA Inc.; (iii) 120,000 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock; (iv) 227,500 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021; and (v) 150,000 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days of May 21, 2021.

(12)

Consists of (i) 6,667 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock held by John Erb in joint tenancy with his spouse; and (ii) 193,750 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

(13)

Consists of (i) 3,334 shares of common stock issuable upon the conversion of Series B-2 Preferred Stock; and (ii) 193,750 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days of May 21, 2021.

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DESCRIPTION OF CAPITAL STOCK

The following descriptions are summaries of the material terms of our amended and restated certificate of incorporation, amended and restated bylaws and of the DGCL. Because the following is only a summary, it does not contain all of the information that may be important to you. For a complete description, you should refer to our amended and restated certificate of incorporation and amended and restated bylaws, copies of which have been filed as exhibits to the registration statement of which this prospectus is part.

General

Upon the completion of this offering and the filing of our amended and restated certificate of incorporation, our authorized capital stock will consist of                 authorized shares of capital stock, of which           are designated as common stock and           are designated as preferred stock. All of our outstanding shares of common stock are, and the shares of common stock to be issued in this offering will be, fully paid and nonassessable.

Common Stock

Outstanding Shares

As of March 31, 2021, there would have been        shares of common stock outstanding, held by stockholders of record, after giving effect to the automatic conversion of all our preferred stock outstanding into an aggregate of         shares of our common stock immediately prior to the completion of this offering.

Voting Rights

Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of common stockholders. Subject to preferences that may be applicable to any outstanding preferred shares, each share of common stock is entitled to share pro rata in any distributions. In any distribution of capital assets, such as liquidation, whether voluntary or involuntary, holders of the common stock are entitled to receive pro rata the assets remaining after payment of liabilities and liquidation preferences of any outstanding preferred stock.

Dividends

The payment of dividends in the future, if any, rests within the discretion of our Board of Directors and will depend on, among other things, our earnings, capital requirements, and financial condition. Due to our anticipated financial needs and future plans, we do not contemplate paying any dividends on any of our stock in the foreseeable future.

Liquidation

In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.

Rights and Preferences

Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to our common stock. The rights, preferences and privileges of the holders of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred stock that we may designate in the future.

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Preferred Stock

Upon the completion of this offering, all outstanding shares of our preferred stock will be automatically converted into an aggregate of         shares of common stock. Under the terms of our amended and restated certificate of incorporation that will become effective immediately prior to the completion of this offering, our board of directors is authorized to direct us to issue shares of preferred stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.

The purpose of authorizing our board of directors to issue preferred stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate purposes, could have the effect of making it more difficult for a third-party to acquire, or could discourage a third-party from seeking to acquire, a majority of our outstanding voting stock. Upon the completion of this offering, there will be no shares of preferred stock outstanding, and we have no present plans to issue any shares of preferred stock.

Warrants

As of March 31, 2021, we had warrants to purchase an aggregate of 564,191 shares with a weighted average exercise price of $2.30 per share. These warrants may be exercised at any time and from time to time, in whole or in part.

Additionally, under the Cheshire Purchase Agreement, as long as the Cheshire Note remains outstanding, the Company is required to issue to Cheshire additional warrants, on the first date of each month beginning on May 1, 2020, to purchase up to $75,000 of shares of our preferred stock. As of May 1, 2021, Cheshire holds warrants to purchase up to $1,725,000 of shares of our preferred stock.

Stock Options and Equity Plan Shares

As of March 31, 2021, stock options to purchase 3,552,505 shares of our common stock were outstanding at a weighted-average exercise price of $3.21 per share. 559,500 shares of our common stock remain available for future issuance as of March 31, 2021 under our 2019 plan.

Registration Rights

We are party to a Series A Investor Rights Agreement, Series B Investor Rights Agreement, Series B-2 Investor Rights Agreement and Series C Side Letter (collectively, the “investor rights agreements”), pursuant to which holders of our Series A Convertible Preferred Stock, Series B Convertible Preferred Stock, Series B-2 Convertible Preferred Stock and Series C Convertible Preferred Stock, respectively, are entitled to customary demand, “piggyback” and S-3 registration rights if we conduct a public offering of our common stock in the future, and will retain these registration rights upon the conversion of their shares upon the completion of this offering (collectively, the “registration rights”). As a result, whenever we propose to file a registration statement under the Securities Act other than with respect to a demand registration or a registration statement on Form S-8, these holders will be entitled to notice of the registration and will have the right to include their registrable securities in the registration subject to certain limitations. Further, six months after the consummation of this offering, in the event that at least 50% of holders under the respective investor rights agreement, provide us with a written request to register their shares, and the anticipated aggregate offering proceeds are over $2.0 million, we will be required to use best efforts to effect such registration as soon as practicable. Once the Company has effected one registration pursuant to this demand registration right, it is no longer obligated to effect any further demand registrations pursuant to the respective investor rights agreement. Further, if any holder requests that the Company file a registration statement on Form S-3, we are eligible to file Form S-3, and the anticipated aggregate offering proceeds are greater than $1,000,000, than we will be required to use reasonable best efforts to effect the registration of such shares. Once the Company has effected a total of two registrations pursuant to the previously noted demand registration right and Form S-3 registration rights, the Company will no longer be obligated to

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effect any further registrations pursuant to the respective investor rights agreement. We will generally be obligated to pay all registration expenses in connection with these registration obligations, regardless of whether a registration statement is filed or becomes effective. These registration rights will terminate either (i) three years after the consummation of this offering or (ii) as to each holder, at such time that such holder can sell all of its registrable securities pursuant to Rule 144 under the Securities Act within any three month period.

Upon the consummation of the offering,          shares of common stock will have registration rights following the automatic conversion of all outstanding preferred stock to common stock.

Anti-Takeover Provisions of Delaware Law and Our Charter Documents

Some provisions of Delaware law and our amended and restated certificate of incorporation and our amended and restated bylaws that will become effective immediately prior to the completion of this offering contain provisions that could make the following transactions more difficult: acquisition of us by means of a tender offer; acquisition of us by means of a proxy contest or otherwise; or removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions that might result in a premium over the market price for our shares.

These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.

Section 203 of the Delaware General Corporation Law

We are subject to Section 203 of the DGCL, which prohibits persons deemed “interested stockholders” from engaging in a “business combination” with a publicly-held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an antitakeover effect with respect to transactions not approved in advance by the board of directors, such as discouraging takeover attempts that might result in a premium over the market price of our common stock.

Elimination of Stockholder Action by Written Consent

Our amended and restated certificate of incorporation, which will be in effect immediately prior to the completion of this offering, will provide that all stockholder actions must be effected at a duly called meeting of stockholders and not by consent in writing. A special meeting of stockholders may be called only by a majority of our board of directors, the chair of our board of directors, or our chief executive officer.

Amendment of Charter Provisions

Our amended and restated certificate of incorporation will further provide that the affirmative vote of holders of at least 66 2/3% of the voting power of all of the then outstanding shares of voting stock, voting as a single class, will be required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating to the size of the board, removal of directors, special meetings, actions by written consent and cumulative voting. The affirmative vote of holders of at

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least 66 2/3% of the voting power of all of the then outstanding shares of voting stock, voting as a single class, will be required to amend or repeal our amended and restated bylaws, although our amended and restated bylaws may be amended by a simple majority vote of our board of directors.

Classified Board; Election and Removal of Directors

Our amended and restated certificate of incorporation will further provide that our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered terms, and will give our board of directors the exclusive right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director.

Choice of Forum

Our amended and restated certificate of incorporation will provide that, unless our board of directors consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) will be the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of us; (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees or agents to us or our stockholders; (iii) any action asserting a claim against us arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation and our amended and restated bylaws; or (iv) any action asserting a claim against us governed by the internal affairs doctrine, except, in each case, (A) any claim as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination), (B) which is vested in the exclusive jurisdiction of a court or forum other than such court, or (C) for which such court does not have subject matter jurisdiction.

Limitation of Liability and Indemnification

The Delaware General Corporation Law, our amended and restated certificate of incorporation and our amended and restated bylaws provide for the indemnification of our directors and officers for judgments, penalties, fines and expenses incurred by them in connection with any proceeding or lawsuit to which they might become a party because of their position with our company, provided that certain prescribed conditions are met. To the extent that any such indemnification may be related to liability arising under the Securities Act, the SEC takes the position that such indemnification is against the public policy underlying the Securities Act and is for that reason unenforceable.

Listing

We have applied to list our common stock on The Nasdaq Capital Market under the trading symbol “MIRO”.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is           .

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SHARES ELIGIBLE FOR FUTURE SALE

Prior to this offering, there has been no public market for our common stock. Future sales of substantial amounts of our common stock in the public market after this offering, or the perception that those sales may occur, could adversely affect the prevailing market price for our common stock. Furthermore, since only a limited number of shares will be available for sale shortly after this offering because of contractual and legal restrictions on resale described below, sales of substantial amounts of common stock in the public market after the restrictions lapse could adversely affect the prevailing market price of our common stock as well as our ability to raise equity capital in the future. Based on the number of shares of common stock outstanding as of March 31, 2021, upon the completion of this offering and (i) assuming the automatic conversion of all our preferred stock outstanding as of March 31, 2021 into an aggregate of      shares of our common stock immediately prior to the completion of this offering, (ii) no exercise of the underwriter’s option to purchase additional shares of common stock, and (iii) no exercise of outstanding options or warrants, we will have outstanding an aggregate of approximately      shares of common stock. All of the shares sold in this offering will be freely tradable unless purchased by our “affiliates” as such term is defined in Rule 144 under the Securities Act or purchased by existing stockholders and their affiliated entities that are subject to lock-up agreements. All remaining shares of common stock held by existing stockholders immediately prior to the consummation of this offering will be “restricted securities,” as such term is defined in Rule 144. These restricted securities were issued and sold in private transactions and are eligible for public sale only if registered under the Securities Act or if they qualify for an exemption from registration under the Securities Act, including the exemptions provided by Rule 144 or Rule 701 of the Securities Act, which rules are summarized below.

As a result of the lock-up agreements referred to below and the provisions of Rule 144 and Rule 701 under the Securities Act, based on the number of shares of our common stock outstanding as of March 31, 2021, the remaining shares of our common stock will generally become for sale in the public market are as follows:

Approximate Number of Shares	First Date Available for Sale on the Public Markets
shares	181 days after the date of this prospectus, upon expiration of the lock-up agreements referred to below, subject in some cases to applicable volume, manner of sale and other limitations under Rule 144 and Rule 701.

We may issue shares of common stock from time to time as consideration for future acquisitions, investments or other corporate purposes.

In the event that any such acquisition, investment or other transaction is significant, the number of shares of common stock that we may issue may in turn be significant. We may also grant registration rights covering those shares of common stock issued in connection with any such acquisition and investment. In addition, the shares of common stock reserved for future issuance under our 2019 Plan will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements, a registration statement under the Securities Act or an exemption from registration, including Rule 144 and Rule 701.

Rule 144

In general, pursuant to Rule 144 under the Securities Act, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, any person who is not an affiliate of ours at any time during the three months preceding a sale and has held their shares for at least six months, including the holding period of any prior owner other than one of our affiliates, may sell shares without restriction, provided current public information about us is available. In addition, under Rule 144, any person who is not an affiliate of ours at any time during the three months preceding a sale and has held their shares for at least one year, including the holding period of any prior owner other

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than one of our affiliates, would be entitled to sell an unlimited number of shares immediately following the completion of this offering without regard to whether current public information about us is available.

Beginning 90 days after the effective date of the registration statement of which this prospectus is a part, a person who is an affiliate of ours and who has beneficially owned restricted securities for at least six months, including the holding period of any prior owner other than one of our affiliates, is entitled to sell a number of restricted shares within any three-month period that does not exceed the greater of:

•

1% of the number of common shares then outstanding, which will equal approximately shares of common stock upon the completion of this offering; or

•

the average weekly trading volume of our common stock on The Nasdaq Capital Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

Sales of restricted shares under Rule 144 held by our “affiliates” are also subject to requirements regarding the manner of sale, notice and the availability of current public information about us. Rule 144 also provides that affiliates relying on Rule 144 to sell shares of our common stock that are not restricted shares must nonetheless comply with the same restrictions applicable to restricted shares, other than the holding period requirement. Notwithstanding the availability of Rule 144, the holders of substantially all of our restricted securities have entered into lock-up agreements as referenced above and their restricted securities will become eligible for sale (subject to the above limitations under Rule 144) upon the expiration of the restrictions set forth in those agreements.

Rule 701

Pursuant to Rule 701 under the Securities Act, shares of our common stock acquired upon the exercise of currently outstanding options or pursuant to other rights granted under our stock incentive plans may be resold by:

•

persons other than “affiliates,” beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject only to the manner-of-sale provisions of Rule 144; and

•

Our “affiliates,” beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject to the manner-of-sale and volume limitations, current public information and filing requirements of Rule 144, in each case, without compliance with the six-month holding period requirement of Rule 144.

Lock-Up Agreements

We, along with our directors, executive officers and substantially all of our other stockholders, have agreed with the underwriter that for the period from the date of the lock-up agreement continuing through the date 180 days after the date of this prospectus we and they will not sell, offer to sell, contract to sell or lend, effect any short sale or establish or increase any put equivalent position or liquidate or decrease any call equivalent position, pledge, hypothecate, grant any security interest in or in any other way transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exchangeable for shares of common stock, or enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common stock.

After this offering, certain of our employees, including our executive officers and/or directors may enter into written trading plans that are intended to comply with Rule 10b5-1 under the Exchange Act. Sales under these trading plans would not be permitted until the expiration of the lock-up agreements relating to the offering described above.

Registration Rights

Upon the completion of this offering, the holders of           shares of our preferred stock or their transferees, which will be converted to common stock upon the completion of this offering, will be

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entitled to various rights with respect to the registration of these shares under the Securities Act, subject to the lock-up agreements described under “ — Lock-Up Agreements” above. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates, immediately upon the effectiveness of the registration. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock. See the section titled “Description of Capital Stock — Registration Rights.”

Equity Incentive Plans

We intend to file with the SEC a registration statement on Form S-8 under the Securities Act covering the shares of common stock reserved for issuance under our 2019 Plan. The registration statement is expected to be filed and become effective upon the consummation of this offering. Accordingly, shares registered under the registration statement will be available for sale in the open market following its effective date, subject to vesting restrictions, Rule 144 volume limitations and the lock-up agreements described above, if applicable.

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS

The following discussion is a summary of the material U.S. federal income tax consequences to Non-U.S. Holders (as defined below) of the purchase, ownership and disposition of our common stock issued pursuant to this offering, but does not purport to be a complete analysis of all potential tax effects. The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local or non-U.S. tax laws are not discussed. This discussion is based on the Code, Treasury Regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the U.S. Internal Revenue Service, or the IRS, in each case in effect as of the date hereof. These authorities may change or be subject to differing interpretations. Any such change or differing interpretation may be applied retroactively in a manner that could adversely affect a Non-U.S. Holder of our common stock. We have not sought and will not seek any rulings from the IRS regarding the matters discussed below. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the tax consequences of the purchase, ownership and disposition of our common stock.

This discussion is limited to Non-U.S. Holders that hold our common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences relevant to a Non- U.S. Holder’s particular circumstances, including the impact of the Medicare contribution tax on net investment income. In addition, it does not address consequences relevant to Non-U.S. Holders subject to special rules, including, without limitation:

•

U.S. expatriates and former citizens or long-term residents of the United States;

•

persons subject to the alternative minimum tax;

•

persons holding our common stock as part of a hedge, straddle or other risk reduction strategy or as part of a conversion transaction or other integrated investment;

•

banks, insurance companies and other financial institutions;

•

brokers, dealers or traders in securities;

•

“controlled foreign corporations,” “passive foreign investment companies” and corporations that accumulate earnings to avoid U.S. federal income tax;

•

partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors therein);

•

tax-exempt organizations or governmental organizations;

•

persons deemed to sell our common stock under the constructive sale provisions of the Code;

•

persons who hold or receive our common stock pursuant to the exercise of any employee stock option or otherwise as compensation;

•

tax-qualified retirement plans;

•

“qualified foreign pension funds” and entities all of the interests of which are held by qualified foreign pension funds; and

•

persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an applicable financial statement.

If an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds our common stock, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership and certain determinations made at the partner level. Accordingly, partnerships holding our common stock and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.

THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT TAX ADVICE. INVESTORS SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS

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ANY TAX CONSEQUENCES OF THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK ARISING UNDER THE U.S. FEDERAL ESTATE OR GIFT TAX LAWS OR UNDER THE LAWS OF ANY STATE, LOCAL OR NON-U.S. TAXING JURISDICTION OR UNDER ANY APPLICABLE INCOME TAX TREATY.

Definition of a Non-U.S. Holder

For purposes of this discussion, a “Non-U.S. Holder” is any beneficial owner of our common stock that is neither a “U.S. person” nor an entity treated as a partnership for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federal income tax purposes, is or is treated as any of the following:

•

an individual who is a citizen or resident of the United States;

•

a corporation or entity treated as a corporation that is created or organized under the laws of the United States, any state thereof, or the District of Columbia;

•

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

•

a trust that (i) is subject to the primary supervision of a U.S. court and the control of one or more “United States persons” ​(within the meaning of Section 7701(a)(30) of the Code), or (ii) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.

Distributions

As described in the section titled “Dividend Policy,” we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. However, if we make distributions of cash or property on our common stock, such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital and first be applied against and reduce a Non-U.S. Holder’s adjusted tax basis in its common stock, but not below zero. Any excess will be treated as capital gain and will be treated as described below under “ — Sale or Other Taxable Disposition.”

Subject to the discussions below on effectively connected income, backup withholding and the Foreign Account Tax Compliance Act, or FATCA, dividends paid to a Non-U.S. Holder of our common stock will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax treaty, provided the Non-U.S. Holder furnishes a valid IRS Form W-8BEN or W-8BEN-E (or other applicable documentation) certifying qualification for the lower treaty rate). A Non-U.S. Holder that does not timely furnish the required documentation, but that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable income tax treaty.

If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment or fixed base in the United States to which such dividends are attributable), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax described above. To claim the exemption, the Non-U.S. Holder must furnish to the applicable withholding agent a valid IRS Form W-8ECI, certifying that the dividends are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States.

Any such effectively connected dividends generally will be subject to U.S. federal income tax on a net income basis at the regular graduated rates. A Non-U.S. Holder that is a corporation also generally will be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on its effectively connected earnings and profits attributable to such dividends, as adjusted for certain items. Non-U.S. Holders should consult their tax advisors regarding any applicable tax treaties that may provide for different rules.

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Sale or Other Taxable Disposition

Subject to the discussions below regarding backup withholding and FATCA, a Non-U.S. Holder will not be subject to U.S. federal income tax on any gain realized upon the sale or other taxable disposition of our common stock unless:

•

the gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment or fixed base in the United States to which such gain is attributable);

•

the Non-U.S. Holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of the disposition and certain other requirements are met; or

•

our common stock constitutes a U.S. real property interest, or USRPI, by reason of our status as a U.S. real property holding corporation, or USRPHC, for U.S. federal income tax purposes.

Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular graduated rates. A Non-U.S. Holder that is a corporation also generally will be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on its effectively connected earnings and profits attributable to such gain, as adjusted for certain items.

Gain described in the second bullet point above will be subject to U.S. federal income tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty), which may be offset by U.S. source capital losses of the Non-U.S. Holder (even though the individual is not considered a resident of the United States), provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with respect to such losses.

With respect to the third bullet point above, we believe we currently are not, and do not anticipate becoming, a USRPHC. However, because the determination of whether we are a USRPHC depends on the fair market value of our USRPIs relative to the fair market value of our non-U.S. real property interests and our other business assets, there can be no assurance we currently are not a USRPHC or will not become one in the future. Even if we are or were to become a USRPHC, gain arising from the sale or other taxable disposition by a Non-U.S. Holder of our common stock will not be subject to U.S. federal income tax if our common stock is “regularly traded,” as defined by applicable Treasury Regulations, on an established securities market, and such Non-U.S. Holder owned, actually and constructively, 5% or less of our common stock throughout the shorter of the five-year period ending on the date of the sale or other taxable disposition or the Non-U.S. Holder’s holding period. If we are a USRPHC and either our common stock is not regularly traded on an established securities market or a Non-U.S. Holder holds more than 5% of our common stock, actually or constructively, during the applicable testing period, such Non-U.S. Holder will generally be taxed on any gain in the same manner as gain that is effectively connected with the conduct of a U.S. trade or business, except that the branch profits tax generally will not apply.

Non-U.S. Holders should consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.

Information Reporting and Backup Withholding

Payments of dividends on our common stock will not be subject to backup withholding, provided the holder either certifies its non-U.S. status by furnishing a valid IRS Form W-8BEN, W-8BEN-E or W-8ECI or otherwise establishes an exemption. However, information returns are required to be filed with the IRS in connection with any dividends on our common stock paid to the Non-U.S. Holder, regardless of whether any tax was actually withheld. In addition, proceeds of the sale or other taxable disposition of our common stock within the United States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information reporting, if the applicable withholding agent receives the certification described above or the holder otherwise establishes an exemption. Proceeds of a disposition of our common stock conducted through a non-U.S. office of a

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non-U.S. broker that does not have certain enumerated relationships with the United States generally will not be subject to backup withholding or information reporting.

Copies of information returns that are filed with the IRS also may be made available under the provisions of an applicable treaty or agreement to the tax authorities of the country in which the Non-U.S. Holder resides or is established.

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a Non-U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.

Additional Withholding Tax on Payments Made to Foreign Accounts

Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (commonly referred to as FATCA) on certain types of payments made to non-U.S. financial institutions and certain other non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on, or (subject to the proposed Treasury Regulations discussed below) gross proceeds from the sale or other disposition of, our common stock paid to a “foreign financial institution” or a “non-financial foreign entity” ​(each as defined in the Code), unless (i) the foreign financial institution undertakes certain diligence and reporting obligations, (ii) the non-financial foreign entity either certifies it does not have any “substantial United States owners” ​(as defined in the Code) or furnishes identifying information regarding each substantial United States owner or (iii) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these rules. If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in clause (i) above, it must enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertakes to identify accounts held by certain “specified United States persons” or “United States-owned foreign entities” ​(each as defined in the Code), annually report certain information about such accounts, and withhold 30% on certain payments to non-compliant foreign financial institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the United States governing FATCA may be subject to different rules.

Under the applicable Treasury Regulations and administrative guidance, withholding under FATCA generally applies currently to payments of dividends on our common stock. While withholding under FATCA would have applied also to payments of gross proceeds from the sale or other disposition of our common stock on or after January 1, 2019, proposed Treasury Regulations eliminate FATCA withholding on payments of gross proceeds entirely. Taxpayers generally may rely on these proposed Treasury Regulations until final Treasury Regulations are issued.

Prospective investors should consult their tax advisors regarding the potential application of withholding under FATCA to their investment in our common stock.

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UNDERWRITING

The underwriter named below has agreed to buy, subject to the terms of the underwriting agreement, the number of shares of common stock listed opposite its name. The underwriter is committed to purchase and pay for all of the shares if any are purchased, other than those shares covered by the over-allotment option described below. Craig-Hallum Capital Group LLC is the sole book-running manager for the offering.

Underwriter	Number of Shares
Craig-Hallum Capital Group LLC	​
Total	​

The underwriter is committed to purchase all the shares of common stock offered by us other than those covered by the option to purchase additional shares of common stock described below, if it purchases any shares of common stock. The obligations of the underwriter may be terminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriter’s obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by the underwriter of officers’ certificates and legal opinions.

The underwriter has advised us that it proposes to offer the shares of common stock to the public at a price of $      per share. The underwriter proposes to offer the shares of common stock to certain dealers at the same price less a concession of not more than $      per share. After the offering, these figures may be changed by the underwriter.

The shares sold in this offering are expected to be ready for delivery against payment in immediately available funds on or about           , 2021, subject to customary closing conditions. The underwriter may reject all or part of any order.

Over-allotment option

We have granted to the underwriter an option to purchase up to an additional           shares of common stock from us at the same price to the public, and with the same underwriting discount, as set forth in the table below. The underwriter may exercise this option any time during the 30-day period after the date of this prospectus, but only to cover over-allotments, if any. To the extent the underwriter exercises the option, the underwriter will become obligated, subject to certain conditions, to purchase the shares for which it exercises the option.

Discounts, Commissions and Reimbursement

The table below summarizes the underwriting discounts that we will pay to the underwriter. These amounts are shown assuming both no exercise and full exercise of the over-allotment option. In addition to the underwriting discount, we have agreed to pay up to $285,000 of the fees and expenses of the underwriter, which may include the fees and expenses of counsel to the underwriter.

​	​	​	​	Total(1)
​	Per Share			Total with No Over-Allotment			Total with Over-Allotment
Public offering price	​	$		​	$		​	$
Underwriting discount (7%)	​	$		​	$		​	$
Proceeds, before expenses, to us)	​	$		​	$		​	$	​

(1)

Does not include warrants to purchase shares of common stock equal to 5.0% of the number of shares of common stock sold in the offering to be issued to the underwriter at the closing.

We estimate that the total expenses of this offering, excluding underwriting discounts, will be $      . This includes $285,000 of fees and expenses of the underwriter. These expenses are payable by us.

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Except as disclosed in this prospectus, the underwriter has not received and will not receive from us any other item of compensation or expense in connection with this offering considered by FINRA to be underwriting compensation under FINRA Rule 5110. The underwriting discount was determined through an arms’ length negotiation between us and the underwriter.

Indemnification

We have agreed to indemnify the underwriter against certain liabilities, including civil liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the underwriter may be required to make in respect of those liabilities.

Lock-Up Agreements

We, each of our directors and officers and certain of our significant stockholders have agreed not to offer, sell, agree to sell, directly or indirectly, or otherwise dispose of any shares of common stock or any securities convertible into or exchangeable for shares of common stock without the prior written consent of the underwriter for a period of 180 days after the date of this prospectus. These lock-up agreements provide limited exceptions and their restrictions may be waived at any time by the underwriter.

Underwriter’s Warrants

In connection with the successful completion of this offering, for the price of $50, the underwriter may purchase a warrant to purchase shares of our common stock equal to 5.0% of the shares sold in this offering at an exercise price that is 110.0% of the public offering price per share in this offering; provided that the underwriter will only receive such warrants relating to the over-allotment option upon the closing (if any) of the over-allotment option. The warrants are exercisable during the period commencing on the date of the prospectus and ending five years from the date of this prospectus.

The warrants have been deemed compensation by the Financial Industry Regulatory Authority, or FINRA, and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA. Pursuant to FINRA Rule 5110(g), the warrants and any shares issued upon exercise thereof will not be sold, transferred, assigned, pledged or hypothecated, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of the securities by any person, for a period of 180 days immediately following the date of effectiveness or commencement of sales in this offering, except: (i) the transfer of any security by operation of law or by reason of our reorganization; (ii) the transfer of any security to any FINRA member firm participating in the offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction set forth above for the remainder of the time period; (iii) the transfer of any security if the aggregate amount of our securities held by the placement agent or related persons do not exceed 1% of the securities being offered; (iv) the transfer of any security that is beneficially owned on a pro-rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund and the participating members in the aggregate do not own more than 10% of the equity in the fund; or (v) the exercise or conversion of any security, if all securities remain subject to the lock-up restriction set forth above for the remainder of the time period.

Electronic Offer, Sale and Distribution of Securities

A prospectus in electronic format may be made available on the website maintained by the underwriter and the underwriter may distribute prospectuses electronically. Other than the prospectus in electronic format, the information on the website maintained by the underwriter is not part of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or the underwriter in its capacity as underwriter, and should not be relied upon by investors.

Determination of Offering Price

The underwriter has advised us that it proposes to offer the shares directly to the public at the estimated initial public offering price range set forth on the cover page of this preliminary prospectus.

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That price range and the initial public offering price are subject to change as a result of market conditions and other factors. Prior to this offering, no public market exists for our common stock. The initial public offering price of the shares was determined by negotiation between us and the underwriter. The principal factors considered in determining the initial public offering price of the shares included:

•

the information in this prospectus and otherwise available to the underwriter, including our financial information;

•

the history and the prospects for the industry in which we compete;

•

the ability and experience of our management;

•

the prospects for our future earnings;

•

the present state of our development and our current financial condition;

•

the general condition of the economy and the securities markets in the United States at the time of this initial public offering;

•

the time and additional investment of capital required to market our product candidates;

•

the recent market prices of, and the demand for, publicly-traded securities of generally comparable companies; and

•

other factors as were deemed relevant.

We cannot be sure that the initial public offering price will correspond to the price at which the shares of common stock will trade in the public market following this offering or that an active trading market for the shares of common stock will develop or continue after this offering.

Price Stabilization, Short Positions and Penalty Bids

To facilitate this offering, the underwriter may engage in transactions that stabilize, maintain or otherwise affect the price of our common stock during and after the offering. Specifically, the underwriter may create a short position in our common stock for its own accounts by selling more shares of common stock than we have sold to the underwriter. The underwriter may close out any short position by purchasing shares in the open market.

In addition, the underwriter may stabilize or maintain the price of our common stock by bidding for or purchasing shares in the open market and may impose penalty bids. If penalty bids are imposed, selling concessions allowed to broker-dealers participating in this offering are reclaimed if shares previously distributed in this offering are repurchased, whether in connection with stabilization transactions or otherwise. The effect of these transactions may be to stabilize or maintain the market price of our common stock at a level above that which might otherwise prevail in the open market. The imposition of a penalty bid may also affect the price of our common stock to the extent that it discourages resales of our common stock. The magnitude or effect of any stabilization or other transactions is uncertain. These transactions may be effected on The Nasdaq Capital Market or otherwise and, if commenced, may be discontinued at any time.

In connection with this offering, the underwriter and selling group members may also engage in passive market making transactions in our common stock on The Nasdaq Capital Market. Passive market making consists of displaying bids on The Nasdaq Capital Market limited by the prices of independent market makers and effecting purchases limited by those prices in response to order flow. Rule 103 of Regulation M promulgated by the Securities and Exchange Commission limits the amount of net purchases that each passive market maker may make and the displayed size of each bid. Passive market making may stabilize the market price of our common stock at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.

Neither we nor the underwriter make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor the underwriter make any representation that the underwriter will engage in these transactions or that any transaction, if commenced, will not be discontinued without notice.

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Electronic Offer, Sale and Distribution of Shares

The underwriter or syndicate members may facilitate the marketing of this offering online directly or through one of their respective affiliates. In those cases, prospective investors may view offering terms and a prospectus online and place orders online or through their financial advisors. Such websites and the information contained on such websites, or connected to such sites, are not incorporated into and are not a part of this prospectus.

Other Relationships

The underwriter and its affiliates are full service financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The underwriter has in the past, and may in the future, engage in investment banking and other commercial dealings in the ordinary course of business with us or our affiliates. The underwriter has in the past, and may in the future, receive customary fees and commissions for these transactions.

In the ordinary course of their various business activities, the underwriter and its affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve securities and/or instruments of the issuer. The underwriter and its affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that it acquires, long and/or short positions in such securities and instruments.

Listing

In connection with this offering, we have applied to have our common stock listed on The Nasdaq Capital Market under the symbol “MIRO.” There is no assurance, however, that our common stock will ever be listed on The Nasdaq Capital Market or any other national securities exchange.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is                 .

Selling Restrictions

Australia

No placement document, prospectus, product disclosure statement or other disclosure document has been lodged with the Australian Securities and Investments Commission, or the ASIC, in relation to the offering.

This prospectus does not constitute a prospectus, product disclosure statement or other disclosure document under the Corporations Act 2001, or the Corporations Act, and does not purport to include the information required for a prospectus, product disclosure statement or other disclosure document under the Corporations Act.

Any offer in Australia of the shares may only be made to persons, the Exempt Investors, who are “sophisticated investors” ​(within the meaning of section 708(8) of the Corporations Act), “professional investors” ​(within the meaning of section 708(11) of the Corporations Act) or otherwise pursuant to one or more exemptions contained in section 708 of the Corporations Act so that it is lawful to offer the shares without disclosure to investors under Chapter 6D of the Corporations Act.

The shares applied for by Exempt Investors in Australia must not be offered for sale in Australia in the period of 12 months after the date of allotment under the offering, except in circumstances where disclosure to investors under Chapter 6D of the Corporations Act would not be required pursuant to an exemption under section 708 of the Corporations Act or otherwise or where the offer is pursuant to a

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disclosure document which complies with Chapter 6D of the Corporations Act. Any person acquiring shares must observe such Australian on-sale restrictions.

This prospectus contains general information only and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does not contain any securities recommendations or financial product advice. Before making an investment decision, investors need to consider whether the information in this prospectus is appropriate to their needs, objectives and circumstances, and, if necessary, seek expert advice on those matters.

Canada

The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45 106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31 103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus supplement (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 of National Instrument 33 105 Underwriting Conflicts (NI 33 105), the underwriter is not required to comply with the disclosure requirements of NI 33 105 regarding underwriter conflicts of interest in connection with this offering.

China

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to “qualified domestic institutional investors.”

European Economic Area

In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, each, a Relevant Member State, an offer to the public of any shares of our common stock may not be made in that Relevant Member State, except that an offer to the public in that Relevant Member State of any shares of our common stock may be made at any time under the following exemptions under the Prospectus Directive, if they have been implemented in that Relevant Member State:

•

to any legal entity which is a qualified investor as defined in the Prospectus Directive;

•

to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representatives for any such offer; or

•

in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of shares of our common stock shall result in a requirement for the publication by us or any underwriter of a prospectus pursuant to Article 3 of the Prospectus Directive.

For the purposes of this provision, the expression an “offer to the public” in relation to any shares of our common stock in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any shares of our common stock to be

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offered so as to enable an investor to decide to purchase any shares of our common stock, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State, the expression “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member State), and includes any relevant implementing measure in the Relevant Member State, and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.

France

This document is not being distributed in the context of a public offering of financial securities (offre au public de titres financiers) in France within the meaning of Article L.411-1 of the French Monetary and Financial Code (Code monétaire et financier) and Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in France.

This document and any other offering material relating to the securities has not been, and will not be, submitted to the AMF for approval in France and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in France.

Such offers, sales and distributions have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D. 744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors (cercle restreint d’investisseurs non-qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-4, D.744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation.

Pursuant to Article 211-3 of the General Regulation of the AMF, investors in France are informed that the securities cannot be distributed (directly or indirectly) to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of the French Monetary and Financial Code.

Ireland

The information in this document does not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish regulatory authority as the information has not been prepared in the context of a public offering of securities in Ireland within the meaning of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005 (the “Prospectus Regulations”). The securities have not been offered or sold, and will not be offered, sold or delivered directly or indirectly in Ireland by way of a public offering, except to (i) qualified investors as defined in Regulation 2(l) of the Prospectus Regulations and (ii) fewer than 100 natural or legal persons who are not qualified investors.

Israel

The securities offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority (the ISA), or ISA, nor have such securities been registered for sale in Israel. The shares and warrants may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the quality of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.

Japan

The securities have not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the “FIEL”)

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pursuant to an exemption from the registration requirements applicable to a private placement of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and the regulations promulgated thereunder). Accordingly, the securities may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires securities may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition by any such person of securities is conditional upon the execution of an agreement to that effect.

Portugal

This document is not being distributed in the context of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal, within the meaning of Article 109 of the Portuguese Securities Code (Código dos Valores Mobiliários). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This document and any other offering material relating to the securities have not been, and will not be, submitted to the Portuguese Securities Market Commission (Comissão do Mercado de Valores Mobiliários) for approval in Portugal and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of securities in Portugal are limited to persons who are “qualified investors” ​(as defined in the Portuguese Securities Code). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

Sweden

This document has not been, and will not be, registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document may not be made available, nor may the securities be offered for sale in Sweden, other than under circumstances that are deemed not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel med finansiella instrument). Any offering of securities in Sweden is limited to persons who are “qualified investors” ​(as defined in the Financial Instruments Trading Act). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

Switzerland

The shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or the SIX, or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the shares or the offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this document nor any other offering or marketing material relating to the offering, or the shares have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of shares will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA, and the offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. Accordingly, no public distribution, offering or advertising, as defined in CISA, its implementing ordinances and notices, and no distribution to any non-qualified investor, as defined in CISA, its implementing ordinances and notices, shall be undertaken in or from Switzerland, and the investor protection afforded to acquirers of interests in collective investment schemes under CISA does not extend to acquirers of shares.

United Kingdom

Neither the information in this document nor any other document relating to the offer has been delivered for approval to the Financial Services Authority in the United Kingdom and no prospectus

161

(within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)) has been published or is intended to be published in respect of the securities. This document is issued on a confidential basis to “qualified investors” ​(within the meaning of section 86(7) of FSMA) in the United Kingdom, and the securities may not be offered or sold in the United Kingdom by means of this document, any accompanying letter or any other document, except in circumstances that do not require the publication of a prospectus pursuant to section 86(1) FSMA. This document should not be distributed, published or reproduced, in whole or in part, nor may its contents be disclosed by recipients to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) received in connection with the issue or sale of the securities have only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of FSMA does not apply to us.

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together “relevant persons”). The investments to which this document relates are available only to, and any invitation, offer or agreement to purchase will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

162

LEGAL MATTERS

The validity of the issuance of our common stock offered in this prospectus will be passed upon for us by Faegre Drinker Biddle & Reath LLP. Certain legal matters in connection with this offering will be passed upon for the underwriter by Fredrikson & Byron, P.A., Minneapolis, Minnesota.

EXPERTS

The financial statements of Miromatrix Medical Inc. as of December 31, 2020 and 2019, and for each of the years in the two-year period ended December 31, 2020, have been audited by Baker Tilly US, LLP, an independent registered public accounting firm as stated in their report (which report expresses an unqualified opinion and includes an explanatory paragraph relating to the Company’s ability to continue as a going concern), and included in this prospectus and registration statement in reliance upon the authority of such firm as experts in accounting and auditing.

WHERE YOU CAN FIND ADDITIONAL INFORMATION

We have filed with the SEC a registration statement on Form S-1, including exhibits and schedules, under the Securities Act, with respect to the shares of common stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the common stock offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference. You can read our SEC filings, including the registration statement, over the Internet at the SEC’s website at www.sec.gov.

Upon the completion of this offering, we will be subject to the information reporting requirements of the Exchange Act and we will file reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available for inspection at the web site of the SEC referred to above. We also maintain a website at www.miromatrix.com, at which, following the completion of this offering, you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on or accessible through our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.

163

FINANCIAL STATEMENTS

​	Page
Audited Financial Statements as of and for the Years December 31, 2020 and 2019 and the Unaudited Financials Statements as of March 31, 2021 and for the Three Months Ended March 31, 2021 and 2020	​
Report of Independent Registered Public Accounting Firm	F-2
Audited Balance Sheets as of December 31, 2020 and 2019 and Unaudited Balance Sheets as of March 31, 2021	F-3
Audited Statements of Operations for the Years Ended December 31, 2020 and 2019 and Unaudited Statements of Operations for the Three Months Ended March 31, 2021 and 2020	F-4
Audited Statements of Shareholders’ Equity for the Years Ended December 31, 2020 and 2019 and Unaudited Statements of Shareholders’ Equity for the Three Months Ended March 31, 2021 and 2020	F-5
Audited Statements of Cash Flows for the Years Ended December 31, 2020 and 2019 and Unaudited Statements of Cash Flows for the Three Months Ended March 31, 2021 and 2020	F-6
Notes to Financial Statements	F-7 to F-26

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and the Board of Directors of Miromatrix Medical Inc.:

Opinion on the Financial Statements

We have audited the accompanying balance sheets of Miromatrix Medical Inc. (the “Company”) as of December 31, 2020 and 2019, the related statements of operations, shareholders’ deficit and cash flows, for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of their operations and their cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.

Going concern

The accompanying financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 2 of the financial statements, the Company has recurring losses from operations, an accumulated deficit, expects to incur losses for the foreseeable future and needs additional working capital. These are the matters that raise substantial doubt about their ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not contain any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Baker Tilly US, LLP

We have served as the Company’s auditor since 2015.

Minneapolis, Minnesota
March 26, 2021

Baker Tilly US, LLP, trading as Baker Tilly, is a member of the global network of Baker Tilly International Ltd., the members of which are separate and independent legal entities.

F-2

MIROMATRIX MEDICAL INC.

BALANCE SHEETS

​

December 31, 2020

December 31, 2019

March 31, 2021

March 31, 2021 Pro forma Shareholders Deficit

​

​

​

​

​

​

​

(unaudited)

(See Note 1) (unaudited)

ASSETS

​

​

​

​

​

​

​

​

​

​

​

​

Current assets:

​

​

​

​

​

​

​

​

​

​

​

​

Cash and cash equivalents

​

$

4,444,395

​

$

3,250,014

​

$

4,263,528

​

​

​

Accounts receivable, less allowance for doubtful accounts of $0, $51,230 and $0 as of December 31, 2020 and 2019 and March 31,2021, respectively

​

​

—

​

​

42,175

​

​

—

​

​

​

Receivable from Reprise Biomedical, Inc.

​

​

15,202

​

​

228,251

​

​

6,108

​

​

​

Grant receivable

​

​

100,000

​

​

257,380

​

​

150,000

​

​

​

Prepaid expenses and other current assets

​

​

130,576

​

​

95,102

​

​

644,457

​

​

​

Total current assets

​

​

4,690,173

​

​

3,872,922

​

​

5,064,093

​

​

​

Lab equipment, furniture and leasehold improvements, net

​

​

324,534

​

​

371,733

​

​

300,435

​

​

​

Investment in Reprise Biomedical, Inc.

​

​

239,721

​

​

3,475,000

​

​

—

​

​

​

Other assets

​

​

—

​

​

26,156

​

​

—

​

​

​

Total assets

​

$

5,254,428

​

$

7,745,811

​

$

5,364,528

​

​

​

LIABILITIES AND SHAREHOLDERS’ DEFICIT

​

​

​

​

​

​

​

​

​

​

​

​

Current liabilities:

​

​

​

​

​

​

​

​

​

​

​

​

Current portion of long-term debt

​

$

6,413,733

​

$

264,713

​

$

6,091,485

​

​

​

Accounts payable

​

​

130,160

​

​

302,983

​

​

301,063

​

​

​

Accrued interest expense

​

​

612,705

​

​

—

​

​

905,014

​

​

​

Embedded derivative liability

​

​

246,962

​

​

—

​

​

52,991

​

​

​

Accrued expenses

​

​

760,889

​

​

1,055,670

​

​

1,251,617

​

​

​

Total current liabilities

​

​

8,164,449

​

​

1,623,366

​

​

8,602,170

​

​

​

Accrued royalties

​

​

488,368

​

​

—

​

​

611,841

​

​

​

Long-term debt, less current portion

​

​

928,623

​

​

873,141

​

​

743,377

​

​

​

Accrued interest

​

​

45,691

​

​

21,193

​

​

51,984

​

​

​

Total liabilities

​

​

9,627,131

​

​

2,517,700

​

​

10,009,372

​

​

​

Commitments and contingencies

​

​

​

​

​

​

​

​

​

​

​

​

Mezzanine equity:

​

​

​

​

​

​

​

​

​

​

​

​

Convertible preferred stock – Series B-2, par value $0.00001; 2,500,000 shares authorized; 2,095,874 issued and outstanding as of December 31, 2020 and 2019 and March 31, 2021 (Liquidation preference $15,719,055)

​

​

15,670,097

​

​

15,670,097

​

​

15,670,097

​

​

—

Convertible preferred stock – Series B, par value $0.00001; 4,000,000 shares authorized; 3,218,282 issued and outstanding as of December 31, 2020 and 2019 and March 31, 2021 (Liquidation preference $24,137,115)

​

​

23,865,732

​

​

23,865,732

​

​

23,865,732

​

​

—

Convertible preferred stock – Series A, par value $0.00001; 3,300,000 shares authorized; 3,000,380 issued and outstanding as of December 31, 2020 and 2019 and March 31, 2021 (Liquidation preference $7,500,950)

​

​

7,125,661

​

​

7,125,661

​

​

7,125,661

​

​

—

Shareholders’ deficit:

​

​

​

​

​

​

​

​

​

​

​

​

Common stock, par value $0.00001; 30,000,000 shares authorized; 2,185,822, 2,075,822 and 2,290,822 issued and outstanding as of December 31, 2020 and 2019 and March 31, 2021, respectively

​

​

22

​

​

21

​

​

23

​

$

106

Additional paid-in capital

​

​

8,346,943

​

​

7,638,190

​

​

8,509,143

​

​

55,170,550

Accumulated deficit

​

​

(59,381,158)

​

​

(49,071,590)

​

​

(59,815,500)

​

​

(59,815,500)

Total shareholders’ deficit

​

​

(51,034,193)

​

​

(41,433,379)

​

​

(51,306,334)

​

​

(4,644,844)

Total Liabilities, Mezzanine Equity and Shareholders’ Deficit

​

$

5,254,428

​

$

7,745,811

​

$

5,364,528

​

​

​

See Notes to Financial Statements

F-3

MIROMATRIX MEDICAL INC.

STATEMENTS OF OPERATIONS

​

Year Ended December 31, 2020

Year Ended December 31, 2019

Three Months Ended March 31, 2021

Three Months Ended March 31, 2020

​

​

​

​

​

​

​

(unaudited)

(unaudited)

Licensing revenue

​

$

46,530

​

$

250,000

​

$

6,108

​

$

11,088

Cost of goods sold

​

​

500,000

​

​

250,000

​

​

125,000

​

​

125,000

Gross margin

​

​

(453,470)

​

​

—

​

​

(118,892)

​

​

(113,912)

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

Research & development

​

​

7,280,798

​

​

6,266,670

​

​

1,868,001

​

​

1,801,378

Regulatory and clinical

​

​

265,885

​

​

289,020

​

​

83,705

​

​

73,106

Quality

​

​

149,199

​

​

—

​

​

85,787

​

​

—

General & administration

​

​

2,109,196

​

​

2,435,974

​

​

562,874

​

​

465,663

Total operating expenses

​

​

9,805,078

​

​

8,991,664

​

​

2,600,367

​

​

2,340,147

Operating loss from continuing operations

​

​

(10,258,548)

​

​

(8,991,664)

​

​

(2,719,259)

​

​

(2,454,059)

​

​

​

​

​

​

Interest income

​

​

8,733

​

​

106,428

​

​

40

​

​

5,863

Interest expense

​

​

(656,552)

​

​

(48,385)

​

​

(305,374)

​

​

(37,175)

Amortization of discount on note

​

​

(108,620)

​

​

—

​

​

(32,586)

​

​

(10,862)

Change in fair value of derivative

​

​

(51,446)

​

​

—

​

​

193,971

​

​

—

Research grants

​

​

992,144

​

​

431,880

​

​

150,537

​

​

180,000

Loss from continuing operations

​

​

(10,074,289)

​

​

(8,501,741)

​

​

(2,712,671)

​

​

(2,316,233)

Gain on equity investment

​

​

—

​

​

4,495,500

​

​

—

​

​

—

Equity loss in affiliate

​

​

(2,358,392)

​

​

(1,025,000)

​

​

(223,633)

​

​

(640,000)

Gain on sale of equity investment

​

​

2,123,113

​

​

—

​

​

1,983,912

​

​

—

Gain on debt extinguishment

​

​

—

​

​

—

​

​

518,050

​

​

—

Gain on disposal of discontinued operations (Note 3)

​

​

—

​

​

1,802,555

​

​

—

​

​

—

Loss from discontinued operations (Note 3)

​

​

—

​

​

(818,113)

​

​

—

​

​

—

Net loss

​

$

(10,309,568)

​

$

(4,046,799)

​

$

(434,342)

​

$

(2,956,233)

Net loss per share, basic and diluted

​

$

(4.76)

​

$

(1.98)

​

$

(0.19)

​

$

(1.40)

Weighted average shares used in computing net loss per share, basic and diluted

​

​

2,165,105

​

​

2,043,356

​

​

2,255,378

​

​

2,108,981

Pro forma net loss per share, basic and diluted (unaudited)

​

$

(0.98)

​

​

​

​

$

(0.04)

​

​

​

Pro forma weighted average common shares outstanding, basic and diluted (unaudited)

​

​

10,479,641

​

​

​

​

​

10,569,914

​

​

​

See Notes to Financial Statements

F-4

MIROMATRIX MEDICAL INC.

STATEMENTS OF SHAREHOLDERS’ DEFICIT
Years Ended December 31, 2020 and 2019 and
Three Months Ended March 31, 2021

​

Common Stock

Additional Paid-in Capital

Accumulated Deficit

Total Shareholders’ Deficit

​

Shares

Amounts

Balance at December 31, 2018

​

2,025,822

​

$

20

​

$

6,657,203

​

$

(45,024,791)

​

$

(38,367,568)

Stock-based compensation expense

​

—

​

​

—

​

​

867,523

​

​

—

​

​

867,523

Warrant expense

​

—

​

​

—

​

​

50,965

​

​

​

​

​

50,965

Exercise of stock options

​

50,000

​

​

1

​

​

62,499

​

​

—

​

​

62,500

Net loss

​

—

​

​

—

​

​

—

​

​

(4,046,799)

​

​

(4,046,799)

Balance at December 31, 2019

​

2,075,822

​

​

21

​

​

7,638,190

​

​

(49,071,590)

​

​

(41,433,379)

Stock-based compensation expense

​

—

​

​

—

​

​

644,854

​

​

—

​

​

644,854

Exercise of stock options

​

65,000

​

​

1

​

​

7,649

​

​

—

​

​

7,650

Exercise of stock warrants

​

45,000

​

​

—

​

​

56,250

​

​

​

​

​

56,250

Net loss

​

—

​

​

—

​

​

—

​

​

(10,309,568)

​

​

(10,309,568)

Balance at December 31, 2020

​

2,185,822

​

​

22

​

​

8,346,943

​

​

(59,381,158)

​

​

(51,034,193)

Stock-based compensation expense (unaudited)

​

—

​

​

—

​

​

133,451

​

​

—

​

​

133,451

Exercise of stock options (unaudited)

​

105,000

​

​

1

​

​

28,749

​

​

—

​

​

28,750

Net loss (unaudited)

​

—

​

​

—

​

​

—

​

​

(434,342)

​

​

(434,342)

Balance at March 31, 2021 (unaudited)

​

2,290,822

​

$

23

​

$

8,509,143

​

$

(59,815,500)

​

$

(51,306,334)

See Notes to Financial Statements

F-5

MIROMATRIX MEDICAL INC.

STATEMENTS OF CASH FLOWS

​

Year Ended December 31, 2020

Year Ended December 31, 2019

Three Months Ended March 31, 2021

Three Months Ended March 31, 2020

​

​

​

​

​

​

​

(unaudited)

(unaudited)

Cash flows from operating activities:

​

​

​

​

​

​

​

​

​

​

​

​

Net loss

​

$

(10,309,568)

​

$

(4,046,799)

​

$

(434,342)

​

$

(2,956,233)

Adjustments to reconcile net loss to net cash from operating activities:

​

​

​

​

​

​

​

​

​

​

​

​

Depreciation and amortization

​

​

170,365

​

​

344,131

​

​

30,029

​

​

67,939

Stock-based compensation

​

​

644,854

​

​

918,488

​

​

133,451

​

​

157,398

Reserve for bad debt

​

​

—

​

​

16,230

​

​

—

​

​

—

Amortization of discount on note

​

​

108,620

​

​

—

​

​

32,586

​

​

10,862

Change in fair value of derivative

​

​

51,446

​

​

—

​

​

(193,971)

​

​

—

Forgiveness of paycheck protection program loan

​

​

—

​

​

—

​

​

(518,050)

​

​

—

Gain on disposal of discontinued operations

​

​

—

​

​

(1,802,555)

​

​

—

​

​

—

Gain on equity investment

​

​

—

​

​

(4,495,500)

​

​

—

​

​

—

Equity loss in affiliate

​

​

2,358,392

​

​

1,025,000

​

​

223,633

​

​

640,000

Gain on sale of equity investment

​

​

(2,123,113)

​

​

—

​

​

(1,983,912)

​

​

—

Changes in operating assets and liabilities:

​

​

​

​

​

​

​

​

​

​

​

​

Accounts receivable

​

​

42,175

​

​

169,451

​

​

—

​

​

39,615

Receivable from Reprise Biomedical, Inc.

​

​

213,049

​

​

(228,251)

​

​

9,094

​

​

217,163

Grant receivable

​

​

157,380

​

​

(257,380)

​

​

(50,000)

​

​

257,380

Inventories

​

​

—

​

​

121,340

​

​

—

​

​

—

Prepaid expenses

​

​

(35,474)

​

​

14,497

​

​

(513,881)

​

​

(97,207)

Other assets

​

​

26,156

​

​

—

​

​

—

​

​

—

Accounts payable and accrued expenses

​

​

(467,604)

​

​

(124,566)

​

​

661,631

​

​

(439,791)

Accrued interest

​

​

637,203

​

​

21,193

​

​

303,132

​

​

31,481

Accrued expenses – long-term

​

​

488,368

​

​

—

​

​

123,473

​

​

—

Net cash used in operating activities

​

​

(8,037,751)

​

​

(8,324,721)

​

​

(2,177,127)

​

​

(2,071,393)

Cash flows from investing activities:

​

​

​

​

​

​

​

​

​

​

​

​

Sales of short-term investments

​

​

—

​

​

7,967,112

​

​

—

​

​

—

Proceeds from sale of Acellular business

​

​

—

​

​

2,500,000

​

​

—

​

​

—

Investment in Reprise Biomedical, Inc.

​

​

—

​

​

(4,500)

​

​

—

​

​

—

Proceeds from sale of equity-method investment

​

​

3,000,000

​

​

—

​

​

2,000,000

​

​

—

Purchases of lab equipment, furniture and leasehold improvements

​

​

(123,166)

​

​

(101,452)

​

​

(5,930)

​

​

(7,000)

Net cash provided by (used in) investing activities

​

​

2,876,834

​

​

10,361,160

​

​

1,994,070

​

​

(7,000)

Cash flows from financing activities:

​

​

​

​

​

​

​

​

​

​

​

​

Payments on long-term debt

​

​

(271,999)

​

​

(136,155)

​

​

(26,560)

​

​

(32,108)

Proceeds from long-term debt

​

​

6,563,397

​

​

385,997

​

​

—

​

​

6,000,000

Proceeds from stock warrants exercise

​

​

56,250

​

​

—

​

​

—

​

​

56,250

Proceeds from stock options exercise

​

​

7,650

​

​

62,500

​

​

28,750

​

​

6,250

Net cash provided by financing activities

​

​

6,355,298

​

​

312,342

​

​

2,190

​

​

6,030,392

Increase (decrease) in cash and cash equivalents

​

​

1,194,381

​

​

2,348,781

​

​

(180,867)

​

​

3,951,999

Cash and cash equivalents at beginning of year

​

​

3,250,014

​

​

901,233

​

​

4,444,395

​

​

3,250,014

Cash and cash equivalents at end of year

​

$

4,444,395

​

$

3,250,014

​

$

4,263,528

​

$

7,202,013

Supplemental disclosure of cash flow information:

​

​

​

​

​

​

​

​

​

​

​

​

Interest paid

​

$

19,349

​

$

27,192

​

$

6,772

​

$

5,694

See Notes to Financial Statements

F-6

MIROMATRIX MEDICAL INC.

NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2019 AND THREE MONTHS ENDED MARCH 31, 2021

NOTE 1 — DESCRIPTION OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES

Description of Business

Miromatrix Medical Inc. (the “Company”) is a life science company that has a proprietary technology to remove cells from, or decellularize, and also to recellularize organs and tissues from animal and human sources, facilitating the creation of numerous products (the “Medical Device Business”).

Basis of Preparation

The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP”). In April 2019, the Company’s board of directors approved plans to pursue a potential spin-out of the Acellular business. Effective June 30, 2019, the Company’s board of directors approved plans to spin-out the Acellular business. For all period presented, the Company classified this business as discontinued operations and, accordingly, has reclassified historical financial data presented herein. All footnote disclosures relate to continuing operations unless noted. See further information in Note 3.

Unaudited Interim Financial Statements

The accompanying balance sheet as of March 31, 2021, the statements of operations and cash flows for the three months ended March 31, 2021 and 2020, and the statements of shareholders' deficit for the three months ended March 31, 2021 and the related note information are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company's financial position and shareholders' deficit as of March 31, 2021, and the results of operations and cash flows for the three months ended March 31, 2021 and 2020. The financial data and the other information disclosed in the notes to the financial statements related to these three-month periods are unaudited. The results of the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future period.

Discontinued Operations

The Company records discontinued operations when the disposal of a separately identified business unit constitutes a significant strategic shift in the Company’s operations. In addition, there was no debt related to discontinued operations; therefore, there was no interest allocated to discontinued operations.

Unaudited Pro Forma Balance Sheet and Net Loss

The unaudited pro forma balance sheet and unaudited pro forma net loss information reflects 2,290,822 shares of the Company’s common stock outstanding at March 31, 2021, and assumes (1) the conversion of all 3,000,380 outstanding shares of Series A convertible preferred stock into 3,000,380 shares of the Company’s common stock, (2) conversion of all 3,218,282 shares of Series B convertible preferred stock into 3,218,282 shares of the Company’s common stock, and (3) conversion of all 2,095,874 shares of Series B-2 convertible preferred stock into 2,095,874 shares of the Company’s common stock, in each case in connection with the closing of the Company’s contemplated initial public offering of its common stock (the “IPO”) as of the beginning of the respective period or the date of issuance, if earlier. Shares of common stock to be sold in the Company’s contemplated IPO and related net proceeds are excluded from such pro forma information.

F-7

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. The carrying amount approximates fair value because of the short maturity of those instruments. The Company deposits its cash in high credit quality financial institutions. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses from maintaining balances in excess of the federally insured limits. As of December 31, 2020 and 2019, the Company had $1,575,720 and $3,067,823, respectively, invested in money market funds which are classified as a Level 1 fair valued measured asset since these funds are traded on a regular basis. As of March 31, 2021, the Company had $2,226,595 invested in money market funds which are classified as a level 1 fair valued measures asset.

Equity Method Investments

Investments in 20% to 50%-owned companies are accounted for under the equity method as the Company can exercise significant influence, but not control, over such investments. The equity method requires that gains (losses) are recognized in other income (expense), net in the statements of operations. The gain on equity investment in Reprise Biomedical, Inc. resulted from recording the fair value of the Company’s investment in Reprise upon losing a controlling interest in the Company on June 30, 2019. The Company recorded its equity method share of losses in Reprise from July 1, 2019 through December 31, 2019, from January 1, 2020 to December 31, 2020 and from January  1, 2021 to March 15, 2021 in the statements of operations. Even though the Company’s ownership dropped below 20% on November 15, 2020, the Company still had significant influence over the activities of Reprise due to common board members (See Note 5).

Accounts Receivable

The Company grants credit to customers in the normal course of business, generally without collateral or any other security to support amounts due. Invoices are generally issued with net 30 day terms. Accounts receivable over 30 days are considered past due. The Company does not accrue interest on past due accounts receivable. The Company establishes an allowance for doubtful accounts based upon factors surrounding the credit risk of specific customers and other information, including historical collection information and existing economic conditions. The Company recorded an allowance for doubtful accounts of $0 and $51,230 as of December 31, 2020 and 2019, respectively, and $0 as of March 31, 2021. Receivables are written-off only after all collection attempts have failed and are based on individual credit evaluation and specific circumstances of the customer. Recoveries of receivables previously written off are recorded when received.

Lab Equipment, Furniture and Leasehold Improvements

Lab equipment, furniture and leasehold improvements are stated at cost. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of related assets which range from three to five years for machinery and equipment. Leasehold improvements are depreciated over the shorter of the useful life or the term of the lease. Maintenance, repairs and minor renewals are expensed when incurred. Depreciation and amortization expense related to research and development, such as certain leasehold improvements and lab equipment is presented in research & development expenses in the statements of operations.

Patents

Costs associated with the submission of a patent application are expensed as incurred given the uncertainty of the patents resulting in probable future economic benefits to the Company and are included in general & administration expenses on the statements of operations.

Revenue Recognition

Sales taxes collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from revenues and cost of goods sold in the accompanying statements of operations.

F-8

The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted effective January 1, 2019. The Company recognizes revenue for product sales when its customers obtain control of the products, which occurs at a point in time, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods (included in discontinued operations).

In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps: (i) identify the contract with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) each performance obligation is satisfied.

The Company’s discontinued operations sold its products directly to hospitals, distribution centers and customers located in the United States of America. Revenue from discontinued operations was recognized upon transfer of control of a product to a customer, which occurred at a point in time, generally upon date of shipment of the product directly to the customer by various Company suppliers or at the time the product was utilized in a surgical procedure. The Company maintained ownership of the device inventory until the time of usage under the consignment sales model.

For agreements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur after the minimum guarantee is satisfied, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company assesses the collectability of the consideration and only recognizes revenue when the collectability of the consideration is deemed probable. The Company re-assesses the collectability of the consideration on a periodic basis, typically quarterly, and recognizes revenue deemed probable of being collected.

Cost of Goods Sold

Cost of goods sold for continuing operations consists of royalty expenses.

Research and Development Costs

Research and development expenses consist primarily of engineering, product development, consulting services, materials, depreciation and other costs associated with products and technologies in development. These expenses include employee and non-employee compensation, including stock-based compensation, supplies, materials, consulting, related travel expenses and facility costs. Expenditures for research and development activities are charged to operations as incurred.

Stock-Based Compensation

The Company is required to determine the fair value of equity incentive awards and recognize compensation expense for all equity incentive awards made to employees and directors, including employee stock options. The Company also determines the fair value of non-statutory stock options issued to consultants based on the fair value of the consultant’s commitment at the date of grant. Such expense is recognized over the requisite service period. In addition, stock-based compensation expense recognized in the statements of operations is based on awards expected to vest and therefore the amount of expense has been reduced for estimated forfeitures. The Company uses the straight-line method for expense attribution, except for awards issued with performance-based conditions which require an accelerated attribution method over the requisite performance and service periods.

Under the applicable accounting guidance for equity incentive awards issued to non-employees, the date at which the fair value of such awards is measured is equal to the earlier of: 1) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached; or 2) the date at which the counterparty’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee awards in the statements of operations.

F-9

The valuation model used for calculating the fair value of awards for stock-based compensation expense is the Black-Scholes option-pricing model (the “Black-Scholes model”). The Black-Scholes model requires the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted average period of time that the options granted are expected to be outstanding), the volatility of common stock and an assumed risk-free interest rate. The Company uses the “simplified method” to determine the expected term of the stock option. Volatility is based on an average of the historical volatilities of the common stock of publicly-traded companies with characteristics similar to those of the Company. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected term of the option. The expected dividend assumption is based on the Company’s history of not paying dividends and its expectation that it will not declare dividends for the foreseeable future. Potential forfeitures of awards are estimated based on the Company’s historical forfeiture experience. The estimate of forfeitures will be adjusted over the service period to the extent that actual forfeitures differ, or are expected to differ, from prior estimates.

Deferred Offering Costs

Deferred offering costs, consisting of legal other fees and costs relating to the Company's planned IPO are capitalized within other assets on the balance sheet. The deferred offering costs will be offset against the proceeds received upon the closing of the planned IPO. In the event the planned IPO is terminated, all of the deferred offering costs will be expensed within loss from operations. As of March 31, 2021, $534,000 (unaudited) of deferred offering costs were recorded as other current assets on the consolidated balance sheet. There were no deferred offering costs incurred for the previous periods presented.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents, accounts receivable and accounts payable. Accounts receivable are concentrated primarily with the Company’s distributors and customers. Historically, the Company’s credit losses have been insignificant.

Income Taxes

The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. As of December 31, 2020 and 2019, the Company did not have any material uncertain tax positions.

Deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial statement carrying amount and the tax basis of assets and liabilities. The Company provides for deferred taxes at the enacted tax rate that is expected to apply when the temporary differences reverse. The Company has recorded a full valuation allowance against the net deferred tax asset due to the uncertainty of realizing the related benefits.

The Company has elected to recognize interest on tax deficiencies as interest expense and income tax penalties as general & administration expense. For the years ended December 31, 2020 and 2019, the Company recognized no interest and penalties.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

F-10

Emerging Growth Company Status

The Company is an emerging growth company, as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as to those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset may not be fully recoverable. An impairment loss would be recognized when the estimated future cash flows from the use of the asset are less than the carrying amount of that asset.

Net Loss Per Share

Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. Because we have reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods as all potentially dilutive shares consisting of stock options and warrants were antidilutive in those periods.

Recent Accounting Pronouncements

During May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU No. 2014- 09 establishes principles for recognizing revenue upon the transfer of promised goods or services to customers, in an amount that reflects the expected consideration received in exchange for those goods or services. During 2015 and 2016, the FASB also issued ASU No. 2015-14, which defers the effective date of ASU No. 2014-09; ASU No. 2016-08, “Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which clarifies the implementation guidance on principal versus agent considerations in Topic 606; ASU No. 2016-10, “Identifying Performance Obligations and Licensing”, which clarifies the identification of performance obligations and the licensing implementation guidance; ASU No. 2016-12, “Narrow-Scope Improvements and Practical Expedients” and ASU No. 2016-20, “Technical Corrections and Improvements to Topic 606”, which both affect narrow aspects of Topic 606. Topic 606 (as amended) is effective for fiscal years beginning after December 15, 2018. The amendments may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of initial application. The Company implemented Topic 606 for the year ended December 31, 2019. The effects of the adoption were not material.

During June 2018, the FASB issued ASU 2018-07, “Compensation — Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for nonemployee share-based payment transactions by expanding the scope of Topic 718, Compensation — Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. As a result, nonemployee share-based payment transactions will be measured at the grant-date fair value with no classification reassessment requirements after vesting unless the award is modified, among other amendments included in this ASU. This standard is effective for public business entities for fiscal years beginning after December 15, 2018 including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of ASC 606. The Company also adopted ASC 2018-07 for the year ended December 31, 2019, related to its nonemployee share-based payment awards and the adoption had an immaterial impact on the Company’s financial statements.

F-11

During February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” ASU No. 2016-02 requires lessees to recognize the assets and liabilities that arise from leases on the balance sheet. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. During 2018, the FASB also issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases”, which addresses narrow aspects of the guidance originally issued in ASU No. 2016-02; ASU 2018-11, “Targeted Improvements”, which provides entities with an additional (and optional) transition method whereby an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption and also provides lessors with a practical expedient, by class of underlying asset, to not separate non-lease components from the associated lease component and, instead, to account for those components as a single component. During 2019, the FASB also issued ASU No. 2019-01, which clarified Topic 842’s interim disclosure requirements and amend certain industry-specific guidance related to determining the fair value of leased assets and the cash flow presentation of principal payments received under sales-type and direct finance leases. Topic 842 (as amended) is effective for annual periods beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021. Early adoption is permitted. The Company is currently assessing the effect that Topic 842 (as amended) will have on its results of operations, financial position and cash flows.

NOTE 2 — GOING CONCERN

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company incurred losses from operations and negative cash flows from operations for both of the years ended December 31, 2020 and 2019 and the three months ended March 31, 2021, had an accumulated deficit as of December 31, 2020 and March 31, 2021 and is in need of additional working capital to fund operations. The Company is in the process of obtaining additional financing as there is not enough cash on hand to fund operations through one year from this report’s issuance date. These conditions raise substantial doubt about its ability to continue as a going concern. There is no guarantee that the Company will be able to raise additional equity or debt financing in the future.

To continue in existence and expand its operations, the Company will be required to, and management plans to, raise additional working capital through an equity or debt offering and ultimately attain profitable operations. If the Company is not able to raise additional working capital, it would have a material adverse effect on the operations of the Company and future research, development and commercialization.

NOTE 3 — DISCONTINUED OPERATIONS

The Company previously manufactured and sold acellular medical devices in the hernia mesh and wound care markets through a separately identifiable business unit (the “Acellular Business”). On June 30, 2019, the Acellular Business was spun-out to Reprise Biomedical, Inc. ("Reprise") Therefore, the Company has classified the Acellular Business as discontinued operations for financial reporting purposes in all periods presented. Prior to the spin-out the Company owned 100% of the Acellular business.

At the time of the spin-out the common stock of Reprise was valued at $1 per share and therefore the Company recognized a gain of $4,495,500 on its Reprise common stock holdings. At the time of the spin-out and until November 15, 2020 the Company owned 4,500,000 shares of common stock of Reprise Biomedical, Inc., which represented 45% ownership in Reprise. In November 2020, the Company sold 2,700,000 shares of common stock of Reprise and retained an 18% ownership interest in Reprise. The Company sold its remaining shares of Reprise Biomedical, Inc. in March 2021 for $2,000,000.

The following table shows the results of operations of the Company’s discontinued operations for the years ended December 31, 2020 and 2019 and the three months ended March 31, 2021 and 2020:

F-12

​

Year Ended December 31, 2020

Year Ended December 31, 2019

Three Months Ended March 31, 2021 (unaudited)

Three Months Ended March 31, 2020 (unaudited)

Product revenues

​

$

—

​

$

918,245

​

$

—

​

$

—

Cost of goods sold

​

​

—

​

​

(513,176)

​

​

—

​

​

—

Gross margin

​

​

—

​

​

405,069

​

​

—

​

​

—

Operating expenses

​

​

—

​

​

(1,223,182)

​

​

—

​

​

—

Gain on sale

​

​

—

​

​

1,802,555

​

​

—

​

​

—

Net income (loss) from discontinued operations

​

$

—

​

$

984,442

​

$

—

​

$

—

Cash flows from the Company’s discontinued operations for the year ended December 31, 2020 were $0, $0 and $0 for operating, investing and financing activities, respectively. Cash flows from the Company’s discontinued operations for the year ended December 31, 2019 were $533,679, $0 and $0 for operating, investing and financing activities, respectively. Cash flows from the Company’s discontinued operations for both the three months ended March 31, 2021 and 2020 were $0, $0 and $0 for operating, investing and financing activities, respectively.

NOTE 4 — LAB EQUIPMENT, FURNITURE AND LEASEHOLD IMPROVEMENTS

Lab equipment, furniture and leasehold improvements consisted of the following as of:

​	December 31, 2020			December 31, 2019			March 31, 2021
​	​	​	​	​	​	​	(unaudited)
Lab equipment	​	$	1,480,952	​	$	1,365,511	​	$	1,486,882
Leasehold improvements	​	​	310,225	​	​	310,225	​	​	310,225
Furniture and fixtures & computers	​	​	112,302	​	​	104,577	​	​	112,302
​	​	​	1,903,479	​	​	1,780,313	​	​	1,909,409
Less accumulated depreciation and amortization	​	​	(1,578,945)	​	​	(1,408,580)	​	​	(1,608,974)
​	​	$	324,534	​	$	371,733	​	$	300,435

Depreciation and amortization expense was $170,365 and $333,724 for the years ended December 31, 2020 and 2019, respectively, and $30,029 and $67,938 for the three months ended March 31, 2021 and 2020, respectively.

NOTE 5 — EQUITY METHOD INVESTMENT

As of December 31, 2020 and 2019, the Company had an investment in Reprise Biomedical, Inc. (“Reprise”) that it accounts for under the equity method (See Note 1). The Company considers its investment in Reprise to be significant to its income as of December 31, 2020 and to its assets and income as of December 31, 2019. The Company sold all of its ownership in Reprise on March 15, 2021. Financial information from the financial statements of Reprise are summarized as follows:

​	As of December 31,
​	2020			2019
Current assets	​	$	4,309,045	​	$	9,006,998
Total assets	​	​	5,312,350	​	​	11,342,142
Current liabilities	​	​	2,534,673	​	​	552,660
Non-current liabilities	​	​	489,785	​	​	32,551
Shareholders’ equity	​	​	2,287,892	​	​	10,756,931
Miromatrix Medical Inc. share of shareholders’ equity	​	​	411,821	​	​	4,840,619

F-13

​

For the Year Ended December 31,

For the Three Months Ended March  31,

​

2020

2019

2021

2020

​

​

​

​

​

​

​

(unaudited)

(unaudited)

Net sales

​

$

704,867

​

$

588,051

​

$

93,985

​

$

170,260

Gross margin

​

​

(61,155)

​

​

401,686

​

​

47,708

​

​

116,457

Net loss

​

​

(6,389,453)

​

​

(2,277,790)

​

​

(1,376,522)

​

​

(1,422,565)

Miromatrix Medical Inc. share of net loss

​

​

(2,358,392)

​

​

(1,025,000)

​

​

(223,633)

​

​

(640,000)

NOTE 6 — ACCRUED EXPENSES

Accrued expenses consisted of the following as of:

​	December 31, 2020			December 31, 2019			March 31, 2021
​	​	​	​	​	​	​	(unaudited)
Wages	​	$	217,825	​	$	255,164	​	$	164,457
Legal	​	​	452,778	​	​	244,589	​	​	962,778
Royalties	​	​	3,800	​	​	435,469	​	​	1,527
Key opinion leader compensation	​	​	34,000	​	​	49,240	​	​	34,000
Other	​	​	52,486	​	​	71,208	​	​	88,855
Accrued expenses	​	$	760,889	​	$	1,055,670	​	$	1,251,617

NOTE 7 — FAIR VALUE MEASUREMENT

The fair value of the Company’s financial instruments reflect the amount that the Company estimates that it would receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). ASC 820, Fair Value Measurements and Disclosures establishes a fair value hierarchy that prioritizes the inputs used in valuation techniques into the following three levels:

ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC 820 are described below:

Level 1 Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2 Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.

Level 3 Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.

F-14

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.

The Company classified its equity method investments as Level 3 securities.

The Company classified warrants it issued in the year ended December 31, 2019 in conjunction with a promissory note as Level 3 fair value measurement. The warrants were valued using the Black Scholes option pricing model using an expected life of 10 years, a risk-free interest rate of 2.52%, expected dividend of 0% and an expected volatility of 54.7%. The Company recorded an expense of $50,965 related to these warrants in 2019.

The Company determined that a promissory note issued in March 2020 (“March 2020 Note”) contained a change in control provision which is a level 3 embedded derivative and is required to be bifurcated. In accordance with ASC 815, Derivatives and Hedging, the Company determined the fair value of the derivative liability and recorded it on the balance sheet. At inception, the fair value of the derivative liability was $195,516.

The table below discloses changes in value of the Company’s embedded derivative liabilities discussed above.

Derivative liability balance at December 31, 2019	$	—
Derivative instrument related to March 2020 Note	​	195,516
Gain/Loss recognized to revalue derivative instrument at fair value	​	51,446
Derivative liability balance at December 31, 2020	​	246,962
Gain/Loss recognized to revalue derivative instrument at fair value (unaudited)	​	(193,971)
Derivative liability balance at March 31, 2021 (unaudited)	$	52,991

NOTE 8 — DEBT AND CAPITAL LEASE OBLIGATION

In December 2010, the Company entered into a loan and security agreement with the Minnesota Agricultural and Economic Development Board under which the Company borrowed $250,000. The loan had a maturity date of November 1, 2020. Commencing on December 1, 2014, the loan started to bear interest at a rate of 6% per annum. Per the loan agreement, the Company began making monthly principal and interest payments on December 1, 2015 in the amount of $3,000. The Company made 59 monthly payments, plus one final payment equal to the then unpaid principal and interest. The loan was secured by the Company’s accounts receivable. As of December 31, 2020 and 2019, the principal outstanding on this loan was $0 and $168,193, respectively.

In January 2012, the Company signed a promissory note with the Regents of the University of Minnesota for $405,559. Commencing on January 1, 2016 the promissory note bears interest at 3% per annum, compounded monthly. On or before January 31, 2018, the Company is required to make monthly principal and interest payments of $7,737 until the note is paid in full. The note has a maturity date of December 31, 2022 and is unsecured. In association with the promissory note, the Company issued the Regents of the University of Minnesota warrants to purchase 80,000 shares of the Company’s common stock at an exercise price of $1.69. As of December 31, 2020 and 2019, the principal outstanding on this loan was $172,731 and $258,990, respectively, and $150,759 as of March 31, 2021.

In May 2015, the Company entered into a loan agreement with the Minnesota Department of Employment & Economic Development under which the Company borrowed $250,000. The loan does not bear interest, is due in a lump sum payment on April 1, 2022 and is uncollateralized. If there is a substantial ownership change in the Company (greater than 50% to one entity), the Company will pay the Minnesota Department of Employment & Economic Development additional compensation of $75,000. As of both December 31, 2020 and 2019, the balance outstanding on this loan was $250,000, and $250,000 as of March  31, 2021.

F-15

In October 2018, the Company signed a lease agreement for a piece of equipment that is being accounted for as a capitalized lease. The total cost of the equipment was $102,026. The lease bears interest at 7.2% and the Company will make 60 payments of $2,003 until the lease is paid in full. As of December 31, 2020 and 2019, the amount outstanding on the lease was $57,127 and $74,674, respectively and $52,539 as of March 31, 2021. The lease is secured by the piece of equipment.

In January 2019, Company issued the University of Minnesota (the University) a promissory note in the amount of $385,997 in satisfaction of the Company’s minimum royalty obligation for the year ended December 31, 2018. The note bears interest at 6% per annum and is due on January 31, 2025. In addition, the Company issued the University a 10-year warrant to purchase 20,587 shares of the Company’s common stock at an exercise price of $3.75 per share.

In March 2020, the Company entered into a note and warrant purchase agreement (the “Purchase Agreement”) with one of the Company’s shareholders under which the Company borrowed $6,000,000. As part of the Purchase Agreement, the Company signed a convertible promissory note (the “Note”) and issued the shareholder a warrant (the “Warrant”). The Note is unsecured and has a maturity date of September 6, 2021. If the Company completes a preferred stock offering of at least $34,000,000 prior to the maturity date, the Note and all accrued interest will automatically convert into preferred shares of such offering at the offering price. The Note initially bore interest at 5% per annum. If the Note was not converted prior to May 1, 2020, the interest rate increased to 7% on May 1, 2020 and by an additional 2% on the first day of each subsequent month prior to the maturity date starting on June 1, 2020, provided that the interest rate shall not exceed 20%. The 5-year Warrant has a warrant coverage amount of $750,000 with an exercise price equal to the conversion price of the Note. If the Note had not been converted or repaid in accordance with its terms prior to May 1, 2020, the Company will issue an additional warrant on May 1, 2020, and the first day of each additional month the Note remains outstanding, for $75,000 of warrant coverage. As of December 31, 2020 and March 31, 2021, the balance outstanding on the loan was $6,000,000.

On April 16, 2020, the Company issued a promissory note for $563,397 under the Paycheck Protection Program through the U.S. Small Business Administration (SBA). The PPP was authorized in the Coronavirus Aid, Relief and Economic Security (CARES) Act. The promissory note is uncollateralized and is fully guaranteed by the Federal government. The promissory note bears interest at 1% per annum and is due on April 16, 2022. Per the Paycheck Protection Program’s terms, some or all of the debt may be forgiven based upon the Company’s use of the funds. On March 4, 2021, $513,520 of the promissory note and associated interest of $4,530 were forgiven by the SBA. As of December 31, 2020, the balance outstanding on the loan was $563,397 and $49,877 as of March 31, 2021.

Principal maturities are as follows:

Year ending December 31,	Debt			Capital Lease			Total
2021	​	$	6,481,774	​	$	18,855	​	$	6,500,629
2022	​	​	504,354	​	​	20,261	​	​	524,615
2023	​	​	—	​	​	18,011	​	​	18,011
2024	​	​	—	​	​	—	​	​	—
2025	​	​	385,997	​	​	—	​	​	385,997
Totals	​	​	7,372,125	​	​	57,127	​	​	7,429,252
Less current portion	​	​	(6,481,774)	​	​	(18,855)	​	​	(6,500,629)
Long-term portion	​	$	890,351	​	$	38,272	​	$	928,623

F-16

Year ending March 31,	Debt			Capital Lease			Total
(unaudited)	​	​	​	​	​	​	​	​	​
2022	​	$	6,128,251	​	$	17,544	​	$	6,145,795
2023	​	​	322,385	​	​	20,505	​	​	342,890
2024	​	​	–	​	​	14,490	​	​	14,490
2025	​	​	385,997	​	​	–	​	​	385,997
Totals	​	​	6,836,633	​	​	52,539	​	​	6,889,172
Less current portion	​	​	(6,128,251)	​	​	(17,544)	​	​	(6,145,795)
Long-term portion	​	$	708,382	​	$	34,995	​	$	743,377

NOTE 9 — INCOME TAXES

The Company recorded a net loss for financial and tax reporting purposes during the years ended December 31, 2020 and 2019. As a result of cumulative net operating loss and credit carryforwards, no income taxes were provided. The effective tax rates for the years ended December 31, 2020 and 2019 differ from the federal and state statutory tax rates primarily due to the change in full valuation allowance, nondeductible incentive stock option expense, meals and entertainment expense, and officer life insurance expense the major deferred tax items are as follows at December 31:

​	2020			2019
Assets:	​	​	​	​	​	​
Asset valuation reserves and other	​	$	30,000	​	$	35,000
Depreciation and amortization	​	​	64,000	​	​	23,000
Capitalized R&D expenses	​	​	115,000	​	​	204,000
Option and warrant expense	​	​	1,629,000	​	​	1,158,000
R&D credit	​	​	3,138,000	​	​	1,222,000
Net operating loss carryforwards	​	​	5,644,000	​	​	5,356,000
​	​	​	10,620,000	​	​	7,998,000
Valuation allowance	​	​	(10,620,000)	​	​	(7,998,000)
​	​	$	—	​	$	—

The valuation allowance increased $2,622,000 and $284,000 for the years ended December 31, 2020 and 2019, respectively. The valuation allowance increased in the current year primarily due to the Company’s operating losses.

At December 31, 2020, the Company has available for U.S. federal income tax purposes net operating loss carry-forwards of approximately $25,182,000 and state net operating loss carryforwards of $6,268,000. These carryforwards expire in the years 2030 through 2040. The ultimate utilization of the net operating loss carryforwards may be limited in the future due to changes in the ownership of the Company. This limitation, if applicable, has not been determined by the Company.

The realization of the Company’s deferred tax assets is dependent upon the Company’s ability to generate taxable income in the future. The Company has recorded a 100% valuation allowance against all of the deferred tax assets due to the uncertainty regarding their realizability.

NOTE 10 — SHAREHOLDERS’ DEFICIT AND MEZZANINE EQUITY

The Company currently has 50,000,000 authorized shares of capital stock, of which 30,000,000 are designated as common stock and 20,000,000 are designated as preferred stock, including 3,300,000 shares of Series A Convertible Preferred Stock, 4,000,000 shares of Series B Convertible Preferred Stock and 2,500,000 Series B-2 Convertible Preferred Stock.

F-17

The Company has classified its Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series B-2 Convertible Preferred Stock as mezzanine equity due to a liquidation provision under a change in control.

Common Stock

In 2020, the Company issued 64,000 and 1,000 shares of common stock in connection with the exercise of stock option agreements at exercise prices of $0.10 and $1.25 per share, respectively. The Company also issues 45,000 shares of common stock in connection with the exercise of stock warrant agreements at an exercise price of $1.25 per share.

In 2019, the Company issued 50,000 shares of common stock in connection with the exercise of stock option agreements at exercise price of $1.25 per share.

Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of common shareholders. Subject to preferences that may be applicable to any outstanding preferred shares, each common share is entitled to share pro rata in any distributions. In any distribution of capital assets holders of the common stock are entitled to receive pro rata the assets remaining after payment of liabilities and liquidation preferences of any outstanding preferred stock.

Series A Convertible Preferred Stock

In 2015, the Company issued 29,200 shares of Series A preferred stock in connection with the exercise of warrant agreements at the price of $2.50 per share.

In connection with a license contract signed September 15, 2013, 83,333 shares of Series A preferred stock were issued at the fair market value of $2.50 per share, for a total value of $208,333 which was expensed as research and development expenses in the statement of operations.

In 2013, the Company received gross proceeds of $500,004 in a private placement to various investors for issuance of 208,335 shares of its Series A preferred stock at $2.50 per share (or $2.40 per share if an investor purchased more than 40,000 shares).

In 2012, the Company received gross proceeds of $3,589,406 in a private placement to various investors for issuance of 1,488,836 shares of its Series A preferred stock at $2.50 per share (or $2.40 per share if an investor purchased more than 40,000 shares).

In 2011, the Company received gross proceeds of $2,024,250 in a private placement to various investors for issuance of 829,568 shares of its Series A preferred stock at $2.50 per share (or $2.40 per share if an investor purchased more than 40,000 shares).

In addition, in November 2011, holders of the convertible notes payable issued in 2010 and 2011 converted the principal balance of $845,000 and accrued interest of $57,747 into 361,108 shares of its Series A preferred stock at $2.50 per share.

Conversion.   The holders of Series A Preferred Stock (“Series A Preferred”) have the right to convert such shares, at the option of the holder, at any time into common stock, at the rate of one preferred share for one common share, subject to adjustment. The Series A Preferred will automatically convert into common stock, at the then-applicable conversion rate (i) upon the closing of an underwritten public offering of the Company’s common stock in which the aggregate gross proceeds to the Company equals or exceeds $20,000,000, or (ii) with respect to a particular series of preferred stock, upon the election of the holders of a majority of the then outstanding shares of that series of stock.

Anti-dilution Protection.   If the Company issues additional shares of stock without consideration or for a consideration per share less than the price paid for Series A Preferred, as adjusted for capital reorganization, splits, reclassification, etc. (subject to certain exclusions), then the conversion price for the Series A Preferred will be adjusted using a weighted average anti-dilution formula.

Voting. The holders of Series A Preferred have the right to that number of votes equal to the number of shares of common stock issuable upon conversion of the Series A Preferred. The holders

F-18

of Series A Preferred vote together with the holders of common, Series B Preferred and Series B-2 Preferred shares on all matters except as described herein. Consent of the holders of at least a majority of the outstanding Series A Preferred voting together as a single class will be required before the Company can make any material amendment to the bylaws or articles of incorporation that would have an adverse effect on holders of Series A Preferred.

Liquidation Preference.   In the event of any liquidation or winding up of the Company, the holders of Series A Preferred are entitled to receive, in preference to the holders of common stock and pari passu with the holders of Series B Preferred and Series B-2 Preferred, an amount equal to the price paid per Series A Preferred share, plus all unpaid distributions on such Series A Preferred shares, or the holders may elect to convert such Series A Preferred Shares into common stock. A merger or sale of all or substantially all of the Company’s assets will be treated as a liquidation or winding up for purposes of the liquidation preference.

Series B Convertible Preferred Stock

In 2015, the Company received gross proceeds of $3,441,260 in a private placement to various investors for issuance of 458,842 shares of its Series B preferred stock at $7.50 per share.

In 2014, the Company received gross proceeds of $15,495,795 in a private placement to various investors for issuance of 2,066,106 shares of its Series B preferred stock at $7.50 per share.

In connection with a license contract signed December 1, 2014, 26,667 shares of Series B preferred stock were issued effective January 1, 2015, at the fair market value of $7.50 per share, for a total value of $200,000 which was expensed as research and development expenses in the statement of operations.

In 2013, the Company received gross proceeds of $5,000,000 in a private placement to various investors for issuance of 666,667 shares of its Series B preferred stock at $7.50 per share.

Conversion. The holders of Series B Preferred Stock (“Series B Preferred”) have the right to convert such shares, at the option of the holder, at any time into common stock, at the rate of one preferred share for one common share, subject to adjustment. The Series B Preferred will automatically convert into common stock, at the then-applicable conversion rate (i) upon the closing of an underwritten public offering of the Company’s common stock in which the aggregate gross proceeds to the Company equals or exceeds $20,000,000, or (ii) with respect to a particular series of preferred stock, upon the election of the holders of a majority of the then outstanding shares of that series of stock.

Anti-dilution Protection. If the Company issues additional shares of stock without consideration or for a consideration per share less than the price paid for Series B Preferred, as adjusted for capital reorganization, splits, reclassification, etc. (subject to certain exclusions), then the conversion price for the Series B Preferred will be adjusted using a weighted average anti-dilution formula.

Voting. The holders of Series B Preferred have the right to that number of votes equal to the number of shares of common stock issuable upon conversion of the Series B Preferred. The holders of Series B Preferred vote together with the holders of common, Series A Preferred and Series B-2 Preferred shares on all matters except as described herein. Consent of the holders of at least a majority of the outstanding Series B Preferred voting together as a single class will be required before the Company can make any material amendment to the bylaws or articles of incorporation that would have an adverse effect on holders of Series B Preferred.

Liquidation Preference. In the event of any liquidation or winding up of the Company, the holders of Series B Preferred are entitled to receive, in preference to the holders of common stock and pari passu with the holders of Series A Preferred and Series B-2 Preferred, an amount equal to the price paid per Series B Preferred share, plus all unpaid distributions on such Series B Preferred shares, or the holders may elect to convert such Series B Preferred Shares into common stock. A merger or sale of all or substantially all of the Company’s assets will be treated as a liquidation or winding up for purposes of the liquidation preference.

F-19

Series B-2 Convertible Preferred Stock

In 2018, the Company received gross proceeds of $11,810,269 in a private placement to various investors for issuance of 1,574,706 shares of its Series B-2 preferred stock at $7.50 per share.

In 2017, the Company received gross proceeds of $3,908,753 in a private placement to various investors for issuance of 521,168 shares of its Series B-2 preferred stock at $7.50 per share.

Conversion. The holders of Series B-2 Preferred Stock (“Series B-2 Preferred”) have the right to convert such shares, at the option of the holder, at any time into common stock, at the rate of one preferred share for one common share, subject to adjustment. The Series B-2 Preferred will automatically convert into common stock, at the then-applicable conversion rate (i) upon the closing of an underwritten public offering of the Company’s common stock in which the aggregate gross proceeds to the Company equals or exceeds $20,000,000, or (ii) with respect to a particular series of preferred stock, upon the election of the holders of a majority of the then outstanding shares of that series of stock.

Anti-dilution Protection. If the Company issues additional shares of stock without consideration or for a consideration per share less than the price paid for Series B-2 Preferred, as adjusted for capital reorganization, splits, reclassification, etc. (subject to certain exclusions), then the conversion price for the Series B-2 Preferred will be adjusted using a weighted average anti-dilution formula.

Voting. The holders of Series B-2 Preferred have the right to that number of votes equal to the number of shares of common stock issuable upon conversion of the Series B-2 Preferred. The holders of Series B-2 Preferred vote together with the holders of common, Series A Preferred and Series B Preferred shares on all matters except as described herein. Consent of the holders of at least a majority of the outstanding Series B-2 Preferred voting together as a single class will be required before the Company can make any material amendment to the bylaws or articles of incorporation that would have an adverse effect on holders of Series B-2 Preferred.

Liquidation Preference. In the event of any liquidation or winding up of the Company, the holders of Series B-2 Preferred are entitled to receive, in preference to the holders of common stock and pari passu with the holders of Series A Preferred and Series B-2 Preferred, an amount equal to the price paid per Series B-2 Preferred share, plus all unpaid distributions on such Series B-2 Preferred shares, or the holders may elect to convert such Series B-2 Preferred Shares into common stock. A merger or sale of all or substantially all of the Company’s assets will be treated as a liquidation or winding up for purposes of the liquidation preference.

Stock Options

On February 26, 2010, the Company adopted a stock option plan (the “2010 Plan”) which authorized options to acquire 375,000 shares of the Company’s stock. On June 20, 2011, the number of shares authorized to be issued as options under the plan was increased to 600,000. On September 30, 2013, the number of shares authorized to be issued as options under the plan was increased to 1,300,000. On March 1, 2014, the number of shares authorized to be issued as options under the plan was increased to 1,700,000. On July 31, 2015 the number of shares authorized to be issued as options under the plan was increased to 2,500,000 shares. On August 12, 2016 the number of shares authorized to be issued as options under the plan was increased to 3,250,000 shares. On December 13, 2017 the number of shares authorized to be issued as options under the plan was increased to 3,850,000 shares. At December 31, 2020, there were 3,287,230 options outstanding under the 2010 Plan and 0 options available for grant. At March 31 , 2021, there were 3,117,005 options outstanding under the 2010 Plan and 0 options available for grant.

On July 25, 2019, the Company adopted a stock option plan (the “2019 Plan”) which authorized options to acquire 1,000,000 shares of the Company’s stock. At December 31, 2020, there were 481,500 options outstanding under the 2019 Plan and 518,500 options available for grant. At March 31, 2021, there were 435,500 options outstanding under the 2019 Plan and 559,500 options available for grant.

F-20

The following is a summary of options granted for the year ended December 31:

​	2020					2019
​	Shares		Weighted Average Exercise Price			Shares		Weighted Average Exercise Price
Options outstanding at beginning of the year	​	3,804,750	​	$	3.07	​	3,565,183	​	$	2.99
Granted	​	338,000	​	$	4.03	​	367,000	​	$	3.75
Exercised	​	(65,000)	​	$	0.12	​	(50,000)	​	$	1.25
Canceled or expired	​	(309,020)	​	$	3.70	​	(77,433)	​	$	3.75
Options outstanding at end of the year	​	3,768,730	​	$	3.15	​	3,804,750	​	$	3.07
Options Exercisable	​	3,426,440	​	$	3.09	​	3,237,469	​	$	2.95

The following is a summary of options granted for the three months ended March 31 (unaudited):

​	2021
​	Share		Weighted Average Exercise Price
Options outstanding at beginning of the period	​	3,768,730	​	$	3.15
Granted	​	–	​	$	–
Exercised	​	(105,000)	​	$	0.27
Canceled or expired	​	(111,225)	​	$	2.64
Options outstanding at end of the period	​	3,552,505	​	$	3.25
Options Exercisable	​	3,267,215	​	$	3.21

The weighted average fair value of options granted in 2020 and 2019 was $0.88 and $1.32 per share, respectively.

As of December 31, 2020, there were 3,768,730 common stock options outstanding with a weighted average remaining contractual life of 5.08 years and as of March 31, 2021, there were 3,552,505 common stock options outstanding with a weighted average remaining contractual life of 4.97 years.

As of December 31, 2020, there were 3,426,440 common stock options exercisable with a weighted average remaining contractual life of 4.74 years and as of March 31, 2021 there were 3,267,215 common stock options exercisable with a weighted average remaining contractual life of 4.67 years.

The intrinsic value of both the outstanding options and exercisable options as of December 31, 2020 and 2019, was $1,906,200 and $2,120,380, respectively and was $1,491,000 as of March 31, 2021.

The Company recognized $655,443 and $929,821 of stock-based compensation related to option grants during the years ended December 31, 2020 and 2019, respectively. The Company recognized $133,451 and $157,398 of stock-based compensation related to option grants during the three months ended March 31, 2021 and 2020, respectively. As of December 31, 2020, there was $562,456 of unrecognized compensation costs related to stock option grants which will be recognized over the next four years. $280,269, $182,465, $61,890, and $37,832 will be recognized during the years ending December 31, 2021, 2022, 2023 and 2024, respectively. The Company issues new common shares for options exercised. As of March 31, 2021, there was $406,073 of unrecognized compensations costs related to stock option grants which will be recognized over the next four years.

F-21

Black Scholes Assumptions

The Company uses the Black Scholes option pricing model to estimate the fair value of stock option grants with the following weighted average assumptions:

​	2020	2019
Expected life in years	5.7 years	6.1 years
Risk-free interest rate	0.63%	2.04%
Expected dividend yield	0	0
Expected volatility	35.0%	44.6%

​	Three Months Ended March 31, 2021		Three Months Ended March 31. 2020
​	(unaudited)		(unaudited)
Expected life in years	​	–	4.8 years
Risk-free interest rate	​	–	​	1.47%
Expected dividend yield	​	–	​	0
Expected volatility	​	–	​	35.0%

Stock Warrants

Information with respect to warrants is summarized as follows:

​	Series A Preferred warrants			Common warrants
Warrants outstanding December 31, 2018	​	​	40,000	​	​	588,604
Granted	​	​	—	​	​	20,587
Exercised	​	​	—	​	​	—
Terminated	​	​	—	​	​	—
Warrants outstanding December 31, 2019	​	​	40,000	​	​	609,191
Granted	​	​	—	​	​	—
Exercised	​	​	—	​	​	(45,000)
Terminated	​	​	(40,000)	​	​	—
Warrants outstanding December 31, 2020	​	​	—	​	​	564,191
Warrants outstanding March 31, 2021 (unaudited)	​	​	–	​	​	564,191
Weighted average exercise price:	​	​	​	​	​	​
March 31, 2021 (unaudited)	​	$	–	​	$	2.30
December 31, 2020	​	​	—	​	​	2.30
December 31, 2019	​	​	2.88	​	​	2.22
Weighted average remaining contractual life in years:	​	​	​	​	​	​
March 31, 2021 (unaudited)	​	​	–	​	​	2.28
December 31, 2020	​	​	—	​	​	2.53
December 31, 2019	​	​	0.83	​	​	3.40

F-22

NOTE 11 — EMPLOYEE BENEFIT PLANS

The Company’s employees are eligible to participate in a defined contribution benefit plan. Employees may contribute a percentage of their wages, subject to limits established by the Internal Revenue Code. The Company may elect to make discretionary contributions to the plan. There were no discretionary contributions during the years ended December 31, 2020 and 2019 and the three months ended March 31, 2021 and 2020.

NOTE 12 — SIGNIFICANT CUSTOMERS

Discontinued Operations

The Company has concentrations of its sales and accounts receivable to certain customers. Listed below are the concentrations of these customers as of and for the years ended December 31, 2020 and 2019.

​	Year Ended December 31, 2020				Year Ended December 31, 2019
​	% of Total Revenue		% of Total Accounts Receivable		% of Total Revenue		% of Total Accounts Receivable
Customer A	​	*	​	*	​	17.2%	​	30.8%
Customer B	​	*	​	*	​	13.3%	​	27.7%
Customer C	​	*	​	*	​	*	​	16.1%

* — Indicates less than 10%

Continuing Operations

The Company had one customer that accounted for 100% of total revenue for the years ended December 31, 2020 and 2019 and for the three months ended March 31, 2021. The current receivable for this customer is included in Receivable From Reprise Biomedical, Inc. The long-term receivable related to minimum royalties from this customer has been completely reserved against due to uncertainty regarding collectability.

NOTE 13 — COMMITMENTS AND CONTINGENCIES

Patent License Agreement

Under an Exclusive Patent License Agreement between the Company and the University of Minnesota (the “Agreement”) the Company is required to make minimum royalty payments to the University of Minnesota of $500,000 per year. Under the Patent and Know-How License Agreement with Reprise Biomedical, Inc. (“Reprise”), Reprise has minimum royalty obligations to the Company of $500,000 per year. (See Note 12 and Note 14.)

Leases

In February 2015, the Company executed a lease for a facility in Eden Prairie, Minnesota. The Company has leased this facility through March 31, 2020 at a rate of $13,100 per month with yearly rent increases of approximately 3% per year. In November 2019, the lease for the facility was extended to December 31, 2020 at a rate of $15,100 per month starting April 1, 2020. In August 2020, the lease for this facility was extended to December 31, 2021 at a rate of $16,600 per month starting in January 2021.

In May 2020, the Company executed a lease for a second facility in the same Eden Prairie, Minnesota office park as it’s other facility. The Company leased this space through December 31, 2020 at a rate of $2,500 per month starting in May 2020. In August 2020, the lease for this facility was extended to December 31, 2021 at a rate of $3,400 per month starting in January 2021.

F-23

Total rent expense under operating leases was $201,290 and $196,728 for the years December 31, 2020 and 2019, respectively and $65,013 and $41,299 for the three months ended March 31, 2021 and 2020, respectively. The Company has future minimum non-cancelable lease commitments as follows:

Year ending December 31,	​	​
2021	$	240,386
Total	$	240,386

Employment Agreement

The Company has entered into an employment agreement with its Chief Executive Officer that requires severance payments up to 12 months for termination without cause as defined in the agreement.

License Contract

On December 1, 2014, the Company entered into a research and development contract with an outside developer. The term of the contract was set to expire on December 31, 2016, but in September 2016 the expiration date was extended to December 31, 2017 and in January 2018 the expiration date was extended to June 30, 2019, in May 2019 it was extended to March 30, 2020 and in February 2020 it was extended to February 28, 2021. In February 2021 the contract was extended to December 31, 2021. As partial consideration for the developer’s services, on January 1, 2015, the Company issued 26,667 shares of Series B preferred stock at a fair value of $7.50 per share. The value of these shares was charged to research & development expenses in the statements of operations.

NOTE 14 — RELATED PARTY TRANSACTIONS

A corporation owned by a director of the Company received payments for providing a consultant to the Company of $6,912 and $9,615 for the years ended December 31, 2020 and 2019, respectively and $1,618 and $1,427 for the three months ended March 31, 2021 and 2020, respectively.

The Company received $0 and $12,970 of payments for the years ended December 31, 2020 and 2019, respectively, from Reprise Biomedical, Inc. (“Reprise”) (See Note 3) for providing manufacturing support during the transition period of the spin-out and $46,530 and $250,000 for the years ended December 31, 2020 and 2019, respectively, and $6,108 and $11,088 for the three months ended March 31, 2021 and 2020, respectively, as royalty related to the spin-out of the Acellular business (See Note 16). The Company recorded a long-term receivable of $453,470 related to the minimum royalty due from Reprise for the year ended December 31, 2020 (See Note 14), but due to the uncertainty regarding collectability the Company fully reserved against the receivable. The Company purchased $9,815 and $1,300 of equipment and supplies for the years ended December 31, 2020 and 2019, respectively, from Reprise.

In 2020 and 2019, 0 and 18,500 stock options, respectively, were granted to end user customers in exchange for consulting services as key opinion leaders.

NOTE 15 — NET LOSS PER SHARE

Under the two-class method, for periods with net income, basic net income per common share is computed by dividing the net income attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Net income attributable to common stockholders is computed by subtracting from net income the portion of current year earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the year’s earnings been distributed. No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities have no obligation to fund losses. Diluted net loss per common share is computed under the two-class method by using the weighted average number of shares of common stock outstanding plus, for periods with net income attributable to common stockholders, the potential dilutive effects of stock options and warrants. In addition, the Company analyzes the potential dilutive effect of the outstanding participating securities under the if-converted

F-24

method when calculating diluted earnings per share in which it is assumed that the outstanding participating securities convert into common stock at the beginning of the period. The Company reports the more dilutive of the approaches (two-class or if-converted) as its diluted net income per share during the period. Due to the existence of net losses for the years ended December 31, 2019 and 2020 and for the three months ended March 31, 2021 and 2020, basic and diluted loss per share were the same, as the effect of potentially dilutive securities would have been anti-dilutive.

The following potentially dilutive securities outstanding have been excluded from the computations of diluted weighted average shares outstanding because such securities have an antidilutive impact due to losses reported:

​	Year Ended December 31,				Three Months Ended March 31,
​	2020		2019		2021		2020
​	​	​	​	​	(unaudited)		(unaudited)
Convertible preferred stock outstanding	​	8,314,536	​	8,314,536	​	8,314,536	​	8,314,536
Convertible preferred stock warrants	​	—	​	40,000	​	–	​	40,000
Common stock options outstanding	​	3,768,730	​	3,804,750	​	3,552,505	​	3,777,250
Common stock warrants	​	564,191	​	609,191	​	564,191	​	564,191
​	​	12,647,457	​	12,768,477	​	12,431,232	​	12,695,977

NOTE 16 — SUBSEQUENT EVENTS

The Company has evaluated subsequent events through March 26, 2021, the date on which the financial statements were available to be issued.

Exclusive Patent License Agreement Amendment

On February 21, 2021, the Company and the University of Minnesota (“University”) amended the exclusive patent and license agreement dated February 4, 2010. Under the original agreement the Company was obligated to pay the University a minimum of $500,000 per year in royalties. The Company was to pay the difference between the total amounts actually paid to the University for each year and the minimum sum of $500,000 (the “Difference”) within 30 days following the end of such year. The amendment allows the Company to defer the payment of such Difference for each of calendar years 2020 and 2021 and such Difference added to the minimum sum required for calendar years 2022 and 2023, respectively. The Company has identified this as a type 1 subsequent event and as such has classified the Difference for the year ended 2020 as a long-term accrued royalty.

Patent and Know-How License Agreement

On February 22, 2021 the Company and Reprise Biomedical, Inc. (“Reprise”) amended the Patent and Know-How License Agreement dated June 30, 2019. Under the original agreement Reprise was obligated to pay the Company a minimum of $500,000 per year in royalties. Reprise was to pay the difference between the total amounts actually paid to the Company for each year and the minimum sum of $500,000 (the “Difference”) within 30 days following the end of such year (See Note 13). The amendment allows Reprise to defer the payment of such Difference for each of calendar years 2020 and 2021 and such Difference added to the minimum sum required for calendar years 2022 and 2023, respectively. The Company has identified this as a type 1 subsequent event and as such has classified the Difference for the year ended 2020 as a long-term receivable. Due to the uncertainty regarding the collectability of the receivable, the Company has fully reserved against the receivable and not recorded the associated revenue.

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NOTE 17 — SUBSEQUENT EVENTS  —  UNAUDITED

For the interim financial statements, the Company evaluated subsequent events through May 27, 2021, the date on which these financial statements were available to be issued.

Private Placement of Series C Convertible Preferred Stock

In May of 2021, the Company entered into share purchase agreements with certain investors (together, the “Investors”), under which the Company sold an aggregate of 2,666,667 shares of Series C Convertible Preferred Stock to the Investors, at a price per share of $7.50, for an aggregate purchase price, before fees and expenses, of approximately $20 million (the “Private Placement”). As part of the Private Placement, the Company sold 2,000,000 shares of Series C Preferred Stock to Baxter International Inc., for an aggregate purchase price of $15.0 million and 666,667 shares of Series C Preferred Stock to CareDx, Inc. for an aggregate purchase price of $5 million. In connection with the Private Placement, the Company also entered into an investor rights agreement with each of the Investors, which provide customary piggyback and demand registration rights.

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           Shares

Miromatrix Medical Inc.

Common Stock

PRELIMINARY PROSPECTUS

Craig-Hallum

                 , 2021

Through and including                 , 2021 (25 days after the date of this prospectus), all dealers that buy, sell or trade our common stock, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

PART II
INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13.   Other Expenses of Issuance and Distribution.

The following table sets forth all costs and expenses, other than underwriting discounts and commissions, paid or payable by us in connection with the sale of the common stock being registered. All amounts shown are estimates except for the Securities and Exchange Commission, or SEC, registration fee, the Financial Industry Regulatory Authority, or FINRA, filing fee and the Nasdaq Capital Market listing fee.

Item	Amount
SEC registration fee	​	$	*
FINRA filing fee	​	​	*
Nasdaq Capital Market listing fee	​	​	*
Printing expenses	​	​	*
Legal fees and expenses	​	​	*
Accounting fees and expenses	​	​	*
Transfer agent fees and expenses	​	​	*
Miscellaneous expenses	​	​	*
Total	​	$	*

*

To be provided by amendment.

Item 14.   Indemnification of Directors and Officers.

The registrant is governed by the DGCL. Section 145 of the DGCL provides that a corporation may indemnify any person, including an officer or director, who was or is, or is threatened to be made, a party to any threatened, pending or completed legal action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person was or is an officer, director, employee or agent of such corporation or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided such officer, director, employee or agent acted in good faith and in a manner such person reasonably believed to be in, or not opposed to, the corporation’s best interest and, for criminal proceedings, had no reasonable cause to believe that such person’s conduct was unlawful. A Delaware corporation may indemnify any person, including an officer or director, who was or is, or is threatened to be made, a party to any threatened, pending or contemplated action or suit by or in the right of such corporation, under the same conditions, except that such indemnification is limited to expenses (including attorneys’ fees) actually and reasonably incurred by such person, and except that no indemnification is permitted without judicial approval if such person is adjudged to be liable to such corporation. Where an officer or director of a corporation is successful, on the merits or otherwise, in the defense of any action, suit or proceeding referred to above, or any claim, issue or matter therein, the corporation must indemnify that person against the expenses (including attorneys’ fees) which such officer or director actually and reasonably incurred in connection therewith.

The registrant’s amended and restated bylaws will authorize the indemnification of its officers and directors, consistent with Section 145 of the DGCL.

Reference is made to Section 102(b)(7) of the DGCL, which enables a corporation in its original certificate of incorporation or an amendment thereto to eliminate or limit the personal liability of a director for violations of the director’s fiduciary duty, except (i) for any breach of the director’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) pursuant to Section 174 of the DGCL, which

II-1

provides for liability of directors for unlawful payments of dividends of unlawful stock purchase or redemptions or (iv) for any transaction from which a director derived an improper personal benefit.

We have entered or intend to enter into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.

We maintain a general liability insurance policy that covers certain liabilities of directors and officers of our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.

In the underwriting agreement we will enter into in connection with the sale of common stock being registered hereby, the underwriter will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, or the Securities Act, against certain liabilities.

Item 15.   Recent Sales of Unregistered Securities.

Set forth below is information regarding all unregistered securities sold by us since January 1, 2018.

Common Stock

In 2020, we issued 64,000 and 1,000 shares of common stock in connection with the exercise of stock option agreements at exercise prices of $0.10 and $1.25 per share, respectively. We also issued 45,000 shares of common stock in connection with the exercise of stock warrant agreements at an exercise price of $1.25 per share.

In 2019, we issued 50,000 shares of common stock in connection with the exercise of stock option agreements at exercise price of $1.25 per share.

Series B-2 Convertible Preferred Stock

In 2018, we received gross proceeds of $11,810,269 in a private placement to various investors for issuance of 1,574,706 shares of our Series B-2 preferred stock at $7.50 per share.

Series C Convertible Preferred Stock

In 2021, we received gross proceeds of $20.0 million in a private placement to various investors of 2,666,667 shares of our Series C preferred stock at $7.50 per shares.

Item 16.   Exhibits and Financial Statement Schedules.

a.

Exhibits.   See Exhibit Index attached to this registration statement, which is incorporated by reference herein.

b.

Financial statement schedule.   Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 17.   Undertakings.

The undersigned Registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

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Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

1.

For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant. pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

2.

For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-3

Exhibit Index

Exhibit Number	Exhibit Description
1.1*	Form of Underwriting Agreement
3.1	Amended & Restated Certificate of Incorporation, as currently in effect
3.2	Form of Second Amended and Restated Certificate of Incorporation, to be in effect immediately prior to the completion of this offering
3.3	Bylaws, currently in effect
3.4	Form of Amended and Restated Bylaws, to be in effect immediately prior to the completion of this offering.
4.1*	Specimen Common Stock Certificate of Registrant
4.2	Series A Preferred Stock Investor Rights Agreement, dated November 22, 2011, between the Registrant and certain investors
4.3	Series B Preferred Stock Investor Rights Agreement, dated October 8, 2013, between the Registrant and certain investors
4.4	Series B-2 Preferred Stock Investor Rights Agreement, dated October 16, 2017, between the Registrant and certain investors
4.5	Cheshire Note, dated March 6, 2020, between the Registrant and Cheshire MD Holdings, LLC
4.6	Cheshire Initial Warrant, dated March 6, 2020, between the Registrant and Cheshire MD Holdings, LLC
4.7	Cheshire Form of Subsequent Warrant, between the Registrant and Cheshire MD Holdings, LLC
4.8	Form of Common Stock Warrant issued by the Registrant to certain investors under the 2010 Plan
4.9	Form of Stock Option issued by the Registrant to certain of its directors, officers and employees under the 2010 Plan
4.10	Form of Stock Option issued by the Registrant to certain of its directors, officers and employees under the 2019 Plan
5.1*	Opinion of Faegre Drinker Biddle & Reath LLP
10.1	Exclusive Patent License Agreement, dated February 4, 2010, between the Registrant and the University of Minnesota (the “Minnesota License Agreement)
10.2	First Amendment to the Minnesota License Agreement, dated November 17, 2010, between the Registrant and the University of Minnesota
10.3	Second Amendment to the Minnesota License Agreement, dated March 12, 2013, between the Registrant and the Regents of the University of Minnesota
10.4	Third Amendment to the Minnesota License Agreement, dated December 11, 2014, between the Registrant and the Regents of the University of Minnesota
10.5	Fourth Amendment to the Minnesota License Agreement, dated September 15, 2016, between the Registrant and the Regents of the University of Minnesota
10.6	Fifth Amendment to the Minnesota License Agreement, dated February 21, 2021, between the Registrant and the Regents of the University of Minnesota
10.7	License Agreement, dated January 1, 2011, between the Registrant and Mayo Foundation for Medical Education and Research
10.8	License Agreement, dated September 15, 2013, between the Registrant and Mayo Foundation for Medical Education and Research
10.9	License Agreement, dated December 1, 2014, between the Registrant and Mayo Foundation for Medical Education and Research (the “Mayo License Agreement”)
10.10	First Amendment to the Mayo License Agreement, dated September 20, 2016, between the Registrant and Mayo Foundation for Medical Education and Research
10.11	Second Amendment to the Mayo License Agreement, dated September 12, 2017, between the Registrant and Mayo Foundation for Medical Education and Research

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Exhibit Number	Exhibit Description
10.12	Third Amendment to the Mayo License Agreement, dated February 21, 2017, between the Registrant and Mayo Foundation for Medical Education Research
10.13	Fourth Amendment to the Mayo License Agreement, dated January 24, 2018, between the Registrant and Mayo Foundation for Medical Education and Research
10.14	Fifth Amendment to the Mayo License Agreement, dated May 12, 2019, between the Registrant and Mayo Foundation for Medical Education and Research
10.15	Sixth Amendment to the Mayo License Agreement, dated February 28, 2020, between the Registrant and Mayo Foundation for Medical Education and Research
10.16	Seventh Amendment to the Mayo License Agreement, dated February 26, 2021, between the Registrant and Mayo Foundation for Medical Education and Research
10.17	Sub-License Agreement, dated October 1, 2013, between the Registrant and Texas Heart Institute
10.18	First Amendment to the Sub-License Agreement, dated April 1, 2014, between the Registrant and Texas Heart Institute
10.19	Second Amendment to the Sub-License Agreement, dated September 25, 2018, between the Registrant and Texas Heart
10.20	The Stock Purchase Agreement, dated October 14, 2020, between the Registrant and Reprise Biomedical Inc.
10.21	Patent and Know-How License Agreement, dated June 30, 2019, between the Registrant and Reprise Biomedical Inc.
10.22	First Amendment to the Patent and Know-How License Agreement, dated October 3, 2019, between the Registrant and Reprise Biomedical, Inc.
10.23	Second Amendment to the Patent and Know-How License Agreement, dated February 22, 2021, between the Registrant and Reprise Biomedical, Inc.
10.24	Series C Purchase Agreement, dated May 3, 2021, among the Registrant, Baxter Healthcare Corporation and CareDx, Inc.
10.25	Series C Side Letter, dated May 21, 2021, among the Registrant, Baxter Healthcare Corporation and CareDx, Inc.
10.26+	Miromatrix Inc. 2010 Stock Incentive Plan (the “2010 Plan”)
10.27+	Miromatrix Inc. 2019 Stock Incentive Plan (the “2019 Plan”)
10.28+*	Form of Indemnification Agreement by and between the Registrant and its individual directors and officers
10.29+	Employment Agreement, dated March 3, 2017, between the Registrant and Jeff Ross
10.30+	Miromatrix Inc. 2021 Stock Incentive Plan (the “2021 Plan”)
10.31+	Miromatrix Inc. 2021 Employee Stock Purchase Plan
23.1	Consent of Baker Tilly US, LLP, an Independent Registered Public Accounting Firm
23.2*	Consent of Faegre Drinker Biddle & Reath LLP (included in Exhibit 5.1)
24.1	Power of Attorney (included on the signature page to this registration statement)

*

To be filed by amendment.

+

Indicates management contract or compensatory plan.

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in Eden Prairie, Minnesota, on the 28th day of May, 2021.

Miromatrix Medical Inc.

By:

/s/ Jeff Ross

Name: Jeff Ross
Title:  Chief Executive Officer and Director

POWER OF ATTORNEY

Each of the undersigned directors and officers of Miromatrix Medical Inc. hereby constitutes and appoints each of Jeff Ross and Brian Niebur as his true and lawful attorneys-in-fact and agents with full power of substitution and resubstitution, for him and his name, place and stead, in any and all capacities, to execute any and all amendments (including post-effective amendments) to this registration statement, to sign any registration statement related to this registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, or the Securities Act, and to cause the same to be filed with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and desirable to be done in and about the premises as fully and to all intents and purposes as the undersigned might or could do in person, hereby ratifying and confirming all acts and things that said attorneys-in-fact and agents or any of them, or their or his substitute or substitutes may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

Signature	Title	Date
/s/ Jeff Ross Jeff Ross	Chief Executive Officer and Director (Principal Executive Officer)	May 28, 2021
/s/ Brian Niebur Brian Niebur	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)	May 28, 2021
/s/ Paul Buckman Paul Buckman	Chairman, Board of Directors	May 28, 2021
/s/ Ronald Eibensteiner Ronald Eibensteiner	Director	May 28, 2021
/s/ John Erb John Erb	Director	May 28, 2021
/s/ Mahesh Krishnan Mahesh Krishnan	Director	May 28, 2021
/s/ Mark Wagner Mark Wagner	Director	May 28, 2021

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EX-3.1

Exhibit 3.1

Execution Verison

AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
MIROMATRIX MEDICAL INC.

Miromatrix Medical Inc., a corporation organized and existing under the laws of the State of Delaware (the “Corporation”), certifies that:

A.      The name of the Corporation is Miromatrix Medical Inc. Miromatrix Medical Inc. was originally formed on July 13, 2009, under the name TayTech, Inc.

B.      This Amended and Restated Certificate of Incorporation was duly adopted in accordance with Sections 228, 242 and 245 of the General Corporation Law of the State of Delaware, and restates, integrates and further amends the provisions of the Corporation’s Certificate of Incorporation.

C.      The text of the Certificate of Incorporation is amended and restated to read as set forth in EXHIBIT A attached hereto.

IN WITNESS WHEREOF, Miromatrix Medical Inc. has caused this Amended and Restated Certificate of Incorporation to be signed by a duly authorized officer of the Corporation, on May 21, 2021.

Jeff Ross, Chief Executive Officer

EXHIBIT A

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF
MIROMATRIX MEDICAL INC.

Article I

NAME

The name of the Corporation is Miromatrix Medical Inc. (the “Corporation”).

Article II

REGISTERED AGENT

The address of the Corporation’s registered office in the State of Delaware is 1209 Orange Street, Wilmington, Delaware 19801, located in New Castle County. The name of its registered agent at such address is The Corporation Trust Company.

Article III

PURPOSE

The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.

Article IV

CAPITAL STOCK

1.       Authorized Capital Stock. The aggregate number of shares of stock which the Company is authorized to issue is 65,900,000 shares, of which (i) 50,000,000 shares are designated as common stock, $.00001 par value (the “Common Stock”), and (ii) 15,900,000 shares are designated as preferred stock, $.00001 par value, of which (a) three million three-hundred thousand (3,300,000) shares are designated as Series A Convertible Preferred Stock, $.00001 par value (the “Series A Preferred”), (b) four million (4,000,000) shares are designated as Series B Convertible Preferred Stock, $.00001 par value (“Series B Preferred”), (c) two million five hundred thousand (2,500,000) shares are designated as Series B-2 Convertible Preferred Stock, $.00001 par value (“Series B-2 Preferred”) and (d) six million one hundred thousand (6,100,000) shares are designated as Series C Convertible Preferred Stock, $.00001 par value (“Series C Preferred” and together with the Series A Preferred, Series B Preferred, and Series B-2 Preferred, the “Preferred Stock”).

The Preferred Stock may be divided into, and may be issued from time to time, in one or more series. The Board of Directors of the Company (the “Board”) is authorized from time to time to establish and designate any such series of Preferred Stock, to fix and determine the variations in the relative rights, preferences, privileges and restrictions as between and among such series and any other class of capital stock of the Company and any series thereof, and to fix or alter the number of shares comprising any such series and the designations thereof.

The relative rights, preferences and privileges of the Common Stock and the Preferred Stock are set forth in this Article IV of this Amended and Restated Certificate of Incorporation.

2

2.              Definitions. For purposes of this Amended and Restated Certificate of Incorporation the following definitions shall apply and shall be equally applicable to both the singular and plural forms of the defined terms:

(a)            “Additional Shares of Common Stock” shall mean all shares of Common Stock issued (or deemed to be issued pursuant to Section 6(g)(i) of this Article IV) by the Company after the filing of this Amended and Restated Certificate of Incorporation, other than shares of Common Stock issued or issuable (or deemed issued pursuant to Convertible Securities):

(i)        upon conversion of the Preferred Stock;

(ii)       as a dividend or distribution on the Preferred Stock;

(iii)      upon a stock split, stock dividend or any subdivision of shares of Common Stock;

(iv)      upon conversion of Convertible Securities outstanding at the time of the filing of this Amended and Restated Certificate of Incorporation;

(v)       upon exercise of options and warrants outstanding at the time of the filing of this Amended and Restated Certificate of Incorporation;

(vi)      to employees or directors of, or consultants to, the Company pursuant to any plan approved by the Board;

(vii)     to banks, equipment lessors or other institutional lenders pursuant to a bona fide debt financing, equipment leasing transaction or real property leasing transaction, provided that each of the foregoing has been approved by the Board;

(viii)    in any Qualified Public Offering; and

(ix)      following an affirmative vote or prior written consent of (1) a majority of the then outstanding Series A Preferred, (2) a majority of the then outstanding Series B Preferred, (3) a majority of the then outstanding Series B-2 Preferred and (4) a majority of the then outstanding Series C Preferred.

(b)            “Board” shall mean the Board of Directors of the Company.

(c)            “Conversion Price” shall have the applicable meaning set forth in Section 6 below.

(d)            “Conversion Rights” shall mean the optional and automatic conversion rights of the holders of Preferred Stock set forth in Section 6 below.

(e)            “Convertible Securities” shall mean evidences of indebtedness, shares of stock or other securities (including rights, options or warrants to subscribe for, purchase, or otherwise acquire Common Stock or Convertible Securities) which are at any time, directly or indirectly, convertible into or exchangeable for Common Stock.

3

(f)             “Effective Price” shall mean the price per share for Additional Shares of Common Stock determined by dividing the total number of Additional Shares of Common Stock issued or sold, or deemed to have been issued or sold by the Company under Sections 6(f) and 6(g) of this Article IV, into the aggregate consideration received, or deemed to have been received by the Company for such issue or sale under such Sections 6(f) and 6(g), for such Additional Shares of Common Stock.

(g)            A “Liquidation” of the Company shall include: (a) a liquidation, dissolution or winding up of the Company, whether voluntary or involuntary; (b) a merger, consolidation, share exchange or similar transaction, other than one in which the stockholders of the Company own a majority of the voting power of the outstanding shares of the surviving or acquiring company; or (c) a sale, license, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Company.

(h)            “Person” shall include all natural persons, corporations, business trusts, associations, limited liability companies, partnerships, joint ventures and other entities, governments, agencies and political subdivisions.

(i)             “Purchase Price” shall mean (1) for purposes of a holder of Series A Preferred shall mean $2.50 per share, (2) for purposes of a holder of Series B Preferred shall mean the purchase price per share paid by such holder to the Company (3) for purposes of a holder of Series B-2 Preferred shall mean the purchase price per share paid by such holder to the Company and (4) for purposes of a holder of Series C Preferred shall mean $7.50 per share.

(j)             “Qualified Public Offering” shall mean the closing of a bona fide underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, covering the offering and sale of Common Stock for the account of the Company in which the aggregate gross proceeds received by the Company at the public offering price equals or exceeds $20,000,000 (before deduction of underwriters commissions and expenses).

(k)            “Series A Liquidation Preference” shall mean an amount equal to the Purchase Price of the Series A Preferred, subject to appropriate adjustments for stock splits, stock dividends, reorganizations, consolidations and similar changes affected after the date hereof, in the same manner as set forth in Section 6(f).

(l)             “Series B Liquidation Preference” shall mean an amount equal to the applicable Purchase Price of the Series B Preferred, subject to appropriate adjustments for stock splits, stock dividends, reorganizations, consolidations and similar changes affected after the date hereof, in the same manner as set forth in Section 6(f).

(m)           “Series B-2 Liquidation Preference” shall mean an amount equal to the applicable Purchase Price of the Series B-2 Preferred, subject to appropriate adjustments for stock splits, stock dividends, reorganizations, consolidations and similar changes affected after the date hereof, in the same manner as set forth in Section 6(f).

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(n)            “Series C Liquidation Preference” shall mean an amount equal to the Purchase Price of the Series C Preferred, subject to appropriate adjustments for stock splits, stock dividends, reorganizations, consolidations and similar changes affected after the date hereof, in the same manner as set forth in Section 6(f).

3.              Voting Rights.

(a)            General. Except as otherwise provided in Sections 3(a) of this Article IV, at all meetings of the stockholders of the Company and in the case of any actions of stockholders in lieu of a meeting, each share of Common Stock shall entitle the holder thereof to one vote on such matters, and each holder of Preferred Stock shall have that number of votes on all matters submitted to the stockholders that is equal to the number of shares of Common Stock (including fractions of a share) into which such holder’s shares of Preferred Stock are then convertible, as provided in Section 6 of this Article IV, at the record date for the determination of the stockholders entitled to vote on such matters or, if no such record date is established, at the date such vote is taken or any written consent of such stockholders is effected. Except as may be otherwise provided in this Amended and Restated Certificate of Incorporation or by agreement or by law, the holders of the Common Stock and the holders of the Preferred Stock shall vote together as a single class on all actions to be taken by the stockholders of the Company.

(b)            Additional Class Votes by Series A Preferred. For so long as any of the shares of Series A Preferred remain outstanding, the Company shall not, without the affirmative vote of the holders of at least a majority of all shares of Series A Preferred then outstanding (voting together as a separate class) take any action that constitutes material amendment to the Articles of Incorporation or the Company’s Bylaws which would have an adverse effect on the holders of the Series A Preferred.

(c)            Additional Class Votes by Series C Preferred. For so long as any of the shares of Series C Preferred remain outstanding, the Company shall not, without the affirmative vote of the holders of at least a majority of all shares of Series C Preferred then outstanding (voting together as a separate class) take any action that constitutes material amendment to the Articles of Incorporation or the Company’s Bylaws which would have an adverse effect on the holders of the Series C Preferred.

4.              Dividends. Dividends shall be payable on the shares of Preferred Stock out of funds legally available for the declaration of dividends only if and when declared by the Board. However, in the event that the Company declares or pays any dividends upon the Common Stock (whether payable in cash, securities or other property), other than dividends payable solely in shares of Common Stock, the Company shall also declare and pay to the holders of the Preferred Stock, at the same time that it declares and pays such dividends to the holders of the Common Stock, the dividends which would have been declared and paid with respect to the Common Stock issuable upon conversion of the Preferred Stock had all of the outstanding shares of Preferred Stock been converted immediately prior to the record date for such dividend, or if no record date is fixed, the date as of which the record holders of Common Stock entitled to such dividends are to be determined.

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5.              Liquidation Rights.

(a)            Series C Preferred Stock Preference. In the event of any Liquidation, the holders of the Series C Preferred then outstanding shall be entitled to receive out of the assets of the Company available for distribution to its stockholders, before any payment or declaration and setting apart for payment of any amount that shall be made in respect of the Series A Preferred, Series B Preferred, Series B-2 Preferred or Common Stock, a per share amount equal to the greater of (i) Series C Liquidation Preference plus all accrued or declared but unpaid dividends on the Series C Preferred, if any and (ii) such amount per share as would have been payable had all shares of Series C Preferred been converted into Common Stock pursuant to Section 6(a) of this Article IV immediately prior to such Liquidation. If, upon any Liquidation, the assets of the Company are insufficient to permit the payment of the full Series C Liquidation Preference to all holders of Series C Preferred, then all of the assets of the Company shall be distributed ratably to the holders of the Series C Preferred in proportion to the full amounts to which they would otherwise be respectively entitled.

(b)            Series A, Series B and Series B-2 Preferred Stock Preference. In the event of any Liquidation, the holders of the Series A Preferred, Series B Preferred and Series B-2 Preferred then outstanding shall be entitled to receive out of the assets of the Company available for distribution to its stockholders on a pari passu basis, following the payment of the Series C Liquidation Preference to the holders of the Series C Preferred and before any payment or declaration and setting apart for payment of any amount that shall be made in respect of the Common Stock, (i) a per share amount equal to the Series A Liquidation Preference plus all accrued or declared but unpaid dividends on the Series A Preferred, if any, (ii) a per share amount equal to the Series B Liquidation Preference plus all accrued or declared but unpaid dividends on the Series B Preferred, if any, and (c) a per share amount equal to the Series B-2 Liquidation Preference plus all accrued or declared but unpaid dividends on the Series B-2 Preferred, if any. If, upon any Liquidation, the assets of the Company are insufficient to permit the payment of the full Series A Liquidation Preference to all holders of Series A Preferred, Series B Liquidation Preference to all holders of Series B Preferred and Series B-2 Liquidation Preference to all holders of Series B-2 Preferred, then all of the assets of the Company remaining following payment to the holders of the Series C Preferred pursuant to Section 5(a) of this Article IV shall be distributed ratably to the holders of the Series A Preferred, Series B Preferred and Series B-2 Preferred in proportion to the full amounts to which they would otherwise be respectively entitled.

(c)            Remaining Assets. After payment of the Series A Liquidation Preference to the holders of the Series A Preferred, the Series B Liquidation Preference to the holders of the Series B Preferred, and Series B-2 Liquidation Preference to the holders of the Series B-2 Preferred as required Section 5(b) of this Article IV shall have been made or irrevocably set apart, all remaining assets shall be distributed ratably to the holders of Common Stock.

(d)            Determination of Consideration. To the extent any distribution pursuant to Sections 5(a), 5(b) and 5(c) of this Article IV consists of property other than cash, the value thereof shall, for purposes of such Sections 5(a), 5(b) and 5(c), be determined as follows:

(i)        if such property consists of securities that are traded on a securities exchange, the value shall be deemed to be the average of the closing prices of the securities on such exchange over the 30-day period ending three business days prior to the closing;

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(ii)       if such property consists of securities that are actively traded over-the-counter, the value shall be deemed to be the average of the closing bid or sale prices (whichever is applicable) over the 30-day period ending three business days prior to the closing; and

(iii)      if such property does not consist of securities for which there is an active public market, the value of such property shall be the fair market value thereof as determined in good faith by the Board.

(e)            Notice; Conversion Prior to Liquidating Distributions. Written notice of a Liquidation stating a payment date and the place where said payments shall be made, shall be given by mail, postage prepaid, or by facsimile (provided that non-U.S. residents will be notified by facsimile if a facsimile number is available) not less than twenty (20) days prior to the payment date stated therein, to the holders of record of Preferred Stock, such notice to be addressed to each such holder at his, her or its address as shown by the records of the Company. Any holder of the Preferred Stock may, at his, her or its option, convert all or a portion of his, her or its Preferred Stock into Common Stock conditioned upon a Liquidation and effective on the date thereof and thereby receive distributions with the holders of the Common Stock in lieu of receiving distributions with the holders of the Series Preferred Stock.

6.              Conversion. The holders of the Preferred Stock shall have the following Conversion Rights:

(a)            Optional Conversion of the Preferred Stock. The Preferred Stock shall be convertible, without the payment of any additional consideration by the holder thereof and at the option of the holder thereof, at any time after the first issuance of shares of Preferred Stock by the Company, at the office of the Company or any transfer agent for the Common Stock, into such number of fully paid and nonassessable shares of Common Stock as is determined by dividing the applicable Purchase Price by the applicable Conversion Price, determined as hereinafter provided, in effect at the time of conversion and then multiplying such quotient by the number of shares of such series of Preferred Stock to be converted. Notwithstanding the foregoing, no holder of Series C Preferred exercise its right to convert its shares of Series C Preferred Stock into shares of fully paid and nonassessable Common Stock pursuant to this Section 6(a) until on or after January 1, 2022. The initial “Conversion Price” of each series of Preferred Stock at the time of the filing of this Amended and Restated Certificate of Incorporation shall be equal to the applicable Purchase Price of such series of Preferred Stock. Such Conversion Price shall be subject to adjustment, in order to adjust the number of shares of Common Stock into which a share of the applicable series of Preferred Stock is convertible, as hereinafter provided, including, for the avoidance of doubt, the adjustment to the Conversion Price of the Series C Preferred provided in Section 6(f)(v).

(b)            Automatic Conversion of the Preferred Stock. Upon (i) the completion by the Company of a Qualified Public Offering, or (ii) the date and time, or the occurrence of an event, specified by the vote or written consent of (w) with respect to the Series A Preferred, the holders of at least a majority of all shares of Series A Preferred then outstanding (voting together as a single class), (x) with respect to the Series B Preferred, the holders of at least a majority of all shares of Series B Preferred then outstanding (voting together as a single class), (y) with respect to the Series B-2 Preferred, the holders of at least a majority of all shares of Series B-2 Preferred then outstanding (voting together as a single class) and (z) with respect to the Series C Preferred, the holders of at least a majority of all shares of Series C Preferred then outstanding (voting together as a single class), all outstanding shares of Preferred Stock shall automatically convert into shares of Common Stock as set forth below. Any shares of Preferred Stock so converted may not be reissued by the Company.

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(c)            Fractional Shares. No fractional shares of Common Stock shall be issued upon conversion of the Preferred Stock. In lieu of any fractional share to which any holder would otherwise be entitled upon conversion of some or all of the Preferred Stock owned by such holder, the Company shall pay cash equal to such fraction multiplied by the then effective Conversion Price.

(d)            Mechanics of Optional Conversion. Before any holder of Preferred Stock shall be entitled to convert the same into full shares of Common Stock, such holder shall surrender the certificate or certificates therefor, endorsed or accompanied by written instrument or instruments of transfer, in form satisfactory to the Company, duly executed by the registered holder or by such holder’s attorney duly authorized in writing, at the office of the Company or of any transfer agent for the Common Stock, and shall give written notice to the Company at such office that such holder elects to convert the same and shall state therein such holder’s name or the name of the nominees in which such holder wishes the certificate or certificates for shares of Common Stock to be issued. The Company shall, as soon as practicable thereafter, issue and deliver at such office to such holder of Preferred Stock, or to such holder’s nominee or nominees, a certificate or certificates for the number of shares of Common Stock to which such holder shall be entitled as aforesaid, together with cash in lieu of any fraction of a share. Except as set forth in Section 5(d) of this Article IV, such conversion shall be deemed to have been made immediately prior to the close of business on the date of such surrender of the shares of Preferred Stock to be converted, and the person or persons entitled to receive the shares of Common Stock issuable upon conversion shall be treated for all purposes as the record holder or holders of such shares of Common Stock on such date. From and after such date, all rights of the holder with respect to the Preferred Stock so converted shall terminate, except only the right of such holder, upon the surrender of his, her or its certificate or certificates therefor, to receive certificates for the number of shares of Common Stock issuable upon conversion thereof and cash for fractional shares.

(e)            Mechanics of Automatic Conversion. All holders of record of shares of Preferred Stock will be given at least 20 days’ prior written notice of the anticipated date of any automatic conversion of such series of Preferred Stock referenced in Section 6(b) and three days’ prior written notice of the actual date of such conversion. The Company shall also exercise its best efforts to provide three days’ telephonic notice of such actual conversion date to said holders. Each such notice shall designate a place for automatic conversion of all of the shares of such Preferred Stock pursuant to Section 6(b). Such notices will be sent by mail, first class, postage prepaid to each record holder of Preferred Stock at such holder’s address appearing on the Company’s stock register, or by overnight courier service in the case of the notice prior to the actual date of conversion. On or before the date fixed for conversion, each holder of shares of Preferred Stock shall surrender such holder’s certificate or certificates for all such shares to the Company at the place designated in such notice, and shall thereafter receive certificates for the number of shares of Common Stock or other securities to which such holder is entitled. On the date fixed for conversion, all rights with respect to the Preferred Stock will terminate, except only (i) any rights to receive declared but unpaid dividends with a record date preceding the date of conversion, and (ii) the rights of the holders thereof, upon surrender of their certificate or certificates therefor, to receive certificates for the number of shares of Common Stock or other securities into which such Preferred Stock has been converted and cash for fractional shares. If so required by the Company, certificates surrendered for conversion shall be endorsed or accompanied by a written instrument or instruments of transfer, in form satisfactory to the Company, duly executed by the registered holder or by her, his or its attorney duly authorized in writing. All certificates evidencing shares of Preferred Stock which are required to be surrendered for conversion in accordance with the provisions hereof shall, from and after the date such certificates are so required to be surrendered, be deemed to have been retired and canceled and the shares of Preferred Stock represented thereby converted into Common Stock for all purposes, notwithstanding the failure of the holder or holders thereof to surrender such certificates on or prior to such date. As soon as practicable after the date of such automatic conversion and the surrender of the certificate or certificates for Preferred Stock as aforesaid, the Company shall cause to be issued and delivered to such holder, or to her, his or its written order, a certificate or certificates for the number of full shares of Common Stock or other securities issuable on such conversion in accordance with the provisions hereof and cash as provided in Section 6© in respect of any fraction of a share of Common Stock otherwise issuable upon such conversion.

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(f)             Certain Adjustments to Conversion Price for Stock Splits, Dividends, Mergers, Reorganizations, Etc.

(i)        Adjustment for Stock Splits, Stock Dividends and Combinations of Common Stock. If the Company shall at any time while shares of Preferred Stock are outstanding subdivide or split its outstanding Common Stock into a greater number of shares or declare any dividend payable in Common Stock, the Conversion Price in effect immediately prior to such subdivision, split or dividend shall be proportionately decreased, and conversely, in case the outstanding shares of Common Stock shall be combined into a smaller number of shares, the Conversion Price in effect immediately prior to such combination shall be proportionately increased.

(ii)       Adjustment for Merger or Reorganization, Etc. In the event of a reclassification, reorganization or exchange (other than described in Section 6(f)(i) above) or any consolidation or merger of the Company with another corporation (other than a merger, acquisition or other reorganization constituting a Liquidation), each share of Preferred Stock shall thereafter be convertible into the number of shares of stock or other securities or property to which a holder of the number of shares of Common Stock of the Company deliverable upon conversion of the Preferred Stock would have been entitled upon such reclassification, reorganization, exchange, consolidation, merger or conveyance had the conversion occurred immediately prior to the event; and, in any such case, appropriate adjustment (as determined by the Board) shall be made in the application of the provisions herein set forth with respect to the rights and interests thereafter of the holders of the Preferred Stock, to the end that the provisions set forth herein (including provisions with respect to changes in and other adjustments of the applicable Conversion Price of such series of Preferred Stock) shall thereafter be applicable, as nearly as reasonably may be, in relation to any shares of stock or other property thereafter deliverable upon the conversion of the Preferred Stock.

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(iii)      Adjustments for Other Dividends and Distributions. In the event the Company, at any time or from time to time after the filing of this Amended and Restated Certificate of Incorporation, makes, or fixes a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution payable in securities of the Company other than shares of Common Stock, then and in each such event, provision shall be made so that the holders of Preferred Stock shall receive upon conversion thereof, in addition to the number of shares of Common Stock receivable thereupon, the amount of securities of the Company which they would have received had their Preferred Stock been converted into Common Stock on the date of such event and had they thereafter, during the period from the date of such event to and including the conversion date, retained such securities receivable by them as aforesaid during such period, subject to all other adjustments called for during such period under this Section 6(f) with respect to the rights or the holders of the Preferred Stock.

(iv)      Adjustment to Conversion Price for Issue or Sale of Additional Shares of Common Stock. If, at any time or from time to time on or after the filing of this Amended and Restated Certificate of Incorporation, the Company shall issue or sell Additional Shares of Common Stock (including any Convertible Securities) without consideration or for an Effective Price less than a Conversion Price then in effect for a series of Preferred Stock ,then and in each such case, the such applicable Conversion Price shall be reduced to an adjusted Conversion Price (computed to the nearest cent, a half cent being treated as a full cent), as of the opening of business on the date of such issue or sale, determined by multiplying such applicable Conversion Price by a fraction, (x) the numerator of which shall be the number of shares of Common Stock outstanding immediately prior to such issue plus the number of shares of Common Stock which the aggregate consideration received by the Company for the total number of Additional Shares of Common Stock so issued would purchase at the Conversion Price in effect immediately prior to such issuance, and (y) the denominator of which shall be the number of shares of Common Stock outstanding immediately prior to such issue plus the number of such Additional Shares of Common Stock so issued. For purposes of adjusting the Conversion Price under this Section 6(f), Common Stock outstanding shall include those shares of Common Stock actually issued and outstanding and all shares of Common Stock issuable upon conversion of then outstanding Preferred Stock and Convertible Securities.

(v)       Adjustment to Conversion Price of Series C Preferred in Qualified Public Offering. In the event of a Qualified Public Offering prior to January 1, 2022, the Conversion Price of the Series C Preferred shall be adjusted (computed to the nearest cent, a half cent being treated as a full cent), as of immediately prior to the conversion of the Series C Preferred into Common Stock pursuant to Section 6(b) of this Section IV, to an amount equal to the product of (x) 80% multiplied by (y) the Qualified Public Offering Price. For purposes of adjusting the Conversion Price under this Section 6(f)(v), “Qualified Public Offering Price” shall mean the price of the shares of Common Stock to be sold in the Qualified Public Offering.

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(g)            Further Provisions for Adjustment of Conversion Price. For the purpose of Section 6(f) above, the following provisions shall be applicable:

(i)        Grant of Convertible Securities. If, at any time on or after the filing of this Amended and Restated Certificate of Incorporation, the Company shall issue or sell any Convertible Securities, there shall be determined as of the date of issue the Effective Price per share for which Additional Shares of Common Stock are issuable upon the conversion or exchange thereof, such determination to be made by dividing (x) the total amount received or receivable by the Company as consideration for the issue or sale of such Convertible Securities, plus the minimum aggregate amount of additional consideration, if any, payable to the Company upon the conversion or exchange thereof, by (y) the maximum number of Additional Shares of Common Stock issuable upon conversion or exchange of all of such Convertible Securities; and such issue or sale shall be deemed to be an issue or sale for cash (as of the date of issue or sale of such Convertible Securities) of such maximum number of Additional Shares of Common Stock at the price per share so determined. If such Convertible Securities shall by their terms provide for an increase or increases, with the passage of time, in the amount of additional consideration, if any, payable to the Company, or in the rate of exchange, upon the conversion or exchange thereof the adjusted Conversion Prices shall, forthwith upon any such increase becoming effective, be readjusted (but to no greater extent than originally adjusted) to reflect the same. If any rights of conversion or exchange evidenced by such Convertible Securities shall expire without having been exercised, any adjusted Conversion Price shall forthwith be readjusted to be the adjusted Conversion Price which would have been in effect had an adjustment been made on the basis that the only Additional Shares of Common Stock issued or sold were those actually issued upon the conversion or exchange of such Convertible Securities, and that they were issued or sold for the consideration actually received by the Company upon such conversion or exchange, plus the consideration, if any, actually received by the Company for the issue or sale of such Convertible Securities as were actually converted or exchanged.

(ii)       Determination of Consideration. Upon any issuance or sale for a consideration other than cash, or a consideration part of which is other than cash, of any Additional Shares of Common Stock or Convertible Securities or any rights, warrants or options to subscribe for, purchase or otherwise acquire any Additional Shares of Common Stock or Convertible Securities, the amount of the consideration other than cash received by the Company shall be deemed to be the fair value of such consideration as determined in good faith by the Board. In case any Additional Shares of Common Stock or Convertible Securities or any rights, warrants or options to subscribe for, purchase or otherwise acquire any Additional Shares of Common Stock or Convertible Securities shall be issued or sold together with other stock or securities or other assets of the Company for a consideration which covers two or more thereof, the consideration for the issue or sale of such Additional Shares of Common Stock or Convertible Securities or such rights, warrants or options shall be deemed to be the portion of such consideration allocated thereto in good faith by the Board.

(iii)      Duration of Adjusted Conversion Price. Following each computation or readjustment of an adjusted Conversion Price as provided in this Section 6 of Article IV, such new adjusted Conversion Price shall remain in effect until a further computation or readjustment thereof is required by this Section 6.

(iv)      Other Action Affecting Common Stock. In case, after the filing of this Amended and Restated Certificate of Incorporation, the Company shall take any action affecting its shares of Common Stock, other than an action described above in this Section 6, which in the good faith opinion of the Board would have an adverse effect upon the conversion rights of the Preferred Stock granted herein, the Conversion Price shall be adjusted in such manner and at such time as the Board may in good faith determine to be equitable in the circumstances.

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(v)       Certificate as to Adjustments. Upon the occurrence of each adjustment or readjustment of the Conversion Price pursuant to this Section 6, the Company at its expense shall promptly compute such adjustment or readjustment in accordance with the terms hereof and furnish to each holder of Preferred Stock a certificate setting forth such adjustment or readjustment and showing in reasonable detail the facts upon which such adjustment or readjustment is based. The Company shall, upon the written request, at any time, of any holder of Preferred Stock, furnish or cause to be furnished to such holder a like certificate setting forth: (i) such adjustments and readjustments; (ii) the applicable Conversion Price at the time in effect; and (iii) the number of shares of Common Stock and the amount, if any, of other property which at the time would be received upon the conversion of the Preferred Stock.

(h)            Notices of Record Date. In the event of any taking by the Company of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend (other than a cash dividend which is the same as cash dividends paid in previous quarters) or other distribution, any capital reorganization of the Company, any reclassification or recapitalization of the Company’s capital stock, any consolidation or merger with or into another corporation, any transfer of all or substantially all of the assets of the Company or any dissolution, liquidation or winding up of the Company, the Company shall mail to each holder of Preferred Stock at least twenty (20) days prior to the date specified for the taking of a record, a notice specifying the date on which any such record is to be taken for the purpose of such dividend or distribution.

(i)             Common Stock Reserved. The Company shall reserve and keep available out of its authorized but unissued Common Stock such number of shares of Common Stock as shall from time to time be sufficient to effect (x) conversion of the Preferred Stock and (y) issuance of Common Stock pursuant to any outstanding options, warrants or other rights to acquire Common Stock.

(j)             Payment of Taxes. The Company will pay all taxes (other than taxes based upon income) and other governmental charges that may be imposed with respect to the issue or delivery of shares of Common Stock upon conversion of shares of Preferred Stock, other than any tax or other charge imposed in connection with any transfer involved in the issue and delivery of shares of Common Stock in a name other than that in which the shares of Preferred Stock so converted were registered.

7.             Status of Acquired Shares. Shares of Series B Preferred and Series B-2 Preferred received upon redemption, purchase, conversion or otherwise acquired by the Company will be restored to the status of authorized but unissued shares of Preferred Stock, without designation as to class, and may thereafter be issued, but not as shares of Series B Preferred or Series B-2 Preferred, as applicable.

Article V

BYLAWS

Subject to any additional vote required by this Amended and Restated Certificate of Incorporation, in furtherance and not in limitation of the powers conferred by statute, the Board of Directors is expressly authorized to make, repeal, alter, amend and rescind any or all of the Bylaws of the Corporation.

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Article VI

NUMBER OF DIRECTORS

Subject to any additional vote required by this Amended and Restated Certificate of Incorporation, the number of directors of the Corporation shall be determined in the manner set forth in the Bylaws of the Corporation. Each director shall be entitled to one vote on each matter presented to the Board.

Article VII

ELECTION OF DIRECTORS

Elections of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.

Article VIII

MEETINGS AND BOOKKEEPING

Meetings of stockholders may be held within or without the State of Delaware, as the Bylaws of the Corporation may provide. The books of the Corporation may be kept outside the State of Delaware at such place or places as may be designated from time to time by the Board of Directors or in the Bylaws of the Corporation.

Article IX

LIMITATION ON DIRECTOR LIABILITY

To the fullest extent permitted by law, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. If the General Corporation Law of the State of Delaware or any other law of the State of Delaware is amended after approval by the stockholders of this Article IX to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law of the State of Delaware as so amended.

Any repeal or modification of the foregoing provisions of this Article IX by the stockholders of the Corporation shall not adversely affect any right or protection of a director of the Corporation existing at the time of, or increase the liability of any director of the Corporation with respect to any acts or omissions of such director occurring prior to, such repeal or modification.

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Article X

INDEMNIFICATION

To the fullest extent permitted by applicable law, the Corporation is authorized to provide indemnification of (and advancement of expenses to) directors, officers and agents of the Corporation (and any other persons to which General Corporation Law of the State of Delaware permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the General Corporation Law of the State of Delaware.

Any amendment, repeal or modification of the foregoing provisions of this Article X shall not adversely affect any right or protection of any director, officer or other agent of the Corporation existing at the time of, or increase the liability of any director of the Corporation with respect to any acts or omissions of such director, officer or other agent occurring prior to, such amendment, repeal or modification.

Article XI

AMENDMENT OF CERTIFICATE OF INCORPORATION

Subject to any additional vote required by this Amended and Restated Certificate of Incorporation, the Corporation reserves the right to amend, alter, change or repeal any provision contained in this Amended and Restated Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation.

Article XII

FORUM SELECTION

Unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery in the State of Delaware shall be the sole and exclusive forum for any stockholder (including a beneficial owner) to bring (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s stockholders, (iii) any action asserting a claim against the Corporation, its directors, officers or employees arising pursuant to any provision of the Delaware General Corporation Law or the Company’s certificate of incorporation or bylaws or (iv) any action asserting a claim against the Company, its directors, officers or employees governed by the internal affairs doctrine, except for, as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within 10 days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction. If any provision or provisions of this Article XII shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provisions in any other circumstance and of the remaining provisions of this Article XII (including, without limitation, each portion of any sentence of this Article Thirteenth containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable) and the application of such provision to other persons or entities and circumstances shall not in any way be affected or impaired thereby.

14

Article XIII

FORUM SELECTION FOR SECURITIES MATTERS

Unless the Company consents in writing to the selection of an alternate forum, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.  Any person or entity purchasing or otherwise acquiring any interest in any security of the Company shall be deemed to have notice of and consented to this Article XIV.

***

15

EX-3.2

Exhibit 3.2

SECOND AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
MIROMATRIX MEDICAL INC.

Miromatrix Medical Inc., a corporation organized and existing under the laws of the State of Delaware (the “Corporation”), hereby certifies as follows:

1.            The name of the Corporation is Miromatrix Medical Inc. The Corporation’s original certificate of incorporation was filed with the Secretary of State of Delaware on July 13, 2009.

2.            This Second Amended and Restated Certificate of Incorporation (the “Certificate”) amends, restates and integrates the provisions of the Amended and Restated Certificate of Incorporation, and was duly adopted in accordance with the provisions of Sections 242 and 245 of the General Corporation Law of the State of Delaware (the “DGCL”).

3.            This Certificate was approved by the holders of the requisite number of shares of this Corporation in accordance with Section 228 of the DGCL.

4.            The text of the Amended and Restated Certificate of Incorporation is hereby amended and restated in its entirety to provide as herein set forth in full.

ARTICLE I

The name of the Corporation is Miromatrix Medical Inc.

ARTICLE II

The address of the Corporation’s registered office in the State of Delaware is c/o The Corporation Trust Company, 1209 Orange Street in the City of Wilmington, County of New Castle, Zip Code 19801. The name of its registered agent at such address is The Corporation Trust Company.

ARTICLE III

The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the DGCL.

ARTICLE IV
Capital Stock

The total number of shares of capital stock which the Corporation shall have authority to issue is 110,000,000, of which (i) 100,000,000 shares shall be a class designated as common stock, par value $0.00001 per share (the “Common Stock”), and (ii) 10,000,000 shares shall be a class designated as undesignated preferred stock, par value $0.00001 per share (the “Undesignated Preferred Stock”).

- 1 - 

Except as otherwise provided in any certificate of designations of any series of Undesignated Preferred Stock, the number of authorized shares of the class of Common Stock or Undesignated Preferred Stock may from time to time be increased or decreased (but not below the number of shares of such class outstanding) by the affirmative vote of the holders of a majority in voting power of the outstanding shares of capital stock of the Corporation irrespective of the provisions of Section 242(b)(2) of the DGCL.

The powers, preferences and rights of, and the qualifications, limitations and restrictions upon, each class or series of stock shall be determined in accordance with, or as set forth below in, this Article IV.

A. COMMON STOCK

Subject to all the rights, powers and preferences of the Undesignated Preferred Stock and except as provided by law or in this Certificate (or in any certificate of designations of any series of Undesignated Preferred Stock):

(a)          the holders of the Common Stock shall have the exclusive right to vote for the election of directors of the Corporation (the “Directors”) and on all other matters requiring stockholder action, each outstanding share entitling the holder thereof to one vote on each matter properly submitted to the stockholders of the Corporation for their vote; provided, however, that, except as otherwise required by law, holders of Common Stock, as such, shall not be entitled to vote on any amendment to this Certificate (or on any amendment to a certificate of designations of any series of Undesignated Preferred Stock) that alters or changes the powers, preferences, rights or other terms of one or more outstanding series of Undesignated Preferred Stock if the holders of such affected series of Undesignated Preferred Stock are entitled to vote, either separately or together with the holders of one or more other such series, on such amendment pursuant to this Certificate (or pursuant to a certificate of designations of any series of Undesignated Preferred Stock) or pursuant to the DGCL;

(b)          dividends may be declared and paid or set apart for payment upon the Common Stock out of any assets or funds of the Corporation legally available for the payment of dividends, but only when and as declared by the Board of Directors or any authorized committee thereof; and

(c)          upon the voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the net assets of the Corporation shall be distributed pro rata to the holders of the Common Stock.

B. UNDESIGNATED PREFERRED STOCK

The Board of Directors or any authorized committee thereof is expressly authorized, to the fullest extent permitted by law, to provide by resolution or resolutions for, out of the unissued shares of Undesignated Preferred Stock, the issuance of the shares of Undesignated Preferred Stock in one or more series of such stock, and by filing a certificate of designations pursuant to the DGCL, to establish or change from time to time the number of shares of each such series, and to fix the designations, powers, including voting powers, full or limited, or no voting powers, preferences and the relative, participating, optional or other special rights of the shares of each series and any qualifications, limitations and restrictions thereof.

- 2 - 

ARTICLE V
Stockholder Action

1.            Action Without Meeting. Any action required or permitted to be taken by the stockholders of the Corporation at any annual or special meeting of stockholders of the Corporation must be effected at a duly called annual or special meeting of stockholders and may not be taken or effected by a written consent of stockholders in lieu thereof.

2.            Special Meetings. Except as otherwise required by statute and subject to the rights, if any, of the holders of any series of Undesignated Preferred Stock, special meetings of the stockholders of the Corporation may be called only by (i) the Board of Directors acting pursuant to a resolution approved by the affirmative vote of a majority of the Directors then in office, (ii) the Chairperson of the Board, or (iii) the chief executive officer of the Corporation, and special meetings of stockholders may not be called by any other person or persons. Only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders of the Corporation.

3.            Advance Notice. Advance notice of stockholder nominations for the election of directors and of business to be brought by stockholders before any meeting of the stockholders of the Corporation shall be given in the manner provided in the Bylaws of the Corporation (the “Bylaws”).

4.            Cumulative Voting. There shall be no cumulative voting.

ARTICLE VI
Directors

1.            General. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors except as otherwise provided herein or required by law.

2.            Election of Directors. Election of Directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.

3.            Number of Directors; Term of Office. The number of Directors of the Corporation shall be fixed solely and exclusively by resolution duly adopted from time to time by the Board of Directors. The Directors, other than those who may be elected by the holders of any series of Undesignated Preferred Stock, shall be classified, with respect to the term for which they severally hold office, into three classes. Such classes shall be as nearly equal in number of Directors as reasonably possible. The Board of Directors shall assign Directors into classes at the time the classification becomes effective. The initial Class I Directors shall serve for a term expiring at the first annual meeting of stockholders to be held after the filing of this Certificate, the initial Class II Directors shall serve for a term expiring at the second annual meeting of stockholders to be held after the filing of this Certificate, and the initial Class III Directors shall serve for a term expiring at the third annual meeting of stockholders to be held after the filing of this Certificate. At each annual meeting of stockholders, Directors elected to succeed those Directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting of stockholders after their election. Notwithstanding the foregoing, the Directors elected to each class shall hold office until their successors are duly elected and qualified or until their earlier resignation, death or removal.

- 3 - 

Notwithstanding the foregoing, whenever, pursuant to the provisions of Article IV of this Certificate, the holders of any one or more series of Undesignated Preferred Stock shall have the right, voting separately as a series or together with holders of other such series, to elect Directors at an annual or special meeting of stockholders, the election, term of office, filling of vacancies and other features of such directorships shall be governed by the terms of this Certificate and any certificate of designations applicable to such series.

4.            Vacancies. Subject to the rights, if any, of the holders of any series of Undesignated Preferred Stock to elect Directors and to fill vacancies in the Board of Directors relating thereto, any and all vacancies in the Board of Directors, however occurring, including, without limitation, by reason of an increase in the size of the Board of Directors, or the death, resignation, disqualification or removal of a Director, shall be filled solely and exclusively by the affirmative vote of a majority of the remaining Directors then in office, even if less than a quorum of the Board of Directors, and not by the stockholders. Any Director appointed in accordance with the preceding sentence shall hold office for the remainder of the full term of the class of Directors in which the new directorship was created or the vacancy occurred and until such Director’s successor shall have been duly elected and qualified or until his or her earlier resignation, death or removal. Subject to the rights, if any, of the holders of any series of Undesignated Preferred Stock to elect Directors, when the number of Directors is increased or decreased, the Board of Directors shall, subject to Article VI.3 hereof, determine the class or classes to which the increased or decreased number of Directors shall be apportioned; provided, however, that no decrease in the number of Directors shall shorten the term of any incumbent Director. In the event of a vacancy in the Board of Directors, the remaining Directors, except as otherwise provided by law, shall exercise the powers of the full Board of Directors until the vacancy is filled.

5.            Removal. Subject to the rights, if any, of any series of Undesignated Preferred Stock to elect Directors and to remove any Director whom the holders of any such series have the right to elect, any Director (including persons elected by Directors to fill vacancies in the Board of Directors) may be removed from office only with cause. At least forty-five (45) days prior to any annual or special meeting of stockholders at which it is proposed that any Director be removed from office, written notice of such proposed removal and the alleged grounds thereof shall be sent to the Director whose removal will be considered at the meeting.

ARTICLE VII
Limitation Of Liability

A Director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a Director, except for liability (a) for any breach of the Director’s duty of loyalty to the Corporation or its stockholders, (b) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (c) under Section 174 of the DGCL or (d) for any transaction from which the Director derived an improper personal benefit. If the DGCL is amended after the effective date of this Certificate to authorize corporate action further eliminating or limiting the personal liability of Directors, then the liability of a Director of the Corporation shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended.

- 4 - 

As more fully set forth in the Bylaws, the Corporation may indemnify to the fullest extent permitted by the DGCL any person made or threatened to be made a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he, she, his or her testator or intestate is or was a Director, officer, employee or agent at the request of the Corporation or any predecessor to the Corporation or serves or served at any other enterprise as a Director, officer, employee or agent at the request of the Corporation or any predecessor to the Corporation.

Any amendment, repeal or modification of this Article VII by either of (i) the stockholders of the Corporation or (ii) an amendment to the DGCL, shall not adversely affect any right or protection existing at the time of such amendment, repeal or modification with respect to any acts or omissions occurring before such amendment, repeal or modification of a person serving as a Director at the time of such amendment, repeal or modification.

ARTICLE VIII
Amendment Of Bylaws

1.            Amendment by Directors. Except as otherwise provided by law, the Bylaws of the Corporation may be amended or repealed by the Board of Directors by the affirmative vote of a majority of the Directors then in office.

2.            Amendment by Stockholders. The Bylaws of the Corporation may be amended or repealed at any annual meeting of stockholders, or special meeting of stockholders called for such purpose, by the affirmative vote of at least 66 2/3% of the outstanding shares of capital stock entitled to vote on such amendment or repeal, voting together as a single class; provided, however, that if the Board of Directors recommends that stockholders approve such amendment or repeal at such meeting of stockholders, such amendment or repeal shall only require the affirmative vote of the majority of the outstanding shares of capital stock entitled to vote on such amendment or repeal, voting together as a single class.

ARTICLE IX
Exclusive Forum

Unless this Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) shall, to the fullest extent permitted by law, be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, employee, agent or stockholder of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware, the Certificate or the Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, except, in each case, any claim (A) as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within ten (10) days following such determination), (B) which is vested in the exclusive jurisdiction of a court or forum other than such court, or (C) for which such court does not have subject matter jurisdiction, provided that, for the avoidance of doubt, nothing in this Article IX shall preclude the filing of claims in the federal district courts of the United States of America under the Securities Act of 1933, as amended, or any successor thereto or under the Exchange Act of 1934, as amended, or any successor thereto. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of capital stock of the Corporation shall be deemed to have notice of and to have consented to the provisions of this Article IX.

- 5 - 

ARTICLE X
Amendment Of Certificate Of Incorporation

The Corporation reserves the right to amend or repeal this Certificate in the manner now or hereafter prescribed by statute and this Certificate, and all rights conferred upon stockholders herein are granted subject to this reservation. Whenever any vote of the holders of capital stock of the Corporation is required to amend or repeal any provision of this Certificate, and in addition to any other vote of holders of capital stock that is required by this Certificate or by law, such amendment or repeal shall require the affirmative vote of the majority of the outstanding shares of capital stock entitled to vote on such amendment or repeal, and the affirmative vote of the majority of the outstanding shares of each class entitled to vote thereon as a class, at a duly constituted meeting of stockholders called expressly for such purpose; provided, however, that the affirmative vote of not less than 66 2/3% of the outstanding shares of capital stock entitled to vote on such amendment or repeal shall be required to amend or repeal any provision of Article V, Article VI, Article VII, Article VIII, Article IX or Article X of this Certificate.

- 6 - 

THIS SECOND AMENDED AND RESTATED CERTIFICATE OF INCORPORATION is executed as of this day of __________________, ______.

MIROMATRIX INC.

By:

Name:

Title:

[Signature Page to Second Amended and Restated Certificate of Incorporation]

EX-3.3

Exhibit 3.3

BYLAWS OF
TAYTECH, INC.

ARTICLE I
STOCKHOLDERS

Section 1.1            Annual Meetings. If required by applicable law, an annual meeting of stockholders will be held for the election of directors at such date, time and place, either within or without the State of Delaware, as may be designated by resolution of the Board of Directors from time to time. Any proper business may be transacted at the annual meeting.

Section 1.2            Special Meetings. Special meetings of stockholders for any purpose or purposes may be called at any time only by the Chairman, the Chief Executive Officer, the President, or the Secretary and will be called by any such officer at the request in writing of a majority of the Board of Directors. Such request must state the purpose or purposes of the meeting.

Section 1.3            Section 1. 3. Notice of Meetings. Whenever stockholders are required or permitted to take any action at a meeting, a written notice of the meeting must be given that will state the place, date and hour of the meeting and, in the case of a special meeting, the purpose or purposes for which the meeting is called. Unless otherwise provided by applicable law or regulation, the certificate of incorporation or these bylaws, the written notice of any meeting must be given not less than ten nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. If mailed, such notice will be deemed to be given when deposited in the United States mail, postage prepaid, directed to the stockholder at the stockholder’s address as it appears on records of the corporation.

Section 1.4            Adjournments. Any meeting of stockholders, annual or special, may adjourn from time to time to reconvene at the same or some other place, and notice need not be given of any such adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting the corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than 30 days, or if after the adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned meeting must be given to each stockholder of record entitled to vote at the meeting.

Section 1.5            Quorum. Except as otherwise provided by law or regulation, the certificate of incorporation or these bylaws, at each meeting of stockholders the presence in person or by proxy of the holders of shares of stock having at least a majority of the votes that could be cast by the holders of all outstanding shares of stock entitled to vote at the meeting will constitute a quorum. In the absence of a quorum, the stockholders so present may, by majority vote, adjourn the meeting from time to time in the manner provided in Section 1.4 of these bylaws until a quorum attends. The corporation will not vote shares of its own stock belonging to the corporation or to another corporation, if a majority of the shares entitled to vote in the election of directors of such other corporation is held, directly or indirectly, by the corporation, nor will any such shares be counted for quorum purposes. However, the previous sentence will not limit the right of the corporation to vote stock, including but not limited to its own stock, held by it in a fiduciary capacity.

Bylaws of Tay Tech, Inc. Page 1 

Section 1.6            Organization. Meetings of stockholders will be presided over by the Chairman of the Board, if any, or in such person’s absence by the Vice Chairman of the Board, if any, or in such person’s absence by the Chief Executive Officer, or in such person’s absence by the President (if not the Chief Executive Officer), or in such person’s absence by a Vice President, or in the absence of the foregoing persons by a chairman designated by the Board of Directors, or in the absence of such designation by a chairman chosen at the meeting. The Secretary will act as secretary of the meeting, but in such person’s absence the chairman of the meeting may appoint any person to act as secretary of the meeting. The chairman of the meeting will announce at the meeting of stockholders the date and time of the opening and the closing of the polls for each matter upon which the stockholders will vote.

Section 1.7            Voting. Except as otherwise provided by the certificate of incorporation, each stockholder entitled to vote at any meeting of stockholders is entitled to one vote for each share of stock held by such stockholder that has voting power upon the matter in question. Voting at meetings of stockholders need not be by written ballot and, unless otherwise required by law, need not be conducted by inspectors of election unless so determined by the holders of shares of stock having a majority of the votes that could be cast by the holders of all outstanding shares of stock entitled to vote thereon that are present in person or by proxy at such meeting. At all meetings of stockholders for the election of directors, a plurality of the votes cast will be sufficient to elect. All other elections and questions will, unless otherwise provided by applicable law or regulation, the certificate of incorporation or these bylaws, be decided by the vote of the holders of shares of stock having a majority of the votes that are present in person or represented by proxy at the meeting and entitled to vote on the election or question.

Section 1.8            Proxies. Each stockholder entitled to vote at a meeting of stockholders may authorize another person or persons to act for him or her by proxy in any manner, including without limitation via telephone, Internet or such other manner as permitted by Section 212 of the Delaware General Corporation Law, as amended from time to time, provided that such authorization sets forth or contains information from which the Corporation can determine that the authorization was granted by the stockholder. If the authorization is granted in a manner other than in a written form, the proxy holder will provide such reasonable verification as required by the corporation. A proxy will be irrevocable only if it states that it is irrevocable and if, and only as long as, it is coupled with an interest sufficient in law to support an irrevocable power. A stockholder may revoke any proxy that is not irrevocable by attending the meeting and voting in person or by filing an instrument in writing revoking the proxy or by delivering a proxy in accordance with applicable law bearing a later date to the Secretary of the corporation.

Section 1.9            Fixing Date for Determination of Stockholders of Record.

(a)            The Board of Directors may fix a record date to determine the stockholders entitled to:

(1)            notice of or to vote at any meeting of stockholders or any adjournment thereof;

Bylaws of Tay Tech, Inc. Page 2 

(2)            express consent to corporate action in writing without a meeting;

(3)            receive payment of any dividend or other distribution or allotment of any rights; or

(4)            exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action.

(b)            A record date will not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors.

(c)            The record date:

(1)            in the case of determination of stockholders entitled to vote at any meeting of stockholders or adjournment thereof, will, unless otherwise required by law, not be more than 60 nor less than ten days before the date of such meeting;

(2)            in the case of determination of stockholders entitled to express consent to corporate action in writing without a meeting, will not be more than ten days from the date upon which the resolution fixing the record date is adopted by the Board of Directors; and

(3)            in the case of any other action, will not be more than 60 days prior to such other action.

(d)            If no record date is fixed:

(1)            the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders will be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held;

(2)            the record date for determining stockholders entitled to express consent to corporate action in writing without a meeting when no prior action of the Board of Directors is required by law will be the first date on which a signed written consent setting forth the action taken or proposed to be taken is delivered to the corporation in accordance with applicable law, or, if prior action by the Board of Directors is required by law, will be at the close of business on the day on which the Board of Directors adopts the resolution taking such prior action; and

(3)            the record date for determining stockholders for any other purpose will be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.

(e)            A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders will apply to any adjournment of the meeting although the Board of Directors may fix a new record date for the adjourned meeting.

Bylaws of Tay Tech, Inc. Page 3 

Section 1.10          List of Stockholders Entitled to Vote. The Secretary will prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list will be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten days prior to the meeting, either at a place within the city where the meeting is to be held, which place will be specified in the notice of the meeting, or if not so specified, at the place where the meeting is to be held. The list will also be produced and kept at the time and place of the meeting during the whole time thereof and may be inspected by any stockholder who is present. Upon the willful neglect or refusal of the directors to produce such a list at any meeting for the election of directors, they will be ineligible for election to any office at such meeting. The stock ledger will be the only evidence as to who are the stockholders entitled to examine the stock ledger, the list of stockholders or the books of the corporation, or to vote in person or by proxy at any meeting of stockholders.

Section 1.11          Action By Consent of Stockholders. Unless otherwise restricted by the certificate of incorporation, any action required or permitted to be taken at any annual or special meeting of the stockholders may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing, setting forth the action so taken, is signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted. Any such executed consents must be delivered (by hand or by certified or registered mail, return receipt requested) to the corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the corporation having custody of the book in which proceedings of minutes of stockholders are recorded. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent will be given to those stockholders who have not consented in writing.

Section 1.12          Conduct of Meetings. The Board of Directors of the corporation may adopt by resolution such rules and regulations for the conduct of the meeting of stockholders as it deems appropriate. The chairman of any meeting of stockholders may prescribe such rules, regulations and procedures and do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting, except to the extent inconsistent with such rules and regulations as adopted by the Board of Directors. Such rules, regulations or procedures, whether adopted by the Board of Directors or prescribed by the chairman of the meeting, may include, without limitation, the following: (1) the establishment of an agenda or order of business for the meeting; (2) rules and procedures for maintaining order at the meeting and the safety of those present; (3) limitations on attendance at or participation in the meeting to stockholders of record of the corporation, their duly authorized and constituted proxies or such other persons as the chairman of the meeting shall determine; (4) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (5) limitations on the time allotted to questions or comments by participants. Unless and to the extent determined by the Board of Directors or the chairman of the meeting, meetings of stockholders are not required to be held in accordance with the rules of parliamentary procedure.

Bylaws of Tay Tech, Inc. Page 4 

Section 1.13          Advance Notice of Stockholder Business. As provided in Section 1.2, the business conducted at any special meeting of stockholders will be limited to the purposes stated in the notice of the special meeting. At any annual meeting of stockholders, only such business (other than the nomination and election of directors, which will be subject to Section 1.14) may be conducted that is appropriate for consideration at the meeting and that has been brought before the meeting (1) by or at the direction of the Board of Directors, or (2) by any stockholder of the corporation entitled to vote at the meeting who complies with the notice procedures in this Section 1.13.

(a)            Timing of Notice. For business to be properly brought before any annual meeting by a stockholder, the stockholder must have given timely notice thereof in writing to the Secretary of the corporation. To be timely, a stockholder’s notice must be delivered to the Secretary, or mailed and received at the principal executive office of the corporation, not less than 90 days before the first anniversary of the date of the preceding year’s annual meeting of stockholders. If, however, the date of the annual meeting of stockholders is more than 30 days before or after such anniversary date, notice by a stockholder will be considered timely only if delivered or mailed and received not less than 90 days before such annual meeting or, if later, within ten days after the first public announcement of the date of such annual meeting. Except to the extent otherwise required by law, the adjournment of an annual meeting of stockholders will not commence a new time period for the giving of a stockholder’s notice as required above.

(b)            Content of Notice. For each matter a stockholder proposes to bring before a meeting of stockholders, the stockholder’s notice must state: (1) a brief description of the business desired to be brought before the meeting and the reasons for conducting such business at the meeting, (2) the name and address, as they appear on the corporation’s books, of the stockholder proposing such business, (3) the class or series (if any) and number of shares of the corporation that are beneficially owned by the stockholder, (4) any material interest of the stockholder in such business, and (5) a representation that the stockholder is a holder of record of shares entitled to vote at the meeting and intends to appear in person or by proxy at the meeting to make the proposal.

(c)            Consequences of Failure to Give Timely Notice. Notwithstanding anything in these bylaws to the contrary, no business (other than the nomination and election of directors) will be conducted at any annual meeting of stockholders except in accordance with the procedures set forth in this Section 1.13. If the officer of the corporation chairing the meeting determines that any business proposed to be conducted at the meeting was not properly brought before the meeting in accordance with the procedures described in this Section 1.13, then such officer must declare as such to the meeting and such business will not be transacted.

(d)            Public Announcement. For purposes of this Section 1.13 and Section 1.14, “public announcement” means disclosure (1) when made in a press release reported by the Dow Jones News Service, Associated Press, or comparable national news service, (2) when filed in a document publicly filed by the corporation with the Securities and Exchange Commission pursuant to Section 13, 14, or 15(d) of the Securities Exchange Act of 1934, or (3) when mailed or otherwise delivered as the notice of the meeting pursuant to Section 1.3.

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(e)            Compliance with Law. Notwithstanding the foregoing provisions of this Section 1.13, a stockholder must also comply with all applicable requirements of Delaware law and the Securities Exchange Act of 1934 and the rules and regulations thereunder with respect to the matters set forth in this Section 1.13.

Section 1.14          Advance Notice of Stockholder Nominees. Only persons who are nominated in accordance with the procedures set forth in this Section 1.14 will be eligible for election as directors. Nominations of persons for election to the Board of Directors of the corporation may be made at a meeting of stockholders by or at the direction of the Board of Directors or by any stockholder of the corporation entitled to vote for the election of directors at the meeting who complies with the notice procedures in this Section 1.14.

(a)            Timing of Notice. Nominations by stockholders must be made pursuant to timely notice in writing to the Secretary of the corporation. To be timely, a stockholder’s notice of nominations must be delivered to the Secretary of the corporation, or mailed and received at the principal executive office of the corporation, not less than 90 days before the first anniversary of the date of the preceding year’s annual meeting of stockholders. If, however, the date of the annual meeting of stockholders is more than 30 days before or after such anniversary date, notice by a stockholder will be timely only if so delivered or so mailed and received not less than 90 days before such annual meeting or, if later, within ten days after the first public announcement of the date of such annual meeting. If a special meeting of stockholders of the corporation is called in accordance with Section 1.2 for the purpose of electing one or more directors to the Board of Directors, then a stockholder’s notice of nomination must be delivered to the Secretary of the corporation, or mailed and received at the principal executive office of the corporation, not less than 90 days before such special meeting or, if later, within ten days after the first public announcement of the date of such special meeting. Except to the extent otherwise required by law, the adjournment of a regular or special meeting of stockholders will not commence a new time period for the giving of a stockholder’s notice as described above.

(b)            Content of Notice. A stockholder’s notice to the corporation of nominations for a regular or special meeting of stockholders must set forth (I) as to each person whom the stockholder proposes to nominate for election or re-election as a director: (a) such person’s name, age, business address and residence address and principal occupation or employment, (b) all other information relating to such person that is required to be disclosed in solicitations of proxies for election of directors, or that is otherwise required, pursuant to Regulation I 4A under the Securities Exchange Act of 1934, and (c) such person’s written consent to being named in the proxy statement as a nominee and to serving as a director if elected; and (2) as to the stockholder giving the notice: (a) the name and address, as they appear on the corporation’s books, of such stockholder, (b) the class or series (if any) and number of shares of the corporation that are beneficially owned by such stockholder, and (c) a representation that the stockholder is a holder of record of shares of the corporation entitled to vote for the election of directors and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice. At the request of the Board of Directors, any person nominated by the Board of Directors for election as a director must furnish to the Secretary of the corporation the information required to be set forth in a stockholder’s notice of nomination that pertains to a nominee.

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(c)            Consequences of Failure to Give Timely Notice. Notwithstanding anything in these bylaws to the contrary, no person will be eligible for election as a director of the corporation unless nominated in accordance with the procedures set forth in this Section 1.14. If a nomination was not made in accordance with the procedures prescribed in this Section 1.14, the officer of the corporation chairing the meeting will determine and declare as such to the meeting and the defective nomination will be disregarded.

ARTICLE II
BOARD OF DIRECTORS

Section 2.1            Number; Qualification. The Board of Directors will fix from time to time the number of Directors constituting the Board of Directors. Directors need not be stockholders.

Section 2.2            Initial Directors; Resignation; Vacancies. The Board of Directors will initially consist of the persons named as directors by the incorporator. Any director may resign at any time upon written notice to the corporation. Any newly created directorship or any vacancy occurring in the Board of Directors for any cause may be filled by a majority of the remaining members of the Board of Directors, even if such majority is less than a quorum, or by a plurality of the votes cast at a meeting of stockholders. Each director so elected will hold office until the expiration of the term of office of the director whom such person has replaced or until such person’s successor is elected and qualified.

Section 2.3            Regular Meetings. Regular meetings of the Board of Directors may be held at such places within or without the State of Delaware and at such times as the Board of Directors may from time to time determine, and if so determined notices thereof need not be given.

Section 2.4            Special Meetings. Special meetings of the Board of Directors may be held at any time or place within or without the State of Delaware whenever called by the Chairman, the Chief Executive Officer, the President, any Vice President, the Secretary, or by any two members of the Board of Directors. Notice of a special meeting of the Board of Directors must be given by the person or persons calling the meeting at least 48 hours before the special meeting. Notice may be given in person, or by mail, courier, facsimile, electronic communication, or other methods permitted by statute.

Section 2.5            Telephonic Meetings Permitted. Members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting thereof by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting pursuant to this bylaw shall constitute presence in person at such meeting.

Section 2.6            Quorum: Vote Required for Action. At all meetings of the Board of Directors a majority of the whole Board of Directors will constitute a quorum for the transaction of business. Except in cases in which the certificate of incorporation or these bylaws otherwise provide, the vote of a majority of the directors present at a meeting at which a quorum is present will be the act of the Board of Directors.

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Section 2.7            Organization. Meetings of the Board of Directors will be presided over by the Chairman of the Board, if any, or in such person’s absence by the Vice Chairman of the Board, if any, or in such person’s absence by the Chief Executive Officer, or in such person’s absence by the President (if not the Chief Executive Officer), or in such person’s absence by a chairman chosen at the meeting. The Secretary will act as secretary of the meeting, but in such person’s absence the chairman of the meeting may appoint any person to act as secretary of the meeting.

Section 2.8            Informal Action by Directors. Unless otherwise restricted by the certificate of incorporation or these bylaws, any action required or permitted to be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken without a meeting if all members of the Board of Directors or such committee, as the case may be, consent thereto in writing, and the writing or writings are filed with the minutes of proceedings of the Board of Directors or such committee.

ARTICLE III
COMMITTEES

Section 3.1            The Board of Directors may, by resolution passed by a majority of the whole Board of Directors, designate one or more committees, each committee to consist of one or more of the directors of the corporation. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of the committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not he, she, or they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in place of any such absent or disqualified members. Any such committee, to the extent permitted by law and to the extent provided in the resolution of the Board of Directors, will have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation.

Section 3.2            Committee Rules. Unless the Board of Directors otherwise provides, each committee designated by the Board of Directors may make, alter and repeal rules for the conduct of its business. In the absence of such rules each committee will conduct its business in the same manner as the Board of Directors conducts its business pursuant to Article II of these bylaws.

ARTICLE IV
Officers

Section 4.1            Executive Officers; Election; Qualifications; Term of Office; Resignation; Removal; Vacancies. The Board of Directors will elect a Chief Executive Officer and Secretary, and it may, if it so determines, choose a Chairman of the Board and a Vice Chairman of the Board from among its members. The Board of Directors may also choose one or more Presidents, one or more Vice Presidents, one or more Assistant Secretaries, a Treasurer and one or more Assistant Treasurers, and any other officers as the Board of Directors by a majority vote of the total number of directors may designate. Each such officer will hold office until his or her successor is elected and qualified or until such person’s earlier resignation or removal. Any officer may resign at any time upon written notice to the corporation. The Board of Directors may remove any officer with or without cause at any time, but such removal will be without prejudice to the contractual rights of such officer, if any, with the corporation. Any number of offices may be held by the same person. Any vacancy occurring in any office of the corporation by death, resignation, removal or otherwise may be filled for the unexpired portion of the term by the Board of Directors at any regular or special meeting.

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Section 4.2            Powers and Duties of Executive Officers. The officers of the corporation will have such powers and duties in the management of the corporation as may be prescribed in a resolution by the Board of Directors and, to the extent not so provided, as generally pertain to their respective offices, subject to the control of the Board of Directors.

ARTICLE V
STOCK

Section 5.1            Certificates. Every holder of stock will be entitled to have a certificate signed by or in the name of the corporation by the Chairman or Vice Chairman of the Board of Directors, if any, or the Chief Executive Officer, the President or a Vice President, and by the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary, of the corporation certifying the number of shares owned by such person in the corporation. Any of or all the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate has ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he or she was such officer, transfer agent, or registrar at the date of issue.

Section 5.2            Lost, Stolen or Destroyed Stock Certificates; Issuance of New Certificates. The corporation may issue a new stock certificate in the place of any certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the corporation may require the owner of the lost, stolen or destroyed certificate, or such person’s legal representative, to give the corporation a bond sufficient to indemnify it against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate.

ARTICLE VI
INDEMNIFICATION

Section 6.1            Right to Indemnification. The corporation will indemnify and hold harmless, to the fullest extent permitted by applicable law as it presently exists or may hereafter be amended, any person who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative (a “proceeding”) by reason of the fact that he or she, or a person for whom such person is the legal representative, is or was a director or officer of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust, enterprise or nonprofit entity, including service with respect to employee benefit plans, against all liability and loss suffered and expenses (including attorneys’ fees) reasonably incurred by such person. The corporation will indemnify a person in connection with a proceeding (or part thereof) initiated by such person only if the proceeding (or part thereof) was authorized by the Board of Directors of the corporation.

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Section 6.2            Prepayment of Expenses. The corporation will pay the expenses of a director or officer (including attorneys’ fees) incurred in defending any proceeding in advance of its final disposition, but only if the director or officer promises to repay all amounts advanced if it is determined that the director or officer is not entitled to be indemnified under this Article VI or otherwise.

Section 6.3            Claims. If a claim for indemnification or payment of expenses under this Article VI is not paid within 60 days after a written claim therefor has been received by the corporation, the claimant may file suit to recover the unpaid amount of such claim and, if successful in whole or in part, will be entitled to be paid the expense of prosecuting such claim. In any such action the corporation has the burden of proving that the claimant was not entitled to the requested indemnification or payment of expenses under applicable law.

Section 6.4            Nonexclusivity of Rights. The rights conferred on any person by this Article VI are not exclusive of any other rights that such person may have or hereafter acquire under any statute, provision of the certificate of incorporation, these bylaws, agreement, vote of stockholders or disinterested directors or otherwise.

Section 6.5            Other Indemnification. The corporation’s obligation, if any, to indemnify any person who was or is serving at its request as a director, officer, employee or agent of another entity will be reduced by any amount such person may collect as indemnification from such other entity.

Section 6.6            Amendment or Repeal. Any repeal or modification of the foregoing provisions of this Article VI will not adversely affect any right or protection hereunder of any person in respect of any act or omission occurring prior to the time of such repeal or modification.

ARTICLE VII
MISCELLANEOUS

Section 7.1            Fiscal Year. The fiscal year of the corporation will be determined by resolution of the Board of Directors.

Section 7.2            Seal. The corporation has no seal.

Section 7.3            Waiver of Notice of Meetings of Stockholders, Directors and Committees. Any written waiver of notice, signed by the person entitled to notice, whether before or after the time stated therein, will be deemed equivalent to notice. Attendance of a person at a meeting will constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Except as required by law or these bylaws, neither the business to be transacted at, nor the purpose of, any regular, annual, or special meeting of the stockholders, directors, or members of a committee of directors need be specified in any written waiver of notice.

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Section 7.4            Interested Directors; Quorum.

(a)            No transaction between the corporation and one or more of its directors or officers, or between the corporation and any other organization in which one or more of its, directors or officers are directors or officers, or have a financial interest, will be voidable solely for this reason, or solely because the director or officer is present at or participates in the meeting of the Board of Directors or committee thereof that authorizes the transaction, or solely because any such director’s or officer’s votes are counted for such purpose, if:

(1)            the material facts as to the director’s or officer’s relationship or interest and as to the transaction are disclosed or are known to the Board of Directors or the committee, and the Board of Directors or committee in good faith authorizes the transaction by the affirmative votes of a majority of the disinterested directors, even though the disinterested directors be less than a quorum; or

(2)            the material facts as to the director’s or officer’s relationship or interest and as to the contract or transaction are disclosed or are known to the stockholders entitled to vote thereon, and the contract or transaction is specifically approved in good faith by vote of the stockholders; or

(3)            the contract or transaction is fair as to the corporation as of the time it is authorized, approved or ratified by the Board of Directors, a committee thereof, or the stockholders.

(b)            Interested directors may be counted in determining the presence of a quorum at a meeting of the Board of Directors or of a committee that authorizes the contract or transaction.

Section 7.5            Form of Records. Any records maintained by the corporation in the regular course of its business, including its stock ledger, books of account and minute books, may be kept in electronic format, provided that the records so kept can be converted into clearly legible form within a reasonable time.

Section 7.6            Amendment of Bylaws. These bylaws may be altered or repealed, and new bylaws made, in the manner prescribed in the certificate of incorporation.

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EX-3.4

Exhibit 3.4

AMENDED AND RESTATED
BYLAWS
OF
MIROMATRIX INC.
(the “Corporation”)

ARTICLE I
Stockholders

Section 1.01. Annual Meeting. The annual meeting of stockholders (any such meeting being referred to in these Bylaws as an “Annual Meeting”) shall be held at the hour, date and place within or without the United States which is fixed by the Corporation’s Board of Directors (the “Board of Directors”), which time, date and place may subsequently be changed at any time by vote of the Board of Directors. If no Annual Meeting has been held for a period of thirteen (13) months after the Corporation’s last Annual Meeting, a special meeting in lieu thereof may be held, and such special meeting shall have, for the purposes of these Bylaws or otherwise, all the force and effect of an Annual Meeting. Any and all references hereafter in these Bylaws to an Annual Meeting or Annual Meetings also shall be deemed to refer to any special meeting(s) in lieu thereof.

Section 1.02. Notice of Stockholder Business and Nominations.

(a) Annual Meetings of Stockholders.

(1) Nominations of persons for election to the Board of Directors and the proposal of other business to be considered by the stockholders may be brought before an Annual Meeting (i) by or at the direction of the Board of Directors or (ii) by any stockholder of the Corporation who was a stockholder of record at the time of giving notice provided for in this Bylaw, who is entitled to vote at the meeting, who is present (in person or by proxy) at the meeting and who complies with the notice procedures set forth in this Bylaw as to such nomination or business. For the avoidance of doubt, the foregoing clause (ii) shall be the exclusive means for a stockholder to bring nominations or business properly before an Annual Meeting (other than matters properly brought under Rule 14a-8 (or any successor rule) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), and such stockholder must comply with the notice and other procedures set forth in Section 1.2(a)(2) and (3) of this Bylaw to bring such nominations or business properly before an Annual Meeting. In addition to the other requirements set forth in this Bylaw, for any proposal of business to be considered at an Annual Meeting, it must be a proper subject for action by stockholders of the Corporation under Delaware law.

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(2) For nominations or other business to be properly brought before an Annual Meeting by a stockholder pursuant to clause (ii) of Section 1.2(a)(1) of this Bylaw, the stockholder must (i) have given Timely Notice (as defined below) thereof in writing to the Secretary of the Corporation, (ii) have provided any updates or supplements to such notice at the times and in the forms required by this Bylaw and (iii) together with the beneficial owner(s), if any, on whose behalf the nomination or business proposal is made, have acted in accordance with the representations set forth in the Solicitation Statement (as defined below) required by this Bylaw. To be timely, a stockholder’s written notice shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the ninetieth (90th) day nor earlier than the close of business on the one hundred twentieth (120th) day prior to the one-year anniversary of the preceding year’s Annual Meeting; provided, however, that in the event the Annual Meeting is first convened more than thirty (30) days before or more than sixty (60) days after such anniversary date, or if no Annual Meeting were held in the preceding year, notice by the stockholder to be timely must be received by the Secretary of the Corporation not later than the close of business on the later of the ninetieth (90th) day prior to the scheduled date of such Annual Meeting or the tenth (10th) day following the day on which public announcement of the date of such meeting is first made (such notice within such time periods shall be referred to as “Timely Notice”). Notwithstanding anything to the contrary provided herein, for the first Annual Meeting following the initial public offering of common stock of the Corporation, a stockholder’s notice shall be timely if received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the later of the ninetieth (90th) day prior to the scheduled date of such Annual Meeting or the tenth (10th) day following the day on which public announcement of the date of such Annual Meeting is first made or sent by the Corporation. Such stockholder’s Timely Notice shall set forth:

(A) as to each person whom the stockholder proposes to nominate for election or reelection as a director, all information relating to such person that is required to be disclosed in solicitations of proxies for election of directors in an election contest, or is otherwise required, in each case pursuant to Regulation 14A under the Exchange Act (including such person’s written consent to being named in the proxy statement as a nominee and to serving as a director if elected);

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(B) as to any other business that the stockholder proposes to bring before the meeting, a brief description of the business desired to be brought before the meeting, the reasons for conducting such business at the meeting, and any material interest in such business of each Proposing Person (as defined below);

(C) (i) the name and address of the stockholder giving the notice, as they appear on the Corporation’s books, and the names and addresses of the other Proposing Persons (if any) and (ii) as to each Proposing Person, the following information: (a) the class or series and number of all shares of capital stock of the Corporation which are, directly or indirectly, owned beneficially or of record by such Proposing Person or any of its affiliates or associates (as such terms are defined in Rule 12b-2 promulgated under the Exchange Act), including any shares of any class or series of capital stock of the Corporation as to which such Proposing Person or any of its affiliates or associates has a right to acquire beneficial ownership at any time in the future, (b) all Synthetic Equity Interests (as defined below) in which such Proposing Person or any of its affiliates or associates, directly or indirectly, holds an interest including a description of the material terms of each such Synthetic Equity Interest, including without limitation, identification of the counterparty to each such Synthetic Equity Interest and disclosure, for each such Synthetic Equity Interest, as to (x) whether or not such Synthetic Equity Interest conveys any voting rights, directly or indirectly, in such shares to such Proposing Person, (y) whether or not such Synthetic Equity Interest is required to be, or is capable of being, settled through delivery of such shares and (z) whether or not such Proposing Person and/or, to the extent known, the counterparty to such Synthetic Equity Interest has entered into other transactions that hedge or mitigate the economic effect of such Synthetic Equity Interest, (c) any proxy (other than a revocable proxy given in response to a public proxy solicitation made pursuant to, and in accordance with, the Exchange Act), agreement, arrangement, understanding or relationship pursuant to which such Proposing Person has or shares a right to, directly or indirectly, vote any shares of any class or series of capital stock of the Corporation, (d) any rights to dividends or other distributions on the shares of any class or series of capital stock of the Corporation, directly or indirectly, owned beneficially by such Proposing Person that are separated or separable from the underlying shares of the Corporation, and (e) any performance-related fees (other than an asset based fee) that such Proposing Person, directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or series of capital stock of the Corporation or any Synthetic Equity Interests (the disclosures to be made pursuant to the foregoing clauses (a) through (e) are referred to, collectively, as “Material Ownership Interests”) and (iii) a description of the material terms of all agreements, arrangements or understandings (whether or not in writing) entered into by any Proposing Person or any of its affiliates or associates with any other person for the purpose of acquiring, holding, disposing or voting of any shares of any class or series of capital stock of the Corporation;

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(D) (i) a description of all agreements, arrangements or understandings by and among any of the Proposing Persons, or by and among any Proposing Persons and any other person (including with any proposed nominee(s)), pertaining to the nomination(s) or other business proposed to be brought before the meeting of stockholders (which description shall identify the name of each other person who is party to such an agreement, arrangement or understanding), and (ii) identification of the names and addresses of other stockholders (including beneficial owners) known by any of the Proposing Persons to support such nominations or other business proposal(s), and to the extent known the class and number of all shares of the Corporation’s capital stock owned beneficially or of record by such other stockholder(s) or other beneficial owner(s); and

(E) a statement whether or not the stockholder giving the notice and/or the other Proposing Person(s), if any, will deliver a proxy statement and form of proxy to holders of, in the case of a business proposal, at least the percentage of voting power of all of the shares of capital stock of the Corporation required under applicable law to approve the proposal or, in the case of a nomination or nominations, at least the percentage of voting power of all of the shares of capital stock of the Corporation reasonably believed by such Proposing Person to be sufficient to elect the nominee or nominees proposed to be nominated by such stockholder (such statement, the “Solicitation Statement”).

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For purposes of this Article I of these Bylaws, the term “Proposing Person” shall mean the following persons: (i) the stockholder of record providing the notice of nominations or business proposed to be brought before a stockholders’ meeting, and (ii) the beneficial owner(s), if different, on whose behalf the nominations or business proposed to be brought before a stockholders’ meeting is made. For purposes of this Section 1.2 of these Bylaws, the term “Synthetic Equity Interest” shall mean any transaction, agreement or arrangement (or series of transactions, agreements or arrangements), including, without limitation, any derivative, swap, hedge, repurchase or so-called “stock borrowing” agreement or arrangement, the purpose or effect of which is to, directly or indirectly: (a) give a person or entity economic benefit and/or risk similar to ownership of shares of any class or series of capital stock of the Corporation, in whole or in part, including due to the fact that such transaction, agreement or arrangement provides, directly or indirectly, the opportunity to profit or avoid a loss from any increase or decrease in the value of any shares of any class or series of capital stock of the Corporation, (b) mitigate loss to, reduce the economic risk of or manage the risk of share price changes for, any person or entity with respect to any shares of any class or series of capital stock of the Corporation, (c) otherwise provide in any manner the opportunity to profit or avoid a loss from any decrease in the value of any shares of any class or series of capital stock of the Corporation, or (d) increase or decrease the voting power of any person or entity with respect to any shares of any class or series of capital stock of the Corporation.

(3) To be eligible to be a nominee of any stockholder for election or reelection as a director of the Corporation, a person must deliver (in accordance with the time periods prescribed for nominations of persons for election to the Board of Directors by stockholders under this Section 1.2) to the Secretary at the principal executive offices of the Corporation a written questionnaire with respect to the background and qualification of such individual and the background of any other person or entity on whose behalf, directly or indirectly, the nomination is being made (which questionnaire shall be provided by the Secretary upon written request), all information relating to such person that would be required to be disclosed in solicitations of proxies by the Corporation for election of such person as a director in an election contest, or is otherwise required, in each case pursuant to Regulation 14A under the Exchange Act, and a written representation and agreement (in the form provided by the Secretary upon written request) that such individual (a) is not and will not become a party to (1) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such person, if elected as a director of the Corporation, will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation and (2) any Voting Commitment that could limit or interfere with such individual’s ability to comply, if elected as a director of the Corporation, with such individual’s fiduciary duties under applicable law, (b) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed therein, (c) in such individual’s personal capacity and on behalf of any person or entity on whose behalf, directly or indirectly, the nomination is being made, would be in compliance, if elected as a director of the Corporation, and will comply, with all applicable corporate governance, conflict of interest, confidentiality and stock ownership and trading policies and guidelines of the Corporation publicly disclosed from time to time and (d) consents to being named as a nominee in the Corporation’s proxy statement pursuant to Rule 14a-4(d) under the Exchange Act and any associated proxy card of the Corporation and agrees to serve if elected as a director.

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(4) A stockholder providing Timely Notice of nominations or business proposed to be brought before an Annual Meeting and any person providing information pursuant to Section 1.2(a)(3) shall, in each case, further update and supplement such notice and information, if necessary, so that the information (including, without limitation, the Material Ownership Interests information) provided or required to be provided therein pursuant to this Bylaw shall be true and correct as of the record date for the meeting and as of the date that is ten (10) business days prior to such Annual Meeting, and such update and supplement shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the fifth (5th) business day after the record date for the Annual Meeting (in the case of the update and supplement required to be made as of the record date), and not later than the close of business on the eighth (8th) business day prior to the date of the Annual Meeting (in the case of the update and supplement required to be made as of ten (10) business days prior to the meeting).

(5) Notwithstanding anything in the second sentence of Section 1.2(a)(2) of this Bylaw to the contrary, in the event that the number of directors to be elected to the Board of Directors of the Corporation is increased and there is no public announcement naming all of the nominees for director or specifying the size of the increased Board of Directors made by the Corporation at least ten (10) days before the last day a stockholder may deliver a notice of nomination in accordance with the second sentence of Section 1.2(a)(2), a stockholder’s notice required by this Bylaw shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be received by the Secretary of the Corporation not later than the close of business on the tenth (10th) day following the day on which such public announcement is first made by the Corporation.

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(b) General.

(1) Only such persons who are nominated in accordance with the provisions of this Bylaw shall be eligible for election and to serve as directors and only such business shall be conducted at an Annual Meeting as shall have been brought before the meeting in accordance with the provisions of this Bylaw or in accordance with Rule 14a-8 under the Exchange Act. The Board of Directors or a designated committee thereof shall have the power to determine whether a nomination or any business proposed to be brought before the meeting was made in accordance with the provisions of this Bylaw. If neither the Board of Directors nor such designated committee makes a determination as to whether any stockholder proposal or nomination was made in accordance with the provisions of this Bylaw, the presiding officer of the Annual Meeting shall have the power and duty to determine whether the stockholder proposal or nomination was made in accordance with the provisions of this Bylaw. If the Board of Directors or a designated committee thereof or the presiding officer, as applicable, determines that any stockholder proposal or nomination was not made in accordance with the provisions of this Bylaw, such proposal or nomination shall be disregarded and shall not be presented for action at the Annual Meeting.

(2) Except as otherwise required by law, nothing in this Section 1.2 shall obligate the Corporation or the Board of Directors to include in any proxy statement or other stockholder communication distributed on behalf of the Corporation or the Board of Directors information with respect to any nominee for director or any other matter of business submitted by a stockholder.

(3) Notwithstanding the foregoing provisions of this Section 1.2, if the nominating or proposing stockholder (or a qualified representative of the stockholder) does not appear at the Annual Meeting to present a nomination or any business, such nomination or business shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 1.2, to be considered a qualified representative of the proposing stockholder, a person must be authorized by a written instrument executed by such stockholder or an electronic transmission delivered by such stockholder to act for such stockholder as proxy at the meeting of stockholders and such person must produce such written instrument or electronic transmission, or a reliable reproduction of the written instrument or electronic transmission, to the presiding officer at the meeting of stockholders.

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(4) For purposes of this Bylaw, “public announcement” shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press or comparable national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.

(5) Notwithstanding the foregoing provisions of this Bylaw, a stockholder shall also comply with all applicable requirements of the Exchange Act and the rules and regulations thereunder with respect to the matters set forth in this Bylaw. Nothing in this Bylaw shall be deemed to affect any rights of (i) stockholders to have proposals included in the Corporation’s proxy statement pursuant to Rule 14a-8 (or any successor rule), as applicable, under the Exchange Act and, to the extent required by such rule, have such proposals considered and voted on at an Annual Meeting or (ii) the holders of any series of Undesignated Preferred Stock to elect directors under specified circumstances.

Section 1.03. Special Meetings. Except as otherwise required by statute and subject to the rights, if any, of the holders of any series of Undesignated Preferred Stock, special meetings of the stockholders of the Corporation may be called only by (i) the Board of Directors acting pursuant to a resolution approved by the affirmative vote of a majority of the Directors then in office, (ii) the Chairperson of the Board (as defined below) or (iii) the Chief Executive Officer of the Corporation. The Board of Directors may postpone or reschedule any previously scheduled special meeting of stockholders. Only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders of the Corporation. Nominations of persons for election to the Board of Directors of the Corporation and stockholder proposals of other business shall not be brought before a special meeting of stockholders to be considered by the stockholders unless such special meeting is held in lieu of an annual meeting of stockholders in accordance with Section 1.1 of these Bylaws, in which case such special meeting in lieu thereof shall be deemed an Annual Meeting for purposes of these Bylaws and the provisions of Section 1.2 of these Bylaws shall govern such special meeting.

Section 1.04. Notice of Meetings; Adjournments.

(a) A notice of each Annual Meeting stating the hour, date and place, if any, of such Annual Meeting and the means of remote communication, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, shall be given not less than ten (10) days nor more than sixty (60) days before the Annual Meeting, to each stockholder entitled to vote thereat by delivering such notice to such stockholder or by mailing it, postage prepaid, addressed to such stockholder at the address of such stockholder as it appears on the Corporation’s stock transfer books. Without limiting the manner by which notice may otherwise be given to stockholders, any notice to stockholders may be given by electronic transmission in the manner provided in Section 232 of the Delaware General Corporation Law (“DGCL”).

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(b) Notice of all special meetings of stockholders shall be given in the same manner as provided for Annual Meetings, except that the notice of all special meetings shall state the purpose or purposes for which the meeting has been called.

(c) Notice of an Annual Meeting or special meeting of stockholders need not be given to a stockholder if a waiver of notice is executed, or waiver of notice by electronic transmission is provided, before or after such meeting by such stockholder or if such stockholder attends such meeting, unless such attendance is for the express purpose of objecting at the beginning of the meeting to the transaction of any business because the meeting was not lawfully called or convened.

(d) The Board of Directors may postpone and reschedule any previously scheduled Annual Meeting or special meeting of stockholders and any record date with respect thereto, regardless of whether any notice or public disclosure with respect to any such meeting has been sent or made pursuant to Section 1.2 of these Bylaws or otherwise. In no event shall the public announcement of an adjournment, postponement or rescheduling of any previously scheduled meeting of stockholders commence a new time period for the giving of a stockholder’s notice under this Article I of these Bylaws.

(e) When any meeting is convened, the presiding officer may adjourn the meeting if (i) no quorum is present for the transaction of business, (ii) the Board of Directors determines that adjournment is necessary or appropriate to enable the stockholders to consider fully information which the Board of Directors determines has not been made sufficiently or timely available to stockholders, or (iii) the Board of Directors determines that adjournment is otherwise in the best interests of the Corporation. When any Annual Meeting or special meeting of stockholders is adjourned to another hour, date or place, notice need not be given of the adjourned meeting other than an announcement at the meeting at which the adjournment is taken of the hour, date and place, if any, to which the meeting is adjourned and the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such adjourned meeting; provided, however, that if the adjournment is for more than thirty (30) days from the meeting date, or if after the adjournment a new record date is fixed for the adjourned meeting, notice of the adjourned meeting and the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such adjourned meeting shall be given to each stockholder of record entitled to vote thereat and each stockholder who, by law or under the Certificate of Incorporation of the Corporation (as the same may hereafter be amended and/or restated, the “Certificate”) or these Bylaws, is entitled to such notice.

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Section 1.05. Quorum. A majority of the shares entitled to vote, present in person or represented by proxy, shall constitute a quorum at any meeting of stockholders. If less than a quorum is present at a meeting, the holders of voting stock representing a majority of the voting power present at the meeting or the presiding officer may adjourn the meeting from time to time, and the meeting may be held as adjourned without further notice, except as provided in Section 1.4. At such adjourned meeting at which a quorum is present, any business may be transacted which might have been transacted at the meeting as originally noticed. The stockholders present at a duly constituted meeting may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a quorum.

Section 1.06. Voting and Proxies. Stockholders shall have one vote for each share of stock entitled to vote owned by them of record according to the stock ledger of the Corporation as of the record date, unless otherwise provided by law or by the Certificate. Stockholders may vote either (i) in person, (ii) by written proxy or (iii) by a transmission permitted by Section 212 of the DGCL. Any copy, facsimile telecommunication or other reliable reproduction of the writing or transmission permitted by Section 212 of the DGCL may be substituted for or used in lieu of the original writing or transmission for any and all purposes for which the original writing or transmission could be used, provided that such copy, facsimile telecommunication or other reproduction shall be a complete reproduction of the entire original writing or transmission. Proxies shall be filed in accordance with the procedures established for the meeting of stockholders. Except as otherwise limited therein or as otherwise provided by law, proxies authorizing a person to vote at a specific meeting shall entitle the persons authorized thereby to vote at any adjournment of such meeting, but they shall not be valid after final adjournment of such meeting. A proxy with respect to stock held in the name of two or more persons shall be valid if executed by or on behalf of any one of them unless at or prior to the exercise of the proxy the Corporation receives a specific written notice to the contrary from any one of them.

Section 1.07. Action at Meeting. When a quorum is present at any meeting of stockholders, any matter before any such meeting (other than an election of a director or directors) shall be decided by a majority of the votes properly cast for and against such matter, except where a larger vote is required by law, by the Certificate or by these Bylaws. Any election of directors by stockholders shall be determined by a plurality of the votes properly cast on the election of directors.

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Section 1.08. Stockholder Lists. The Secretary or an Assistant Secretary (or the Corporation’s transfer agent or other person authorized by these Bylaws or by law) shall prepare and make, at least ten (10) days before every Annual Meeting or special meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for a period of at least ten (10) days prior to the meeting in the manner provided by law. The list shall also be open to the examination of any stockholder during the whole time of the meeting as provided by law.

Section 1.09. Presiding Officer. The Board of Directors shall designate a representative to preside over all Annual Meetings or special meetings of stockholders; provided that if the Board of Directors does not so designate such a presiding officer, then the Chairperson of the Board of Directors (the “Chairperson of the Board”), if one is elected, shall preside over such meetings. If the Board of Directors does not so designate such a presiding officer and there is no Chairperson of the Board or the Chairperson of the Board is unable to so preside or is absent, then the Chief Executive Officer, if one is elected, shall preside over such meetings, provided further that if there is no Chief Executive Officer or the Chief Executive Officer is unable to so preside or is absent, then the President shall preside over such meetings. The presiding officer at any Annual Meeting or special meeting of stockholders shall have the power, among other things, to adjourn such meeting at any time and from time to time, subject to Sections 1.4 and 1.5 of this Article I. The order of business and all other matters of procedure at any meeting of the stockholders shall be determined by the presiding officer.

Section 1.10. Inspectors of Elections. The Corporation shall, in advance of any meeting of stockholders, appoint one or more inspectors to act at the meeting and make a written report thereof. The Corporation may designate one or more persons as alternate inspectors to replace any inspector who fails to act. If no inspector or alternate is able to act at a meeting of stockholders, the presiding officer shall appoint one or more inspectors to act at the meeting. Any inspector may, but need not, be an officer, employee or agent of the Corporation. Each inspector, before entering upon the discharge of his or her duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of his or her ability. The inspectors shall perform such duties as are required by the DGCL, including the counting of all votes and ballots. The inspectors may appoint or retain other persons or entities to assist the inspectors in the performance of the duties of the inspectors. The presiding officer may review all determinations made by the inspectors, and in so doing the presiding officer shall be entitled to exercise his or her sole judgment and discretion and he or she shall not be bound by any determinations made by the inspectors. All determinations by the inspectors and, if applicable, the presiding officer, shall be subject to further review by any court of competent jurisdiction.

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ARTICLE II
Directors

Section 2.01. Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors except as otherwise provided by the Certificate or required by law.

Section 2.02. Number and Terms. The number of directors of the Corporation shall be fixed solely and exclusively by resolution duly adopted from time to time by the Board of Directors. The directors shall hold office in the manner provided in the Certificate.

Section 2.03. Qualification. No director need be a stockholder of the Corporation.

Section 2.04. Vacancies. Vacancies in the Board of Directors shall be filled in the manner provided in the Certificate.

Section 2.05. Removal. Directors may be removed from office only in the manner provided in the Certificate.

Section 2.06. Resignation. A director may resign at any time by giving written notice to the Chairperson of the Board, if one is elected, the President or the Secretary. A resignation shall be effective upon receipt, unless the resignation otherwise provides.

Section 2.07. Regular Meetings. The regular annual meeting of the Board of Directors may be held, without notice other than this Section 2.7, on the same date and at the same place as the Annual Meeting following the close of such meeting of stockholders. Other regular meetings of the Board of Directors may be held at such hour, date and place as the Board of Directors may by resolution from time to time determine and publicize by means of reasonable notice given to any director who is not present at the meeting at which such resolution is adopted.

Section 2.08. Special Meetings. Special meetings of the Board of Directors may be called, orally or in writing, by or at the request of a majority of the directors, the Chairperson of the Board, if one is elected, or the President. The person calling any such special meeting of the Board of Directors may fix the hour, date and place thereof.

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Section 2.09. Notice of Meetings. Notice of the hour, date and place of all special meetings of the Board of Directors shall be given to each director by the Secretary or an Assistant Secretary, or in case of the death, absence, incapacity or refusal of such persons, by the Chairperson of the Board, if one is elected, or the President or such other officer designated by the Chairperson of the Board, if one is elected, or the President. Notice of any special meeting of the Board of Directors shall be given to each director in person, by telephone, or by electronic mail or other form of electronic communication, sent to his or her business or home address, at least forty-eight (48) hours in advance of the meeting. Such notice shall be deemed to be delivered when hand-delivered to such address, read to such director by telephone, or dispatched or transmitted if sent by electronic mail or other form of electronic communications. A written waiver of notice signed before or after a meeting by a director and filed with the records of the meeting shall be deemed to be equivalent to notice of the meeting. The attendance of a director at a meeting shall constitute a waiver of notice of such meeting, except where a director attends a meeting for the express purpose of objecting at the beginning of the meeting to the transaction of any business because such meeting is not lawfully called or convened. Except as otherwise required by law, by the Certificate or by these Bylaws, neither the business to be transacted at, nor the purpose of, any meeting of the Board of Directors need be specified in the notice or waiver of notice of such meeting.

Section 2.10. Quorum. At any meeting of the Board of Directors, a majority of the total number of directors shall constitute a quorum for the transaction of business, but if less than a quorum is present at a meeting, a majority of the directors present may adjourn the meeting from time to time, and the meeting may be held as adjourned without further notice. Any business which might have been transacted at the meeting as originally noticed may be transacted at such adjourned meeting at which a quorum is present. For purposes of this section, the total number of directors includes any unfilled vacancies on the Board of Directors.

Section 2.11. Action at Meeting. At any meeting of the Board of Directors at which a quorum is present, the vote of a majority of the directors present shall constitute action by the Board of Directors, unless otherwise required by law, by the Certificate or by these Bylaws.

Section 2.12. Action by Consent. Any action required or permitted to be taken at any meeting of the Board of Directors may be taken without a meeting if all members of the Board of Directors consent thereto in writing or by electronic transmission and the writing or writings or electronic transmission or transmissions are filed with the records of the meetings of the Board of Directors. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form. Such consent shall be treated as a resolution of the Board of Directors for all purposes.

Section 2.13. Manner of Participation. Directors may participate in meetings of the Board of Directors by means of conference telephone or other communications equipment by means of which all directors participating in the meeting can hear each other, and participation in a meeting in accordance herewith shall constitute presence in person at such meeting for purposes of these Bylaws.

Section 2.14. Presiding Director. The Board of Directors shall designate a representative to preside over all meetings of the Board of Directors, provided that if the Board of Directors does not so designate such a presiding director or such designated presiding director is unable to so preside or is absent, then the Chairperson of the Board, if one is elected, shall preside over all meetings of the Board of Directors. If both the designated presiding director, if one is so designated, and the Chairperson of the Board, if one is elected, are unable to preside or are absent, the Board of Directors shall designate an alternate representative to preside over a meeting of the Board of Directors.

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Section 2.15. Committees. The Board of Directors, by vote of a majority of the directors then in office, may elect one or more committees, including, without limitation, a Compensation Committee, a Nominating & Corporate Governance Committee and an Audit Committee, and may delegate thereto some or all of its powers except those which by law, by the Certificate or by these Bylaws may not be delegated. Except as the Board of Directors may otherwise determine, any such committee may make rules for the conduct of its business, but unless otherwise provided by the Board of Directors or in such rules, its business shall be conducted so far as possible in the same manner as is provided by these Bylaws for the Board of Directors; provided that for the avoidance of doubt, any meeting of a committee of the Board shall follow the notice procedures set forth in Section 1.9. All members of such committees shall hold such offices at the pleasure of the Board of Directors. The Board of Directors may abolish any such committee at any time. Any committee to which the Board of Directors delegates any of its powers or duties shall keep records of its meetings and shall report its action to the Board of Directors.

Section 2.16. Compensation of Directors. Directors shall receive such compensation for their services as shall be determined by a majority of the Board of Directors, or a designated committee thereof, provided that directors who are serving the Corporation as employees and who receive compensation for their services as such, shall not receive any salary or other compensation for their services as directors of the Corporation.

ARTICLE III
Officers

Section 3.01. Enumeration. The officers of the Corporation shall consist of a President, a Treasurer, a Secretary and such other officers, including, without limitation, a Chairperson of the Board of Directors, a Chief Executive Officer and one or more Vice Presidents, Assistant Vice Presidents, Assistant Treasurers and Assistant Secretaries, as the Board of Directors may determine.

Section 3.02. Election. The Board of Directors shall elect, from time to time at a regular or special meeting, the President, the Treasurer and the Secretary. Other officers may be elected by the Board of Directors at any regular or special meeting.

Section 3.03. Qualification. No officer need be a stockholder or a director. Any person may occupy more than one office of the Corporation at any time.

Section 3.04. Tenure. Except as otherwise provided by the Certificate or by these Bylaws, each of the officers of the Corporation shall hold office until his or her successor is elected and qualified or until his or her earlier resignation or removal.

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Section 3.05. Resignation. Any officer may resign by delivering his or her written resignation to the Corporation addressed to the President or the Secretary, and such resignation shall be effective upon receipt, unless the resignation otherwise provides.

Section 3.06. Removal. Except as otherwise provided by law, the Board of Directors may remove any officer with or without cause by the affirmative vote of a majority of the directors then in office.

Section 3.07. Absence or Disability. In the event of the absence or disability of any officer, the Board of Directors may designate another officer to act temporarily in place of such absent or disabled officer.

Section 3.08. Vacancies. Any vacancy in any office may be filled for the unexpired portion of the term by the Board of Directors.

Section 3.09. President. The President shall, subject to the direction of the Board of Directors, have such powers and shall perform such duties as the Board of Directors may from time to time designate.

Section 3.10. Chairperson of the Board. The Chairperson of the Board, if one is elected, shall have such powers and shall perform such duties as the Board of Directors may from time to time designate.

Section 3.11. Chief Executive Officer. The Chief Executive Officer, if one is elected, shall have such powers and shall perform such duties as the Board of Directors may from time to time designate.

Section 3.12. Vice Presidents and Assistant Vice Presidents. Any Vice President and any Assistant Vice President shall have such powers and shall perform such duties as the Board of Directors or the Chief Executive Officer may from time to time designate.

Section 3.13. Treasurer and Assistant Treasurers. The Treasurer shall, subject to the direction of the Board of Directors and except as the Board of Directors or the Chief Executive Officer may otherwise provide, have general charge of the financial affairs of the Corporation and shall cause to be kept accurate books of account. The Treasurer shall have custody of all funds, securities, and valuable documents of the Corporation. He or she shall have such other duties and powers as may be designated from time to time by the Board of Directors or the Chief Executive Officer. Any Assistant Treasurer shall have such powers and perform such duties as the Board of Directors or the Chief Executive Officer may from time to time designate.

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Section 3.14. Secretary and Assistant Secretaries. The Secretary shall record all the proceedings of the meetings of the stockholders and the Board of Directors (including committees of the Board of Directors) in books kept for that purpose. In his or her absence from any such meeting, a temporary secretary chosen at the meeting shall record the proceedings thereof. The Secretary shall have charge of the stock ledger (which may, however, be kept by any transfer or other agent of the Corporation). The Secretary shall have custody of the seal of the Corporation, and the Secretary, or an Assistant Secretary shall have authority to affix it to any instrument requiring it, and, when so affixed, the seal may be attested by his or her signature or that of an Assistant Secretary. The Secretary shall have such other duties and powers as may be designated from time to time by the Board of Directors or the Chief Executive Officer. In the absence of the Secretary, any Assistant Secretary may perform his or her duties and responsibilities. Any Assistant Secretary shall have such powers and perform such duties as the Board of Directors or the Chief Executive Officer may from time to time designate.

Section 3.15. Other Powers and Duties. Subject to these Bylaws and to such limitations as the Board of Directors may from time to time prescribe, the officers of the Corporation shall each have such powers and duties as generally pertain to their respective offices, as well as such powers and duties as from time to time may be conferred by the Board of Directors or the Chief Executive Officer.

ARTICLE IV
Capital Stock

Section 4.01. Certificates of Stock. Each stockholder shall be entitled to a certificate of the capital stock of the Corporation in such form as may from time to time be prescribed by the Board of Directors. Such certificate shall be signed by any two authorized officers of the Corporation. The Corporation’s seal and the signatures by the Corporation’s officers, the transfer agent or the registrar may be facsimiles. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed on such certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if he or she were such officer, transfer agent or registrar at the time of its issue. Every certificate for shares of stock which are subject to any restriction on transfer and every certificate issued when the Corporation is authorized to issue more than one class or series of stock shall contain such legend with respect thereto as is required by law. Notwithstanding anything to the contrary provided in these Bylaws, the Board of Directors may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated shares (except that the foregoing shall not apply to shares represented by a certificate until such certificate is surrendered to the Corporation), and by the approval and adoption of these Bylaws the Board of Directors has determined that all classes or series of the Corporation’s stock may be uncertificated, whether upon original issuance, re-issuance, or subsequent transfer.

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Section 4.02. Transfers. Subject to any restrictions on transfer and unless otherwise provided by the Board of Directors, shares of stock that are represented by a certificate may be transferred on the books of the Corporation by the surrender to the Corporation or its transfer agent of the certificate theretofore properly endorsed or accompanied by a written assignment or power of attorney properly executed, with transfer stamps (if necessary) affixed, and with such proof of the authenticity of signature as the Corporation or its transfer agent may reasonably require. Shares of stock that are not represented by a certificate may be transferred on the books of the Corporation by submitting to the Corporation or its transfer agent such evidence of transfer and following such other procedures as the Corporation or its transfer agent may require.

Section 4.03. Record Holders. Except as may otherwise be required by law, by the Certificate or by these Bylaws, the Corporation shall be entitled to treat the record holder of stock as shown on its books as the owner of such stock for all purposes, including the payment of dividends and the right to vote with respect thereto, regardless of any transfer, pledge or other disposition of such stock, until the shares have been transferred on the books of the Corporation in accordance with the requirements of these Bylaws.

Section 4.04. Record Date. In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date: (a) in the case of determination of stockholders entitled to vote at any meeting of stockholders, shall, unless otherwise required by law, not be more than sixty (60) nor less than ten (10) days before the date of such meeting and (b) in the case of any other action, shall not be more than sixty (60) days prior to such other action. If no record date is fixed: (i) the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held; and (ii) the record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.

Section 4.05. Replacement of Certificates. In case of the alleged loss, destruction or mutilation of a certificate of stock of the Corporation, a duplicate certificate may be issued in place thereof, upon such terms as the Board of Directors may prescribe.

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ARTICLE V
Indemnification

Section 5.01. Definitions. For purposes of this Article:

(a) “Corporate Status” describes the status of a person who is serving or has served (i) as a Director of the Corporation, (ii) as an Officer of the Corporation, (iii) as a Non-Officer Employee of the Corporation, or (iv) as a director, partner, trustee, officer, employee or agent of any other corporation, partnership, limited liability company, joint venture, trust, employee benefit plan, foundation, association, organization or other legal entity which such person is or was serving at the request of the Corporation. For purposes of this Section 5.1(a), a Director, Officer or Non-Officer Employee of the Corporation who is serving or has served as a director, partner, trustee, officer, employee or agent of a Subsidiary shall be deemed to be serving at the request of the Corporation. Notwithstanding the foregoing, “Corporate Status” shall not include the status of a person who is serving or has served as a director, officer, employee or agent of a constituent corporation absorbed in a merger or consolidation transaction with the Corporation with respect to such person’s activities prior to said transaction, unless specifically authorized by the Board of Directors or the stockholders of the Corporation;

(b) “Director” means any person who serves or has served the Corporation as a director on the Board of Directors;

(c) “Disinterested Director” means, with respect to each Proceeding in respect of which indemnification is sought hereunder, a Director of the Corporation who is not and was not a party to such Proceeding;

(d) “Expenses” means all attorneys’ fees, retainers, court costs, transcript costs, fees of expert witnesses, private investigators and professional advisors (including, without limitation, accountants and investment bankers), travel expenses, duplicating costs, printing and binding costs, costs of preparation of demonstrative evidence and other courtroom presentation aids and devices, costs incurred in connection with document review, organization, imaging and computerization, telephone charges, postage, delivery service fees, and all other disbursements, costs or expenses of the type customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be a witness in, settling or otherwise participating in, a Proceeding;

(e) “Liabilities” means judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement;

(f) “Non-Officer Employee” means any person who serves or has served as an employee or agent of the Corporation, but who is not or was not a Director or Officer;

(g) “Officer” means any person who serves or has served the Corporation as an officer of the Corporation appointed by the Board of Directors;

(h) “Proceeding” means any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, inquiry, investigation, administrative hearing or other proceeding, whether civil, criminal, administrative, arbitrative or investigative; and

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(i) “Subsidiary” shall mean any corporation, partnership, limited liability company, joint venture, trust or other entity of which the Corporation owns (either directly or through or together with another Subsidiary of the Corporation) either (i) a general partner, managing member or other similar interest or (ii) (A) fifty percent (50%) or more of the voting power of the voting capital equity interests of such corporation, partnership, limited liability company, joint venture or other entity, or (B) fifty percent (50%) or more of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other entity.

Section 5.02. Indemnification of Directors and Officers.

(a) Subject to the operation of Section 5.4 of these Bylaws, each Director and Officer shall be indemnified and held harmless by the Corporation to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than such law permitted the Corporation to provide prior to such amendment), and to the extent authorized in this Section 5.2.

(1) Actions, Suits and Proceedings Other than By or In the Right of the Corporation. Each Director and Officer shall be indemnified and held harmless by the Corporation against any and all Expenses and Liabilities that are incurred or paid by such Director or Officer or on such Director’s or Officer’s behalf in connection with any Proceeding or any claim, issue or matter therein (other than an action by or in the right of the Corporation), which such Director or Officer is, or is threatened to be made, a party to or participant in by reason of such Director’s or Officer’s Corporate Status, if such Director or Officer acted in good faith and in a manner such Director or Officer reasonably believed to be in or not opposed to the best interests of the Corporation and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful.

(2) Actions, Suits and Proceedings By or In the Right of the Corporation. Each Director and Officer shall be indemnified and held harmless by the Corporation against any and all Expenses that are incurred by such Director or Officer or on such Director’s or Officer’s behalf in connection with any Proceeding or any claim, issue or matter therein by or in the right of the Corporation, which such Director or Officer is, or is threatened to be made, a party to or participant in by reason of such Director’s or Officer’s Corporate Status, if such Director or Officer acted in good faith and in a manner such Director or Officer reasonably believed to be in or not opposed to the best interests of the Corporation; provided, however, that no indemnification shall be made under this Section 5.2(a)(2) in respect of any claim, issue or matter as to which such Director or Officer shall have been finally adjudged by a court of competent jurisdiction to be liable to the Corporation, unless, and only to the extent that, the Court of Chancery or another court in which such Proceeding was brought shall determine upon application that, despite adjudication of liability, but in view of all the circumstances of the case, such Director or Officer is fairly and reasonably entitled to indemnification for such Expenses that such court deems proper.

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(3) Survival of Rights. The rights of indemnification provided by this Section 5.2 shall continue as to a Director or Officer after he or she has ceased to be a Director or Officer and shall inure to the benefit of his or her heirs, executors, administrators and personal representatives.

(4) Actions by Directors or Officers. Notwithstanding the foregoing, the Corporation shall indemnify any Director or Officer seeking indemnification in connection with a Proceeding initiated by such Director or Officer only if such Proceeding (including any parts of such Proceeding not initiated by such Director or Officer) was authorized in advance by the Board of Directors of the Corporation, unless such Proceeding was brought to enforce such Officer’s or Director’s rights to indemnification or, in the case of Directors, advancement of Expenses under these Bylaws in accordance with the provisions set forth herein.

Section 5.03. Indemnification of Non-Officer Employees. Subject to the operation of Section 5.4 of these Bylaws, each Non-Officer Employee may, in the discretion of the Board of Directors, be indemnified by the Corporation to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended, against any or all Expenses and Liabilities that are incurred by such Non-Officer Employee or on such Non-Officer Employee’s behalf in connection with any threatened, pending or completed Proceeding, or any claim, issue or matter therein, which such Non-Officer Employee is, or is threatened to be made, a party to or participant in by reason of such Non-Officer Employee’s Corporate Status, if such Non-Officer Employee acted in good faith and in a manner such Non-Officer Employee reasonably believed to be in or not opposed to the best interests of the Corporation and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful. The rights of indemnification provided by this Section 5.3 shall exist as to a Non-Officer Employee after he or she has ceased to be a Non-Officer Employee and shall inure to the benefit of his or her heirs, personal representatives, executors and administrators. Notwithstanding the foregoing, the Corporation may indemnify any Non-Officer Employee seeking indemnification in connection with a Proceeding initiated by such Non-Officer Employee only if such Proceeding was authorized in advance by the Board of Directors.

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Section 5.04. Determination. Unless ordered by a court, no indemnification shall be provided pursuant to this Article V to a Director, to an Officer or to a Non-Officer Employee unless a determination shall have been made that such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation and, with respect to any criminal Proceeding, such person had no reasonable cause to believe his or her conduct was unlawful. Such determination shall be made by (a) a majority vote of the Disinterested Directors, even though less than a quorum of the Board of Directors, (b) a committee comprised of Disinterested Directors, such committee having been designated by a majority vote of the Disinterested Directors (even though less than a quorum), (c) if there are no such Disinterested Directors, or if a majority of Disinterested Directors so directs, by independent legal counsel in a written opinion, or (d) by the stockholders of the Corporation.

Section 5.05. Advancement of Expenses to Directors Prior to Final Disposition.

(a) The Corporation shall advance all Expenses incurred by or on behalf of any Director in connection with any Proceeding in which such Director is involved by reason of such Director’s Corporate Status within thirty (30) days after the receipt by the Corporation of a written statement from such Director requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by such Director and shall be preceded or accompanied by an undertaking by or on behalf of such Director to repay any Expenses so advanced if it shall ultimately be determined that such Director is not entitled to be indemnified against such Expenses. Notwithstanding the foregoing, the Corporation shall advance all Expenses incurred by or on behalf of any Director seeking advancement of expenses hereunder in connection with a Proceeding initiated by such Director only if such Proceeding (including any parts of such Proceeding not initiated by such Director) was (i) authorized by the Board of Directors or (ii) brought to enforce such Director’s rights to indemnification or advancement of Expenses under these Bylaws.

(b) If a claim for advancement of Expenses hereunder by a Director is not paid in full by the Corporation within thirty (30) days after receipt by the Corporation of documentation of Expenses and the required undertaking, such Director may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim and if successful in whole or in part, such Director shall also be entitled to be paid the expenses of prosecuting such claim. The failure of the Corporation (including its Board of Directors or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning the permissibility of such advancement of Expenses under this Article V shall not be a defense to an action brought by a Director for recovery of the unpaid amount of an advancement claim and shall not create a presumption that such advancement is not permissible. The burden of proving that a Director is not entitled to an advancement of expenses shall be on the Corporation.

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(c) In any suit brought by the Corporation to recover an advancement of Expenses pursuant to the terms of an undertaking, the Corporation shall be entitled to recover such Expenses upon a final adjudication that the Director has not met any applicable standard for indemnification set forth in the DGCL.

Section 5.06. Advancement of Expenses to Officers and Non-Officer Employees Prior to Final Disposition.

(a) The Corporation may, at the discretion of the Board of Directors, advance any or all Expenses incurred by or on behalf of any Officer or any Non-Officer Employee in connection with any Proceeding in which such person is involved by reason of his or her Corporate Status as an Officer or Non-Officer Employee upon the receipt by the Corporation of a statement or statements from such Officer or Non-Officer Employee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by such Officer or Non-Officer Employee and shall be preceded or accompanied by an undertaking by or on behalf of such person to repay any Expenses so advanced if it shall ultimately be determined that such Officer or Non-Officer Employee is not entitled to be indemnified against such Expenses.

(b) In any suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation shall be entitled to recover such expenses upon a final adjudication that the Officer or Non-Officer Employee has not met any applicable standard for indemnification set forth in the DGCL.

Section 5.07. Contractual Nature of Rights.

(a) The provisions of this Article V shall be deemed to be a contract between the Corporation and each Director and Officer entitled to the benefits hereof at any time while this Article V is in effect, in consideration of such person’s past or current and any future performance of services for the Corporation. Neither amendment, repeal or modification of any provision of this Article V nor the adoption of any provision of the Certificate of Incorporation inconsistent with this Article V shall eliminate or reduce any right conferred by this Article V in respect of any act or omission occurring, or any cause of action or claim that accrues or arises or any state of facts existing, at the time of or before such amendment, repeal, modification or adoption of an inconsistent provision (even in the case of a proceeding based on such a state of facts that is commenced after such time), and all rights to indemnification and advancement of Expenses granted herein or arising out of any act or omission shall vest at the time of the act or omission in question, regardless of when or if any proceeding with respect to such act or omission is commenced. The rights to indemnification and to advancement of expenses provided by, or granted pursuant to, this Article V shall continue notwithstanding that the person has ceased to be a Director or Officer of the Corporation and shall inure to the benefit of the estate, heirs, executors, administrators, legatees and distributes of such person.

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(b) If a claim for indemnification hereunder by a Director or Officer is not paid in full by the Corporation within sixty (60) days after receipt by the Corporation of a written claim for indemnification, such Director or Officer may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim, and if successful in whole or in part, such Director or Officer shall also be entitled to be paid the expenses of prosecuting such claim. The failure of the Corporation (including its Board of Directors or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning the permissibility of such indemnification under this Article V shall not be a defense to an action brought by a Director or Officer for recovery of the unpaid amount of an indemnification claim and shall not create a presumption that such indemnification is not permissible. The burden of proving that a Director or Officer is not entitled to indemnification shall be on the Corporation.

(c) In any suit brought by a Director or Officer to enforce a right to indemnification hereunder, it shall be a defense that such Director or Officer has not met any applicable standard for indemnification set forth in the DGCL.

Section 5.08. Non-Exclusivity of Rights. The rights to indemnification and to advancement of Expenses set forth in this Article V shall not be exclusive of any other right which any Director, Officer, or Non-Officer Employee may have or hereafter acquire under any statute, provision of the Certificate or these Bylaws, agreement, vote of stockholders or Disinterested Directors or otherwise.

Section 5.09. Insurance. The Corporation may maintain insurance, at its expense, to protect itself and any Director, Officer or Non-Officer Employee against any liability of any character asserted against or incurred by the Corporation or any such Director, Officer or Non-Officer Employee, or arising out of any such person’s Corporate Status, whether or not the Corporation would have the power to indemnify such person against such liability under the DGCL or the provisions of this Article V.

Section 5.10. Other Indemnification. The Corporation’s obligation, if any, to indemnify or provide advancement of Expenses to any person under this Article V as a result of such person serving, at the request of the Corporation, as a director, partner, trustee, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount such person may collect as indemnification or advancement of Expenses from such other corporation, partnership, joint venture, trust, employee benefit plan or enterprise (the “Primary Indemnitor”). Any indemnification or advancement of Expenses under this Article V owed by the Corporation as a result of a person serving, at the request of the Corporation, as a director, partner, trustee, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall only be in excess of, and shall be secondary to, the indemnification or advancement of Expenses available from the applicable Primary Indemnitor(s) and any applicable insurance policies.

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ARTICLE VI
Miscellaneous Provisions

Section 6.01. Fiscal Year. The fiscal year of the Corporation shall be determined by the Board of Directors.

Section 6.02. Seal. The Board of Directors shall have power to adopt and alter the seal of the Corporation.

Section 6.03. Execution of Instruments. All deeds, leases, transfers, contracts, bonds, notes and other obligations to be entered into by the Corporation in the ordinary course of its business without director action may be executed on behalf of the Corporation by the Chairperson of the Board, if one is elected, the Chief Executive Officer, the President or the Treasurer or any other officer, employee or agent of the Corporation as the Board of Directors or a committee of the Board of Directors may authorize.

Section 6.04. Voting of Securities. Unless the Board of Directors otherwise provides, the Chairperson of the Board, if one is elected, the Chief Executive Officer, the President or the Treasurer may waive notice of and act on behalf of the Corporation, or appoint another person or persons to act as proxy or attorney in fact for the Corporation with or without discretionary power and/or power of substitution, at any meeting of stockholders or shareholders of any other corporation or organization, any of whose securities are held by the Corporation.

Section 6.05. Resident Agent. The Board of Directors may appoint a resident agent upon whom legal process may be served in any action or proceeding against the Corporation.

Section 6.06. Corporate Records. The original or attested copies of the Certificate, Bylaws and records of all meetings of the incorporators, stockholders and the Board of Directors and the stock transfer books, which shall contain the names of all stockholders, their record addresses and the amount of stock held by each, may be kept outside the State of Delaware and shall be kept at the principal office of the Corporation, at an office of its counsel, at an office of its transfer agent or at such other place or places as may be designated from time to time by the Board of Directors.

Section 6.07. Certificate. All references in these Bylaws to the Certificate shall be deemed to refer to the Amended and Restated Certificate of Incorporation of the Corporation, as amended and/or restated and in effect from time to time.

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Section 6.08. Exclusive Jurisdiction of Delaware Courts. Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) shall, to the fullest extent permitted by law, be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, employee, agent or stockholder of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware, the Certificate or the Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, except, in each case, any claim (A) as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within ten (10) days following such determination), (B) which is vested in the exclusive jurisdiction of a court or forum other than such court, or (C) for which such court does not have subject matter jurisdiction, provided that, for the avoidance of doubt, nothing in this Section 6.8 shall preclude the filing of claims in the federal district courts of the United States of America under the Securities Act of 1933, as amended, or any successor thereto or under the Exchange Act, or any successor thereto. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Section 6.8.

Section 6.09. Amendment of Bylaws.

(a) Amendment by Directors. Except as provided otherwise by law, these Bylaws may be amended or repealed by the Board of Directors by the affirmative vote of a majority of the directors then in office.

(b) Amendment by Stockholders. These Bylaws may be amended or repealed at any Annual Meeting, or special meeting of stockholders called for such purpose in accordance with these Bylaws, by the affirmative vote of at least sixty-six and two thirds percent (66 2/3%) of the outstanding shares entitled to vote on such amendment or repeal, voting together as a single class; provided, however, that if the Board of Directors recommends that stockholders approve such amendment or repeal at such meeting of stockholders, such amendment or repeal shall only require the affirmative vote of the majority of the outstanding shares entitled to vote on such amendment or repeal, voting together as a single class. Notwithstanding the foregoing, stockholder approval shall not be required unless mandated by the Certificate, these Bylaws, or other applicable law.

Section 6.10. Notices. If mailed, notice to stockholders shall be deemed given when deposited in the mail, postage prepaid, directed to the stockholder at such stockholder’s address as it appears on the records of the Corporation. Without limiting the manner by which notice otherwise may be given to stockholders, any notice to stockholders may be given by electronic transmission in the manner provided in Section 232 of the DGCL.

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Section 6.11. Waivers. A written waiver of any notice, signed by a stockholder or director, or waiver by electronic transmission by such person, whether given before or after the time of the event for which notice is to be given, shall be deemed equivalent to the notice required to be given to such person. Neither the business to be transacted at, nor the purpose of, any meeting need be specified in such a waiver.

Adopted _______________, 2021 and effective as of _______________, 2021.

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EX-4.2

Exhibit 4.2

MIROMATRIX MEDICAL, INC.

INVESTOR RIGHTS AGREEMENT

This INVESTOR RIGHTS AGREEMENT (this “Agreement”) is effective as of the 22nd day of November, 2011, by and among MIROMATRIX, INC., a Delaware corporation (the “Company”), and the persons and entities listed on the Schedule of Investors attached hereto as Exhibit A who hold Series A Convertible Preferred Stock, as defined herein, (such persons and entities sometimes referred to herein, together with their transferees as permitted by Section 9 as the “Holders”). Together, the parties to this Agreement are referred to as the “Parties.”

RECITALS

A.In connection with and in consideration of the purchase and sale of shares of Series A Preferred as part of a new offering, the Parties desire to provide for the registration of Common Stock to be issued upon conversion of the Series A Preferred, in accordance with the terms of this Agreement; and

B.The Company desires to also grant to each Holder certain rights with respect to the receipt of information about the Company;

NOW THEREFORE, the Parties agree as follows:

1.Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:

“Affiliate” means, as to any person, a person that directly or indirectly, through one or more intermediaries, controls or is controlled by, or is under common control with, such person. The term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting stock or an equity interest, by contract, or otherwise.

“Commission” means the Securities and Exchange Commission of the United States or any other U.S. federal agency at the time administering the Securities Act.

“Common Holder” means a holder of shares of the Company’s Common Stock.

“Common Stock” means the Common Stock of the Company, $0.00001 par value.

“Exchange Act” means the Securities Exchange Act of 1934, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same are in effect at the time.

“Family Group” has the meaning assigned in Section 9 hereof

“Form S-3” has the meaning assigned in Section 4(a) hereof.

“Indemnified Party” has the meaning assigned in Section 7(c) hereof

1

Miromatrix Medical, Inc.
Investor Rights Agreement

“Indemnifying Party” has the meaning assigned in Section 7(c) hereof

“Initiating Holders” has the meaning assigned in Section 2(a) hereof.

“IPO” means the closing of the Company’s first public offering of Common Stock pursuant to a registration statement declared effective by the Commission.

“Material Adverse Information” has the meaning assigned in Section 5(c) hereof

“Preferred Stock” means the Series A Preferred.

“Registration Expenses” means all expenses, except as otherwise stated below, incurred by the Company in complying with Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and disbursements of counsel for the Company, blue sky fees, and expenses and the expense of any special audits incident to or required by any such registration. Registration Expenses also includes the reasonable fees and disbursements of one counsel for the selling Holders up to a maximum of $5,000 for each Registration. Registration Expenses shall not include any Selling Expenses.

“Registrable Securities” means (i) Common Stock issued or issuable on conversion of Preferred Stock held by Holders; and (ii) any Common Stock issued or issuable in respect of such Common Stock upon any split, dividend, recapitalization or similar event. Common Stock or other securities will only be treated as Registrable Securities if it has not been (A) sold to or through a broker or dealer or underwriter in a public distribution or a public securities transaction or (B) sold in a transaction exempt from the registration and prospectus delivery requirements of the Securities Act so that all transfer restrictions and restrictive legends with respect thereto are removed upon the consummation of such sale.

The terms “register,” “registered” and “registration” refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement by the Commission and such other governmental or regulatory bodies as are appropriate.

“Rule 145 Transaction” means any transaction described in Rule 145(a) promulgated by the Commission under the Securities Act.

“Securities Act” means the Securities Act of 1933, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same shall be in effect at the time.

“Selling Expenses” means all underwriting discounts, selling commissions, stock transfer taxes and fees of counsel to Holders (other than the fees and disbursements of counsel specifically included in the definition of Registration Expenses) applicable to the securities registered by the Holders.

2

Miromatrix Medical, Inc.
Investor Rights Agreement

“Series A Preferred” means the Series A Convertible Preferred Stock of the Company.

2.Requested Registration.

(a)Request for Registration. In case the Company receives from the Holders of at least fifty percent (50%) of the Registrable Securities on or following the date which is six (6) months after the date the Company completes an IPO, a written request that the Company effect a registration with respect to Registrable Securities having a reasonably anticipated aggregate offering price, before deduction of underwriter discounts and commissions, of at least $2,000,000 (such requesting holder or holders, the “Initiating Holders”), the Company will:

(i) promptly give written notice of the proposed registration, qualification or compliance to all other Holders who are not Initiating Holders; and

(ii) as soon as practicable, use its reasonable best efforts to effect such registration, qualification, or compliance (including, without limitation, appropriate qualification under applicable blue sky or other state securities laws and appropriate compliance with applicable regulations issued under the Securities Act and any other governmental requirements or regulations) as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder(s) joining in such request as are specified in a written request received by the Company within twenty (20) days after the mailing of such written notice from the Company (collectively, the “Other Holders”);

Provided, however, that the Company is not obligated to take any action to effect any such registration, qualification or compliance pursuant to this Section 2 [Requested Registration]:

(A) In any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance;

(B) During the period starting with the date sixty (60) days prior to the Company’s estimated date of filing of any registration statement pertaining to securities of the Company sold by the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan) and ending one hundred eighty (180) days following the effective date of any public offering by the Company of such securities, provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective and further provided that the Company may delay any such registration not more than one time during any twelve month period;

3

Miromatrix Medical, Inc.
Investor Rights Agreement

(C) After the Company has effected one (1) registration pursuant to this Section 2 [Requested Registration], and such registration has been declared or ordered effective; or

(D) If the Company furnishes to such Initiating Holders and Other Holders a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its stockholders to temporarily delay the filing of such registration statement, then the Company’s obligation to use its best efforts to register, qualify or comply under this Section 2 [Requested Registration] shall be deferred for a period not to exceed one hundred eighty (180) days from the date of receipt of written request from the Initiating Holders.

Subject to the foregoing clauses (A) through (D), the Company will file a registration statement covering the Registrable Securities so requested to be registered as soon as practicable after receipt of the request or requests of the Initiating Holders and the Other Holders.

(b)Underwriting. In the event that the Initiating Holders indicate in their written request pursuant to Section 2(a) that a registration pursuant to this Section 2 [Requested Registration] is for a registered public offering involving an underwriting, the Company will so advise the Holders as part of the notice given pursuant to Section 2(a)(i). In such event, the right of any Holder, as the case may be, to registration pursuant to this Section 2 [Requested Registration] will be conditioned upon such Holder’s participation in the underwriting arrangements required by this Section 2 [Requested Registration], and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent requested will be limited to the extent provided herein.

The Company (together with all Initiating Holders and Other Holders proposing to distribute their securities through such underwriting) will enter into an underwriting agreement in customary form with the managing underwriter selected by the Company (which underwriter will be acceptable to a majority in interest of the Initiating Holders with such acceptance not to be unreasonably withheld). Notwithstanding any other provision of this Section 2 [Requested Registration], if the managing underwriter advises the Initiating Holders in writing that marketing factors require a limitation of the number of shares to be underwritten, then the Company will so advise the Initiating Holders and the Other Holders, and the number of Registrable Securities that may be included in the registration and underwriting will be allocated among the Initiating Holders and the Other Holders in proportion, as nearly as practicable, to the respective amounts of Registrable Securities that such Initiating Holders and Other Holders have requested pursuant to Section 2(a) hereof to include in such registration. No Registrable Securities or other securities excluded from the underwriting by reason of the underwriter’s marketing limitation will be included in such registration. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Initiating Holder or Other Holder to the nearest one hundred (100) shares.

4

Miromatrix Medical, Inc.
Investor Rights Agreement

If any Initiating Holder or Other Holder disapproves of the terms of the underwriting, such person may elect, unless otherwise agreed in writing by such Initiating Holder or Other Holder, to withdraw therefrom by written notice to the Company and the managing underwriter. The Registrable Securities or other securities so withdrawn will also be withdrawn from registration.

3.Company Registration.

(a)Notice of Registration. If the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans, (ii) a registration relating solely to a Rule 145 Transaction, or (iii) a registration on any form which does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities or a registration in which the only Common Stock being registered is Common Stock issuable upon the conversion of debt securities which are also concurrently being registered, the Company will:

(i) promptly give to each Holder written notice thereof; and

(ii) subject to Section 3(b), include in such registration (and any related qualification under blue sky laws or other compliance), and in any underwriting involved therein, all the Registrable Securities specified in a written request or requests, made within twenty (20) days after the mailing of such written notice from the Company, by any Holder. If any Holder decides not to include all of its Registrable Securities in such registration, such Holder will nevertheless continue to have the right to include any Registrable Securities in any subsequent registration statements as may be filed by the Company with respect to offerings of its securities, all upon the terms and conditions set forth herein.

(b)Underwriting. If the registration of which the Company gives notice is for a registered public offering involving an underwriting, the Company will so advise the Holders as a part of the written notice given pursuant to Section 3(a)(i). In such event, the right of any Holder to registration pursuant to this Section 3 [Company Registration] will be conditioned upon such Holder’s participation in such underwriting and the inclusion of Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting, together with the Company, will enter into an underwriting agreement in customary form with the managing underwriter selected for such underwriting by the Company. Notwithstanding any other provision of this Section 3 [Company Registration], if the managing underwriter determines that marketing factors require a limitation of the number of Registrable Securities to be underwritten, the managing underwriter may eliminate, or may limit on a m) rata basis (based on the total number of the Registrable Securities entitled to registration held by the Holder) the number of Registrable Securities to be included in such registration; provided that no such reduction will be made with respect to securities being offered by the Company for its own account. The Company will advise all Holders proposing to distribute their securities through such underwriting of any such limitations, and the number of shares of Registrable Securities that may be included in the registration. To facilitate the allocation of shares in accordance with the above provisions, the Company may round the number of Registrable Securities allocated to any Holder proposing to distribute their securities through such underwriting to the nearest one hundred (100) Registrable Securities. If any Holder proposing to distribute their securities through such underwriting disapproves of the terms of any such underwriting, he may elect, unless otherwise agreed in writing by such Holder to withdraw therefrom by written notice to the Company and the managing underwriter. Any securities excluded or withdrawn from such underwriting will be withdrawn from such registration.

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(c)Right to Terminate Registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 3 [Company Registration] prior to or after the effectiveness of such registration whether or not any Holder has elected to include Registrable Securities in such registration.

4.Registration on Form S-3.

(a)Request for Registration. If any Holder(s) request that the Company file a registration statement on Form S-3 or any successor form thereto under the Securities Act (“Form S-3”) for a public offering of Registrable Securities, the reasonably anticipated aggregate price to the public of which would exceed $1,000,000 and the Company is a registrant entitled to use Form S-3 to register the Registrable Securities for such an offering, the Company will use its reasonable best efforts to cause such Registrable Securities to be registered for the offering on such form and to cause such Registrable Securities to be qualified in such jurisdictions as the Holder(s) may reasonably request. The substantive provisions of Section 2(b) shall be applicable to each registration initiated under this Section 4 [Registration on Form S-3].

(b)Limitations. Notwithstanding the foregoing, the Company will not be obligated to take any action pursuant to this Section 4 [Registration on Form S-3]:

(i) in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance;

(ii) during the period starting with the date sixty (60) days prior to the Company’s estimated date of filing, and ending on the date one hundred eighty (180) days immediately following the effective date of any registration statement pertaining to securities of the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan), provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective, and further provided that the Company may delay any such registration not more than one time during any twelve month period;

(iii) if the Company furnishes to such Holder a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its owners to temporarily delay filing of such registration statements, then the Company’s obligation to use its best efforts to file a registration statement shall be deferred for a period not to exceed one hundred eighty (180) days from the receipt of the request to file such registration by such Holder;

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(iv) if the Company has effected a total of two (2) registrations pursuant to Section 2 [Requested Registration] and this Section 4 [Registration on Form S-3] and each such registration has been declared or ordered effective; or

(v) if the Company has effected the registration of any Registrable Securities pursuant to Section 2 [Requested Registration] or this Section 4 [Registration on Form S-3] at any time during the previous twelve (12) month period.

5.Expenses of Registration.

(a)Registration Expenses. The Company will be responsible for all Registration Expenses, exclusive of underwriting discounts and commissions or legal fees of the Holders incurred in connection with all registrations pursuant to this Agreement.

(b)Selling Expenses. Unless otherwise stated, all Selling Expenses relating to securities registered on behalf of the Holders shall be borne by the Holders pro rata on the basis of the number of Registrable Securities so registered.

(c)Expenses Upon Withdrawal. Notwithstanding anything herein to the contrary, the Company will not be required to pay (and the Holders will be required to pay as set forth below) for expenses of any registration proceeding begun pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form 5-3], the request of which has been subsequently withdrawn by the Initiating Holders unless (a) the withdrawal is based upon Material Adverse Information concerning the Company of which the Initiating Holders were not aware at the time of such request or (b) the Holders of a majority of Registrable Securities agree to forfeit their right to one (1) registration pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form S-3], as the case may be, in which event such right shall be forfeited by all Holders. If the Holders are required to pay Registration Expenses pursuant hereto, such expenses (which will not be deemed to include (i) the cost of normal audits of the Company that would have been performed in any event, or (ii) the time of any executive or other personnel of the Company involved in the preparation of the registration statement) will be borne by the Holders of securities (including Registrable Securities) requesting such registration in proportion to the number of shares for which registration was requested. For purposes of this Section 5(c), “Material Adverse Information” means information relating to any occurrence that is materially adverse as to the business, properties or financial condition of the Company, but does not include information relating to the economy or financial markets generally or the Company’s industry generally unless such information relating to the economy or financial markets would have a disproportionate effect on the Company.

6.Registration Procedures. In the case of each registration, qualification or compliance effected by the Company pursuant to this Agreement, the Company will:

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(a) Keep each Holder advised as to the initiation of each registration, qualification and compliance and as to the completion thereof;

(b)Prepare and, as soon as practicable, file with the Commission a registration statement with respect to such securities and use its reasonable best efforts to cause such registration statement to become and remain effective until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration;

(c)Prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to make and to keep such registration statement effective and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all securities proposed to be registered in such registration statement until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration statement;

(d)Furnish to the Holders participating in such registration and to the underwriters of the securities being registered such reasonable number of copies of the registration statement, preliminary prospectus, final prospectus and such other documents as such parties may reasonably request in order to facilitate the public offering of such securities; and

(e)Use its commercially reasonable best efforts to register or qualify the Registrable Securities covered by such registration statement under the securities or blue sky laws of such states as the Holders reasonably request, maintain any such registration or qualification current until the earlier of the sale of the Registrable Securities so registered or (90) days subsequent to the effective date of the registration statement; and take any and all other reasonable actions either necessary or advisable to enable the Holders to consummate the public sale or other disposition of the Registrable Securities in jurisdictions where the Holders desire to effect such sales or other disposition (but the Company is not required to take any action that would subject it to the general jurisdiction of the courts of any jurisdiction in which it is not so subject or to qualify as a foreign corporation in any jurisdiction where the Company is not so qualified).

7.Indemnification.

(a)By Company. To the extent permitted by law, the Company will indemnify each Holder, each of their officers and directors and partners, and each Affiliate of such Holder, and each underwriter, if any, and each Affiliate of any underwriter, with respect to each registration, qualification or compliance which has been effected pursuant to this Agreement, against all expenses, claims, losses, damages or liabilities (or actions in respect thereof) (collectively, “Claims”), including any Claims incurred in settlement of any litigation, commenced or threatened, arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement or prospectus, or any amendment or supplement thereto, incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and the Company will reimburse each such Holder, each of their officers and directors and Affiliates, each such underwriter and their Affiliates, for any legal and any other expenses reasonably incurred in connection with investigating, preparing or defending any such Claim, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld, delayed or conditioned), and the Company will not be liable in any such case to the extent that any such Claim arises out of or is based on any untrue statement or omission or alleged untrue statement or omission, made in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, Affiliate or underwriter. If the Holders are represented by counsel other than counsel for the Company, the Company will not be obligated under this Section 7(a) to reimburse legal fees and expenses of more than one separate counsel for the Holders.

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(b)By Holders. To the extent permitted by law, each Holder will, if Registrable Securities held by such Holder are included in the securities as to which such registration, qualification or compliance is being effected, indemnify the Company, each of its directors and officers and its legal counsel and independent accountants, each underwriter, if any, of the Company’s securities covered by such a registration statement, each Affiliate of the Company or such underwriter, and each other such Holder, each of their officers and directors and each Affiliate, against all Claims (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document, or any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and will reimburse the Company, such Holders, such directors, officers, legal counsel, independent accountants, persons, underwriters or Affiliates for any legal or any other expenses reasonably incurred in connection with investigating or defending any such Claim in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular or other document in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld, delayed or conditioned.

(c)Procedures. Each party entitled to indemnification under this Section 7 [Indemnification] (the “Indemnified Party”) will give notice to the party required to provide indemnification (the “Indemnifying Party”) promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and will permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom, provided that counsel for the Indemnifying Party, who will conduct the defense of such claim or litigation, will be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at its own expense; provided, however, that the failure of any Indemnified Party to give notice as provided herein will not relieve the Indemnifying Party of its obligations under this Agreement unless the failure to give such notice is prejudicial to an Indemnifying Party’s ability to defend such action. No Indemnifying Party, in the defense of any such claim or litigation, will, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation.

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(d)Contributions. If the indemnification provided for in this Section 7 [Indemnification] is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any Claim, the Indemnifying Party, in lieu of indemnifying such Indemnified Party thereunder, will, to the extent permitted by applicable law contribute to the amount paid or payable by such Indemnified Party as a result of such Claim in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other in connection with that which resulted in such Claim, as well as any other relevant equitable considerations. The relative fault of the Indemnifying Party and of the Indemnified Party will be determined by a court of law by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party and the parties’ relative intent, provided that, in no event will any contribution by a Holder pursuant to this Section 7(d) exceed the proceeds from the offering received by such Holder.

8.Information by Holder. The Holder(s) of Registrable Securities included in any registration will furnish to the Company such information, including information regarding such Holder(s), the Registrable Securities held by them and the distribution proposed, as the Company may request in writing to enable the Company to comply with the provisions hereof in connection with any registration, qualification or compliance referred to in this Agreement. It shall be a condition precedent to the obligations of the Company to take any action pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] with respect to Registrable Securities of any Holder that such Holder shall furnish to the Company such information.

9.Transfer of Registration Rights. The rights to cause the Company to register securities granted Holders under Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof may be assigned (but only with all related obligations) in connection with any transfer or assignment by a Holder of Registrable Securities, provided that: (i) such transfer or assignment is for at least twenty-five percent (25%) of such Holder’s Registrable Securities (except for transfers in which the transferor is a partnership and the transferee is a partner or former partner in such partnership or transfers to a Holder’s Family Group, in which case such rights may be transferred without regard to the number of shares so transferred); (ii) such transfer of any Registrable Securities is lawful under all applicable securities laws; and (iii) such Assignment will only be effective only if immediately following such transfer the transferee agrees in writing delivered promptly to the Company to be bound by the terms and conditions of this Agreement as though the transferee were a Holder hereunder. The transfer or assignment of all Registrable Securities of any Holder will divest such transferring or assigning Holder of registration rights hereunder. “Family Group” means such Holder’s spouse, siblings, ancestors and descendants (whether natural or adopted), any spouses of such siblings, ancestors and descendants, any siblings of such ancestors and descendants, and any trust established solely for the benefit of one or more of such Holder, spouse, siblings, ancestors and/or descendants.

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10. Termination. All rights granted and obligations imposed pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] of this Agreement shall terminate (i) as to all Holders on the earlier of three (3) years after the date of the Company’s IPO or (ii) as to each Holder at such time as such Holder (together with such Holder’s Affiliates) can sell all of such Holder’s Registrable Securities pursuant to Rule 144 under the Securities Act within any three (3) month period.

11.Information Rights.

(a)Delivery of Annual Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, an income statement for such fiscal year and a balance sheet of the Company as of the end of such year, such year-end financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles.

(b)Delivery of Quarterly Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three fiscal quarters of the Company, an income statement for such fiscal quarter and a balance sheet of the Company as of the end of such quarter, such financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles. The Company will accompany each delivery of quarterly financial statements with a letter to the Holders updating them on the current progress of the Company.

(c)Termination of Information Covenants. The covenants set forth in this Section 11 [Information Rights] shall terminate as to each Holder and be of no further force or effect immediately upon the IPO. The information rights may be transferred to a transferee, provided that the Company is given prior written notice of such transfer.

(d)Confidentiality of Information. Each Holder agrees that any information obtained by such Holder pursuant to this Section 11 [Information Rights] which is, or would reasonably be perceived to be, proprietary to the Company or otherwise confidential will not be used or disclosed without the prior written consent of the Company. Each Holder further acknowledges and understands that any information so obtained which may be considered material non-public information will not be utilized by such Holder in connection with purchases and/or sales of the Company’s securities, except in compliance with applicable state and federal antifraud statutes.

12.Miscellaneous.

(a)Governing Law. This Agreement will be governed by and construed under the internal laws of the State of Delaware, without regard to conflicts of laws provisions.

(b)Exclusive Jurisdiction.

THE PARTIES AGREE THAT ALL DISPUTES ARISING AMONG THEM ARISING OUT OF, IN CONNECTION WITH, RELATED TO, OR INCIDENTAL TO THE RELATIONSHIP AMONG THE PARTIES TO THIS AGREEMENT, WHETHER ARISING IN CONTRACT, TORT, EQUITY OR OTHERWISE, SHALL BE RESOLVED ONLY IN THE UNITED STATES FEDERAL COURTS OR MINNESOTA STATE COURTS LOCATED IN HENNEPIN COUNTY, MINNESOTA. THE PARTIES WAIVE IN ALL DISPUTES ANY OBJECTIONS THEY MAY HAVE TO THE LOCATION OF ANY COURT LOCATED IN HENNEPIN COUNTY, MINNESOTA CONSIDERING ANY SUCH DISPUTE.

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(c)Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Holders of 50% of the then outstanding Registrable Securities. Any amendment or waiver effected in accordance with this paragraph will be binding upon the Company and each Holder of any securities subject to this Agreement (including securities into which such securities are convertible) and future holders of all such securities. Any Holder may waive its rights or the Company’s obligations hereunder without obtaining the consent of any other person.

(d)Severability. If any provision of this Agreement or any portion thereof is finally determined to be unlawful or unenforceable, such provision or portion thereof will be deemed to be severed from this Agreement. Every other provision, and any portion of such an invalidated provision that is not invalidated by such a determination, will remain in full force and effect.

(e)Notices. Any notice required or permitted under this Agreement must be given in writing and will be deemed effectively given upon personal delivery; upon confirmed transmission by telecopy or telex; or upon deposit with a national postal service, postage prepaid, addressed, (i) if to the Company: 18683 Bearpath Trail, Eden Prairie, MN 55347, Attention: President and CEO, and (ii) if to the Holders, at the address for such Holders listed on the signature page of this Agreement. All notices shall be delivered to the addresses maintained in the Company’s records for such Holders. Notices will be effective upon receipt, or in the case of delivery by mail, ten (10) days after being deposited, first class postage prepaid, in the mails of a national postal service, or in the case of notice by facsimile copy, when verbal communication of receipt is obtained, in each case when addressed as aforesaid.

(f)Entire Agreement; Successors. This Agreement constitutes the entire agreement among the parties hereto pertaining to the subject matter hereof, and any and other written or oral agreements pertaining to the subject matter hereof between or among any parties hereto are expressly canceled. Subject to the terms hereof, this Agreement will inure to the benefit of any successor or assign of any party hereto.

(g)Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument, and any of which will be enforceable against the person who has executed the same.

(h)Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

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(i) Execution and Delivery. A facsimile, telecopy, .pdf or other reproduction of this Agreement may be executed by one or more parties hereto, and an executed copy of this Agreement may be delivered by one or more parties hereto by facsimile, .pdf or similar electronic transmission device pursuant to which the signature of or on behalf of such party can be seen, and such execution and delivery will be considered valid, binding and effective for all purposes.

(signature page follows]

*          *          *

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IN WITNESS WHEREOF, the parties have executed this Investor Rights Agreement as of the date first above written.

COMPANY:	MIROMATRIX MEDICAL, INC.
	By:	/s/ Robert Cohen
		Robert Cohen, CEO

HOLDER:

Individual Holder:	Signature:
	Print Name:
Entity Holder:	Name of Entity:
	By (signature):
	Title:

[Signature Page to Investor Rights Agreement)

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EX-4.3

Exhibit 4.3

MIROMATRIX MEDICAL INC.

INVESTOR RIGHTS AGREEMENT

This INVESTOR RIGHTS AGREEMENT (this “Agreement”) is effective as of the 8^th day of October, 2013, by and among MIROMATRIX MEDICAL INC., a Delaware corporation (the “Company”), and the persons and entities listed on the Schedule of Investors attached hereto as Exhibit A who hold Series B Convertible Preferred Stock, as defined herein, (such persons and entities sometimes referred to herein, together with their transferees as permitted by Section 9 as the “Holders”). Together, the parties to this Agreement are referred to as the “Parties.”

RECITALS

A.       In connection with and in consideration of the purchase and sale of shares of Series B Preferred as part of a new offering, the Parties desire to provide for the registration of Common Stock to be issued upon conversion of the Series B Preferred, in accordance with the terms of this Agreement; and

B.       The Company desires to also grant to each Holder certain rights with respect to the receipt of information about the Company;

NOW THEREFORE, the Parties agree as follows:

1.)Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:

“Affiliate” means, as to any person, a person that directly or indirectly, through one or more intermediaries, controls or is controlled by, or is under common control with, such person. The term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting stock or an equity interest, by contract, or otherwise.

“Commission” means the Securities and Exchange Commission of the United States or any other U.S. federal agency at the time administering the Securities Act.

“Common Holder” means a holder of shares of the Company’s Common Stock.

“Common Stock” means the Common Stock of the Company, $0.00001 par value.

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“Exchange Act” means the Securities Exchange Act of 1934, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same are in effect at the time.

“Family Group” has the meaning assigned in Section 9 hereof.

“Form S-3” has the meaning assigned in Section 4(a) hereof.

“Indemnified Party” has the meaning assigned in Section 7(c) hereof.

“Indemnifying Party” has the meaning assigned in Section 7(c) hereof.

“Initiating Holders” has the meaning assigned in Section 2(a) hereof.

“IPO” means the closing of the Company’s first public offering of Common Stock pursuant to a registration statement declared effective by the Commission.

“Material Adverse Information” has the meaning assigned in Section 5(c) hereof.

“Preferred Stock” means the Series B Preferred.

“Registration Expenses” means all expenses, except as otherwise stated below, incurred by the Company in complying with Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and disbursements of counsel for the Company, blue sky fees, and expenses and the expense of any special audits incident to or required by any such registration. Registration Expenses also includes the reasonable fees and disbursements of one counsel for the selling Holders up to a maximum of $5,000 for each Registration. Registration Expenses shall not include any Selling Expenses.

“Registrable Securities” means (i) Common Stock issued or issuable on conversion of Preferred Stock held by Holders; and (ii) any Common Stock issued or issuable in respect of such Common Stock upon any split, dividend, recapitalization or similar event. Common Stock or other securities will only be treated as Registrable Securities if it has not been (A) sold to or through a broker or dealer or underwriter in a public distribution or a public securities transaction or (B) sold in a transaction exempt from the registration and prospectus delivery requirements of the Securities Act so that all transfer restrictions and restrictive legends with respect thereto are removed upon the consummation of such sale.

The terms “register,” “registered” and “registration” refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement by the Commission and such other governmental or regulatory bodies as are appropriate.

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“Rule 145 Transaction” means any transaction described in Rule 145(a) promulgated by the Commission under the Securities Act.

“Securities Act” means the Securities Act of 1933, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same shall be in effect at the time.

“Selling Expenses” means all underwriting discounts, selling commissions, stock transfer taxes and fees of counsel to Holders (other than the fees and disbursements of counsel specifically included in the definition of Registration Expenses) applicable to the securities registered by the Holders.

“Series B Preferred” means the Series B Convertible Preferred Stock of the Company.

2.)Requested Registration.

(a)Request for Registration. In case the Company receives from the Holders of at least fifty percent (50%) of the Registrable Securities on or following the date which is six (6) months after the date the Company completes an IPO, a written request that the Company effect a registration with respect to Registrable Securities having a reasonably anticipated aggregate offering price, before deduction of underwriter discounts and commissions, of at least $2,000,000 (such requesting holder or holders, the “Initiating Holders”), the Company will:

i. promptly give written notice of the proposed registration, qualification or compliance to all other Holders who are not Initiating Holders; and

ii. as soon as practicable, use its reasonable best efforts to effect such registration, qualification, or compliance (including, without limitation, appropriate qualification under applicable blue sky or other state securities laws and appropriate compliance with applicable regulations issued under the Securities Act and any other governmental requirements or regulations) as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder(s) joining in such request as are specified in a written request received by the Company within twenty (20) days after the mailing of such written notice from the Company (collectively, the “Other Holders”);

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Provided, however, that the Company is not obligated to take any action to effect any such registration, qualification or compliance pursuant to this Section 2 [Requested Registration]:

A. In any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance;

B. During the period starting with the date sixty (60) days prior to the Company’s estimated date of filing of any registration statement pertaining to securities of the Company sold by the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan) and ending one hundred eighty (180) days following the effective date of any public offering by the Company of such securities, provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective and further provided that the Company may delay any such registration not more than one time during any twelve month period;

C. After the Company has effected one (1) registration pursuant to this Section 2 [Requested Registration], and such registration has been declared or ordered effective; or

D. If the Company furnishes to such Initiating Holders and Other Holders a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its stockholders to temporarily delay the filing of such registration statement, then the Company’s obligation to use its best efforts to register, qualify or comply under this Section 2 [Requested Registration] shall be deferred for a period not to exceed one hundred eighty (180) days from the date of receipt of written request from the Initiating Holders.

Subject to the foregoing clauses (A) through (D), the Company will file a registration statement covering the Registrable Securities so requested to be registered as soon as practicable after receipt of the request or requests of the Initiating Holders and the Other Holders.

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(b)Underwriting. In the event that the Initiating Holders indicate in their written request pursuant to Section 2(a) that a registration pursuant to this Section 2 [Requested Registration] is for a registered public offering involving an underwriting, the Company will so advise the Holders as part of the notice given pursuant to Section 2(a)(i). In such event, the right of any Holder, as the case may be, to registration pursuant to this Section 2 [Requested Registration] will be conditioned upon such Holder’s participation in the underwriting arrangements required by this Section 2 [Requested Registration], and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent requested will be limited to the extent provided herein.

The Company (together with all Initiating Holders and Other Holders proposing to distribute their securities through such underwriting) will enter into an underwriting agreement in customary form with the managing underwriter selected by the Company (which underwriter will be acceptable to a majority in interest of the Initiating Holders with such acceptance not to be unreasonably withheld). Notwithstanding any other provision of this Section 2 [Requested Registration], if the managing underwriter advises the Initiating Holders in writing that marketing factors require a limitation of the number of shares to be underwritten, then the Company will so advise the Initiating Holders and the Other Holders, and the number of Registrable Securities that may be included in the registration and underwriting will be allocated among the Initiating Holders and the Other Holders in proportion, as nearly as practicable, to the respective amounts of Registrable Securities that such Initiating Holders and Other Holders have requested pursuant to Section 2(a) hereof to include in such registration. No Registrable Securities or other securities excluded from the underwriting by reason of the underwriter’s marketing limitation will be included in such registration. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Initiating Holder or Other Holder to the nearest one hundred (100) shares.

If any Initiating Holder or Other Holder disapproves of the terms of the underwriting, such person may elect, unless otherwise agreed in writing by such Initiating Holder or Other Holder, to withdraw therefrom by written notice to the Company and the managing underwriter. The Registrable Securities or other securities so withdrawn will also be withdrawn from registration.

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3.)Company Registration.

(a)Notice of Registration. If the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans, (ii) a registration relating solely to a Rule 145 Transaction, or (iii) a registration on any form which does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities or a registration in which the only Common Stock being registered is Common Stock issuable upon the conversion of debt securities which are also concurrently being registered, the Company will:

i. promptly give to each Holder written notice thereof; and

ii. subject to Section 3(b), include in such registration (and any related qualification under blue sky laws or other compliance), and in any underwriting involved therein, all the Registrable Securities specified in a written request or requests, made within twenty (20) days after the mailing of such written notice from the Company, by any Holder. If any Holder decides not to include all of its Registrable Securities in such registration, such Holder will nevertheless continue to have the right to include any Registrable Securities in any subsequent registration statements as may be filed by the Company with respect to offerings of its securities, all upon the terms and conditions set forth herein.

(b)Underwriting. If the registration of which the Company gives notice is for a registered public offering involving an underwriting, the Company will so advise the Holders as a part of the written notice given pursuant to Section 3(a)(i). In such event, the right of any Holder to registration pursuant to this Section 3 [Company Registration] will be conditioned upon such Holder’s participation in such underwriting and the inclusion of Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting, together with the Company, will enter into an underwriting agreement in customary form with the managing underwriter selected for such underwriting by the Company. Notwithstanding any other provision of this Section 3 [Company Registration], if the managing underwriter determines that marketing factors require a limitation of the number of Registrable Securities to be underwritten, the managing underwriter may eliminate, or may limit on a pro rata basis (based on the total number of the Registrable Securities entitled to registration held by the Holder) the number of Registrable Securities to be included in such registration; provided that no such reduction will be made with respect to securities being offered by the Company for its own account. The Company will advise all Holders proposing to distribute their securities through such underwriting of any such limitations, and the number of shares of Registrable Securities that may be included in the registration. To facilitate the allocation of shares in accordance with the above provisions, the Company may round the number of Registrable Securities allocated to any Holder proposing to distribute their securities through such underwriting to the nearest one hundred (100) Registrable Securities. If any Holder proposing to distribute their securities through such underwriting disapproves of the terms of any such underwriting, he may elect, unless otherwise agreed in writing by such Holder to withdraw therefrom by written notice to the Company and the managing underwriter. Any securities excluded or withdrawn from such underwriting will be withdrawn from such registration.

(c)Right to Terminate Registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 3 [Company Registration] prior to or after the effectiveness of such registration whether or not any Holder has elected to include Registrable Securities in such registration.

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4.)Registration on Form S-3.

(a)Request for Registration. If any Holder(s) request that the Company file a registration statement on Form S-3 or any successor form thereto under the Securities Act (“Form S-3”) for a public offering of Registrable Securities, the reasonably anticipated aggregate price to the public of which would exceed $1,000,000 and the Company is a registrant entitled to use Form S-3 to register the Registrable Securities for such an offering, the Company will use its reasonable best efforts to cause such Registrable Securities to be registered for the offering on such form and to cause such Registrable Securities to be qualified in such jurisdictions as the Holder(s) may reasonably request. The substantive provisions of Section 2(b) shall be applicable to each registration initiated under this Section 4 [Registration on Form S-3].

(b)Limitations. Notwithstanding the foregoing, the Company will not be obligated to take any action pursuant to this Section 4 [Registration on Form S-3]:

i. in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance;

ii. during the period starting with the date sixty (60) days prior to the Company’s estimated date of filing, and ending on the date one hundred eighty (180) days immediately following the effective date of any registration statement pertaining to securities of the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan), provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective, and further provided that the Company may delay any such registration not more than one time during any twelve month period;

iii. if the Company furnishes to such Holder a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its owners to temporarily delay filing of such registration statements, then the Company’s obligation to use its best efforts to file a registration statement shall be deferred for a period not to exceed one hundred eighty (180) days from the receipt of the request to file such registration by such Holder;

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iv. if the Company has effected a total of two (2) registrations pursuant to Section 2 [Requested Registration] and this Section 4 [Registration on Form S-3] and each such registration has been declared or ordered effective; or

v. if the Company has effected the registration of any Registrable Securities pursuant to Section 2 [Requested Registration] or this Section 4 [Registration on Form S-3] at any time during the previous twelve (12) month period.

5.)Expenses of Registration.

(a)Registration Expenses. The Company will be responsible for all Registration Expenses, exclusive of underwriting discounts and commissions or legal fees of the Holders incurred in connection with all registrations pursuant to this Agreement.

(b)Selling Expenses. Unless otherwise stated, all Selling Expenses relating to securities registered on behalf of the Holders shall be borne by the Holders pro rata on the basis of the number of Registrable Securities so registered.

(c)Expenses Upon Withdrawal. Notwithstanding anything herein to the contrary, the Company will not be required to pay (and the Holders will be required to pay as set forth below) for expenses of any registration proceeding begun pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form S-3], the request of which has been subsequently withdrawn by the Initiating Holders unless (a) the withdrawal is based upon Material Adverse Information concerning the Company of which the Initiating Holders were not aware at the time of such request or (b) the Holders of a majority of Registrable Securities agree to forfeit their right to one (1) registration pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form S-3], as the case may be, in which event such right shall be forfeited by all Holders. If the Holders are required to pay Registration Expenses pursuant hereto, such expenses (which will not be deemed to include (i) the cost of normal audits of the Company that would have been performed in any event, or (ii) the time of any executive or other personnel of the Company involved in the preparation of the registration statement) will be borne by the Holders of securities (including Registrable Securities) requesting such registration in proportion to the number of shares for which registration was requested. For purposes of this Section 5(c), “Material Adverse Information” means information relating to any occurrence that is materially adverse as to the business, properties or financial condition of the Company, but does not include information relating to the economy or financial markets generally or the Company’s industry generally unless such information relating to the economy or financial markets would have a disproportionate effect on the Company.

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6.)Registration Procedures. In the case of each registration, qualification or compliance effected by the Company pursuant to this Agreement, the Company will:

(a)Keep each Holder advised as to the initiation of each registration, qualification and compliance and as to the completion thereof;

(b)Prepare and, as soon as practicable, file with the Commission a registration statement with respect to such securities and use its reasonable best efforts to cause such registration statement to become and remain effective until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration;

(c)Prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to make and to keep such registration statement effective and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all securities proposed to be registered in such registration statement until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration statement;

(d)Furnish to the Holders participating in such registration and to the underwriters of the securities being registered such reasonable number of copies of the registration statement, preliminary prospectus, final prospectus and such other documents as such parties may reasonably request in order to facilitate the public offering of such securities; and

(e)Use its commercially reasonable best efforts to register or qualify the Registrable Securities covered by such registration statement under the securities or blue sky laws of such states as the Holders reasonably request, maintain any such registration or qualification current until the earlier of the sale of the Registrable Securities so registered or (90) days subsequent to the effective date of the registration statement; and take any and all other reasonable actions either necessary or advisable to enable the Holders to consummate the public sale or other disposition of the Registrable Securities in jurisdictions where the Holders desire to effect such sales or other disposition (but the Company is not required to take any action that would subject it to the general jurisdiction of the courts of any jurisdiction in which it is not so subject or to qualify as a foreign corporation in any jurisdiction where the Company is not so qualified).

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7.) Indemnification.

(a)By Company. To the extent permitted by law, the Company will indemnify each Holder, each of their officers and directors and partners, and each Affiliate of such Holder, and each underwriter, if any, and each Affiliate of any underwriter, with respect to each registration, qualification or compliance which has been effected pursuant to this Agreement, against all expenses, claims, losses, damages or liabilities (or actions in respect thereof) (collectively, “Claims”), including any Claims incurred in settlement of any litigation, commenced or threatened, arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement or prospectus, or any amendment or supplement thereto, incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and the Company will reimburse each such Holder, each of their officers and directors and Affiliates, each such underwriter and their Affiliates, for any legal and any other expenses reasonably incurred in connection with investigating, preparing or defending any such Claim, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld, delayed or conditioned), and the Company will not be liable in any such case to the extent that any such Claim arises out of or is based on any untrue statement or omission or alleged untrue statement or omission, made in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, Affiliate or underwriter. If the Holders are represented by counsel other than counsel for the Company, the Company will not be obligated under this Section 7(a) to reimburse legal fees and expenses of more than one separate counsel for the Holders.

(b)By Holders. To the extent permitted by law, each Holder will, if Registrable Securities held by such Holder are included in the securities as to which such registration, qualification or compliance is being effected, indemnify the Company, each of its directors and officers and its legal counsel and independent accountants, each underwriter, if any, of the Company’s securities covered by such a registration statement, each Affiliate of the Company or such underwriter, and each other such Holder, each of their officers and directors and each Affiliate, against all Claims (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document, or any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and will reimburse the Company, such Holders, such directors, officers, legal counsel, independent accountants, persons, underwriters or Affiliates for any legal or any other expenses reasonably incurred in connection with investigating or defending any such Claim in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular or other document in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld, delayed or conditioned.

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(c)Procedures. Each party entitled to indemnification under this Section 7 [Indemnification] (the “Indemnified Party”) will give notice to the party required to provide indemnification (the “Indemnifying Party”) promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and will permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom, provided that counsel for the Indemnifying Party, who will conduct the defense of such claim or litigation, will be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at its own expense; provided, however, that the failure of any Indemnified Party to give notice as provided herein will not relieve the Indemnifying Party of its obligations under this Agreement unless the failure to give such notice is prejudicial to an Indemnifying Party’s ability to defend such action. No Indemnifying Party, in the defense of any such claim or litigation, will, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation.

(d)Contributions. If the indemnification provided for in this Section 7 [Indemnification] is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any Claim, the Indemnifying Party, in lieu of indemnifying such Indemnified Party thereunder, will, to the extent permitted by applicable law contribute to the amount paid or payable by such Indemnified Party as a result of such Claim in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other in connection with that which resulted in such Claim, as well as any other relevant equitable considerations. The relative fault of the Indemnifying Party and of the Indemnified Party will be determined by a court of law by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party and the parties’ relative intent, provided that, in no event will any contribution by a Holder pursuant to this Section 7(d) exceed the proceeds from the offering received by such Holder.

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8.)Information by Holder. The Holder(s) of Registrable Securities included in any registration will furnish to the Company such information, including information regarding such Holder(s), the Registrable Securities held by them and the distribution proposed, as the Company may request in writing to enable the Company to comply with the provisions hereof in connection with any registration, qualification or compliance referred to in this Agreement. It shall be a condition precedent to the obligations of the Company to take any action pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] with respect to Registrable Securities of any Holder that such Holder shall furnish to the Company such information.

9.)Transfer of Registration Rights. The rights to cause the Company to register securities granted Holders under Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof may be assigned (but only with all related obligations) in connection with any transfer or assignment by a Holder of Registrable Securities, provided that: (i) such transfer or assignment is for at least twenty-five percent (25%) of such Holder’s Registrable Securities (except for transfers in which the transferor is a partnership and the transferee is a partner or former partner in such partnership or transfers to a Holder’s Family Group, in which case such rights may be transferred without regard to the number of shares so transferred); (ii) such transfer of any Registrable Securities is lawful under all applicable securities laws; and (iii) such Assignment will only be effective only if immediately following such transfer the transferee agrees in writing delivered promptly to the Company to be bound by the terms and conditions of this Agreement as though the transferee were a Holder hereunder. The transfer or assignment of all Registrable Securities of any Holder will divest such transferring or assigning Holder of registration rights hereunder. “Family Group” means such Holder’s spouse, siblings, ancestors and descendants (whether natural or adopted), any spouses of such siblings, ancestors and descendants, any siblings of such ancestors and descendants, and any trust established solely for the benefit of one or more of such Holder, spouse, siblings, ancestors and/or descendants.

10.)Termination. All rights granted and obligations imposed pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] of this Agreement shall terminate (i) as to all Holders on the earlier of three (3) years after the date of the Company’s IPO or (ii) as to each Holder at such time as such Holder (together with such Holder’s Affiliates) can sell all of such Holder’s Registrable Securities pursuant to Rule 144 under the Securities Act within any three (3) month period.

11.) Information Rights.

(a)Delivery of Annual Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, an income statement for such fiscal year and a balance sheet of the Company as of the end of such year, such year-end financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles.

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(b)Delivery of Quarterly Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three fiscal quarters of the Company, an income statement for such fiscal quarter and a balance sheet of the Company as of the end of such quarter, such financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles. The Company will accompany each delivery of quarterly financial statements with a letter to the Holders updating them on the current progress of the Company.

(c)Termination of Information Covenants. The covenants set forth in this Section 11 [Information Rights] shall terminate as to each Holder and be of no further force or effect immediately upon the IPO. The information rights may be transferred to a transferee, provided that the Company is given prior written notice of such transfer.

(d)Confidentiality of Information. Each Holder agrees that any information obtained by such Holder pursuant to this Section 11 [Information Rights] which is, or would reasonably be perceived to be, proprietary to the Company or otherwise confidential will not be used or disclosed without the prior written consent of the Company. Each Holder further acknowledges and understands that any information so obtained which may be considered material non-public information will not be utilized by such Holder in connection with purchases and/or sales of the Company’s securities, except in compliance with applicable state and federal antifraud statutes.

12.)Miscellaneous.

(a)Governing Law. This Agreement will be governed by and construed under the internal laws of the State of Delaware, without regard to conflicts of laws provisions.

(b)Exclusive Jurisdiction.

THE PARTIES AGREE THAT ALL DISPUTES ARISING AMONG THEM ARISING OUT OF, IN CONNECTION WITH, RELATED TO, OR INCIDENTAL TO THE RELATIONSHIP AMONG THE PARTIES TO THIS AGREEMENT, WHETHER ARISING IN CONTRACT, TORT, EQUITY OR OTHERWISE, SHALL BE RESOLVED ONLY IN THE UNITED STATES FEDERAL COURTS OR MINNESOTA STATE COURTS LOCATED IN HENNEPIN COUNTY, MINNESOTA. THE PARTIES WAIVE IN ALL DISPUTES ANY OBJECTIONS THEY MAY HAVE TO THE LOCATION OF ANY COURT LOCATED IN HENNEPIN COUNTY, MINNESOTA CONSIDERING ANY SUCH DISPUTE.

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(c) Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Holders of 50% of the then outstanding Registrable Securities. Any amendment or waiver effected in accordance with this paragraph will be binding upon the Company and each Holder of any securities subject to this Agreement (including securities into which such securities are convertible) and future holders of all such securities. Any Holder may waive its rights or the Company’s obligations hereunder without obtaining the consent of any other person.

(d)Severability. If any provision of this Agreement or any portion thereof is finally determined to be unlawful or unenforceable, such provision or portion thereof will be deemed to be severed from this Agreement. Every other provision, and any portion of such an invalidated provision that is not invalidated by such a determination, will remain in full force and effect.

(e)Notices. Any notice required or permitted under this Agreement must be given in writing and will be deemed effectively given upon personal delivery; upon confirmed transmission by telecopy or telex; or upon deposit with a national postal service, postage prepaid, addressed, (i) if to the Company: 18683 Bearpath Trail, Eden Prairie, MN 55347, Attention: President and CEO, and (ii) if to the Holders, at the address for such Holders listed on the signature page of this Agreement. All notices shall be delivered to the addresses maintained in the Company’s records for such Holders. Notices will be effective upon receipt, or in the case of delivery by mail, ten (10) days after being deposited, first class postage prepaid, in the mails of a national postal service, or in the case of notice by facsimile copy, when verbal communication of receipt is obtained, in each case when addressed as aforesaid.

(f)Entire Agreement; Successors. This Agreement constitutes the entire agreement among the parties hereto pertaining to the subject matter hereof, and any and other written or oral agreements pertaining to the subject matter hereof between or among any parties hereto are expressly canceled. Subject to the terms hereof, this Agreement will inure to the benefit of any successor or assign of any party hereto.

(g)Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument, and any of which will be enforceable against the person who has executed the same.

(h)Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

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(i) Execution and Delivery. A facsimile, telecopy, .pdf or other reproduction of this Agreement may be executed by one or more parties hereto, and an executed copy of this Agreement may be delivered by one or more parties hereto by facsimile, .pdf or similar electronic transmission device pursuant to which the signature of or on behalf of such party can be seen, and such execution and delivery will be considered valid, binding and effective for all purposes.

(signature page follows]

*         *          *

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IN WITNESS WHEREOF, the parties have executed this Investor Rights Agreement as of the date first above written.

COMPANY:	MIROMATRIX MEDICAL INC.
	By:	/s/ Robert Cohen
		Robert Cohen, CEO

[Signature Page to Investor Rights Agreement]

IN WITNESS WHEREOF, the parties have executed this Investor Rights Agreement as of the date first above written.

HOLDER:
Individual Holder:	Signature:
	Print Name:

Entity Holder:	Name of Entity:
	By (signature):

Print Signatory Name:

Title:

[Signature Page to Investor Rights Agreement]

EX-4.4

Exhibit 4.4

MIROMATRIX MEDICAL INC.

INVESTOR RIGHTS AGREEMENT

This INVESTOR RIGHTS AGREEMENT (this "Agreement") is effective as of the 16th day of October, 2017, by and among MIROMATRIX MEDICAL INC., a Delaware corporation (the "Company"), and the persons and entities listed on the Schedule of Investors attached hereto as Exhibit A who hold Series B-2 Convertible Preferred Stock, as defined herein, (such persons and entities sometimes referred to herein, together with their transferees as permitted by Section 9 as the "Holders"). Together, the parties to this Agreement are referred to as the "Parties."

RECITALS

A.       In connection with and in consideration of the purchase and sale of shares of Series B-2 Preferred as part of a new offering, the Parties desire to provide for the registration of Common Stock to be issued upon conversion of the Series B-2 Preferred, in accordance with the terms of this Agreement; and

B.       The Company desires to also grant to each Holder certain rights with respect to the receipt of information about the Company;

NOW THEREFORE, the Parties agree as follows:

1.)Certain Definitions. As used in this Agreement, the following terms shall have the following respective meanings:

"Affiliate" means, as to any person, a person that directly or indirectly, through one or more intermediaries, controls or is controlled by, or is under common control with, such person. The term "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting stock or an equity interest, by contract, or otherwise.

"Commission" means the Securities and Exchange Commission of the United States or any other U.S. federal agency at the time administering the Securities Act.

"Common Holder" means a holder of shares of the Company's Common Stock.

"Common Stock" means the Common Stock of the Company, $0.00001 par value.

"Exchange Act" means the Securities Exchange Act of 1934, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same are in effect at the time.

"Family Group" has the meaning assigned in Section 9 hereof. "Form S-3" has the meaning assigned in Section 4(a) hereof. "Indemnified Party" has the meaning assigned in Section 7(c) hereof.

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"Indemnifying Party" has the meaning assigned in Section 7(c) hereof.

"Initiating Holders" has the meaning assigned in Section 2(a) hereof.

"IPO" means the closing of the Company's first public offering of Common Stock pursuant to a registration statement declared effective by the Commission.

"Material Adverse Information" has the meaning assigned in Section 5(c) hereof.

"Preferred Stock" means the Series B-2 Preferred.

"Registration Expenses" means all expenses, except as otherwise stated below, incurred by the Company in complying with Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and disbursements of counsel for the Company, blue sky fees, and expenses and the expense of any special audits incident to or required by any such registration. Registration Expenses also includes the reasonable fees and disbursements of one counsel for the selling Holders up to a maximum of $5,000 for each Registration. Registration Expenses shall not include any Selling Expenses.

"Registrable Securities" means (i) Common Stock issued or issuable on conversion of Preferred Stock held by Holders; and (ii) any Common Stock issued or issuable in respect of such Common Stock upon any split, dividend, recapitalization or similar event. Common Stock or other securities will only be treated as Registrable Securities if it has not been (A) sold to or through a broker or dealer or underwriter in a public distribution or a public securities transaction or (B) sold in a transaction exempt from the registration and prospectus delivery requirements of the Securities Act so that all transfer restrictions and restrictive legends with respect thereto are removed upon the consummation of such sale.

The terms "register," "registered" and "registration" refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement by the Commission and such other governmental or regulatory bodies as are appropriate.

"Rule 145 Transaction" means any transaction described in Rule 145(a) promulgated by the Commission under the Securities Act.

"Securities Act" means the Securities Act of 1933, as amended, or any similar United States federal statute and the rules and regulations of the Commission thereunder, all as the same shall be in effect at the time.

"Selling Expenses" means all underwriting discounts, selling commissions, stock transfer taxes and fees of counsel to Holders (other than the fees and disbursements of counsel specifically included in the definition of Registration Expenses) applicable to the securities registered by the Holders.

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"Series B-2 Preferred" means the Series B-2 Convertible Preferred Stock of the Company.

2.)Requested Registration.

(a)Request for Registration. In case the Company receives from the Holders of at least fifty percent (50%) of the Registrable Securities on or following the date which is six (6) months after the date the Company completes an IPO, a written request that the Company effect a registration with respect to Registrable Securities having a reasonably anticipated aggregate offering price, before deduction of underwriter discounts and commissions, of at least $2,000,000 (such requesting holder or holders, the "Initiating Holders"), the Company will:

i. promptly give written notice of the proposed registration, qualification or compliance to all other Holders who are not Initiating Holders; and

ii. as soon as practicable, use its reasonable best efforts to effect such registration, qualification, or compliance (including, without limitation, appropriate qualification under applicable blue sky or other state securities laws and appropriate compliance with applicable regulations issued under the Securities Act and any other governmental requirements or regulations) as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder(s) joining in such request as are specified in a written request received by the Company within twenty (20) days after the mailing of such written notice from the Company (collectively, the "Other Holders");

Provided, however, that the Company is not obligated to take any action to effect any such registration, qualification or compliance pursuant to this Section 2 [Requested Registration]:

A. In any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance;

B. During the period starting with the date sixty (60) days prior to the Company's estimated date of filing of any registration statement pertaining to securities of the Company sold by the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan) and ending one hundred eighty (180) days following the effective date of any public offering by the Company of such securities, provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective and further provided that the Company may delay any such registration not more than one time during any twelve month period;

C. After the Company has effected one (1) registration pursuant to this Section 2 [Requested Registration], and such registration has been declared or ordered effective; or

D. If the Company furnishes to such Initiating Holders and Other Holders a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its stockholders to temporarily delay the filing of such registration statement, then the Company's obligation to use its best efforts to register, qualify or comply under this Section 2 [Requested Registration] shall be deferred for a period not to exceed one hundred eighty (180) days from the date of receipt of written request from the Initiating Holders.

Subject to the foregoing clauses (A) through (D), the Company will file a registration statement covering the Registrable Securities so requested to be registered as soon as practicable after receipt of the request or requests of the Initiating Holders and the Other Holders.

Miromatrix Medical Inc.
Investor Rights Agreement

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(b)Underwriting. In the event that the Initiating Holders indicate in their written request pursuant to Section 2(a) that a registration pursuant to this Section 2 [Requested Registration] is for a registered public offering involving an underwriting, the Company will so advise the Holders as part of the notice given pursuant to Section 2(a)(i). In such event, the right of any Holder, as the case may be, to registration pursuant to this Section 2 [Requested Registration] will be conditioned upon such Holder's participation in the underwriting arrangements required by this Section 2 [Requested Registration], and the inclusion of such Holder's Registrable Securities in the underwriting to the extent requested will be limited to the extent provided herein.

The Company (together with all Initiating Holders and Other Holders proposing to distribute their securities through such underwriting) will enter into an underwriting agreement in customary form with the managing underwriter selected by the Company (which underwriter will be acceptable to a majority in interest of the Initiating Holders with such acceptance not to be unreasonably withheld). Notwithstanding any other provision of this Section 2 [Requested Registration], if the managing underwriter advises the Initiating Holders in writing that marketing factors require a limitation of the number of shares to be underwritten, then the Company will so advise the Initiating Holders and the Other Holders, and the number of Registrable Securities that may be included in the registration and underwriting will be allocated among the Initiating Holders and the Other Holders in proportion, as nearly as practicable, to the respective amounts of Registrable Securities that such Initiating Holders and Other Holders have requested pursuant to Section 2(a) hereof to include in such registration. No Registrable Securities or other securities excluded from the underwriting by reason of the underwriter's marketing limitation will be included in such registration. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Initiating Holder or Other Holder to the nearest one hundred (100) shares.

If any Initiating Holder or Other Holder disapproves of the terms of the underwriting, such person may elect, unless otherwise agreed in writing by such Initiating Holder or Other Holder, to withdraw therefrom by written notice to the Company and the managing underwriter. The Registrable Securities or other securities so withdrawn will also be withdrawn from registration.

Miromatrix Medical Inc.
Investor Rights Agreement

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3.)Company Registration.

(a)Notice of Registration. If the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans, (ii) a registration relating solely to a Rule 145 Transaction, or (iii) a registration on any form which does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities or a registration in which the only Common Stock being registered is Common Stock issuable upon the conversion of debt securities which are also concurrently being registered, the Company will:

i. promptly give to each Holder written notice thereof; and

ii. subject to Section 3(b), include in such registration (and any related qualification under blue sky laws or other compliance), and in any underwriting involved therein, all the Registrable Securities specified in a written request or requests, made within twenty (20) days after the mailing of such written notice from the Company, by any Holder. If any Holder decides not to include all of its Registrable Securities in such registration, such Holder will nevertheless continue to have the right to include any Registrable Securities in any subsequent registration statements as may be filed by the Company with respect to offerings of its securities, all upon the terms and conditions set forth herein.

(b)Underwriting. If the registration of which the Company gives notice is for a registered public offering involving an underwriting, the Company will so advise the Holders as a part of the written notice given pursuant to Section 3(a)(i). In such event, the right of any Holder to registration pursuant to this Section 3 [Company Registration] will be conditioned upon such Holder's participation in such underwriting and the inclusion of Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting, together with the Company, will enter into an underwriting agreement in customary form with the managing underwriter selected for such underwriting by the Company. Notwithstanding any other provision of this Section 3 [Company Registration], if the managing underwriter determines that marketing factors require a limitation of the number of Registrable Securities to be underwritten, the managing underwriter may eliminate, or may limit on a pro rata basis (based on the total number of the Registrable Securities entitled to registration held by the Holder) the number of Registrable Securities to be included in such registration; provided that no such reduction will be made with respect to securities being offered by the Company for its own account. The Company will advise all Holders proposing to distribute their securities through such underwriting of any such limitations, and the number of shares of Registrable Securities that may be included in the registration. To facilitate the allocation of shares in accordance with the above provisions, the Company may round the number of Registrable Securities allocated to any Holder proposing to distribute their securities through such underwriting to the nearest one hundred (100) Registrable Securities. If any Holder proposing to distribute their securities through such underwriting disapproves of the terms of any such underwriting, he may elect, unless otherwise agreed in writing by such Holder to withdraw therefrom by written notice to the Company and the managing underwriter. Any securities excluded or withdrawn from such underwriting will be withdrawn from such registration.

(c)Right to Terminate Registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 3 [Company Registration] prior to or after the effectiveness of such registration whether or not any Holder has elected to include Registrable Securities in such registration.

Miromatrix Medical Inc.
Investor Rights Agreement

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4.)Registration on Form S-3.

(a)Request for Registration. If any Holder(s) request that the Company file a registration statement on Form S-3 or any successor form thereto under the Securities Act ("Form S-3") for a public offering of Registrable Securities, the reasonably anticipated aggregate price to the public of which would exceed $1,000,000 and the Company is a registrant entitled to use Form S-3 to register the Registrable Securities for such an offering, the Company will use its reasonable best efforts to cause such Registrable Securities to be registered for the offering on such form and to cause such Registrable Securities to be qualified in such jurisdictions as the Holder(s) may reasonably request. The substantive provisions of Section 2(b) shall be applicable to each registration initiated under this Section 4 [Registration on Form S-3].

(b)Limitations. Notwithstanding the foregoing, the Company will not be obligated to take any action pursuant to this Section 4 [Registration on Form S-3]:

i. in any particular jurisdiction in which the Company would be required to execute a general consent to service of process m effecting such registration, qualification or compliance;

ii. during the period starting with the date sixty (60) days prior to the Company's estimated date of filing, and ending on the date one hundred eighty (180) days immediately following the effective date of any registration statement pertaining to securities of the Company (other than a registration of securities in a Rule 145 Transaction or with respect to an employee benefit plan), provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective, and further provided that the Company may delay any such registration not more than one time during any twelve month period;

iii. if the Company furnishes to such Holder a certificate signed by the President of the Company stating that, in the good faith judgment of the Board of Directors, it would be beneficial to the Company or its owners to temporarily delay filing of such registration statements, then the Company's obligation to use its best efforts to file a registration statement shall be deferred for a period not to exceed one hundred eighty (180) days from the receipt of the request to file such registration by such Holder;

iv. if the Company has effected a total of two (2) registrations pursuant to Section 2 [Requested Registration] and this Section 4 [Registration on Form S-3] and each such registration has been declared or ordered effective; or

v. if the Company has effected the registration of any Registrable Securities pursuant to Section 2 [Requested Registration] or this Section 4 [Registration on Form S-3] at any time during the previous twelve (12) month period.

Miromatrix Medical Inc.
Investor Rights Agreement

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5.)Expenses of Registration.

(a)Registration Expenses. The Company will be responsible for all Registration Expenses, exclusive of underwriting discounts and commissions or legal fees of the Holders incurred in connection with all registrations pursuant to this Agreement.

(b)Selling Expenses. Unless otherwise stated, all Selling Expenses relating to securities registered on behalf of the Holders shall be borne by the Holders pro rata on the basis of the number of Registrable Securities so registered.

(c)Expenses Upon Withdrawal. Notwithstanding anything herein to the contrary, the Company will not be required to pay (and the Holders will be required to pay as set forth below) for expenses of any registration proceeding begun pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form S-3], the request of which has been subsequently withdrawn by the Initiating Holders unless (a) the withdrawal is based upon Material Adverse Information concerning the Company of which the Initiating Holders were not aware at the time of such request or (b) the Holders of a majority of Registrable Securities agree to forfeit their right to one (1) registration pursuant to Section 2 [Requested Registration] or Section 4 [Registration on Form S-3], as the case may be, in which event such right shall be forfeited by all Holders. If the Holders are required to pay Registration Expenses pursuant hereto, such expenses (which will not be deemed to include (i) the cost of normal audits of the Company that would have been performed in any event, or (ii) the time of any executive or other personnel of the Company involved in the preparation of the registration statement) will be borne by the Holders of securities (including Registrable Securities) requesting such registration in proportion to the number of shares for which registration was requested. For purposes of this Section 5(c), "Material Adverse Information" means information relating to any occurrence that is materially adverse as to the business, properties or financial condition of the Company, but does not include information relating to the economy or financial markets generally or the Company's industry generally unless such information relating to the economy or financial markets would have a disproportionate effect on the Company.

6.)Registration Procedures.. In the case of each registration, qualification or compliance effected by the Company pursuant to this Agreement, the Company will:

(a) Keep each Holder advised as to the initiation of each registration, qualification and compliance and as to the completion thereof;

(b)Prepare and, as soon as practicable, file with the Commission a registration statement with respect to such securities and use its reasonable best efforts to cause such registration statement to become and remain effective until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration;

(c)Prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to make and to keep such registration statement effective and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all securities proposed to be registered in such registration statement until the earlier of the sale of the Registrable Securities so registered or sixty (60) days subsequent to the effective date of such registration statement;

(d)Furnish to the Holders participating in such registration and to the underwriters of the securities being registered such reasonable number of copies of the registration statement, preliminary prospectus, final prospectus and such other documents as such parties may reasonably request in order to facilitate the public offering of such securities; and

(e)Use its commercially reasonable best efforts to register or qualify the Registrable Securities covered by such registration statement under the securities or blue sky laws of such states as the Holders reasonably request, maintain any such registration or qualification current until the earlier of the sale of the Registrable Securities so registered or (90) days subsequent to the effective date of the registration statement; and take any and all other reasonable actions either necessary or advisable to enable the Holders to consummate the public sale or other disposition of the Registrable Securities in jurisdictions where the Holders desire to effect such sales or other disposition (but the Company is not required to take any action that would subject it to the general jurisdiction of the courts of any jurisdiction in which it is not so subject or to qualify as a foreign corporation in any jurisdiction where the Company is not so qualified).

Miromatrix Medical Inc.
Investor Rights Agreement

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7.)Indemnification.

(a)By Company. To the extent permitted by law, the Company will indemnify each Holder, each of their officers and directors and partners, and each Affiliate of such Holder, and each underwriter, if any, and each Affiliate of any underwriter, with respect to each registration, qualification or compliance which has been effected pursuant to this Agreement, against all expenses, claims, losses, damages or liabilities (or actions in respect thereof) (collectively, "Claims"), including any Claims incurred in settlement of any litigation, commenced or threatened, arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement or prospectus, or any amendment or supplement thereto, incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and the Company will reimburse each such Holder, each of their officers and directors and Affiliates, each such underwriter and their Affiliates, for any legal and any other expenses reasonably incurred in connection with investigating, preparing or defending any such Claim, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld, delayed or conditioned), and the Company will not be liable in any such case to the extent that any such Claim arises out of or is based on any untrue statement or omission or alleged untrue statement or omission, made in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, Affiliate or underwriter. If the Holders are represented by counsel other than counsel for the Company, the Company will not be obligated under this Section 7(a) to reimburse legal fees and expenses of more than one separate counsel for the Holders.

(b)By Holders. To the extent permitted by law, each Holder will, if Registrable Securities held by such Holder are included in the securities as to which such registration, qualification or compliance is being effected, indemnify the Company, each of its directors and officers and its legal counsel and independent accountants, each underwriter, if any, of the Company's securities covered by such a registration statement, each Affiliate of the Company or such underwriter, and each other such Holder, each of their officers and directors and each Affiliate, against all Claims (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document, or any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading, and will reimburse the Company, such Holders, such directors, officers, legal counsel, independent accountants, persons, underwriters or Affiliates for any legal or any other expenses reasonably incurred in connection with investigating or defending any such Claim in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular or other document in reliance upon and in conformity with information furnished to the Company expressly for use in connection with such registration by such Holder, provided that the indemnity agreement contained in this subsection shall not apply to amounts paid in settlement of any such Claim if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld, delayed or conditioned.

(c)Procedures. Each party entitled to indemnification under this Section 7 [Indemnification] (the "Indemnified Party") will give notice to the party required to provide indemnification (the "Indemnifying Party") promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and will permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom, provided that counsel for the Indemnifying Party, who will conduct the defense of such claim or litigation, will be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at its own expense; provided, however, that the failure of any Indemnified Party to give notice as provided herein will not relieve the Indemnifying Party of its obligations under this Agreement unless the failure to give such notice is prejudicial to an Indemnifying Party's ability to defend such action. No Indemnifying Party, in the defense of any such claim or litigation, will, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation.

(d)Contributions. If the indemnification provided for in this Section 7 [Indemnification] is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any Claim, the Indemnifying Party, in lieu of indemnifying such Indemnified Party thereunder, will, to the extent permitted by applicable law contribute to the amount paid or payable by such Indemnified Party as a result of such Claim in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other in connection with that which resulted in such Claim, as well as any other relevant equitable considerations. The relative fault of the Indemnifying Party and of the Indemnified Party will be determined by a court of law by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party and the parties' relative intent, provided that, in no event will any contribution by a Holder pursuant to this Section 7(d) exceed the proceeds from the offering received by such Holder.

Miromatrix Medical Inc.
Investor Rights Agreement

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8.)Information by Holder. The Holder(s) of Registrable Securities included in any registration will furnish to the Company such information, including information regarding such Holder(s), the Registrable Securities held by them and the distribution proposed, as the Company may request in writing to enable the Company to comply with the provisions hereof in connection with any registration, qualification or compliance referred to in this Agreement. It shall be a condition precedent to the obligations of the Company to take any action pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] with respect to Registrable Securities of any Holder that such Holder shall furnish to the Company such information.

9.)Transfer of Registration Rights. The rights to cause the Company to register securities granted Holders under Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] hereof may be assigned (but only with all related obligations) in connection with any transfer or assignment by a Holder of Registrable Securities, provided that: (i) such transfer or assignment is for at least twenty-five percent (25%) of such Holder's Registrable Securities (except for transfers in which the transferor is a partnership and the transferee is a partner or former partner in such partnership or transfers to a Holder's Family Group, in which case such rights may be transferred without regard to the number of shares so transferred); (ii) such transfer of any Registrable Securities is lawful under all applicable securities laws; and (iii) such Assignment will only be effective only if immediately following such transfer the transferee agrees in writing delivered promptly to the Company to be bound by the terms and conditions of this Agreement as though the transferee were a Holder hereunder. The transfer or assignment of all Registrable Securities of any Holder will divest such transferring or assigning Holder of registration rights hereunder. "Family Group" means such Holder's spouse, siblings, ancestors and descendants (whether natural or adopted), any spouses of such siblings, ancestors and descendants, any siblings of such ancestors and descendants, and any trust established solely for the benefit of one or more of such Holder, spouse, siblings, ancestors and/or descendants.

10.)Termination. All rights granted and obligations imposed pursuant to Sections 2 [Requested Registration], 3 [Company Registration] and 4 [Registration on Form S-3] of this Agreement shall terminate (i) as to all Holders on the earlier of three (3) years after the date of the Company's IPO or (ii) as to each Holder at such time as such Holder (together with such Holder's Affiliates) can sell all of such Holder's Registrable Securities pursuant to Rule 144 under the Securities Act within any three (3) month period.

11.)Information Rights.

(a)Delivery of Annual Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, an income statement for such fiscal year and a balance sheet of the Company as of the end of such year, such year-end financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles.

(b)Delivery of Quarterly Financial Statements. The Company will deliver to each Holder, as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three fiscal quarters of the Company, an income statement for such fiscal quarter and a balance sheet of the Company as of the end of such quarter, such financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles. The Company will accompany each delivery of quarterly financial statements with a letter to the Holders updating them on the current progress of the Company.

(c)Termination of Information Covenants. The covenants set forth in this Section 11 [Information Rights] shall terminate as to each Holder and be of no further force or effect immediately upon the IPO. The information rights may be transferred to a transferee, provided that the Company is given prior written notice of such transfer.

(d)Confidentiality of Information. Each Holder agrees that any information obtained by such Holder pursuant to this Section 11 [Information Rights] which is, or would reasonably be perceived to be, proprietary to the Company or otherwise confidential will not be used or disclosed without the prior written consent of the Company. Each Holder further acknowledges and understands that any information so obtained which may be considered material non-public information will not be utilized by such Holder in connection with purchases and/or sales of the Company's securities, except in compliance with applicable state and federal antifraud statutes.

Miromatrix Medical Inc.
Investor Rights Agreement

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12.)Miscellaneous.

(a)Governing Law. This Agreement will be governed by and construed under the internal laws of the State of Delaware, without regard to conflicts of laws provisions.

(b)Exclusive Jurisdiction.

THE PARTIES AGREE THAT ALL DISPUTES ARISING AMONG THEM ARISING OUT OF, IN CONNECTION WITH, RELATED TO, OR INCIDENTAL TO THE RELATIONSHIP AMONG THE PARTIES TO THIS AGREEMENT, WHETHER ARISING IN CONTRACT, TORT, EQUITY OR OTHERWISE, SHALL BE RESOLVED ONLY IN THE UNITED STATES FEDERAL COURTS OR MINNESOTA STATE COURTS LOCATED IN HENNEPIN COUNTY, MINNESOTA. THE PARTIES WAIVE IN ALL DISPUTES ANY OBJECTIONS THEY MAY HAVE TO THE LOCATION OF ANY COURT LOCATED IN HENNEPIN COUNTY, MINNESOTA CONSIDERING ANY SUCH DISPUTE.

(c)Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Holders of 50% of the then outstanding Registrable Securities. Any amendment or waiver effected in accordance with this paragraph will be binding upon the Company and each Holder of any securities subject to this Agreement (including securities into which such securities are convertible) and future holders of all such securities. Any Holder may waive its rights or the Company's obligations hereunder without obtaining the consent of any other person.

(d)Severability. If any provision of this Agreement or any portion thereof is finally determined to be unlawful or unenforceable, such provision or portion thereof will be deemed to be severed from this Agreement. Every other provision, and any portion of such an invalidated provision that is not invalidated by such a determination, will remain in full force and effect.

(e)Notices. Any notice required or permitted under this Agreement must be given in writing and will be deemed effectively given upon personal delivery; upon confirmed transmission by telecopy or telex; or upon deposit with a national postal service, postage prepaid, addressed, (i) if to the Company: 10399 West 70th Street, Eden Prairie, MN 55344, Attention: CEO, and (ii) if to the Holders, at the address for such Holders listed on the signature page of this Agreement. All notices shall be delivered to the addresses maintained in the Company's records for such Holders. Notices will be effective upon receipt, or in the case of delivery by mail, ten (I 0) days after being deposited, first class postage prepaid, in the mails of a national postal service, or in the case of notice by facsimile copy, when verbal communication of receipt is obtained, in each case when addressed as aforesaid.

(f)Entire Agreement; Successors. This Agreement constitutes the entire agreement among the parties hereto pertaining to the subject matter hereof, and any and other written or oral agreements pertaining to the subject matter hereof between or among any parties hereto are expressly canceled. Subject to the terms hereof, this Agreement will inure to the benefit of any successor or assign of any party hereto.

(g)Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument, and any of which will be enforceable against the person who has executed the same.

(h)Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

(i)Execution and Delivery. A facsimile, telecopy, .pdf or other reproduction of this Agreement may be executed by one or more parties hereto, and an executed copy of this Agreement may be delivered by one or more parties hereto by facsimile, .pdf or similar electronic transmission device pursuant to which the signature of or on behalf of such party can be seen, and such execution and delivery will be considered valid, binding and effective for all purposes.

[signature page follows]

*     *     *

Miromatrix Medical Inc.
Investor Rights Agreement

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IN WITNESS WHEREOF, the parties have executed this Investor Rights Agreement as of the date first above written.

COMPANY: MIROMATRIX MEDICAL INC.

By:	/s/ Jeff Ross
	Jeff Ross, Chief Executive Officer

[Signature Page to Investor Rights Agreement]

Miromatrix Medical Inc.
Investor Rights Agreement

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EX-4.5

Exhibit 4.5

NOTE AND WARRANT PURCHASE AGREEMENT

This Note and Warrant Purchase Agreement, dated as of March 6, 2020 (this “Agreement”), is entered into by and between Miromatrix Medical Inc., a Delaware corporation (the “Company”), and Cheshire MD Holdings, LLC, a Delaware limited liability company (the “Investor”).

RECITALS

A.On the terms and subject to the conditions set forth herein, the Investor is willing to purchase from the Company, and the Company is willing to sell to the Investor, a convertible promissory note in the principal amount of $6,000,000, together with a related warrant to acquire shares of the Company’s capital stock.

B.Capitalized terms not otherwise defined herein shall have the meaning set forth in the form of Note (as defined below) attached hereto as Exhibit A.

AGREEMENT

NOW THEREFORE, in consideration of the foregoing, and the representations, warranties, and conditions set forth below, the parties hereto, intending to be legally bound, hereby agree as follows:

1.The Note and Warrants.

(a)Issuance of Note. Subject to all of the terms and conditions hereof, the Company agrees to issue and sell to the Investor, and the Investor agrees to purchase, a convertible promissory note in the form of Exhibit A hereto (the “Note”) in the principal amount of $6,000,000.

(b)Issuance of Warrants. Concurrently with the issuance of the Note to the Investor, the Company will issue to the Investor a warrant in the form attached hereto as Exhibit B (the “Initial Warrant”) to purchase up to a number of shares of the Company’s preferred stock as set forth in the Initial Warrant. If the Note has not been converted or repaid in accordance with its terms prior to May 1, 2020, then the Company shall issue to the Investor an additional warrant on May 1, 2020, and thereafter, on the first day of each subsequent month for so long as the Note is outstanding, the Company shall issue the Investor an additional warrant (collectively, the “Subsequent Warrants,” and together with the Initial Warrant, the “Warrants”). Each Subsequent Warrant shall be in the same form of the Initial Warrant, except that the Warrant Coverage Amount (as defined in the Initial Warrant) shall be $75,000.

(c)Delivery. The sale and purchase of the Note and the Initial Warrant shall take place at a closing (the “Closing”) to be held at such place and time as the Company and the Investor may determine (the “Closing Date”). At the Closing, the Company will deliver to the Investor the Note and the Initial Warrant to be purchased by the Investor, against receipt by the Company of $6,000,000 in cash, paid by wire transfer (the “Purchase Price”). The Note and Warrants will be registered in the Investor’s name in the Company’s records.

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(d) Use of Proceeds. The proceeds of the sale and issuance of the Note shall be used for (i) general corporate purposes, (ii) scheduled payments under the Company’s indebtedness listed on the Disclosure Schedules (as defined below) and (iii) repayment of the Note in accordance with its terms. The proceeds of the sale and issuance of the Note shall not be used to repay any other outstanding indebtedness or repurchase the Company’s outstanding equity.

(e)Payments. The Company will make all payments due under the Note as required in accordance with the terms of the Note.

2.Representations and Warranties of the Company. Except as set forth in the disclosure schedules accompanying this Agreement (collectively, the “Disclosure Schedules”), the Company represents and warrants to the Investor that:

(a)Due Incorporation, Qualification, etc. The Company (i) is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware; (ii) has the power and authority to own, lease and operate its properties and carry on its business as now conducted; and (iii) is duly qualified, licensed to do business and in good standing as a foreign corporation in each jurisdiction where the failure to be so qualified or licensed could reasonably be expected to materially and adversely affect the business, properties, assets (including intangible assets), prospects, liabilities, operations, or condition (financial or otherwise) of the Company (a “Material Adverse Effect”).

(b)Capitalization.

(i)The authorized capital of the Company (the “Capital Stock”) consists, immediately prior to the Closing, of:

(i)30,000,000 shares of common stock, $0.00001 par value per share (the “Common Stock”), 2,120,822 shares of which are issued and outstanding immediately prior to the Closing. All of the outstanding shares of Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws. The Company holds no Common Stock in its treasury.

(ii)20,000,000 shares of preferred stock, $0.00001 par value per share (the “Preferred Stock”), of which 3,300,000 shares have been designated Series A Preferred Stock, $0.00001 par value per share, 3,000,380 of which are issued and outstanding; of which 4,000,000 shares have been designated Series B Preferred Stock, $0.00001 par value per share, 3,218,282 of which are issued and outstanding; of which 2,500,000 shares have been designated Series B-2 Preferred Stock, $0.00001 par value per share, 2,095,874 of which are issued and outstanding. The rights, privileges and preferences of the Preferred Stock are as stated in the Company’s certificate of incorporation and as provided by the Delaware General Corporation Law. The Company holds no Preferred Stock in its treasury.

(ii)The Company has reserved 3,850,000 shares of Common Stock for issuance to officers, directors, employees and consultants of the Company pursuant to the Company’s 2010 Stock Incentive Plan duly adopted by the Board of Directors and approved by the Company stockholders (the “2010 Stock Plan”). Of such reserved shares of Common Stock, no shares have been issued pursuant to restricted stock purchase agreements, options to purchase 3,550,500 shares of Common Stock have been granted and are currently outstanding, and 43,225 shares of Common Stock remain available for issuance to officers, directors, employees and consultants pursuant to the 2010 Stock Plan. The Company has furnished to the Investor complete and accurate copies of the 2010 Stock Plan and forms of agreements used thereunder.

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(iii)The Company has reserved 1,000,000 shares of Common Stock for issuance to officers, directors, employees and consultants of the Company pursuant to the Company’s 2019 Equity Incentive Plan duly adopted by the Board of Directors (the “2019 Stock Plan”). The Company will be submitting the 2019 Stock Plan for approval by the Company stockholders at the next meeting of the Company’s stockholders. Of such reserved shares of Common Stock, no shares have been issued pursuant to restricted stock purchase agreements, options to purchase 296,000 shares of Common Stock have been granted and are currently outstanding, and 704,000 shares of Common Stock remain available for issuance to officers, directors, employees and consultants pursuant to the 2019 Stock Plan. The Company has furnished to the Investor complete and accurate copies of the 2019 Stock Plan and forms of agreements used thereunder.

(iv)All of the outstanding shares of Capital Stock of the Company have been duly and validly issued and are fully paid and non-assessable and were issued in accordance with the registration or qualification requirements of the Securities Act of 1933, as amended (the “Securities Act”), and any relevant foreign and state securities laws or pursuant to valid exemptions therefrom. Upon their issuance in accordance with the terms of this Note, the shares issuable upon conversion of this Note will be duly authorized, validly issued, fully paid and non-assessable shares of Capital Stock of the Company, free of all preemptive or similar rights. All of the outstanding shares of the Common Stock and all shares of the Common Stock underlying outstanding options are subject to a lock-up or market standoff agreement of not less than one hundred eighty (180) days following the Company’s initial public offering pursuant to a registration statement filed with the Securities and Exchange Commission (the “SEC”) under the Securities Act.

(v)The equity securities (“Equity Securities”) of the Company have the respective rights, preferences and privileges set forth in the Company’s certificate of incorporation or bylaws in effect on the date hereof. Other than the equity awards described in Sections 2(b)(ii) and (iii), there are as of the date of this Agreement no options, warrants or rights to purchase Equity Securities of the Company authorized, issued or outstanding, and the Company is not obligated in any other manner to issue shares of its Equity Securities. There are no restrictions on the transfer of Equity Securities of the Company, other than those imposed by relevant state and federal securities laws, and no holder of any Equity Security of the Company or individual, corporation, partnership, trust, limited liability company, association or other entity (“Person”) is entitled to preemptive or similar statutory or contractual rights, either arising pursuant to any agreement or instrument to which the Company is a party or that are otherwise binding upon the Company. The offer and sale of all Equity Securities of the Company issued before the Closing Date complied with or were exempt from registration or qualification under all applicable federal and state securities laws. No Person has the right to demand or other rights to cause the Company to file any registration statement under the Securities Act, relating to any Equity Securities of the Company presently outstanding or that may be subsequently issued, or any right to participate in any such registration statement.

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(c) Authority. The execution, delivery and performance by the Company of each Transaction Document to be executed by the Company and the consummation of the transactions contemplated thereby (i) are within the power of the Company and (ii) have been duly authorized by all necessary actions on the part of the Company.

(d)Enforceability. Each Transaction Document executed, or to be executed, by the Company has been, or will be, duly executed and delivered by the Company and constitutes, or will constitute, a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as limited by bankruptcy, insolvency or other laws of general application relating to or affecting the enforcement of creditors’ rights generally and general principles of equity.

(e)Non-Contravention. The execution and delivery by the Company of the Transaction Documents executed by the Company and the performance and consummation of the transactions contemplated thereby do not and will not (i) violate the Company’s certificate of incorporation or bylaws or any material judgment, order, writ, decree, statute, rule or regulation applicable to the Company; (ii) violate any provision of, or result in the breach or the acceleration of, or entitle any other Person to accelerate (whether after the giving of notice or lapse of time or both), any material mortgage, indenture, agreement, instrument or contract to which the Company is a party or by which it is bound; or (iii) result in the creation or imposition of any security interest, mortgage, pledge, lien, claim, charge or other encumbrance (“Lien”) upon any property, asset or revenue of the Company or the suspension, revocation, impairment, forfeiture, or nonrenewal of any material permit, license, authorization or approval applicable to the Company, its business or operations, or any of its assets or properties.

(f)Subsidiaries. Other than the Company’s ownership interest in Reprise Biomedical, Inc., the Company does not own or control, directly or indirectly, any interest in any corporation, partnership, limited liability company, association or other business entity.

(g)Approvals. No consent, approval, order or authorization of, or registration, declaration or filing with, any governmental authority or other Person (including, without limitation, the shareholders of any Person) is required in connection with the execution and delivery of the Transaction Documents executed by the Company and the performance and consummation of the transactions contemplated thereby, other than such as have been obtained and remain in full force and effect and other than such qualifications or filings under applicable securities laws as may be required in connection with the transactions contemplated by this Agreement.

(h)No Violation or Default. The Company is not in violation of or in default with respect to (i) its certificate of incorporation or bylaws or any judgment, (ii) any order, writ, statute, rule or regulation applicable to such Person, (iii) any mortgage or indenture or instrument to which such Person is a party or by which it is bound or (iv) any material contract to which such Person is a party or by which it is bound (nor is there any waiver in effect which, if not in effect, would result in such a violation or default).

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(i)Litigation. No actions (including, without limitation, derivative actions), suits, proceedings or investigations are pending or, to the knowledge of the Company, threatened in writing against the Company at law or in equity in any court or before any other governmental authority that if adversely determined (i) would (alone or in the aggregate) result in a material liability or (ii) seeks to enjoin, either directly or indirectly, the execution, delivery or performance by the Company of the Transaction Documents or the transactions contemplated thereby.

(j)Agreements; Actions.

(i)Except for the Transaction Documents, there are no agreements, understandings, instruments, contracts or proposed transactions to which the Company is a party or by which it is bound that involve (A) obligations (contingent or otherwise) of, or payments to, the Company in excess of $250,000, (B) the license of any patent, copyright, trademark, trade secret or other proprietary right to or from the Company, (C) the grant of rights to manufacture, produce, assemble, license, market, or sell its products to any other Person that limit the Company’s exclusive right to develop, manufacture, assemble, distribute, market or sell its products, or (D) indemnification by the Company with respect to infringements of proprietary rights.

(ii)The Company has not (A) incurred any indebtedness for money borrowed or incurred any other liabilities individually in excess of $25,000 or in excess of $50,000 in the aggregate, or (B) made any loans or advances to any Person, other than ordinary advances for travel expenses, in each case that are not included in the Company’s balance sheet dated as of December 31, 2019 that has been delivered to the Company.

(iii)Other than (i) standard employee benefits generally made available to all employees, (ii) standard director and officer indemnification agreements approved by the Board of Directors, and (iii) the purchase of shares of the Company’s capital stock and the issuance of options to purchase shares of the Company’s Common Stock, in each instance, approved in the written minutes of the Board of Directors (previously provided to the Investor or its counsel to the extent requested), there are no agreements, understandings or proposed transactions between the Company and any of its officers, directors, consultants or key employees, or any affiliate thereof.

(iv)The Company is not a guarantor or indemnitor of any indebtedness of any other Person.

(k)Intellectual Property.

(i)The Company owns or possesses sufficient legal rights to all (A) patents, patent applications and inventions; (B) trademarks, service marks, trade names, trade dress, logos, domain names or corporate names and registrations and applications for registration thereof, together with all of the goodwill associated therewith; (C) copyrights (registered or unregistered) and copyrightable works and registrations and applications for registrations thereof; (D) computer software, data, and databases and documentation thereof; (E) trade secrets and other confidential information; and (F) licenses, information and proprietary rights and processes (collectively, “Company Intellectual Property”) necessary for or used in connection with its business without (to the Company’s actual knowledge after reasonable inquiry) any conflict with, or infringement of, the rights of others. To the Company’s actual knowledge after reasonable inquiry, no product or service marketed or sold (or presently proposed to be marketed or sold) by the Company violates or will violate any license or infringes or will infringe any intellectual property rights of any other party. The Company has not received any written communications alleging that the Company has violated or, by conducting their business, would violate any of the patents, trademarks, service marks, trade names, copyrights or trade secrets or other proprietary rights of any other person or entity. To the knowledge of the Company, none of its employees is obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would interfere with the use of his or her best efforts to promote the interests of the Company. The Company does not believe it is or will be necessary to utilize any inventions of any of its (A) employees made prior to or outside the scope of their employment by the Company or (B) independent consultants made outside of their engagement with the Company.

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(ii)Each present and former employee of the Company who either alone or in concert with others develops, invents, programs or designs any Company Intellectual Property and each officer of the Company has executed a Proprietary Information and Inventions Agreement (“PIIA”). Each present and former consultant to the Company that has had access to Company Intellectual Property has entered into a Proprietary Information and Inventions Agreement or consulting agreement containing similar protections (together with the PIIA, the “Confidential Information Agreement”). No such employee, officer or consultant has excluded works or inventions from his or her Confidential Information Agreement. To the knowledge of the Company, no officer, key employee or consultant of the Company is, or by performing any currently contemplated services to the Company would be, in violation of his or her Confidential Information Agreement or any prior employee contract, consulting agreement or proprietary information and inventions assignment agreement with any other entity or third party.

(l)Financial Statements. The financial statements of the Company that have been delivered to the Investor (i) are in accordance with the books and records of the Company and have been maintained in accordance with good business practice; (ii) have been prepared in conformity with GAAP except, with respect to the unaudited financial statements, for the absence of footnotes and subject to normal year-end adjustments; and (iii) fairly present the financial position of the Company as of the dates presented therein and the results of operations, changes in financial positions or cash flows, as the case may be, for the periods presented therein. The Company does not have any contingent obligations, liability for taxes or other outstanding obligations which are material in the aggregate, except as disclosed in the most recent financial statements furnished by the Company to the Investor prior to the date hereof.

(m)Changes. Since December 31, 2019, there has not been any change in the assets, liabilities, financial condition or operating results of the Company from that reflected in the Financial Statements, except changes in the ordinary course of business that have not caused, in the aggregate, a Material Adverse Effect;

(i)any material damage, destruction or loss, whether or not covered by insurance;

(ii)any waiver or compromise by the Company of a valuable right or of a material debt owed to it;

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(iii) any satisfaction or discharge of any lien, claim, or encumbrance or encumbrance or payment of any obligation by the Company, except in the ordinary course of business;

(iv)any material change to a material contract or agreement by which the Company or any of its assets is bound or subject;

(v)any material change in any compensation arrangement or agreement with any employee, officer, director or stockholder;

(vi)any resignation or termination of employment of any officer or key employee of the Company;

(vii)any mortgage, pledge, transfer of a security interest in, or lien, created by the Company, with respect to any of its material properties or assets, except liens for taxes not yet due or payable and liens that arise in the ordinary course of business and do not materially impair the Company’s ownership or use of such property or assets;

(viii)any loans or guarantees made by the Company to or for the benefit of its employees, officers or directors, or any members of their immediate families, other than travel advances and other advances made in the ordinary course of its business;

(ix)any declaration, setting aside or payment or other distribution in respect of any of the Company’s capital stock, or any direct or indirect redemption, purchase, or other acquisition of any of such stock by the Company;

(x)any sale, assignment or transfer of any Company Intellectual Property;

(xi)receipt of notice that there has been a loss of, or material order cancellation by, any major customer of the Company;

(xii)any other event or condition of any character, other than events affecting the economy or the Company’s industry generally, that could reasonably be expected to result in a Material Adverse Effect; or

(xiii)          any arrangement or commitment by the Company to do any of the things described in this Subsection 2(m).

(n)Accuracy of Information Furnished. None of the Transaction Documents and none of the other certificates, statements or information furnished to the Investor by or on behalf of the Company in connection with the Transaction Documents or the transactions contemplated thereby contains or will contain any untrue statement of a material fact or omits or will omit to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company has not received any indication, whether in writing or otherwise, from the potential lead investors for the contemplated Series C Preferred Stock equity financing of at least $34,000,000 (the “Contemplated Equity Financing”) in each case as discussed with the Investor, that such investors will not participate in such Contemplated Equity Financing, and the Company has no reason to believe that such Contemplated Equity Financing will not take place prior to December 31, 2020.

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(o) No “Bad Actor” Disqualification. The Company has exercised reasonable care, in accordance with the SEC rules and guidance, to determine whether any Covered Person (as defined below) is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act (“Disqualification Events”). To the Company’s knowledge, no Covered Person is subject to a Disqualification Event, except for a Disqualification Event covered by Rule 506(d)(2) or (d)(3) under the Securities Act. The Company has complied, to the extent applicable, with any disclosure obligations under Rule 506(e) under the Securities Act. “Covered Persons” are those persons specified in Rule 506(d)(1) under the Securities Act.

3.Representations and Warranties of Investor. The Investor represents and warrants to the Company upon the acquisition of the Note and the Warrants as follows:

(a)Binding Obligation. The Investor has full legal capacity, power and authority to execute and deliver this Agreement and the Transaction Documents and to perform its obligations hereunder and thereunder. This Agreement and the Transaction Documents constitute valid and binding obligations of the Investor, enforceable in accordance with their terms, except as limited by bankruptcy, insolvency or other laws of general application relating to or affecting the enforcement of creditors’ rights generally and general principles of equity.

(b)Securities Law Compliance. The Investor has been advised that the Note, the Warrants and the underlying securities have not been registered under the Securities Act, or any state securities laws and, therefore, cannot be resold unless they are registered under the Securities Act and applicable state securities laws or unless an exemption from such registration requirements is available. The Investor is aware that the Company is under no obligation to effect any such registration with respect to the Note, the Warrants or the underlying securities or to file for or comply with any exemption from registration. The Investor has not been formed solely for the purpose of making this investment and is purchasing the Note and the Warrants to be acquired by the Investor hereunder for its own account for investment, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and Investor has no present intention of selling, granting any participation in, or otherwise distributing the same. The Investor has such knowledge and experience in financial and business matters that the Investor is capable of evaluating the merits and risks of such investment, is able to incur a complete loss of such investment without impairing the Investor’s financial condition and is able to bear the economic risk of such investment for an indefinite period of time. The Investor is an accredited investor as such term is defined in Rule 501 of Regulation D under the Securities Act and shall submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Investor has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to accredited investor status. Any such information is true, correct, timely and complete. The residency of the Investor (or, in the case of a partnership or corporation, such entity’s principal place of business) is correctly set forth beneath the Investor’s name on the signature page thereto.

(c)Access to Information. The Investor acknowledges that the Company has given the Investor access to the corporate records and accounts of the Company and to all information in its possession relating to the Company, has made its officers and representatives available for interview by the Investor, and has furnished the Investor with all documents and other information required for the Investor to make an informed decision with respect to the purchase of the Note and the Warrants.

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4.Conditions to Closing of the Investor. The Investor’s obligations at the Closing are subject to the fulfillment, on or prior to the Closing Date, of all of the following conditions, any of which may be waived in whole or in part by the Investor:

(a)Representations and Warranties. The representations and warranties made by the Company in Section 2 shall be true and correct on the Closing Date.

(b)Governmental Approvals and Filings. Except for any notices required or permitted to be filed after the Closing Date with certain federal and state securities commissions, the Company shall have obtained all governmental approvals required in connection with the lawful sale and issuance of the Note and Warrants.

(c)Legal Requirements. At the Closing, the sale and issuance by the Company, and the purchase by the Investor, of the Note and the Warrants shall be legally permitted by all laws and regulations to which the Investor or the Company are subject.

(d)Proceedings and Documents. All corporate and other proceedings in connection with the transactions contemplated at the Closing and all documents and instruments incident to such transactions shall be reasonably satisfactory in substance and form to the Investor.

(e)Transaction Documents. The Company shall have duly executed and delivered to the Investor the following documents (collectively, the Transaction Documents):

(i)This Agreement; and

(ii)The Note and the Initial Warrant issued hereunder.

(f)Corporate Documents. The Company shall have delivered to the Investor each of the following:

(i)a certificate of the Secretary of the Company, dated the Closing Date, certifying that (a) the certificate of incorporation of the Company, certified as of a recent date by the Secretary of State of the State of Delaware and attached thereto, is in full force and effect and has not been amended, supplemented, revoked or repealed since the date of such certification; (b) attached thereto is a true and correct copy of the bylaws of the Company as in effect on the Closing Date; and (c) attached thereto are true and correct copies of resolutions duly adopted by the Board of Directors of the Company and continuing in effect, which authorize the execution, delivery and performance by the Company of this Agreement, the Warrants and the Note and the consummation of the transactions contemplated hereby and thereby; and

(ii)a Certificate of Good Standing or comparable certificate as to the Company, certified as of a recent date prior to the Closing Date by the Secretary of State of Delaware.

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5.Conditions to Obligations of the Company. The Company’s obligation to issue and sell the Note and the Initial Warrant at the Closing is subject to the fulfillment, on or prior to the Closing Date, of the following conditions, any of which may be waived in whole or in part by the Company:

(a)Representations and Warranties. The representations and warranties made by the Investor in Section 3 hereof shall be true and correct when made, and shall be true and correct on the Closing Date.

(b)Governmental Approvals and Filings. Except for any notices required or permitted to be filed after the Closing Date with certain federal and state securities commissions, the Company shall have obtained all governmental approvals required in connection with the lawful sale and issuance of the Note and the Warrants.

(c)Legal Requirements. At the Closing, the sale and issuance by the Company, and the purchase by the applicable Investors, of the Note and the Warrants shall be legally permitted by all laws and regulations to which the Investor or the Company are subject.

(d)Purchase Price. The Investor shall have delivered to the Company the Purchase Price.

6.Covenants. The Company agrees and covenants as follows:

(a)(i) Prior to May 1, 2020, the Company will not take any action to accept, solicit, initiate, encourage, or assist the submission of any proposal, negotiation, or offer from any person or entity relating to any debt or equity financing of the Company from any person or entity that engages in, as a material part of its business, the provision of dialysis services (each, a “Competitor”); and (ii) following May 1, 2020, so long as the Note remains outstanding, any time the Company proposes to accept any debt or equity financing (including securities convertible into equity) from a Competitor, the Company shall deliver to the Investor the terms and conditions (including a term sheet, if applicable) of such financing. The Investor shall have ten (10) business days to elect to make an investment on the same terms in lieu of such Competitor. If the Investor does not elect to make such investment, the Company and Competitor may consummate a financing on the same terms as delivered to the Investor. Any amendment or change to a proposed financing shall be treated the same as a new financing for purposes of this subsection 6(a).

(b)In the event that the Company, at any time prior to conversion or repayment of the Note, issues any convertible security (other than options to purchase Common Stock under the 2019 Stock Plan) (each a “Subsequent Convertible Instrument” and, collectively, the “Subsequent Convertible Instruments”) on terms that differ from the Note, then, in each case, the Company will provide to the Investor written notice of such new issuance, including the terms of any Subsequent Convertible Instrument, no later than five (5) days after the closing date thereof. In the event the Investor determines, in its sole discretion, that any Subsequent Convertible Instrument contains terms more favorable to the holder(s) thereof than the terms set forth in its Note, the Investor will promptly notify the Company of such determination and the Note shall automatically be deemed to be amended to reflect such more favorable terms (subject to appropriate adjustment based on economic terms).

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(c) In the case of (i) a Qualified Financing or (ii) a Non-Qualified Financing in which the Investor elects to convert the Note, the Company will ensure that the Investor shall be entitled to the same economic rights provided to all investors in such financing and to the same contractual rights provided to all investors who are investing a comparable (or lower) dollar amount in such financing, and shall ensure that the Investor shall be a “Major Investor” for all purposes of the financing documents entered into in connection with the Qualified Financing or Non-Qualified Financing, as applicable.

(d)The Investor and the Company will coordinate in good faith on a statement disclosing DaVita Inc. and its affiliates’ (“DaVita”) involvement with the Company. The Company may disclose the Investor’s name as a passive investor in the Company to potential investors in a Qualified Financing or a Non-Qualified Financing, provided, that, (i) the Company shall notify the Investor prior to such disclosure and (ii) the Company shall facilitate an introduction between the Investor and any potential investor so disclosed to the extent requested by the Investor. Except as provided above, the Company will not use the name or trademarks of DaVita or refer to DaVita’s relationship to the Company, in any form of advertising, publicity or release without the Investor’s prior written approval in the Investor’s sole direction. Except as provided above, the Company will not disclose, publish or make known to third parties that the Investor is associated with DaVita or that DaVita is an indirect investor in the Company without the Investor’s prior written consent.

(e)So long as the Note remains outstanding, the Company shall not, without the prior written consent of the Investor:

(i)change the composition of the company’s Board of Directors, except to the extent a member of the Board of Directors resigns, retires or is incapable to perform due to death or disability;

(ii)create, incur, assume guarantee or be or remain liable with respect to any Indebtedness or allow or suffer to exist any mortgage, lien, pledge, charge, security interest or other encumbrance upon or in any property or assets owned by the Company, in each case except as reflected on the Disclosure Schedules. “Indebtedness” shall include any (i) indebtedness for borrowed money, (ii) indebtedness evidenced by a note, bond, debenture or similar instrument or commercial paper (including purchase money obligations), (iii) obligations to reimburse or repay in respect of letters of credit, surety bonds or similar instruments, (iv) obligations under financing leases, and (v) capital leases for equipment entered into after the date of this Agreement to the extent that the aggregate value of all of such new capital leases exceed $150,000;

(iii)incorporate, form or otherwise create any new direct or indirect subsidiaries, or permit any subsidiary of the Company to become a party to any joint venture, partnership or similar arrangement;

(iv)acquire, in any one transaction or series of related transactions, by purchase of securities or assets or otherwise, for cash or debt, any business or other enterprise;

(v)authorize or make any loans, advances or guarantees to, or for the benefit of, any person or entity;

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(vi) modify in any material respect, the Company’s budget as delivered to and approved by the Company’s Board of Directors;

(vii)sell or divest in any one transaction or series of related transactions, any division or other business enterprise, or any assets, of the Company or any subsidiary, other than immaterial amounts sold or divested in the ordinary course of business;

(viii)engage in any business which is not being conducted by the Company on the date of the Closing, other than reasonably-related extensions of the business conducted by the Company on such date;

(ix)settle any outstanding claim, litigation, audit or other dispute for an amount in excess of $20,000 (net of insurance coverage), individually or in the aggregate; or

(x)approve, adopt, authorize, commit or agree to commit to any of the foregoing actions.

(f)The Company shall provide regular updates to the Investor regarding the Contemplated Equity Financing, including, but not limited to, (i) providing any term sheets the Company receives from potential investors within 2 business days of receipt by the Company, (ii) providing prompt notice of any indication that a potential investor declines to invest in the Contemplated Equity Financing, and (iii) providing such other information regarding the status of the Contemplated Equity Financing as reasonably requested by the Investor.

7.Miscellaneous.

(a)Waivers and Amendments. Any provision of this Agreement, the Warrants and the Note may be amended, waived or modified only upon the written consent of the Company and the Investor.

(b)Governing Law. This Agreement and all actions arising out of or in connection with this Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of law provisions of the State of Delaware or of any other state. Notwithstanding any provision of this Agreement to the contrary, this Agreement shall be (to the extent necessary to satisfy the requirements of Section 22062(b)(3)(D) of the California Financial Code) subject to the implied covenant of good faith and fair dealing arising under Section 1655 of the California Civil Code.

(c)Jurisdiction and Venue. Each of the parties hereby submits and consents irrevocably to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for the interpretation and enforcement of the provisions of this Agreement. Each of the parties also agrees that the jurisdiction over such persons and the subject matter of such dispute shall be effected by any manner as may be lawful, and that service in such manner shall constitute valid and sufficient service of process.

(d)Survival. The representations, warranties, covenants and agreements made herein shall survive the execution and delivery of this Agreement.

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(e)Successors and Assigns. Subject to the restrictions on transfer described in Sections 7(f) and 7(g), the rights and obligations of the Company and the Investor shall be binding upon and benefit the successors, assigns, heirs, administrators and transferees of the parties.

(f)Registration, Transfer and Replacement of the Note. The Note issuable under this Agreement shall be a registered note. The Company will keep, at its principal executive office, books for the registration and registration of transfer of the Note. Prior to presentation of the Note for registration of transfer, the Company shall treat such Person in whose name the Note is registered as the owner and holder of the Note for all purposes whatsoever, whether or not the Note shall be overdue, and the Company shall not be affected by notice to the contrary. Subject to any restrictions on or conditions to transfer set forth in any Note, the holder of any Note, at its option, may in person or by duly authorized attorney surrender the same for exchange at the Company’s chief executive office, and promptly thereafter and at the Company’s expense, except as provided below, receive in exchange therefor one or more new Note(s), each in the principal requested by such holder, dated the date to which interest shall have been paid on the Note so surrendered or, if no interest shall have yet been so paid, dated the date of the Note so surrendered and registered in the name of such Person or Persons as shall have been designated in writing by such holder or its attorney for the same principal amount as the then unpaid principal amount of the Note so surrendered. Upon receipt by the Company of evidence reasonably satisfactory to it of the ownership of and the loss, theft, destruction or mutilation of any Note and (a) in the case of loss, theft or destruction, of indemnity reasonably satisfactory to it; or (b) in the case of mutilation, upon surrender thereof, the Company, at its expense, will execute and deliver in lieu thereof a new Note executed in the same manner as the Note being replaced, in the same principal amount as the unpaid principal amount of the Note and dated the date to which interest shall have been paid on the Note or, if no interest shall have yet been so paid, dated the date of the Note.

(g)Assignment by the Company. The rights, interests or obligations hereunder may not be assigned, by operation of law or otherwise, in whole or in part, by the Company without the prior written consent of the Investor.

(h)Entire Agreement. This Agreement together with the other Transaction Documents constitute and contain the entire agreement among the Company and the Investor and supersede any and all prior agreements, negotiations, correspondence, understandings and communications among the parties, whether written or oral, respecting the subject matter hereof.

(i)Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, overnight delivery, postage prepaid, sent by facsimile or electronic mail (if the Investor or any other holder of Company securities) or otherwise delivered by hand, messenger or courier service addressed:

(i)if to the Investor, to the recipients’ addresses or electronic mail addresses shown on the signature page hereto, as may be updated in accordance with the provisions hereof (provided that to be effective, notice by electronic mail must be followed by notice by overnight delivery sent no later than 1 business day following the delivery of such electronic mail notice);

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(ii) if to any other holder of the Note, Warrants or shares issuable upon conversion or exercise thereof, to such address, facsimile number or electronic mail address as shown in the Company’s records, or, until any such holder so furnishes an address, facsimile number or electronic mail address to the Company, then to the address, facsimile number or electronic mail address of the last holder of the Note, Warrants or shares issuable upon conversion or exercise thereof for which the Company has contact information in its records; or

(iii)if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at 10399 West 70th Street, Eden Prairie, MN 55344, or at such other current address as the Company shall have furnished to the Investor.

(j)Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same agreement. Facsimile copies of signed signature pages will be deemed binding originals.

(signature page follows)

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The parties are signing this Note and Warrant Purchase Agreement as of the date stated in the introductory clause.

MIROMATRIX MEDICAL INC.,
a Delaware corporation
By:
Name:	Jeffrey Ross
Title:	Chief Executive Officer

(Signature page for Note and Warrant Purchase Agreement)

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The parties are signing this Note and Warrant Purchase Agreement as of the date stated in the introductory clause.

CHESHIRE MD HOLDINGS, LLC

By:

By:

By:

Notice to the Investor shall be delivered to both of the following recipients.

To be effective, any notice delivered by electronic mail to Investor shall be followed by notice by overnight delivery to each recipient below no later than 1 business day following such electronic mail notice.

Stephen Phillips

Vice President, DaVita Venture Group

2000 16th Street

Denver, CO 80202

Steve.phillips@davita.com

With a copy to: Kathleen Waters

Chief Legal Officer and General Counsel

2000 16th Street

Denver, CO 80202

Kathleen.waters@davita ..com

(Signature page for Note and Warrant Purchase Agreement)

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Exhibit A

FORM OF NOTE

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Exhibit B

FORM OF WARRANT

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EX-4.6

Exhibit 4.6

EXECUTION VERSION

THIS WARRANT AND THE UNDERLYING SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE, TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This warrant must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, transfer, pledge or hypothecation of any interest in any of the securities represented hereby.

WARRANT TO PURCHASE SHARES

of

MIROMATRIX MEDICAL INC.

Dated as of March 6, 2020

Void after the date specified in Section 8

No. C-1 Warrant to Purchase Shares of Preferred Stock (subject to adjustment)

THIS CERTIFIES THAT, for value received, Cheshire MD Holdings, LLC, or its registered assigns (the “Holder”), is entitled, subject to the provisions and upon the terms and conditions set forth herein, to purchase from Miromatrix Medical Inc., a Delaware corporation (the “Company”), the Company’s Shares (as defined below), in the amounts, at such times and at the price per share set forth in Section 1. The term “Warrant” as used herein shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein. This Warrant is issued in connection with the transactions described in the Note and Warrant Purchase Agreement, dated as of March 6, 2020, by and among the Company and the purchasers described therein (the “Purchase Agreement”). Capitalized terms that are not defined herein shall have the same meaning as defined in the Purchase Agreement.

The following is a statement of the rights of the Holder and the conditions to which this Warrant is subject, and to which Holder, by acceptance of this Warrant, agrees:

1.             Number and Price of Shares; Exercise Period.

(a)            Definition of Shares. “Shares” shall mean the Qualified Financing Shares (as defined the Note) if the Note is converted into the Qualified Financing Shares in a Qualified Financing (as defined in the Note) pursuant to the terms thereof. If the Note is converted into the Voluntary Conversion Shares (as defined in the Note) pursuant to the terms thereof, then “Shares” shall mean the Voluntary Conversion Shares.

(b)            Number of Shares. Subject to any previous exercise of the Warrant, the Holder shall have the right to purchase up to the number of Shares that equals the quotient obtained by dividing (x) $750,000 (the “Warrant Coverage Amount”) by (y) the Exercise Price (as defined below), prior to (or in connection with) the expiration of this Warrant as provided in Section 8.

(c)            Exercise Price. The exercise price per Share (the “Exercise Price”) shall be equal to (i) the Conversion Price (as defined in the Note) if the Note has converted into the Qualified Financing Shares in a Qualified Financing, or (ii) if the Note has converted into the Voluntary Conversion Shares, the lowest price per share paid by the other purchasers of the Voluntary Conversion Shares sold in the Non-Qualified Financing.

(d)            Exercise Period. This Warrant shall be exercisable, in whole or in part, after the earlier of (i) the closing date of the Company’s Qualified Financing or (ii) conversion of the Note in a Non-Qualified Financing and prior to (or in connection with) the expiration of this Warrant as set forth in Section 8.

2.             Exercise of the Warrant.

(a)            Exercise. The purchase rights represented by this Warrant may be exercised at the election of the Holder, in whole or in part, in accordance with Section 1, by:

(i)          the tender to the Company at its principal office (or such other office or agency as the Company may designate) of a notice of exercise in the form of Exhibit A (the “Notice of Exercise”), duly completed and executed by or on behalf of the Holder, together with the surrender of this Warrant; and

(ii)         the payment to the Company of an amount equal to (x) the Exercise Price multiplied by (y) the number of Shares being purchased, by (a) wire transfer or certified, cashier’s or other check acceptable to the Company and payable to the order of the Company; (b) surrender and cancellation of promissory notes or other instruments representing indebtedness of the Company to the Holder; or (c) a combination of (a) and (b).

(b)            Net Issue Exercise. In lieu of exercising this Warrant pursuant to Section 2(a)(ii), if the fair market value of one Share is greater than the Exercise Price (at the date of calculation as set forth below), the Holder may elect to receive a number of Shares equal to the value of this Warrant (or of any portion of this Warrant being canceled) by surrender of this Warrant at the principal office of the Company (or such other office or agency as the Company may designate) together with a properly completed and executed Notice of Exercise reflecting such election, in which event the Company shall issue to the Holder that number of Shares computed using the following formula:

X =     Y (A – B)     A

Where:

X	=	The number of Shares to be issued to the Holder
Y	=	The number of Shares purchasable under this Warrant or, if only a portion of the Warrant is being exercised, the portion of the Warrant being canceled (at the date of such calculation)
A	=	The fair market value of one Share (at the date of such calculation)
B	=	The Exercise Price (as adjusted to the date of such calculation)

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For purposes of the calculation above, the fair market value of one Share shall be determined by the Board of Directors of the Company, acting in good faith; provided, however, that:

(i)          where a public market exists for the Company’s common stock at the time of such exercise, the fair market value per Share shall be the product of (x) the average of the closing bid and asked prices of the common stock or the closing price quoted on the national securities exchange on which the common stock is listed as published in the Wall Street Journal, as applicable, for the ten (10) trading day period ending five (5) trading days prior to the date of determination of fair market value and (y) the number of shares of common stock into which each Share is convertible at the time of such exercise, as applicable; and

(ii)         if the Warrant is exercised in connection with the Company’s initial public offering of common stock, the fair market value per Share shall be the product of (x) the per share offering price to the public of the Company’s initial public offering and (y) the number of shares of common stock into which each Share is convertible at the time of such exercise, as applicable.

(c)            Stock Certificates. The rights under this Warrant shall be deemed to have been exercised and the Shares issuable upon such exercise shall be deemed to have been issued immediately prior to the close of business on the date this Warrant is exercised in accordance with its terms, and the person entitled to receive the Shares issuable upon such exercise shall be treated for all purposes as the holder of record of such Shares as of the close of business on such date. As promptly as reasonably practicable on or after such date, the Company shall issue and deliver to the person or persons entitled to receive the same a certificate or certificates (or a notice of issuance of uncertificated shares, if applicable) for that number of shares issuable upon such exercise. In the event that the rights under this Warrant are exercised in part and have not expired, the Company shall execute and deliver a new Warrant reflecting the number of Shares that remain subject to this Warrant.

(d)            No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of the rights under this Warrant. In lieu of such fractional share to which the Holder would otherwise be entitled, the Company shall make a cash payment equal to the Exercise Price multiplied by such fraction.

(e)            Conditional Exercise. The Holder may exercise this Warrant conditioned upon (and effective immediately prior to) consummation of any transaction that would cause the expiration of this Warrant pursuant to Section 8 by so indicating in the notice of exercise.

(f)             Automatic Exercise. If the Holder of this Warrant has not elected to exercise this Warrant prior to expiration of this Warrant pursuant to Section 8, then this Warrant shall automatically (without any act on the part of the Holder) be exercised pursuant to Section 2(b) effective immediately prior to the expiration of the Warrant to the extent such net issue exercise would result in the issuance of Shares, unless Holder shall earlier provide written notice to the Company that the Holder desires that this Warrant expire unexercised. If this Warrant is automatically exercised, the Company shall notify the Holder of the automatic exercise as soon as reasonably practicable, and the Holder shall surrender the Warrant to the Company in accordance with the terms hereof.

(g)           Reservation of Stock. The Company agrees during the term the rights under this Warrant are exercisable to reserve and keep available from its authorized and unissued shares of preferred stock (or any such other class or series of stock then issuable upon exercise of this Warrant) for the purpose of effecting the exercise of this Warrant such number of shares (and shares of common stock for issuance on conversion of such shares) as shall from time to time be sufficient to effect the exercise of the rights under this Warrant; and if at any time the number of authorized but unissued shares of preferred stock (or any such other class or series of stock then issuable upon exercise of this Warrant) (and shares of common stock for issuance on conversion of such shares) shall not be sufficient for purposes of the exercise of this Warrant in accordance with its terms and the conversion of the Shares, without limitation of such other remedies as may be available to the Holder, the Company will use its best efforts to take such corporate action as may, in the opinion of counsel, be necessary to increase its authorized and unissued shares of its preferred stock (and shares of common stock for issuance on conversion of such shares) to a number of shares as shall be sufficient for such purposes. The Company represents and warrants that all shares that may be issued upon the exercise of this Warrant will, when issued in accordance with the terms hereof, be validly issued, fully paid and nonassessable.

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3.             Replacement of the Warrant. Subject to the receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and substance to the Company or, in the case of mutilation, on surrender and cancellation of this Warrant, the Company at the expense of the Holder shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor and amount.

4.             Transfer of the Warrant.

(a)            Warrant Register. The Company shall maintain a register (the “Warrant Register”) containing the name and address of the Holder or Holders. Until this Warrant is transferred on the Warrant Register in accordance herewith, the Company may treat the Holder as shown on the Warrant Register as the absolute owner of this Warrant for all purposes, notwithstanding any notice to the contrary. Any Holder of this Warrant (or of any portion of this Warrant) may change its address as shown on the Warrant Register by written notice to the Company requesting a change.

(b)            Warrant Agent. The Company may appoint an agent for the purpose of maintaining the Warrant Register referred to in Section 4(a), issuing the Shares or other securities then issuable upon the exercise of the rights under this Warrant, exchanging this Warrant, replacing this Warrant or conducting related activities.

(c)            Transferability of the Warrant. Subject to the provisions of this Warrant with respect to compliance with the Securities Act of 1933, as amended (the “Securities Act”) and limitations on assignments and transfers, including without limitation compliance with the restrictions on transfer set forth in Section 5, title to this Warrant may be transferred by endorsement (by the transferor and the transferee executing the assignment form attached as Exhibit B (the “Assignment Form”)) and delivery in the same manner as a negotiable instrument transferable by endorsement and delivery.

(d)            Exchange of the Warrant upon a Transfer. On surrender of this Warrant (and a properly endorsed Assignment Form) for exchange, subject to the provisions of this Warrant with respect to compliance with the Securities Act and limitations on assignments and transfers, the Company shall issue to or on the order of the Holder a new warrant or warrants of like tenor, in the name of the Holder or as the Holder (on payment by the Holder of any applicable transfer taxes) may direct, for the number of shares issuable upon exercise hereof, and the Company shall register any such transfer upon the Warrant Register. This Warrant (and the securities issuable upon exercise of the rights under this Warrant) must be surrendered to the Company or its warrant or transfer agent, as applicable, as a condition precedent to the sale, pledge, hypothecation or other transfer of any interest in any of the securities represented hereby.

(e)            Taxes. In no event shall the Company be required to pay any tax which may be payable in respect of any transfer involved in the issue and delivery of any certificate, or a book entry, in a name other than that of the Holder, and the Company shall not be required to issue or deliver any such certificate, or make such book entry, unless and until the person or persons requesting the issue or entry thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid or is not payable.

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5.             Restrictions on Transfer of the Warrant and Shares; Compliance with Securities Laws. By acceptance of this Warrant, the Holder agrees to comply with the following:

(a)            Restrictions on Transfers. Any transfer of this Warrant or the Shares or the shares of common stock issuable upon conversion of the Shares (the “Securities”) must be in compliance with all applicable federal and state securities laws. The Holder agrees not to make any sale, assignment, transfer, pledge or other disposition of all or any portion of the Securities, or any beneficial interest therein, unless and until the transferee thereof has agreed in writing for the benefit of the Company to take and hold such Securities subject to, and to be bound by, the terms and conditions set forth in this Warrant to the same extent as if the transferee were the original Holder hereunder.

(b)            Investment Representation Statement. Unless the rights under this Warrant are exercised pursuant to an effective registration statement under the Securities Act that includes the Shares with respect to which the Warrant was exercised, it shall be a condition to any exercise of the rights under this Warrant that the Holder shall have confirmed to the satisfaction of the Company in writing, substantially in the form of Exhibit A-1, that the Shares so purchased are being acquired solely for the Holder’s own account and not as a nominee for any other party, for investment and not with a view toward distribution or resale and that the Holder shall have confirmed such other matters related thereto as may be reasonably requested by the Company.

(c)            Securities Law Legend. Each certificate, instrument or book entry representing the Securities shall (unless otherwise permitted by the provisions of this Warrant) be notated with a legend substantially similar to the following (in addition to any legend required by state securities laws):

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This certificate must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, TRANSFER, pledge OR hypothecation of any interest in any of the securities represented hereby.

(d)            Instructions Regarding Transfer Restrictions. The Holder consents to the Company making a notation on its records and giving instructions to any transfer agent in order to implement the restrictions on transfer established in this Section 5.

(e)            Removal of Legend. The legend referring to federal and state securities laws identified in Section 5(d) notated on any certificate evidencing the Shares (and the common stock issuable upon conversion thereof) and the stock transfer instructions and record notations with respect to such securities shall be removed, and the Company shall issue a certificate without such legend to the holder of such securities (to the extent the securities are certificated), if (i) such securities are registered under the Securities Act, or (ii) such holder provides the Company with an opinion of counsel reasonably acceptable to the Company to the effect that a sale or transfer of such securities may be made without registration, qualification or legend.

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6.             Adjustments. Subject to the expiration of this Warrant pursuant to Section 8, the number and kind of shares purchasable hereunder and the Exercise Price therefor are subject to adjustment from time to time, as follows:

(a)            Merger or Reorganization. If at any time there shall be any reorganization, recapitalization, merger or consolidation (a “Reorganization”) involving the Company (other than as otherwise provided for herein or as would cause the expiration of this Warrant under Section 8) in which shares of the Company’s stock are converted into or exchanged for securities, cash or other property, then, as a part of such Reorganization, lawful provision shall be made so that the Holder shall thereafter be entitled to receive upon exercise of this Warrant, the kind and amount of securities, cash or other property of the successor corporation resulting from such Reorganization, equivalent in value to that which a holder of the Shares deliverable upon exercise of this Warrant would have been entitled in such Reorganization if the right to purchase the Shares hereunder had been exercised immediately prior to such Reorganization. In any such case, appropriate adjustment (as determined in good faith by the Board of Directors of the successor corporation) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of the Holder after such Reorganization to the end that the provisions of this Warrant shall be applicable after the event, as near as reasonably may be, in relation to any shares or other securities deliverable after that event upon the exercise of this Warrant.

(b)            Reclassification of Shares. If the securities issuable upon exercise of this Warrant are changed into the same or a different number of securities of any other class or classes by reclassification, capital reorganization, conversion of all outstanding shares of the relevant class or series (other than as would cause the expiration of this Warrant pursuant to Section 8) or otherwise (other than as otherwise provided for herein) (a “Reclassification”), then, in any such event, in lieu of the number of Shares which the Holder would otherwise have been entitled to receive, the Holder shall have the right thereafter to exercise this Warrant for a number of shares of such other class or classes of stock that a holder of the number of securities deliverable upon exercise of this Warrant immediately before that change would have been entitled to receive in such Reclassification, all subject to further adjustment as provided herein with respect to such other shares.

(c)            Subdivisions and Combinations. In the event that the outstanding shares of the securities issuable upon exercise of this Warrant are subdivided (by stock split, by payment of a stock dividend or otherwise) into a greater number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such subdivision shall, concurrently with the effectiveness of such subdivision, be proportionately increased, and the Exercise Price shall be proportionately decreased, and in the event that the outstanding shares of the securities issuable upon exercise of this Warrant are combined (by reclassification or otherwise) into a lesser number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such combination shall, concurrently with the effectiveness of such combination, be proportionately decreased, and the Exercise Price shall be proportionately increased.

(d)            Redemption. In the event that all of the outstanding shares of the securities issuable upon exercise of this Warrant are redeemed in accordance with the Company’s certificate of incorporation, this Warrant shall thereafter be exercisable for a number of shares of the Company’s common stock equal to the number of shares of common stock that would have been received if this Warrant had been exercised in full immediately prior to such redemption and the preferred stock received thereupon had been simultaneously converted into common stock.

(e)            Notice of Adjustments. Upon any adjustment in accordance with this Section 6, the Company shall give notice thereof to the Holder, which notice shall state the event giving rise to the adjustment, the Exercise Price as adjusted and the number of securities or other property purchasable upon the exercise of the rights under this Warrant, setting forth in reasonable detail the method of calculation of each. The Company shall, upon the written request of any Holder, furnish or cause to be furnished to such Holder a certificate setting forth (i) such adjustments, (ii) the Exercise Price at the time in effect and (iii) the number of securities and the amount, if any, of other property that at the time would be received upon exercise of this Warrant.

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7.             Notification of Certain Events. Prior to the expiration of this Warrant pursuant to Section 8, in the event that the Company shall authorize:

(a)            the issuance of any dividend or other distribution on the capital stock of the Company (other than (i) dividends or distributions otherwise provided for in Section 6, (ii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries upon termination of their employment or services pursuant to agreements providing for the right of said repurchase; (iii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries pursuant to rights of first refusal or first offer contained in agreements providing for such rights; or (iv) repurchases of capital stock of the Company in connection with the settlement of disputes with any stockholder), whether in cash, property, stock or other securities;

(b)            the voluntary liquidation, dissolution or winding up of the Company; or

(c)            any transaction resulting in the expiration of this Warrant pursuant to Section 8(b) or 8(c);

the Company shall send to the Holder of this Warrant at least 10 days prior written notice of the date on which a record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b) or (c), as applicable. The notice provisions set forth in this section may be shortened or waived prospectively or retrospectively by the consent of the Holder of this Warrant.

8.             Expiration of the Warrant. This Warrant shall expire and shall no longer be exercisable as of the earlier of:

(a)            5:00 p.m., Pacific time, on March 6, 2025;

(b)            (i) the acquisition of the Company by another entity by means of any transaction or series of related transactions to which the Company is a party (including, without limitation, any stock acquisition, reorganization, merger or consolidation, but excluding any sale of stock for capital raising purposes and any transaction effected primarily for purposes of changing the Company’s jurisdiction of incorporation) other than a transaction or series of related transactions in which the holders of the voting securities of the Company outstanding immediately prior to such transaction or series of related transactions retain, immediately after such transaction or series of transactions, as a result of shares in the Company held by such holders prior to such transaction or series of transactions, at least a majority of the total voting power represented by the outstanding voting securities of the Company or such other surviving or resulting entity (or if the Company or such other surviving or resulting entity is a wholly-owned subsidiary immediately following such acquisition, its parent), or (ii) a sale, lease or other disposition of all or substantially all of the assets of the Company and its subsidiaries taken as a whole by means of any transaction or series of related transactions, except where such sale, lease or other disposition is to a wholly-owned subsidiary of the Company; or

(c)            immediately prior to the closing of a firm commitment underwritten initial public offering pursuant to an effective registration statement filed under the Securities Act covering the offering and sale of the Company’s common stock.

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9.             No Rights as a Stockholder. Nothing contained herein shall entitle the Holder to any rights as a stockholder of the Company or to be deemed the holder of any securities that may at any time be issuable on the exercise of the rights hereunder for any purpose nor shall anything contained herein be construed to confer upon the Holder, as such, any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action (whether upon any recapitalization, issuance of stock, reclassification of stock, change of par value or change of stock to no par value, consolidation, merger, conveyance or otherwise) or to receive notice of meetings, or to receive dividends or subscription rights or any other rights of a stockholder of the Company until the rights under the Warrant shall have been exercised and the Shares purchasable upon exercise of the rights hereunder shall have become deliverable as provided herein.

10.           Representations and Warranties of the Holder. By acceptance of this Warrant, the Holder represents and warrants to the Company as follows:

(a)            No Registration. The Holder understands that the Securities have not been, and will not be, registered under the Securities Act by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Holder’s representations as expressed herein or otherwise made pursuant hereto.

(b)            Investment Intent. The Holder is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Holder has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

(c)            Investment Experience. The Holder has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

(d)            Speculative Nature of Investment. The Holder understands and acknowledges that the Company has a limited financial and operating history and that its investment in the Company is highly speculative and involves substantial risks. The Holder can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

(e)            Access to Data. The Holder has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Holder understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Holder acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

(f)             Accredited Investor. The Holder is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Holder has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

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(g)            Residency. The residency of Holder (or, in the case of a partnership or corporation, such entity’s principal place of business) has been correctly provided to the Company.

(h)            Restrictions on Resales. The Holder acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Holder is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Holder acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Holder wishes to sell the Securities and that, in such event, the Holder may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Holder acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Holder understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales and that such persons and the brokers who participate in the transactions do so at their own risk.

(i)             No Public Market. The Holder understands and acknowledges that no public market now exists for any of the securities issued by the Company and that the Company has made no assurances that a public market will ever exist for the Company’s securities.

(j)              Brokers and Finders. The Holder has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Holder, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

(k)            Legal Counsel. The Holder has had the opportunity to review this Warrant, the exhibits and schedules attached hereto and the transactions contemplated by this Warrant with its own legal counsel. The Holder is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by this Warrant.

(l)            Tax Advisors. The Holder has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by this Warrant. With respect to such matters, the Holder relies solely on any such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Holder understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment and the transactions contemplated by this Warrant.

11.           Miscellaneous.

(a)            Amendments. Except as expressly provided herein, neither this Warrant nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument referencing this Warrant and signed by the Company and the Holder.

(b)           Waivers. No waiver of any single breach or default shall be deemed a waiver of any other breach or default theretofore or thereafter occurring.

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(c)            Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, postage prepaid, sent by facsimile or electronic mail (if to the Holder) or otherwise delivered by hand, messenger or courier service addressed:

(i)          if to the Holder, to the Holder at the Holder’s address, facsimile number or electronic mail address as shown in the Company’s records, as may be updated in accordance with the provisions hereof, or until any such Holder so furnishes an address, facsimile number or electronic mail address to the Company, then to and at the address, facsimile number or electronic mail address of the last holder of this Warrant for which the Company has contact information in its records; or

(ii)         if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at the Company’s address as shown on the signature page hereto, or at such other current address as the Company shall have furnished to the Holder.

Each such notice or other communication shall for all purposes of this Warrant be treated as effective or having been given (i) if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if sent by mail, at the earlier of its receipt or five days after the same has been deposited in a regularly maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day. In the event of any conflict between the Company’s books and records and this Warrant or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.

(d)           Governing Law. This Warrant and all actions arising out of or in connection with this Warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of law provisions of the State of Delaware, or of any other state.

(e)            Jurisdiction and Venue. Each of the Holder and the Company hereby submits and consents irrevocably to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for the interpretation and enforcement of the provisions of this Warrant. Each of the Holder and the Company also agrees that the jurisdiction over such persons and the subject matter of such dispute shall be effected by any manner as may be lawful, and that service in such manner shall constitute valid and sufficient service of process.

(f)            Titles and Subtitles. The titles and subtitles used in this Warrant are used for convenience only and are not to be considered in construing or interpreting this Warrant. All references in this Warrant to sections, paragraphs and exhibits shall, unless otherwise provided, refer to sections and paragraphs hereof and exhibits attached hereto.

(g)            Severability. If any provision of this Warrant becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, portions of such provision, or such provision in its entirety, to the extent necessary, shall be severed from this Warrant, and such illegal, unenforceable or void provision shall be replaced with a valid and enforceable provision that will achieve, to the extent possible, the same economic, business and other purposes of the illegal, unenforceable or void provision. The balance of this Warrant shall be enforceable in accordance with its terms.

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(h)            Waiver of Jury Trial. Each of the Holder and the Company waives, to the fullest extent permitted by law, any and all right to trial by jury in any legal proceeding (whether based on contract, tort or otherwise) arising out of or related to this Warrant.

(i)            California Corporate Securities Law. THE SALE OF THE SECURITIES THAT ARE THE SUBJECT OF THIS WARRANT HAS NOT BEEN QUALIFIED WITH THE COMMISSIONER OF CORPORATIONS OF THE STATE OF CALIFORNIA AND THE ISSUANCE OF SUCH SECURITIES OR THE PAYMENT OR RECEIPT OF ANY PART OF THE CONSIDERATION THEREFOR PRIOR TO SUCH QUALIFICATION IS UNLAWFUL, UNLESS THE SALE OF SECURITIES IS EXEMPT FROM QUALIFICATION BY SECTION 25100, 25102, OR 25105 OF THE CALIFORNIA CORPORATIONS CODE. THE RIGHTS OF ALL PARTIES TO THIS WARRANT ARE EXPRESSLY CONDITIONED UPON THE QUALIFICATION BEING OBTAINED, UNLESS THE SALE IS SO EXEMPT.

(j)            Saturdays, Sundays and Holidays. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday, Sunday or U.S. federal holiday, then such action may be taken or such right may be exercised on the next succeeding day that is not a Saturday, Sunday or U.S. federal holiday.

(k)            Rights and Obligations Survive Exercise of the Warrant. Except as otherwise provided herein, the rights and obligations of the Company and the Holder under this Warrant shall survive exercise of this Warrant.

(l)             Entire Agreement. Except as expressly set forth herein, this Warrant (including the exhibits attached hereto) constitutes the entire agreement and understanding of the Company and the Holder with respect to the subject matter hereof and supersede all prior agreements and understandings relating to the subject matter hereof.

(signature page follows)

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The Company signs this Warrant as of the date stated on the first page.

MIROMATRIX MEDICAL INC.
By:
Name:
Title:
Address:
10399 West 70th Street, Eden Prairie, MN 55344

AGREED AND ACKNOWLEDGED,

Cheshire MD Holdings, LLC

By:

Name:

Title:

EXHIBIT A

NOTICE OF EXERCISE

TO:                     MIROMATRIX MEDICAL INC. (the “Company”)

Attention:          President

(1) Exercise. The undersigned elects to purchase the following pursuant to the terms of the attached warrant:

Number of shares:

Type of security:

(2) Method of Exercise. The undersigned elects to exercise the attached warrant pursuant to:

 A cash payment or cancellation of indebtedness, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any.

 The net issue exercise provisions of Section 2(b) of the attached warrant.

(3) Stock. Please make a book entry and, if the shares are certificated, issue a certificate or certificates representing the shares in the name of:

 The undersigned

 Other—Name:

Address:

(4) Unexercised Portion of the Warrant. Please issue a new warrant for the unexercised portion of the attached warrant in the name of:

 The undersigned

 Other—Name:

Address:

 Not applicable

(5) Investment Intent. The undersigned represents and warrants that the aforesaid shares are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties of the undersigned set forth in Section 11 of the attached warrant are true and correct as of the date hereof.

(6) Investment Representation Statement and Market Stand-Off Agreement. The undersigned has executed, and delivers herewith, an Investment Representation Statement and Market Stand-Off Agreement in a form substantially similar to the form attached to the warrant as Exhibit A-1.

(7) Consent to Receipt of Electronic Notice. Subject to the limitations set forth in Delaware General Corporation Law §232(e), the undersigned consents to the delivery of any notice to stockholders given by the Company under the Delaware General Corporation Law or the Company’s certificate of incorporation or bylaws by (i) facsimile telecommunication to the facsimile number provided below (or to any other facsimile number for the undersigned in the Company’s records), (ii) electronic mail to the electronic mail address provided below (or to any other electronic mail address for the undersigned in the Company’s records), (iii) posting on an electronic network together with separate notice to the undersigned of such specific posting or (iv) any other form of electronic transmission (as defined in the Delaware General Corporation Law) directed to the undersigned. This consent may be revoked by the undersigned by written notice to the Company and may be deemed revoked in the circumstances specified in Delaware General Corporation Law §232.

(Print name of the warrant holder)

(Signature)

(Name and title of signatory, if applicable)

(Date)

(Fax number)

(Email address)

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EXHIBIT A-l

INVESTMENT REPRESENTATION STATEMENT

AND

MARKET STAND-OFF AGREEMENT

INVESTOR:

COMPANY: MIROMATRIX MEDICAL INC.

SECURITIES:	THE WARRANT ISSUED ON [INSERT DATE] (THE “WARRANT”) AND THE SECURITIES ISSUED OR ISSUABLE UPON EXERCISE THEREOF (INCLUDING UPON SUBSEQUENT CONVERSION OF THOSE SECURITIES)
DATE:	______________________________

In connection with the purchase or acquisition of the above-listed Securities, the undersigned Investor represents and warrants to, and agrees with, the Company as follows:

1.            No Registration. The Investor understands that the Securities have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein or otherwise made pursuant hereto.

2.            Investment Intent. The Investor is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Investor has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

3.            Investment Experience. The Investor has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

4.            Speculative Nature of Investment. The Investor understands and acknowledges that the Company has a limited financial and operating history and that its investment in the Company is highly speculative and involves substantial risks. The Investor can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

5.            Access to Data. The Investor has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Investor understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Investor acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

6.            Accredited Investor. The Investor is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Investor has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

7.            Residency. The residency of the Investor (or, in the case of a partnership or corporation, such entity’s principal place of business) is correctly set forth on the signature page hereto.

8.            Restrictions on Resales. The Investor acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Investor is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Investor acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Investor wishes to sell the Securities and that, in such event, the Investor may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Investor understands and acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Investor understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for those offers or sales and that those persons and the brokers who participate in the transactions do so at their own risk.

9.            No Public Market. The Holder understands and acknowledges that no public market now exists for any of the securities issued by the Company and that the Company has made no assurances that a public market will ever exist for the Company’s securities.

10.         Brokers and Finders. The Investor has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Investor, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

11.          Legal Counsel. The Investor has had the opportunity to review the Warrant, the exhibits and schedules attached thereto and the transactions contemplated by the Warrant with its own legal counsel. The Investor is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by the Warrant.

12.          Tax Advisors. The Investor has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by the Warrant. With respect to such matters, the Investor relies solely on such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Investor understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment or the transactions contemplated by the Warrant.

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13.            No “Bad Actor” Disqualification. Neither (i) the Investor, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s voting equity securities (in accordance with Rule 506(d) of the Securities Act) held by the Investor is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act, except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the purchase or acquisition of the Securities, in writing in reasonable detail to the Company.

(signature page follows)

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The Investor is signing this Investment Representation Statement and Market Stand-Off Agreement on the date first written above.

INVESTOR
Cheshire MD Holdings, LLC
By:
Name:
Title:

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EXHIBIT B

ASSIGNMENT FORM

ASSIGNOR:

COMPANY: MIROMATRIX MEDICAL INC.

WARRANT: THE WARRANT TO PURCHASE SHARES OF PREFERRED STOCK ISSUED ON [INSERT DATE] (THE “WARRANT”)

DATE: _________________________

(1) Assignment. The undersigned registered holder of the Warrant (“Assignor”) assigns and transfers to the assignee named below (“Assignee”) all of the rights of Assignor under the Warrant, with respect to the number of shares set forth below:

Name of Assignee: _______________________________________________________________________________________________

Address of Assignee: _____________________________________________________________________________________________

Number of Shares Assigned: ________________________________________________________________________________________

and does irrevocably constitute and appoint ______________________ as attorney to make such transfer on the books of Miromatrix Medical Inc., maintained for the purpose, with full power of substitution in the premises.

(2) Obligations of Assignee. Assignee agrees to take and hold the Warrant and any shares of stock to be issued upon exercise of the rights thereunder (and any shares issuable upon conversion thereof) (the “Securities”) subject to, and to be bound by, the terms and conditions set forth in the Warrant to the same extent as if Assignee were the original holder thereof.

(3) Investment Intent. Assignee represents and warrants that the Securities are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that Assignee has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties set forth in Section 11 of the Warrant are true and correct as to Assignee as of the date hereof.

(4) Investment Representation Statement and Market Stand-Off Agreement. Assignee has executed, and delivers herewith, an Investment Representation Statement and Market Stand-Off Agreement in a form substantially similar to the form attached to the Warrant as Exhibit A-1.

(5) No “Bad Actor” Disqualification. Neither (i) Assignee, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s securities held or to be held by Assignee is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act of 1933, as amended (the “Securities Act”), except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the transfer of the Securities, in writing in reasonable detail to the Company.

Assignor and Assignee are signing this Assignment Form on the date first set forth above.

ASSIGNOR	ASSIGNEE
(Print name of Assignor)	(Print name of Assignee)
(Signature of Assignor)	(Signature of Assignee)
(Print name of signatory, if applicable)	(Print name of signatory, if applicable)
(Print title of signatory, if applicable)	(Print title of signatory, if applicable)
Address:	Address:

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EX-4.7

Exhibit 4.7

FINAL FORM

THIS WARRANT AND THE UNDERLYING SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE, TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This warrant must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, transfer, pledge or hypothecation of any interest in any of the securities represented hereby.

WARRANT TO PURCHASE SHARES

of

MIROMATRIX MEDICAL INC.

Dated as of [●], 202[0/1]

Void after the date specified in Section 8

No. C-[●] Warrant to Purchase Shares of Preferred Stock (subject to adjustment)

THIS CERTIFIES THAT, for value received, Cheshire MD Holdings, LLC, or its registered assigns (the “Holder”), is entitled, subject to the provisions and upon the terms and conditions set forth herein, to purchase from Miromatrix Medical Inc., a Delaware corporation (the “Company”), the Company’s Shares (as defined below), in the amounts, at such times and at the price per share set forth in Section 1. The term “Warrant” as used herein shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein. This Warrant is issued in connection with the transactions described in the Note and Warrant Purchase Agreement, dated as of March 6, 2020, by and among the Company and the purchasers described therein (the “Purchase Agreement”). Capitalized terms that are not defined herein shall have the same meaning as defined in the Purchase Agreement.

The following is a statement of the rights of the Holder and the conditions to which this Warrant is subject, and to which Holder, by acceptance of this Warrant, agrees:

1.              Number and Price of Shares; Exercise Period.

(a)              Definition of Shares. “Shares” shall mean the Qualified Financing Shares (as defined the Note) if the Note is converted into the Qualified Financing Shares in a Qualified Financing (as defined in the Note) pursuant to the terms thereof. If the Note is converted into the Voluntary Conversion Shares (as defined in the Note) pursuant to the terms thereof, then “Shares” shall mean the Voluntary Conversion Shares.

(b)              Number of Shares. Subject to any previous exercise of the Warrant, the Holder shall have the right to purchase up to the number of Shares that equals the quotient obtained by dividing (x) $75,000 (the “Warrant Coverage Amount”) by (y) the Exercise Price (as defined below), prior to (or in connection with) the expiration of this Warrant as provided in Section 8.

(c)              Exercise Price. The exercise price per Share (the “Exercise Price”) shall be equal to (i) the Conversion Price (as defined in the Note) if the Note has converted into the Qualified Financing Shares in a Qualified Financing, or (ii) if the Note has converted into the Voluntary Conversion Shares, the lowest price per share paid by the other purchasers of the Voluntary Conversion Shares sold in the Non-Qualified Financing.

(d)              Exercise Period. This Warrant shall be exercisable, in whole or in part, after the earlier of (i) the closing date of the Company’s Qualified Financing or (ii) conversion of the Note in a Non-Qualified Financing and prior to (or in connection with) the expiration of this Warrant as set forth in Section 8.

2.              Exercise of the Warrant.

(a)              Exercise. The purchase rights represented by this Warrant may be exercised at the election of the Holder, in whole or in part, in accordance with Section 1, by:

(i)              the tender to the Company at its principal office (or such other office or agency as the Company may designate) of a notice of exercise in the form of Exhibit A (the “Notice of Exercise”), duly completed and executed by or on behalf of the Holder, together with the surrender of this Warrant; and

(ii)             the payment to the Company of an amount equal to (x) the Exercise Price multiplied by (y) the number of Shares being purchased, by (a) wire transfer or certified, cashier’s or other check acceptable to the Company and payable to the order of the Company; (b) surrender and cancellation of promissory notes or other instruments representing indebtedness of the Company to the Holder; or (c) a combination of (a) and (b).

(b)              Net Issue Exercise. In lieu of exercising this Warrant pursuant to Section 2(a)(ii), if the fair market value of one Share is greater than the Exercise Price (at the date of calculation as set forth below), the Holder may elect to receive a number of Shares equal to the value of this Warrant (or of any portion of this Warrant being canceled) by surrender of this Warrant at the principal office of the Company (or such other office or agency as the Company may designate) together with a properly completed and executed Notice of Exercise reflecting such election, in which event the Company shall issue to the Holder that number of Shares computed using the following formula:

X =       Y (A – B)        A

Where:

X	=	The number of Shares to be issued to the Holder
Y	=	The number of Shares purchasable under this Warrant or, if only a portion of the Warrant is being exercised, the portion of the Warrant being canceled (at the date of such calculation)
A	=	The fair market value of one Share (at the date of such calculation)
B	=	The Exercise Price (as adjusted to the date of such calculation)

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For purposes of the calculation above, the fair market value of one Share shall be determined by the Board of Directors of the Company, acting in good faith; provided, however, that:

(i)              where a public market exists for the Company’s common stock at the time of such exercise, the fair market value per Share shall be the product of (x) the average of the closing bid and asked prices of the common stock or the closing price quoted on the national securities exchange on which the common stock is listed as published in the Wall Street Journal, as applicable, for the ten (10) trading day period ending five (5) trading days prior to the date of determination of fair market value and (y) the number of shares of common stock into which each Share is convertible at the time of such exercise, as applicable; and

(ii)              if the Warrant is exercised in connection with the Company’s initial public offering of common stock, the fair market value per Share shall be the product of (x) the per share offering price to the public of the Company’s initial public offering and (y) the number of shares of common stock into which each Share is convertible at the time of such exercise, as applicable.

(c)              Stock Certificates. The rights under this Warrant shall be deemed to have been exercised and the Shares issuable upon such exercise shall be deemed to have been issued immediately prior to the close of business on the date this Warrant is exercised in accordance with its terms, and the person entitled to receive the Shares issuable upon such exercise shall be treated for all purposes as the holder of record of such Shares as of the close of business on such date. As promptly as reasonably practicable on or after such date, the Company shall issue and deliver to the person or persons entitled to receive the same a certificate or certificates (or a notice of issuance of uncertificated shares, if applicable) for that number of shares issuable upon such exercise. In the event that the rights under this Warrant are exercised in part and have not expired, the Company shall execute and deliver a new Warrant reflecting the number of Shares that remain subject to this Warrant.

(d)              No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of the rights under this Warrant. In lieu of such fractional share to which the Holder would otherwise be entitled, the Company shall make a cash payment equal to the Exercise Price multiplied by such fraction.

(e)              Conditional Exercise. The Holder may exercise this Warrant conditioned upon (and effective immediately prior to) consummation of any transaction that would cause the expiration of this Warrant pursuant to Section 8 by so indicating in the notice of exercise.

(f)              Automatic Exercise. If the Holder of this Warrant has not elected to exercise this Warrant prior to expiration of this Warrant pursuant to Section 8, then this Warrant shall automatically (without any act on the part of the Holder) be exercised pursuant to Section 2(b) effective immediately prior to the expiration of the Warrant to the extent such net issue exercise would result in the issuance of Shares, unless Holder shall earlier provide written notice to the Company that the Holder desires that this Warrant expire unexercised. If this Warrant is automatically exercised, the Company shall notify the Holder of the automatic exercise as soon as reasonably practicable, and the Holder shall surrender the Warrant to the Company in accordance with the terms hereof.

(g)              Reservation of Stock. The Company agrees during the term the rights under this Warrant are exercisable to reserve and keep available from its authorized and unissued shares of preferred stock (or any such other class or series of stock then issuable upon exercise of this Warrant) for the purpose of effecting the exercise of this Warrant such number of shares (and shares of common stock for issuance on conversion of such shares) as shall from time to time be sufficient to effect the exercise of the rights under this Warrant; and if at any time the number of authorized but unissued shares of preferred stock (or any such other class or series of stock then issuable upon exercise of this Warrant) (and shares of common stock for issuance on conversion of such shares) shall not be sufficient for purposes of the exercise of this Warrant in accordance with its terms and the conversion of the Shares, without limitation of such other remedies as may be available to the Holder, the Company will use its best efforts to take such corporate action as may, in the opinion of counsel, be necessary to increase its authorized and unissued shares of its preferred stock (and shares of common stock for issuance on conversion of such shares) to a number of shares as shall be sufficient for such purposes. The Company represents and warrants that all shares that may be issued upon the exercise of this Warrant will, when issued in accordance with the terms hereof, be validly issued, fully paid and nonassessable.

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3.              Replacement of the Warrant. Subject to the receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and substance to the Company or, in the case of mutilation, on surrender and cancellation of this Warrant, the Company at the expense of the Holder shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor and amount.

4.              Transfer of the Warrant.

(a)              Warrant Register. The Company shall maintain a register (the “Warrant Register”) containing the name and address of the Holder or Holders. Until this Warrant is transferred on the Warrant Register in accordance herewith, the Company may treat the Holder as shown on the Warrant Register as the absolute owner of this Warrant for all purposes, notwithstanding any notice to the contrary. Any Holder of this Warrant (or of any portion of this Warrant) may change its address as shown on the Warrant Register by written notice to the Company requesting a change.

(b)              Warrant Agent. The Company may appoint an agent for the purpose of maintaining the Warrant Register referred to in Section 4(a), issuing the Shares or other securities then issuable upon the exercise of the rights under this Warrant, exchanging this Warrant, replacing this Warrant or conducting related activities.

(c)              Transferability of the Warrant. Subject to the provisions of this Warrant with respect to compliance with the Securities Act of 1933, as amended (the “Securities Act”) and limitations on assignments and transfers, including without limitation compliance with the restrictions on transfer set forth in Section 5, title to this Warrant may be transferred by endorsement (by the transferor and the transferee executing the assignment form attached as Exhibit B (the “Assignment Form”)) and delivery in the same manner as a negotiable instrument transferable by endorsement and delivery.

(d)              Exchange of the Warrant upon a Transfer. On surrender of this Warrant (and a properly endorsed Assignment Form) for exchange, subject to the provisions of this Warrant with respect to compliance with the Securities Act and limitations on assignments and transfers, the Company shall issue to or on the order of the Holder a new warrant or warrants of like tenor, in the name of the Holder or as the Holder (on payment by the Holder of any applicable transfer taxes) may direct, for the number of shares issuable upon exercise hereof, and the Company shall register any such transfer upon the Warrant Register. This Warrant (and the securities issuable upon exercise of the rights under this Warrant) must be surrendered to the Company or its warrant or transfer agent, as applicable, as a condition precedent to the sale, pledge, hypothecation or other transfer of any interest in any of the securities represented hereby.

(e)              Taxes. In no event shall the Company be required to pay any tax which may be payable in respect of any transfer involved in the issue and delivery of any certificate, or a book entry, in a name other than that of the Holder, and the Company shall not be required to issue or deliver any such certificate, or make such book entry, unless and until the person or persons requesting the issue or entry thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid or is not payable.

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5.              Restrictions on Transfer of the Warrant and Shares; Compliance with Securities Laws. By acceptance of this Warrant, the Holder agrees to comply with the following:

(a)              Restrictions on Transfers. Any transfer of this Warrant or the Shares or the shares of common stock issuable upon conversion of the Shares (the “Securities”) must be in compliance with all applicable federal and state securities laws. The Holder agrees not to make any sale, assignment, transfer, pledge or other disposition of all or any portion of the Securities, or any beneficial interest therein, unless and until the transferee thereof has agreed in writing for the benefit of the Company to take and hold such Securities subject to, and to be bound by, the terms and conditions set forth in this Warrant to the same extent as if the transferee were the original Holder hereunder.

(b)              Investment Representation Statement. Unless the rights under this Warrant are exercised pursuant to an effective registration statement under the Securities Act that includes the Shares with respect to which the Warrant was exercised, it shall be a condition to any exercise of the rights under this Warrant that the Holder shall have confirmed to the satisfaction of the Company in writing, substantially in the form of Exhibit A-1, that the Shares so purchased are being acquired solely for the Holder’s own account and not as a nominee for any other party, for investment and not with a view toward distribution or resale and that the Holder shall have confirmed such other matters related thereto as may be reasonably requested by the Company.

(c)              Securities Law Legend. Each certificate, instrument or book entry representing the Securities shall (unless otherwise permitted by the provisions of this Warrant) be notated with a legend substantially similar to the following (in addition to any legend required by state securities laws):

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. This certificate must be surrendered to the coMPANY or its transfer agent as a condition precedent to the sale, TRANSFER, pledge OR hypothecation of any interest in any of the securities represented hereby.

(d)              Instructions Regarding Transfer Restrictions. The Holder consents to the Company making a notation on its records and giving instructions to any transfer agent in order to implement the restrictions on transfer established in this Section 5.

(e)              Removal of Legend. The legend referring to federal and state securities laws identified in Section 5(d) notated on any certificate evidencing the Shares (and the common stock issuable upon conversion thereof) and the stock transfer instructions and record notations with respect to such securities shall be removed, and the Company shall issue a certificate without such legend to the holder of such securities (to the extent the securities are certificated), if (i) such securities are registered under the Securities Act, or (ii) such holder provides the Company with an opinion of counsel reasonably acceptable to the Company to the effect that a sale or transfer of such securities may be made without registration, qualification or legend.

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6.              Adjustments. Subject to the expiration of this Warrant pursuant to Section 8, the number and kind of shares purchasable hereunder and the Exercise Price therefor are subject to adjustment from time to time, as follows:

(a)              Merger or Reorganization. If at any time there shall be any reorganization, recapitalization, merger or consolidation (a “Reorganization”) involving the Company (other than as otherwise provided for herein or as would cause the expiration of this Warrant under Section 8) in which shares of the Company’s stock are converted into or exchanged for securities, cash or other property, then, as a part of such Reorganization, lawful provision shall be made so that the Holder shall thereafter be entitled to receive upon exercise of this Warrant, the kind and amount of securities, cash or other property of the successor corporation resulting from such Reorganization, equivalent in value to that which a holder of the Shares deliverable upon exercise of this Warrant would have been entitled in such Reorganization if the right to purchase the Shares hereunder had been exercised immediately prior to such Reorganization. In any such case, appropriate adjustment (as determined in good faith by the Board of Directors of the successor corporation) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of the Holder after such Reorganization to the end that the provisions of this Warrant shall be applicable after the event, as near as reasonably may be, in relation to any shares or other securities deliverable after that event upon the exercise of this Warrant.

(b)              Reclassification of Shares. If the securities issuable upon exercise of this Warrant are changed into the same or a different number of securities of any other class or classes by reclassification, capital reorganization, conversion of all outstanding shares of the relevant class or series (other than as would cause the expiration of this Warrant pursuant to Section 8) or otherwise (other than as otherwise provided for herein) (a “Reclassification”), then, in any such event, in lieu of the number of Shares which the Holder would otherwise have been entitled to receive, the Holder shall have the right thereafter to exercise this Warrant for a number of shares of such other class or classes of stock that a holder of the number of securities deliverable upon exercise of this Warrant immediately before that change would have been entitled to receive in such Reclassification, all subject to further adjustment as provided herein with respect to such other shares.

(c)              Subdivisions and Combinations. In the event that the outstanding shares of the securities issuable upon exercise of this Warrant are subdivided (by stock split, by payment of a stock dividend or otherwise) into a greater number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such subdivision shall, concurrently with the effectiveness of such subdivision, be proportionately increased, and the Exercise Price shall be proportionately decreased, and in the event that the outstanding shares of the securities issuable upon exercise of this Warrant are combined (by reclassification or otherwise) into a lesser number of shares of such securities, the number of Shares issuable upon exercise of the rights under this Warrant immediately prior to such combination shall, concurrently with the effectiveness of such combination, be proportionately decreased, and the Exercise Price shall be proportionately increased.

(d)              Redemption. In the event that all of the outstanding shares of the securities issuable upon exercise of this Warrant are redeemed in accordance with the Company’s certificate of incorporation, this Warrant shall thereafter be exercisable for a number of shares of the Company’s common stock equal to the number of shares of common stock that would have been received if this Warrant had been exercised in full immediately prior to such redemption and the preferred stock received thereupon had been simultaneously converted into common stock.

(e)              Notice of Adjustments. Upon any adjustment in accordance with this Section 6, the Company shall give notice thereof to the Holder, which notice shall state the event giving rise to the adjustment, the Exercise Price as adjusted and the number of securities or other property purchasable upon the exercise of the rights under this Warrant, setting forth in reasonable detail the method of calculation of each. The Company shall, upon the written request of any Holder, furnish or cause to be furnished to such Holder a certificate setting forth (i) such adjustments, (ii) the Exercise Price at the time in effect and (iii) the number of securities and the amount, if any, of other property that at the time would be received upon exercise of this Warrant.

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7.              Notification of Certain Events. Prior to the expiration of this Warrant pursuant to Section 8, in the event that the Company shall authorize:

(a)              the issuance of any dividend or other distribution on the capital stock of the Company (other than (i) dividends or distributions otherwise provided for in Section 6, (ii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries upon termination of their employment or services pursuant to agreements providing for the right of said repurchase; (iii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries pursuant to rights of first refusal or first offer contained in agreements providing for such rights; or (iv) repurchases of capital stock of the Company in connection with the settlement of disputes with any stockholder), whether in cash, property, stock or other securities;

(b)              the voluntary liquidation, dissolution or winding up of the Company; or

(c)              any transaction resulting in the expiration of this Warrant pursuant to Section 8(b) or 8(c);

the Company shall send to the Holder of this Warrant at least 10 days prior written notice of the date on which a record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b) or (c), as applicable. The notice provisions set forth in this section may be shortened or waived prospectively or retrospectively by the consent of the Holder of this Warrant.

8.              Expiration of the Warrant. This Warrant shall expire and shall no longer be exercisable as of the earlier of:

(a)              5:00 p.m., Pacific time, on March 6, 2025;

(b)              (i) the acquisition of the Company by another entity by means of any transaction or series of related transactions to which the Company is a party (including, without limitation, any stock acquisition, reorganization, merger or consolidation, but excluding any sale of stock for capital raising purposes and any transaction effected primarily for purposes of changing the Company’s jurisdiction of incorporation) other than a transaction or series of related transactions in which the holders of the voting securities of the Company outstanding immediately prior to such transaction or series of related transactions retain, immediately after such transaction or series of transactions, as a result of shares in the Company held by such holders prior to such transaction or series of transactions, at least a majority of the total voting power represented by the outstanding voting securities of the Company or such other surviving or resulting entity (or if the Company or such other surviving or resulting entity is a wholly-owned subsidiary immediately following such acquisition, its parent), or (ii) a sale, lease or other disposition of all or substantially all of the assets of the Company and its subsidiaries taken as a whole by means of any transaction or series of related transactions, except where such sale, lease or other disposition is to a wholly-owned subsidiary of the Company; or

(c)              immediately prior to the closing of a firm commitment underwritten initial public offering pursuant to an effective registration statement filed under the Securities Act covering the offering and sale of the Company’s common stock.

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9.              No Rights as a Stockholder. Nothing contained herein shall entitle the Holder to any rights as a stockholder of the Company or to be deemed the holder of any securities that may at any time be issuable on the exercise of the rights hereunder for any purpose nor shall anything contained herein be construed to confer upon the Holder, as such, any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action (whether upon any recapitalization, issuance of stock, reclassification of stock, change of par value or change of stock to no par value, consolidation, merger, conveyance or otherwise) or to receive notice of meetings, or to receive dividends or subscription rights or any other rights of a stockholder of the Company until the rights under the Warrant shall have been exercised and the Shares purchasable upon exercise of the rights hereunder shall have become deliverable as provided herein.

10.            Representations and Warranties of the Holder. By acceptance of this Warrant, the Holder represents and warrants to the Company as follows:

(a)              No Registration. The Holder understands that the Securities have not been, and will not be, registered under the Securities Act by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Holder’s representations as expressed herein or otherwise made pursuant hereto.

(b)              Investment Intent. The Holder is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Holder has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

(c)              Investment Experience. The Holder has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

(d)              Speculative Nature of Investment. The Holder understands and acknowledges that the Company has a limited financial and operating history and that its investment in the Company is highly speculative and involves substantial risks. The Holder can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

(e)              Access to Data. The Holder has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Holder understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Holder acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

(f)              Accredited Investor. The Holder is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Holder has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

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(g)              Residency. The residency of Holder (or, in the case of a partnership or corporation, such entity’s principal place of business) has been correctly provided to the Company.

(h)              Restrictions on Resales. The Holder acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Holder is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Holder acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Holder wishes to sell the Securities and that, in such event, the Holder may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Holder acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Holder understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales and that such persons and the brokers who participate in the transactions do so at their own risk.

(i)              No Public Market. The Holder understands and acknowledges that no public market now exists for any of the securities issued by the Company and that the Company has made no assurances that a public market will ever exist for the Company’s securities.

(j)              Brokers and Finders. The Holder has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Holder, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

(k)              Legal Counsel. The Holder has had the opportunity to review this Warrant, the exhibits and schedules attached hereto and the transactions contemplated by this Warrant with its own legal counsel. The Holder is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by this Warrant.

(l)              Tax Advisors. The Holder has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by this Warrant. With respect to such matters, the Holder relies solely on any such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Holder understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment and the transactions contemplated by this Warrant.

11.            Miscellaneous.

(a)              Amendments. Except as expressly provided herein, neither this Warrant nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument referencing this Warrant and signed by the Company and the Holder.

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(b)              Waivers. No waiver of any single breach or default shall be deemed a waiver of any other breach or default theretofore or thereafter occurring.

(c)              Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, postage prepaid, sent by facsimile or electronic mail (if to the Holder) or otherwise delivered by hand, messenger or courier service addressed:

(i)              if to the Holder, to the Holder at the Holder’s address, facsimile number or electronic mail address as shown in the Company’s records, as may be updated in accordance with the provisions hereof, or until any such Holder so furnishes an address, facsimile number or electronic mail address to the Company, then to and at the address, facsimile number or electronic mail address of the last holder of this Warrant for which the Company has contact information in its records; or

(ii)             if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at the Company’s address as shown on the signature page hereto, or at such other current address as the Company shall have furnished to the Holder.

Each such notice or other communication shall for all purposes of this Warrant be treated as effective or having been given (i) if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if sent by mail, at the earlier of its receipt or five days after the same has been deposited in a regularly maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day. In the event of any conflict between the Company’s books and records and this Warrant or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.

(d)              Governing Law. This Warrant and all actions arising out of or in connection with this Warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of law provisions of the State of Delaware, or of any other state.

(e)              Jurisdiction and Venue. Each of the Holder and the Company hereby submits and consents irrevocably to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for the interpretation and enforcement of the provisions of this Warrant. Each of the Holder and the Company also agrees that the jurisdiction over such persons and the subject matter of such dispute shall be effected by any manner as may be lawful, and that service in such manner shall constitute valid and sufficient service of process.

(f)              Titles and Subtitles. The titles and subtitles used in this Warrant are used for convenience only and are not to be considered in construing or interpreting this Warrant. All references in this Warrant to sections, paragraphs and exhibits shall, unless otherwise provided, refer to sections and paragraphs hereof and exhibits attached hereto.

(g)              Severability. If any provision of this Warrant becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, portions of such provision, or such provision in its entirety, to the extent necessary, shall be severed from this Warrant, and such illegal, unenforceable or void provision shall be replaced with a valid and enforceable provision that will achieve, to the extent possible, the same economic, business and other purposes of the illegal, unenforceable or void provision. The balance of this Warrant shall be enforceable in accordance with its terms.

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(h)              Waiver of Jury Trial. Each of the Holder and the Company waives, to the fullest extent permitted by law, any and all right to trial by jury in any legal proceeding (whether based on contract, tort or otherwise) arising out of or related to this Warrant.

(i)              California Corporate Securities Law. THE SALE OF THE SECURITIES THAT ARE THE SUBJECT OF THIS WARRANT HAS NOT BEEN QUALIFIED WITH THE COMMISSIONER OF CORPORATIONS OF THE STATE OF CALIFORNIA AND THE ISSUANCE OF SUCH SECURITIES OR THE PAYMENT OR RECEIPT OF ANY PART OF THE CONSIDERATION THEREFOR PRIOR TO SUCH QUALIFICATION IS UNLAWFUL, UNLESS THE SALE OF SECURITIES IS EXEMPT FROM QUALIFICATION BY SECTION 25100, 25102, OR 25105 OF THE CALIFORNIA CORPORATIONS CODE. THE RIGHTS OF ALL PARTIES TO THIS WARRANT ARE EXPRESSLY CONDITIONED UPON THE QUALIFICATION BEING OBTAINED, UNLESS THE SALE IS SO EXEMPT.

(j)              Saturdays, Sundays and Holidays. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall be a Saturday, Sunday or U.S. federal holiday, then such action may be taken or such right may be exercised on the next succeeding day that is not a Saturday, Sunday or U.S. federal holiday.

(k)              Rights and Obligations Survive Exercise of the Warrant. Except as otherwise provided herein, the rights and obligations of the Company and the Holder under this Warrant shall survive exercise of this Warrant.

(l)              Entire Agreement. Except as expressly set forth herein, this Warrant (including the exhibits attached hereto) constitutes the entire agreement and understanding of the Company and the Holder with respect to the subject matter hereof and supersede all prior agreements and understandings relating to the subject matter hereof.

(signature page follows)

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The Company signs this Warrant as of the date stated on the first page.

MIROMATRIX MEDICAL INC.

By:

Name: Jeffrey Ross

Title: Chief Executive Officer

Address:

10399 West 70th Street, Eden Prairie, MN 55344

AGREED AND ACKNOWLEDGED,

Cheshire MD Holdings, LLC

By:

Name:

Title:

EXHIBIT A

NOTICE OF EXERCISE

TO: MIROMATRIX MEDICAL INC. (the “Company”)

Attention: Chief Executive Officer

(1) Exercise. The undersigned elects to purchase the following pursuant to the terms of the attached warrant:

Number of shares:

Type of security:

(2) Method of Exercise. The undersigned elects to exercise the attached warrant pursuant to:

¨ A cash payment or cancellation of indebtedness, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any.

¨ The net issue exercise provisions of Section 2(b) of the attached warrant.

(3) Stock. Please make a book entry and, if the shares are certificated, issue a certificate or certificates representing the shares in the name of:

¨ The undersigned

¨ Other—Name:

Address:

(4) Unexercised Portion of the Warrant. Please issue a new warrant for the unexercised portion of the attached warrant in the name of:

¨ The undersigned

¨ Other—Name:

Address:

¨ Not applicable

(5) Investment Intent. The undersigned represents and warrants that the aforesaid shares are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties of the undersigned set forth in Section 11 of the attached warrant are true and correct as of the date hereof.

(6) Investment Representation Statement and Market Stand-Off Agreement. The undersigned has executed, and delivers herewith, an Investment Representation Statement and Market Stand-Off Agreement in a form substantially similar to the form attached to the warrant as Exhibit A-1.

(7) Consent to Receipt of Electronic Notice. Subject to the limitations set forth in Delaware General Corporation Law §232(e), the undersigned consents to the delivery of any notice to stockholders given by the Company under the Delaware General Corporation Law or the Company’s certificate of incorporation or bylaws by (i) facsimile telecommunication to the facsimile number provided below (or to any other facsimile number for the undersigned in the Company’s records), (ii) electronic mail to the electronic mail address provided below (or to any other electronic mail address for the undersigned in the Company’s records), (iii) posting on an electronic network together with separate notice to the undersigned of such specific posting or (iv) any other form of electronic transmission (as defined in the Delaware General Corporation Law) directed to the undersigned. This consent may be revoked by the undersigned by written notice to the Company and may be deemed revoked in the circumstances specified in Delaware General Corporation Law §232.

(Print name of the warrant holder)

(Signature)

(Name and title of signatory, if applicable)

(Date)

(Fax number)

(Email address)

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EXHIBIT A-l

INVESTMENT REPRESENTATION STATEMENT

AND

MARKET STAND-OFF AGREEMENT

INVESTOR:

COMPANY: MIROMATRIX MEDICAL INC.

SECURITIES:	THE WARRANT ISSUED ON [INSERT DATE] (THE “WARRANT”) AND THE SECURITIES ISSUED OR ISSUABLE UPON EXERCISE THEREOF (INCLUDING UPON SUBSEQUENT CONVERSION OF THOSE SECURITIES)
DATE:	_______________________________

In connection with the purchase or acquisition of the above-listed Securities, the undersigned Investor represents and warrants to, and agrees with, the Company as follows:

1.              No Registration. The Investor understands that the Securities have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), by reason of a specific exemption from the registration provisions of the Securities Act, the availability of which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein or otherwise made pursuant hereto.

2.              Investment Intent. The Investor is acquiring the Securities for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, any distribution thereof. The Investor has no present intention of selling, granting any participation in, or otherwise distributing the Securities, nor does it have any contract, undertaking, agreement or arrangement for the same.

3.              Investment Experience. The Investor has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company, and has such knowledge and experience in financial or business matters so that it is capable of evaluating the merits and risks of its investment in the Company and protecting its own interests.

4.              Speculative Nature of Investment. The Investor understands and acknowledges that the Company has a limited financial and operating history and that its investment in the Company is highly speculative and involves substantial risks. The Investor can bear the economic risk of its investment and is able, without impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.

5.              Access to Data. The Investor has had an opportunity to ask questions of officers of the Company, which questions were answered to its satisfaction. The Investor understands that any such discussions, as well as any information issued by the Company, were intended to describe certain aspects of the Company’s business and prospects, but were not necessarily a thorough or exhaustive description. The Investor acknowledges that any business plans prepared by the Company have been, and continue to be, subject to change and that any projections included in such business plans or otherwise are necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the projections will not materialize or will vary significantly from actual results.

6.              Accredited Investor. The Investor is an “accredited investor” within the meaning of Regulation D, Rule 501(a), promulgated by the Securities and Exchange Commission and agrees to submit to the Company such further assurances of such status as may be reasonably requested by the Company. The Investor has furnished or made available any and all information requested by the Company or otherwise necessary to satisfy any applicable verification requirements as to “accredited investor” status. Any such information is true, correct, timely and complete.

7.              Residency. The residency of the Investor (or, in the case of a partnership or corporation, such entity’s principal place of business) is correctly set forth on the signature page hereto.

8.              Restrictions on Resales. The Investor acknowledges that the Securities must be held indefinitely unless subsequently registered under the Securities Act or an exemption from such registration is available. The Investor is aware of the provisions of Rule 144 promulgated under the Securities Act, which permit resale of shares purchased in a private placement subject to the satisfaction of certain conditions, which may include, among other things, the availability of certain current public information about the Company; the resale occurring not less than a specified period after a party has purchased and paid for the security to be sold; the number of shares being sold during any three-month period not exceeding specified limitations; the sale being effected through a “broker’s transaction,” a transaction directly with a “market maker” or a “riskless principal transaction” (as those terms are defined in the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder); and the filing of a Form 144 notice, if applicable. The Investor acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time the Investor wishes to sell the Securities and that, in such event, the Investor may be precluded from selling the Securities under Rule 144 even if the other applicable requirements of Rule 144 have been satisfied. The Investor understands and acknowledges that, in the event the applicable requirements of Rule 144 are not met, registration under the Securities Act or an exemption from registration will be required for any disposition of the Securities. The Investor understands that, although Rule 144 is not exclusive, the Securities and Exchange Commission has expressed its opinion that persons proposing to sell restricted securities received in a private offering other than in a registered offering or pursuant to Rule 144 will have a substantial burden of proof in establishing that an exemption from registration is available for those offers or sales and that those persons and the brokers who participate in the transactions do so at their own risk.

9.              No Public Market. The Holder understands and acknowledges that no public market now exists for any of the securities issued by the Company and that the Company has made no assurances that a public market will ever exist for the Company’s securities.

10.            Brokers and Finders. The Investor has not engaged any brokers, finders or agents in connection with the Securities, and the Company has not incurred nor will incur, directly or indirectly, as a result of any action taken by the Investor, any liability for brokerage or finders’ fees or agents’ commissions or any similar charges in connection with the Securities.

11.            Legal Counsel. The Investor has had the opportunity to review the Warrant, the exhibits and schedules attached thereto and the transactions contemplated by the Warrant with its own legal counsel. The Investor is not relying on any statements or representations of the Company or its agents for legal advice with respect to this investment or the transactions contemplated by the Warrant.

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12.           Tax Advisors. The Investor has reviewed with its own tax advisors the U.S. federal, state and local and non-U.S. tax consequences of this investment and the transactions contemplated by the Warrant. With respect to such matters, the Investor relies solely on such advisors and not on any statements or representations of the Company or any of its agents, written or oral. The Investor understands that it (and not the Company) shall be responsible for its own tax liability that may arise as a result of this investment or the transactions contemplated by the Warrant.

13.            No “Bad Actor” Disqualification. Neither (i) the Investor, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s voting equity securities (in accordance with Rule 506(d) of the Securities Act) held by the Investor is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act, except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the purchase or acquisition of the Securities, in writing in reasonable detail to the Company.

(signature page follows)

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The Investor is signing this Investment Representation Statement and Market Stand-Off Agreement on the date first written above.

INVESTOR

Cheshire MD Holdings, LLC

By:

Name:

Title:

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EXHIBIT B

ASSIGNMENT FORM

ASSIGNOR:

COMPANY: MIROMATRIX MEDICAL INC.

WARRANT: THE WARRANT TO PURCHASE SHARES OF PREFERRED STOCK ISSUED ON [INSERT DATE] (THE “WARRANT”)

DATE:

(1) Assignment. The undersigned registered holder of the Warrant (“Assignor”) assigns and transfers to the assignee named below (“Assignee”) all of the rights of Assignor under the Warrant, with respect to the number of shares set forth below:

Name of Assignee:

Address of Assignee:

Number of Shares Assigned:

and does irrevocably constitute and appoint ______________________ as attorney to make such transfer on the books of Miromatrix Medical Inc., maintained for the purpose, with full power of substitution in the premises.

(2) Obligations of Assignee. Assignee agrees to take and hold the Warrant and any shares of stock to be issued upon exercise of the rights thereunder (and any shares issuable upon conversion thereof) (the “Securities”) subject to, and to be bound by, the terms and conditions set forth in the Warrant to the same extent as if Assignee were the original holder thereof.

(3) Investment Intent. Assignee represents and warrants that the Securities are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that Assignee has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties set forth in Section 11 of the Warrant are true and correct as to Assignee as of the date hereof.

(4) Investment Representation Statement and Market Stand-Off Agreement. Assignee has executed, and delivers herewith, an Investment Representation Statement and Market Stand-Off Agreement in a form substantially similar to the form attached to the Warrant as Exhibit A-1.

(5) No “Bad Actor” Disqualification. Neither (i) Assignee, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of any of the Company’s securities held or to be held by Assignee is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act of 1933, as amended (the “Securities Act”), except as set forth in Rule 506(d)(2)(ii) or (iii) or (d)(3) under the Securities Act and disclosed, reasonably in advance of the transfer of the Securities, in writing in reasonable detail to the Company.

Assignor and Assignee are signing this Assignment Form on the date first set forth above.

ASSIGNOR	ASSIGNEE
(Print name of Assignor)	(Print name of Assignee)
(Signature of Assignor)	(Signature of Assignee)
(Print name of signatory, if applicable)	(Print name of signatory, if applicable)
(Print title of signatory, if applicable)	(Print title of signatory, if applicable)
Address:	Address:

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EX-4.8

Exhibit 4.8

THIS WARRANT AND THE SECURITIES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR ANY APPLICABLE STATE SECURITIES LAWS. THIS WARRANT AND SUCH SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, OR OTHERWISE TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR EVIDENCE SATISFACTORY TO THE COMPANY OF AN APPLICABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR COMPLIANCE WITH RULE 144 UNDER SUCH ACT. THE TRANSFER OF THIS WARRANT IS FURTHER RESTRICTED AS PROVIDED HEREIN.

WARRANT TO PURCHASE

SHARES OF COMMON STOCK

OF

MIROMATRIX MEDICAL INC.

This certifies that as of the date written above (the “Warrant Issue Date”), for value received, [ ] (“Holder”) is entitled, subject to the terms set forth below, to purchase from Miromatrix Medical Inc., a Delaware corporation (the “Company”), such number of fully paid and non-assessable shares of common stock of the Company (“Common Stock”), as set forth in Section 2 hereof (subject to adjustment as provided in Section 10 hereof), upon surrender hereof at the principal office of the Company referred to below, with the Notice of Exercise attached hereto duly executed, and simultaneous payment thereof in lawful money of the United States or otherwise as hereinafter provided, at the Exercise Price as set forth in Section 2 below. The number and Exercise Price of such shares of Common Stock are subject to adjustment as provided below. The term “Warrant” as used herein, shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein.

1.Term of Warrant; Exercisability. Subject to the terms and conditions set forth herein, this Warrant shall be exercisable in whole or in part, at any time or from time to time following the Warrant Issue. Date); provided, however, that, notwithstanding anything to the contrary herein, this Warrant shall expire at 5:00 p.m. on [ ], and shall be void thereafter.

2.Exercise Price and Number of Shares. The Holder is entitled to subscribe for and purchase [ ] shares of Common Stock from the Company at [ ] Dollars per share, subject to any adjustments made pursuant to Section 10 hereof (the “Exercise Price”).

3.Exercise of Warrant.

(A)Manner of Exercise. The purchase rights represented by this Warrant are exercisable by the Holder in whole or in part, at any time, or from time to time, during the term hereof as described in Section 1 above, by the surrender of this Warrant and the Notice of Exercise attached hereto duly completed ‘and executed on behalf of the Holder, at the office of the Company (or such other office or agency of the Company as it may designate by notice in writing to the Holder at the address of the Holder appearing on the books of the Company), together with payment of an amount equal to the Exercise Price multiplied by the number of shares then being purchased, at Holder’s option in cash, by bank cashier’s check or certified check (or other check acceptable to the Company) or by wire transfer to a bank account designated by the Company for that purpose by written notice to Holder.

(B)Effective Time of Exercise. This Warrant shall be deemed to have been exercised immediately prior to the close of business on the date of its surrender for exercise as provided above, and the Holder entitled to receive the shares of Common Stock issuable upon such exercise shall be treated for all purposes as the holder of record of such shares as of the close of business on such date. As promptly as practicable on or after such date and in any event within ten (10) days thereafter, the Company at its expense shall issue and deliver to the Holder a certificate or certificates in the name of the Holder or as such Holder may direct (upon payment by such Holder of any applicable transfer taxes) for the number of shares issuable upon such exercise. In the event that this Warrant is exercised in part, the Company at its expense will execute and deliver a new warrant of like tenor exercisable for the number of shares then remaining for which this warrant may then be exercised.

(C)Net Issue Exercise.

(i)In lieu of exercising this Warrant in the manner provided above in Section 3(A), the Holder may elect to receive shares equal to the value of this Warrant (or portion thereof being exercised) by surrender of this Warrant at the principal office of the Company together with notice of such election on the Notice of Exercise form attached hereto duly executed by such Holder or such Holder’s duly authorized attorney, in which event the Company shall issue to such Holder a number of shares computed using the following formula:

X = Y (A-B)

A

Where               X = The number of shares to be issued to the Holder

Y = The number of shares purchasable under this Warrant or, if only a portion of this Warrant is being exercised, the portion of this Warrant being cancelled (at the date of such calculation)

A = The fair market value of one share (at the date of such calculation)

B = The Exercise Price (as adjusted to the date of such calculation)

(ii)For purposes of this Section 3(C), the fair market value of one share on the date of calculation shall mean the highest price per share which the Company could obtain on the date of calculation from a willing buyer (not a current employee or director) for shares of Common Stock (in the case of an exercise pursuant to Section 2(a)(i)) or Common Stock (in the case of an exercise pursuant to Section 2(a)(ii)), as applicable, sold by the Company from authorized but unissued shares, as determined in good faith by the Board of Directors and agreed to by the Holder.

2

4.No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. In lieu of any fractional share to which the Holder would otherwise be entitled, the Company shall make a cash payment equal to the Exercise Price multiplied by such fraction.

5.Replacement of Warrant. On receipt of evidence reasonably satisfactory to the Company of loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity bond or other security in an amount reasonably satisfactory as sufficient security, or in the case of mutilation, on surrender and cancellation of this Warrant, the Company, at its expense, shall execute and deliver, in lieu of this Warrant, a new warrant of like tenor and amount.

6.Rights of Stockholders.

(A)Limitations on Rights of Warrant. The Holder shall not be entitled to vote or receive dividends or be deemed the holder of Common Stock or any other securities of the Company that may at any time be issuable on the exercise hereof for any purpose, nor shall anything contained herein be construed to confer upon the Holder, as such, any of the rights of a stockholder of the Company or any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action or to receive notice of meetings, or to receive dividends or subscription rights or otherwise until this Warrant shall have been exercised as provided herein.

(B)Notices of Certain Transactions. In case of:

(i)any Common reorganization of the Company, any reclassification of the Common stock of the Company, any consolidation or merger of the Company, any consolidation or merger of the Company with or into another corporation (other than a consolidation or merger in which the Company is the surviving entity), or any transfer of all or substantially all of the assets of the Company, or

(ii)the voluntary or involuntary dissolution, liquidation or winding-up of the Company, or

(iii)the initial public offering of the Company,

then, and in each such case, the Company will mail or cause to be mailed to the Holder a notice specifying, as the case may be, (i) the date on which a record is to be taken for the purpose of such right, and stating the amount and character of such right, or (ii) the effective date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation, winding-up, redemption or conversion is to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or other stock or securities at the time deliverable upon such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation, winding-up, redemption or conversion) are to be determined. Such notice shall be mailed at least ten (10) days prior to the record date or effective date for the event specified in such notice.

3

7.Transfer of Warrant.

(A)Non-transferability of Warrant. This Warrant may be transferred, in whole or part, without consent of the Company, only to an Affiliate of the Holder and to and from the beneficial owner hereof and any nominee from time to time acting as custodian for the beneficial owner hereof, in each case upon receipt of a representation reasonably satisfactory to the Company from the proposed transferee that it is an “accredited investor” as such term is defined in Rule 501 of Regulation D promulgated under the Act and is taking this Warrant for his, her or its own account, for investment and not with a view towards distribution or resale. This Warrant may also be transferred, in whole or part, to a non-Affiliate of the Holder with the prior written consent of the Company. For purposes hereof, the term “Affiliate” means any parent, subsidiary, stockholder, partner, retired partner or member of the Holder, and if the beneficial owner of this Warrant is an individual, any spouse, child, heir, legatee, executor or other personal representative of such individual. Any such transfer shall be made only in compliance with all applicable federal and state securities laws.

(B)Exchange of Warrant Upon Transfer. On the surrender of this Warrant in connection with a transfer pursuant to the terms of Section 7(A), the Company, at its expense, shall issue to the successor a new warrant or warrants of like tenor, in the name of the assignees, successors or heirs, who shall thereupon become the Holder(s) thereof, and shall be subject to all of the terms and conditions thereof.

(C)Compliance With Securities Laws.

(i)The Holder of this Warrant, or if the Holder is a custodian, the beneficial owner of this Warrant, by acceptance hereof, acknowledges that this Warrant and the shares of Common Stock to be issued upon exercise hereof are being acquired solely for the Holder’s (or beneficial owner’s) own account and not as a nominee for any other party, and for investment, and that the Holder will not offer, sell or otherwise dispose of this Warrant or any shares of Common Stock to be issued upon exercise hereof except under circumstances that will not result in a violation of any federal or state securities laws. Upon exercise of this Warrant (other than pursuant to the net exercise provision of Section 3(C)), the Holder shall as a condition to such exercise, if reasonably requested by the Company, confirm in writing, in a form reasonably satisfactory to the Company, that the shares of Common Stock so purchased are being acquired solely for the Holder’s own account and not as a nominee for any other party, for investment, and not with a view toward distribution or resale.

4

(ii)All shares of Common Stock issued upon exercise hereof may be stamped or imprinted with a legend in substantially the following form (in addition to any legend required by state securities laws), so long as such legend is required by applicable law:

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”). THESE SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, OR OTHERWISE TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR EVIDENCE SATISFACTORY TO THE COMPANY OF AN APPLICABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR COMPLIANCE WITH RULE 144 UNDER SUCH ACT.

If the legend is no longer required (as evidenced by a legal opinion >for the Holder or the Company or by evidence otherwise reasonably satisfactory to the Company), the Company will promptly remove such legend.

8.Reservation of Stock. During the term of this Warrant, the Company will at all times have authorized and reserved for the purpose of issuance upon exercise of this Warrant, a sufficient number of shares of the Company’s Common Stock to provide for the exercise of this Warrant. If at any time during the term of this Warrant the number of authorized but unissued shares of Common Stock shall not be sufficient to permit exercise of this Warrant, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes. All shares that may be issued upon the exercise of rights represented by this Warrant upon issuance, will be fully paid and non-assessable, free from all taxes, liens and charges in respect of the issuance thereof.

9.Amendments. This Warrant may not be amended, nor may any provision of this Warrant or any default, misrepresentation, or breach under this Warrant be waived or amended, except in a writing executed by all parties to this Warrant.

10.Special Provision.

(A)Reclassification. If the Company at any time while this Warrant, or any portion thereof, remains outstanding and unexpired, by reclassification of securities or otherwise, shall change any of the securities as to which purchase rights under this Warrant exist into the same or a different number of securities of any other class or classes, this Warrant shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as a result of such change with respect to the securities that were subject to the purchase rights under this Warrant immediately prior to such reclassification or other change and the Exercise Price therefore shall be appropriately adjusted, all subject to further adjustment as provided in this Section 10.

(B)Split, Subdivision, Reverse Split or Combination of Shares. If the Company at any time while this Warrant, or any portion thereof, remains outstanding and unexpired shall issue additional shares of its Common Stock as a dividend with respect to any shares of its Common Stock, or split, subdivide, reverse split or combine the securities as to which purchase rights under this Warrant exist, into a different number of securities of the same class, the Exercise Price per share for such securities shall be proportionately decreased in the case of a stock dividend, split or subdivision or proportionately increased in the case of a combination or reverse split and the number of shares which the Holder hereof shall be entitled to receive upon exercise shall be correspondingly appropriately adjusted.

5

11.No Impairment. The Company will not avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Company, but will at all times in good faith use its best efforts to carry out all of the provisions of this Warrant, including without limitation, the provisions of Section 10, and to take all such action as may be necessary or appropriate in order to protect the exercise rights of the Holder against impairment.

12.Lockup Following Public Offering. The Holder agrees not to offer, sell or otherwise dispose of any of the shares of Common Stock within 180 days following the effective date of an initial public offering of Common Stock by the Company or such shorter time period as approved by the Company in writing or such longer period up to 12 months as may be required by the managing underwriter or otherwise for listing of the Company’s Common Stock.

13.Miscellaneous.

(A)Notices. Any notice required or permitted under this Warrant shall be in writing sent by hand or certified or registered, first class mail, return receipt requested, to:

Holder:
Company:	Miromatrix Medical Inc.
	10399 West 70th Street
	Eden Prairie, MN 55344
	Attention: President and Chief Executive Officer

or to such other address of which either party shall notify the other by similar notice.

(B)Governing Law. This Warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflicts of law provisions.

(C)Successors. This Warrant shall be binding upon any successor(s) or assign(s) of the Company.

(D)Headings. The headings used in this Warrant are used for convenience only and are not to be considered in construing or interpreting this Warrant.

(E)Saturdays, Sundays, and Holidays. If the expiration date of this Warrant falls on a Saturday, Sunday or a Holiday, the term of this Warrant shall be extended to the next business day. “Holiday” as used herein means any day on which the principal office of the Company is officially closed or which is a bank closing day for banks in New York or in the Federal Reserve System. “Close of business” as used herein means close of business in the State of New York.

[Signature Page Follows]

6

IN WITNESS WHEREOF, Miromatrix Medical Inc. has caused this Warrant to be executed by its officer thereunto duly authorized.

	MIROMATRIX MEDICAL INC.
Date:	By:
	Name: Jeffrey J. Ross
	Title: Chief Executive Officer

7

NOTICE OF EXERCISE

To:     Miromatrix Medical Inc.:

1.        The undersigned hereby elects to purchase                             shares of Common Stock of Miromatrix Medical Inc. pursuant to the terms of the attached Warrant:

[Check Appropriate Box]

¨       a.       Tenders herewith payment of the exercise price for such shares in full.

¨       b.       Elects to exercise this Warrant for                             shares of Common Stock purchasable pursuant to the net exercise provisions of Section 3(C) of the Warrant.

2.         If the undersigned is exercising this Warrant pursuant to 1(a) above, the undersigned hereby confirms and acknowledges that the shares of the Common Stock to be issued upon exercise thereof are being acquired solely for the account of the undersigned and not as a nominee for any other party, and for investment and not with a view towards distribution, and that the undersigned will not offer, sell or otherwise dispose of any such shares of Common Stock except under circumstances that will not result in a violation of the Act, as amended, or any state securities laws.

3.       Please issue a certificate or certificates representing said shares of the Common Stock in the name of the undersigned or in such other name as is specified below.

4.         Please issue a new Warrant for the unexercised portion (if any) of the attached Warrant.

Signature	Date
Name                        [PLEASE PRINT]

EX-4.9

Exhibit 4.9

INCENTIVE STOCK OPTION AGREEMENT

This Stock Option Agreement is made and entered into as of [ ], between [ ] (“Employee”) and Miromatrix Medical Inc., a Delaware corporation (the “Company”).

Background

A.       Employee has been hired as an employee of the Company or the Company desires to induce Employee to continue to serve the Company as an employee.

B.       The Company has adopted the 2010 Stock Incentive Plan (the “Plan”) pursuant to which shares of common stock of the Company have been reserved for issuance under the Plan.

AGREEMENT

Now, THEREFORE, the parties hereto agree as follows:

1.Incorporation by Reference. The terms and conditions of the Plan, a copy of which has been delivered to Employee, are hereby incorporated herein and made a part hereof by reference as if set forth in full. In the event of any conflict or inconsistency between the provisions of this Agreement and those of the Plan, the provisions of the Plan shall govern and control.

2.Grant of Option: Purchase Price. Subject to the terms and conditions herein set forth, the Company hereby irrevocably arants from the Plan to Employee the right and option, hereinafter called the “Option”, to purchase all or any part of an aggregate of the number of shares of common stock, $.00001 par value per share, of the Company (the “Shares”) set forth at the end of this Agreement after “Number of Shares:” at the price per Share set forth at the end of this Agreement after “Purchase Price:”, which price is intended to be at least 100% of the fair market value of the Company’s common stock on the grant date (determined in accordance with the Company’s procedures for calculating such fair market value).

3.Exercise and Vesting of Option. The Option shall be exercisable only to the extent that all, or any portion thereof, has vested in the Employee. Except as provided herein in paragraph 4, the Option shall vest in Employee with respect to the Shares in four (4) annual installments as set forth at the end of this Agreement after “Vesting Schedule:,” so long as Employee remains an employee of the Company (each such date is hereinafter referred to singularly as a “Vesting Date” and collectively as “Vesting Dates”).

4.Termination. In the event that the Employee ceases to be an employee of the Company, for any reason or no reason, with or without cause, prior to any Vesting Date, that part of the Option scheduled to vest on such Vesting Date, and all parts of the Option scheduled to vest in the future, shall not vest and all of Employee’s rights to and under such non-vested parts of the Option shall terminate.

5.Term of Option. To the extent vested, and except as otherwise provided in this Agreement, the Option shall be exercisable for ten (10) years from the date of this Agreement; provided, however, that in the event Employee ceases to be an employee of the Company, for any reason or no reason, with or without cause, Director or his her legal representative shall have ninety (90) days from the date that he or she ceases to be an employee, or, if earlier, upon the expiration date of the Option as set forth above, to exercise any part of the Option vested pursuant to Section 3 of this Agreement. Upon the expiration of such ninety (90) day period, or, if earlier, upon the expiration date of the Option as set forth above, the Option shall terminate and become null and void.

6.Breach of Non-Disclosure. Confidential Information. Non-Competition. Non-Solicitation or Invention Assignment Agreements. Notwithstanding anything in this Agreement to the contrary, in the event that Employee materially breaches the terms of any non-disclosure, confidential information, non-competition, non-solicitation or invention assignment covenant or agreement entered into with the Company or any subsidiary of the Company (regardless of how such covenant or agreement is styled or titled), whether such breach occurs before or after he or she ceases to be an employee of the Company, the Company may immediately terminate all rights of Employee under this Agreement without notice of any kind and the Option, both vested and unvested, shall terminate and become null and void.

7.Rights of Option Holder. Employee, as holder of the Option, shall not have any of the rights of a shareholder with respect to the Shares covered by the Option except to the extent that one or more certificates for such Shares shall be delivered to him or her upon the due exercise of all or any part of the Option. Nothing contained in this Agreement shall be deemed to grant Employee any right to continue as a director of the Company for any period of time or to any right to continue his or her present or any other rate of compensation, nor shall this Agreement be construed as giving Employee, Employee’s beneficiaries or any other person any equity or interests of any kind in the assets of the Company or creating a trust of any kind or a fiduciary relationship of any kind between the Company and any such person.

8.Transferability. The Option shall not be transferable except to the extent permitted by the Plan.

9.Securities Law Matters. Employee acknowledges that the Shares to be received by him or her upon exercise of the Option may have not been registered under the Securities Act of 1933 or the Blue Sky laws of any state (collectively, the “Securities Acts”). If such Shares have not been so registered, Employee acknowledges and understands that the Company is under no obligation to register, under the Securities Acts, the Shares received by him or her or to assist him or her in complying with any exemption from such registration if he or she should at a later date wish to dispose of the Shares. Employee acknowledges that if not then registered under the Securities Acts, the Shares shall bear a legend restricting the transferability thereof, such legend to be substantially in the following form:

“The Shares represented by this certificate have not been registered or qualified under federal or state securities laws. The Shares may not be offered for sale, sold, pledged or otherwise disposed of unless so registered or qualified, unless an exemption exists or unless such disposition is not subject to the federal or state securities laws, and the Company may require that the availability or any exemption or the inapplicability of such securities laws be established by an opinion of counsel, which opinion of counsel shall be reasonably satisfactory to the Company.”

10.Employee Representations. Director hereby represents and warrants that Employee has reviewed with his or her own tax advisors the federal, state, and local tax consequences of the transactions contemplated by this Agreement. Employee is relying solely on such advisors and not on any statements or representation of the Company or any of its agents. Employee understands that he or she will be solely responsible for any tax liability that may result to him or her as a result of the transactions contemplated by this Agreement. The Option, if exercised, will be exercised for investment and not with a view to the sale or distribution of the Shares to be received upon exercise thereof.

11.Notices. All notices and other communications provided in this Agreement will be in writing and will be deemed to have been duly given when received by the party to whom it is directed at the following addresses:

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If to the Company:	If to Employee:
Miromatrix Medical Inc.	To the address set forth on the signature page to this Agreement.
18683 Bearpath Trail
Eden Prairie, MN 55347
Attn: Chief Executive Officer

12.Drag-Along Rights. If holders of at least a majority of the outstanding shares of capital stock of the Company entitled to vote (the “Sellers”) desire to sell all of their shares to a bona fide third party purchaser, such Sellers or the Company shall send written notice (the “Drag-Along Notice”) to Employee, setting forth the consideration to he paid by the third party purchaser and tile other terms and conditions of such transaction. The Sellers or the Company may elect to require all, but not less than all, of the Shares purchased by Employee pursuant to this Agreement to be sold to the third party purchaser for the same consideration per share of common stock as the Sellers will receive in such transaction. To exercise such right, the Sellers or the Company shall so indicate in the Drag-Along Notice. If the Sellers or the Company so elect, then not later than five (5) days following the date of the Drag-Along Notice, Employee shall deliver to the Company any certificates representing the Shares held by Employee, accompanied by duly executed instruments of conveyance. If Employee fails to deliver any such certificates to the Sellers or the Company, the Company shall cause the books and records of the Company to show that the Shares are bound by the provisions of this Section 12 and that such Shares shall be transferred only to the third party purchaser. In the event Employee fails to deliver the certificates to the Company as required herein, then the Company may execute any documents as shall be required for the purpose of transferring the Shares on the books and records of the Company, and the Company is hereby appointed the attorney-in-fact of Employee for the purpose of effectuating the requirements of this Section 12.

13.Amendment to Meet the Requirements of Section 409A. Employee acknowledges that the Company, in the exercise of its sole discretion and without the consent of Employee, may amend or modify this Agreement in any manner and delay the payment of any amounts payable pursuant to this Agreement to the minimum extent necessary to meet the requirements of Section 409A of the Code as amplified by any Internal Revenue Service or U.S. Treasury Department regulations or guidance as the Company deems appropriate or advisable.

14.Lock-Up.

(a)Employee agrees that Employee will not offer, pledge, sell, contract to sell, sell any option, sell any contract to purchase, purchase any option, purchase any contract to sell, grant any option, right, or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any Shares (or any other Company securities) or enter into any swap, hedging, or other arranaement that transfers to another, in whole or in part, any of the economic consequences of ownership of any Shares (or any other Company securities) held by Employee (other than those included in the registration) for a period specified by the representative of the underwriters of the Company’s capital stock (or any other Company securities, collectively, the “Stock”) not to exceed ninety (90) days (180 days in the case of an initial public offering), plus any additional periods required by the Financial Industry Regulatory Authority (including under Conduct Rule 2711), after the effective date of any Company registration statement filed under the Securities Act of 1933 (the “Securities Act”).

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(b)Employee agrees to execute and deliver such other agreements as may be reasonably requested by the Company or the underwriter to the extent that such agreements are consistent with the foregoing or that are necessary to give further effect to the provisions set forth in Section 15(a). In addition, if requested by the Company or the representative of the underwriters of shares of the Company’s capital stock, Employee will provide, within 10 days of such request, such information as may be required by the Company or such representative in connection with the completion of any public offering of the Company’s securities pursuant to a registration statement filed under the Securities Act.

(c)The obligations described in this Section 14 will not apply to, a registration relating solely to Employee benefit plans on Form S-8 or similar forms that may be promulgated in the future, or a registration relating solely to a Commission Rule 145 transaction on Form S-4 or similar forms that may be promulgated in the future. The Company may impose stop-transfer instructions with respect to the Shares subject to the foregoing restriction until the end of such period, as applicable.

15.Withholding. The Company shall have the right to (i) withhold and deduct from any payments made under the Plan or from future compensation of Employee (or from other amounts that may be due and owing to Employee from the Company or a subsidiary of the Company), or make other arrangements for the collection of; all legally required amounts necessary to satisfy any and all foreign, federal, state and local withholding and employment-related tax requirements attributable to the Option, or (ii) require Employee promptly to remit the amount of such withholding to the Company before taking any action, including issuing the Shares

16.General.

(a)The Option is granted pursuant to the Plan and is governed by the terms thereof. The Company shall at all times during the term of the Option reserve and keep available such number of Shares as will be sufficient to satisfy the requirements of this Option Agreement.

(b)Nothing herein expressed or implied is intended or shall be construed as conferring upon or giving to any person, firm, or corporation other than the parties hereto, any rights or benefits under or by reason of this Agreement.

(c)Each party hereto agrees to execute such further documents as may be necessary or desirable to effect the purposes of this Agreement.

(d)This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same agreement.

(e)This Agreement, in its interpretation and effect, shall be governed by the laws of the State of Minnesota applicable to contracts executed and to be performed therein.

(f)Any disputes arising out of this Agreement shall be determined in the Hennepin County District Court or the United States Court, District of Minnesota.

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IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first written above.

Number of Shares: [ ]	EMPLOYEE:
Exercise Price: [ ]
	Name:
	Address:
	MIROMATRIX MEDICAL INC.
	By:

Vesting Schedule:

No. of Shares To Be Vested Vesting Date

-5-

EX-4.10

Exhibit 4.10

MIROMATRIX MEDICAL INC.

Non-Qualified Stock Option Agreement

2019 Equity Incentive Plan

Miromatrix Medical Inc. (the “Company”), pursuant to its 2019 Equity Incentive Plan (the “Plan”), hereby grants an Option to purchase shares of the Company’s common stock to you, the Optionee named below. The terms and conditions of the Option Award are set forth in this Agreement, consisting of this cover page and the Option Terms and Conditions on the following pages, and in the copy of the Plan document that has been provided to you. Unless the context indicates otherwise, any capitalized term used in this Agreement that is not defined in this Agreement shall have the meaning set forth in the Plan as it currently exists or as it is amended in the future.

Name of Optionee:
No. of Shares Covered:		Grant Date:
Exercise Price Per Share:		Expiration Date:
Vesting and Exercise Schedule:
Dates	Portion of Shares as to Which Option Becomes Vested and Exercisable

By signing below, you agree to all of the terms and conditions contained in this Agreement and in the Plan document. You acknowledge that you have reviewed these documents and that they set forth the entire agreement between you and the Company regarding your right to purchase shares of the Company’s common stock pursuant to this Option.

OPTIONEE: MIROMATRIX MEDICAL INC.

By:
Name:	Jeffrey Ross
Title:	Chief Executive Officer

Miromatrix Medical Inc.

2019 Equity Incentive Plan

Non-Statutory Stock Option Agreement

Option Terms and Conditions

1. Non-Qualified Stock Option. This Option is not intended to be an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code and will be interpreted accordingly.

2. Vesting and Exercisability of Option.

(a) Scheduled Vesting. This Option will vest and become exercisable as to the number of Shares and on the dates specified in the Vesting and Exercise Schedule on the cover page to this Agreement, so long as your Service to the Company does not end. The Vesting and Exercise Schedule is cumulative, meaning that to the extent the Option has not already been exercised and has not expired, terminated or been cancelled, you or the person otherwise entitled to exercise the Option as provided in this Agreement may at any time purchase all or any portion of the Shares that may then be purchased under that Schedule.

(b) Accelerated Vesting. The vesting and exercisability of this Option may be accelerated during the term of the Option under the circumstances described in Section 12(b) of the Plan, and at the discretion of the Committee in accordance with Section 3(b)(2) of the Plan.

3. Expiration. This Option will expire and will no longer be exercisable at 5:00 p.m. Central Time on the earliest of:

(a) The expiration date specified on the cover page of this Agreement;

(b) Upon your termination of Service for Cause;

(c) Upon the expiration of any applicable period specified in Sections 6(e) and 12(b)(4) of the Plan and in Section 4 of this Agreement during which this Option may be exercised after your termination of Service; or

(d) The date (if any) fixed for termination or cancellation of this Option pursuant to Sections 12(b)(2) or (b)(3) of the Plan.

4. Service Requirement. Except as otherwise provided in Sections 6(e) and 12(b)(4) of the Plan and in this Section 4, this Option may be exercised only while you continue to provide Service to the Company or any Affiliate, and only if you have continuously provided such Service since the date this Option was granted. Notwithstanding the foregoing and the language set forth in Sections 6(e)(3) and 6(e)(4) of the Plan, upon your termination of Service for any reason other than Cause, the currently vested and exercisable portion of this Option may be exercised until the expiration date specified on the cover page of this Agreement.

5. Exercise of Option. Subject to Section 4, the vested and exercisable portion of this Option may be exercised at any time during the Option term by delivering a written notice of exercise to the Company at its principal executive office, and by providing for payment of the exercise price of the Shares being acquired and any related withholding taxes. The notice of exercise, in the form attached as Exhibit A to this Agreement, shall be provided to the Company’s Chief Financial Officer. The notice shall state the number of Shares to be purchased, and shall be signed by the person exercising the Option. If you are not the person exercising the Option, the person submitting the notice must also submit appropriate proof of his/her right to exercise the Option.

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6. Payment of Exercise Price. When you submit your notice of exercise, you must include payment of the exercise price of the Shares being purchased through one or a combination of the following methods:

(a) Cash (including personal check, cashier’s check or money order);

(b) By delivery to the Company of Shares (by actual delivery or attestation of ownership in a form approved by the Company) already owned by you that are not subject to any security interest and that have an aggregate Fair Market Value on the date of exercise equal to the exercise price of the Shares being purchased; or

(c) By authorizing the Company to retain, from the total number of Shares as to which the Option is being exercised, that number of Shares having a Fair Market Value on the date of exercise equal to the exercise price for the total number of Shares as to which the Option is being exercised.

However, if the Committee determines, in any given circumstance, that payment of the exercise price with Shares or by authorizing the Company to retain Shares is undesirable for any reason, you will not be permitted to pay any portion of the exercise price in that manner.

7. Tax Representation. You hereby represent and warrant that you have reviewed with your own tax advisor the federal, state, local or foreign tax consequences of the transactions contemplated by this Agreement. You are relying solely on such advisor and not on any statements or representation of the Company or any of its agents. You understand that you will be solely responsible for any tax liability that may result to you as a result of the transactions contemplated by this Agreement. The Option, if exercised, will be exercised for investment and not with a view to the sale or distribution of the Shares to be received upon exercise thereof.

8. Delivery of Certificate. As soon as practicable after the Company receives the notice and exercise price provided for above, and determined that all conditions to exercise, including Sections 7 and 9 of this Agreement, have been satisfied, it shall deliver to the person exercising the Option, in the name of such person, a certificate or certificates representing the Shares being purchased. The Company shall pay any original issue or transfer taxes with respect to the issue or transfer of the Shares and all fees and expenses incurred by it in connection therewith. All Shares so issued shall be fully paid and nonassessable.

9. Compliance with Laws. This Option may be exercised only if the issuance of Shares upon such exercise complies with all applicable legal requirements, including compliance with the provisions of applicable federal and state securities laws. If the sale of Shares upon the exercise of this Option is not registered under the Securities Act of 1933, as amended (the “Securities Act”), you shall acknowledge at the time of exercise that (i) the Shares you are acquiring are deemed “restricted securities” for purposes of Rules 144 and 701 under the Securities Act, and you are acquiring the Shares for investment purposes and not with a view to the resale or distribution of such Shares, and (ii) the Shares you are acquiring may not be sold, pledged or otherwise transferred without (A) an effective registration or qualification thereof under the Securities Act and the securities laws of any applicable state or other jurisdiction, or (B) evidence, which may include an opinion of counsel, satisfactory to the Company and its counsel that such registration and qualification is not required.

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10. Transfer of Option. During your lifetime, only you (or your guardian or legal representative in the event of legal incapacity) may exercise this Option except in the case of a transfer described below. You may not assign or transfer this Option except (i) for a transfer upon your death in accordance with your will, by the laws of descent and distribution or pursuant to a beneficiary designation submitted in accordance with Section 6(d) of the Plan, (ii) pursuant to a qualified domestic relations order, or (iii) with the prior written approval of the Company, by gift, in a form accepted by the Company, to a transferee permitted under Rule 701 of the Securities Act. The Option held by any such transferee will continue to be subject to the same terms and conditions that were applicable to the Option immediately prior to its transfer and may be exercised by such transferee as and to the extent that the Option has become exercisable and has not terminated in accordance with the provisions of the Plan and this Agreement.

11. No Stockholder Rights Before Exercise. Neither you nor any permitted transferee of this Option will have any of the rights of a stockholder of the Company with respect to any Shares subject to this Option until a certificate evidencing such Shares has been issued (or an appropriate book entry in the Company’s stock register has been made). No adjustments shall be made for dividends or other rights if the applicable record date occurs before your stock certificate has been issued (or an appropriate book entry has been made), except as otherwise described in the Plan.

12. Governing Plan Document. This Agreement and Option are subject to all the provisions of the Plan, and to all interpretations, rules and regulations which may, from time to time, be adopted and promulgated by the Committee pursuant to the Plan. If there is any conflict between the provisions of this Agreement and the Plan, the provisions of the Plan will govern.

13. Choice of Law. This Agreement will be interpreted and enforced under the laws of the state of Minnesota (without regard to its conflicts or choice of law principles).

14. Binding Effect. This Agreement will be binding in all respects on your heirs, representatives, successors and assigns, and on the successors and assigns of the Company.

15. Other Agreements. You agree that in connection with the exercise of this Option, you will execute such documents as may be necessary to become a party to any stockholder, voting or similar agreements as the Company may require.

16. Restrictive Legends. The Company may place a legend or legends on any certificate representing Shares issued upon the exercise of this Option summarizing transfer and other restrictions to which the Shares may be subject under applicable securities laws, other provisions of this Agreement, or other agreements contemplated by Section 15 of this Agreement. You agree that in order to ensure compliance with the restrictions referred to in this Agreement, the Company may issue appropriate “stop transfer” instructions to its transfer agent.

17. Breach of Non-Disclosure, Confidential Information, Non-Competition, Non-Solicitation or Invention Assignment Agreements. Notwithstanding anything in this Agreement to the contrary, in the event you materially breach the terms of any non-disclosure, confidential information, non-competition, non-solicitation or invention assignment covenant or agreement you have with the Company or any Affiliate (regardless of how such covenant or agreement is styled or titled), whether such breach occurs before or after your termination of Service with the Company and all of its Affiliates, the Company may immediately terminate all of your rights under this Agreement without notice of any kind and the Option, both vested and unvested, shall terminate and become null and void.

4 

18. Drag-Along Rights. If holders of at least a majority of the outstanding Shares entitled to vote (the “Sellers”) desire to sell all of their Shares to a bona fide third party purchaser, such Sellers or the Company shall send you written notice (the “Drag-Along Notice”) setting forth the consideration to be paid by the third party purchaser and the other terms and conditions of such transaction. The Sellers or the Company may elect to require all, but not less than all, of the Shares purchased by you pursuant to this Agreement to be sold to the third party purchaser for the same consideration per share of Stock as the Sellers will receive in such transaction. To exercise such right, the Sellers or the Company shall so indicate in the Drag-Along Notice. If the Sellers or the Company so elect, then not later than 5 days following the date of the Drag-Along Notice, you shall deliver to the Company any certificates representing the Shares you hold, accompanied by duly executed instruments of conveyance. If you fail to deliver any such certificates to the Sellers or the Company, the Company shall cause the books and records of the Company to show that such Shares are bound by the provisions of this Section 18 and that such Shares shall be transferred only to the third party purchaser. In the event you fail to deliver the certificates to the Company as required herein, then the Company may execute any documents as shall be required for the purpose of transferring the Shares on the books and records of the Company, and the Company is hereby appointed the attorney-in-fact of Optionee for the purpose of effectuating the requirements of this Section 18.

19. Lock-Up.

(a) You agree that you will not offer, pledge, sell, contract to sell, sell any option, sell any contract to purchase, purchase any option, purchase any contract to sell, grant any option, right, or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any Shares (or any other Company securities) or enter into any swap, hedging, or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any Shares (or any other Company securities) held by you (other than those included in a registration statement) for a period specified by the representative of the underwriters of the Company’s Stock not to exceed 90 days (180 days in the case of an initial public offering), plus any additional periods required by the Financial Industry Regulatory Authority (including under Conduct Rule 2711), after the effective date of any Company registration statement filed under the Securities Act.

(b) You agree to execute and deliver such other agreements as may be reasonably requested by the Company or the underwriter to the extent that such agreements are consistent with the foregoing or that are necessary to give further effect to the provisions set forth in Section 19(a). In addition, if requested by the Company or the representative of the underwriters of shares of the Company’s capital stock, you will provide, within 10 days of such request, such information as may be required by the Company or such representative in connection with the completion of any public offering of the Company’s securities pursuant to a registration statement filed under the Securities Act.

(c) The obligations described in this Section 19 will not apply to a registration relating solely to employee benefit plans on Form S-8 or similar forms that may be promulgated in the future, or a registration relating solely to an SEC Rule 145 transaction on Form S-4 or similar forms that may be promulgated in the future. The Company may impose stop-transfer instructions with respect to the Shares subject to the foregoing restriction until the end of such period, as applicable.

By signing the cover page of this Agreement, you agree to all the terms and conditions described above and in the Plan document.

5 

EXHIBIT A

NOTICE OF EXERCISE

Non-Statutory Stock Option

__________________, 20__

Miromatrix Medical Inc.

[Company Address]

Ladies and Gentlemen:

I hereby exercise the following option (the “Option”) granted to me under the Miromatrix Medical Inc. 2019 Equity Incentive Plan (as amended from time to time, the “Plan”) with respect to the number of shares of common stock of Miromatrix Medical Inc. (the “Company”) indicated below:

Name:

Date of Grant of Option:

Exercise Price Per Share:

Number of Shares With Respect to Which the Option is Hereby Exercised:

Total Exercise Price:

o Enclosed with this Notice is a check, cashier’s check or money order in the amount of the Total Exercise Price.

o       Enclosed with this Notice is a certificate evidencing unencumbered Shares (duly endorsed in blank) having an aggregate Fair Market Value (as defined in the Plan) equal to or in excess of the Total Exercise Price.

o       I elect to pay the Total Exercise Price through a reduction in the number of Shares to be delivered to me upon this exercise of the Option.

In connection with this exercise, I represent, warrant and acknowledge as follows:

· I will provide for the payment to the Company, in a manner agreed to by the Company, of the amount of any required withholding taxes in connection with this exercise as provided in Section 14 of the Plan.

· I am acquiring the Shares as a result of this Option exercise for my own account, and acknowledge that the Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and are deemed to constitute “restricted securities” under Rules 144 and 701 of the Securities Act. I have no present intention of distributing or selling such Shares, and will transfer them only as permitted under applicable federal and state securities laws.

· I am the owner of all Shares delivered with this Notice free and clear of all liens, security interests and other restrictions or encumbrances.

A-1 

Please issue a certificate (the “Certificate”) for the number of Shares with respect to which the Option is being exercised (or the net number of Shares if the Total Exercise Price and/or applicable withholding taxes are being paid through a reduction in the number of Shares to be delivered to me) in the name of the person indicated below and deliver the Certificate to the address indicated below:

Name in Which to Issue Certificate:
Address to Which Certificate Should be Delivered:
	___________________________
Principal Mailing Address for Holder of the Certificate (if different from above):
	____________________________

Very truly yours,

Signature

Name, please print

Social Security Number

A-2 

MIROMATRIX MEDICAL INC. 

Non-Qualified Stock Option Agreement

2019 Equity Incentive Plan

Miromatrix Medical Inc. (the “Company”), pursuant to its 2019 Equity Incentive Plan (the “Plan”), hereby grants an Option to purchase shares of the Company’s common stock to you, the Optionee named below. The terms and conditions of the Option Award are set forth in this Agreement, consisting of this cover page and the Option Terms and Conditions on the following pages, and in the copy of the Plan document that has been provided to you. Unless the context indicates otherwise, any capitalized term used in this Agreement that is not defined in this Agreement shall have the meaning set forth in the Plan as it currently exists or as it is amended in the future.

Name of Optionee:
No. of Shares Covered:	Grant Date:
Exercise Price Per Share:	Expiration Date:
Vesting and Exercise Schedule:
Dates	Portion of Shares as to Which Option Becomes Vested and Exercisable

By signing below, you agree to all of the terms and conditions contained in this Agreement and in the Plan document. You acknowledge that you have reviewed these documents and that they set forth the entire agreement between you and the Company regarding your right to purchase shares of the Company’s common stock pursuant to this Option.

OPTIONEE:	MIROMATRIX MEDICAL INC.
	By:
	Name: Jeffrey Ross
	Title: Chief Executive Officer

Miromatrix Medical Inc. 

2019 Equity Incentive Plan 

Non-Statutory Stock Option Agreement

Option Terms and Conditions

1. Non-Qualified Stock Option. This Option is not intended to be an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code and will be interpreted accordingly.

2. Vesting and Exercisability of Option.

(a) Scheduled Vesting. This Option will vest and become exercisable as to the number of Shares and on the dates specified in the Vesting and Exercise Schedule on the cover page to this Agreement, so long as your Service to the Company does not end. The Vesting and Exercise Schedule is cumulative, meaning that to the extent the Option has not already been exercised and has not expired, terminated or been cancelled, you or the person otherwise entitled to exercise the Option as provided in this Agreement may at any time purchase all or any portion of the Shares that may then be purchased under that Schedule.

(b) Accelerated Vesting. The vesting and exercisability of this Option may be accelerated during the term of the Option under the circumstances described in Section 12(b) of the Plan, and at the discretion of the Committee in accordance with Section 3(b)(2) of the Plan.

3. Expiration. This Option will expire and will no longer be exercisable at 5:00 p.m. Central Time on the earliest of:

(a) The expiration date specified on the cover page of this Agreement;

(b) Upon your termination of Service for Cause;

(c) Upon the expiration of any applicable period specified in Sections 6(e) and 12(b)(4) of the Plan and in Section 4 of this Agreement during which this Option may be exercised after your termination of Service; or

(d) The date (if any) fixed for termination or cancellation of this Option pursuant to Sections 12(b)(2) or (b)(3) of the Plan.

4. Service Requirement. Except as otherwise provided in Sections 6(e) and 12(b)(4) of the Plan and in this Section 4, this Option may be exercised only while you continue to provide Service to the Company or any Affiliate, and only if you have continuously provided such Service since the date this Option was granted. Notwithstanding the foregoing and the language set forth in Sections 6(e)(3) and 6(e)(4) of the Plan, upon your termination of Service for any reason other than Cause, the currently vested and exercisable portion of this Option may be exercised until the expiration date specified on the cover page of this Agreement.

5. Exercise of Option. Subject to Section 4, the vested and exercisable portion of this Option may be exercised at any time during the Option term by delivering a written notice of exercise to the Company at its principal executive office, and by providing for payment of the exercise price of the Shares being acquired and any related withholding taxes. The notice of exercise, in the form attached as Exhibit A to this Agreement, shall be provided to the Company’s Chief Financial Officer. The notice shall state the number of Shares to be purchased, and shall be signed by the person exercising the Option. If you are not the person exercising the Option, the person submitting the notice must also submit appropriate proof of his/her right to exercise the Option.

2

6. Payment of Exercise Price. When you submit your notice of exercise, you must include payment of the exercise price of the Shares being purchased through one or a combination of the following methods:

(a) Cash (including personal check, cashier’s check or money order);

(b) By delivery to the Company of Shares (by actual delivery or attestation of ownership in a form approved by the Company) already owned by you that are not subject to any security interest and that have an aggregate Fair Market Value on the date of exercise equal to the exercise price of the Shares being purchased; or

(c) By authorizing the Company to retain, from the total number of Shares as to which the Option is being exercised, that number of Shares having a Fair Market Value on the date of exercise equal to the exercise price for the total number of Shares as to which the Option is being exercised.

However, if the Committee determines, in any given circumstance, that payment of the exercise price with Shares or by authorizing the Company to retain Shares is undesirable for any reason, you will not be permitted to pay any portion of the exercise price in that manner.

7. Tax Representation. You hereby represent and warrant that you have reviewed with your own tax advisor the federal, state, local or foreign tax consequences of the transactions contemplated by this Agreement. You are relying solely on such advisor and not on any statements or representation of the Company or any of its agents. You understand that you will be solely responsible for any tax liability that may result to you as a result of the transactions contemplated by this Agreement. The Option, if exercised, will be exercised for investment and not with a view to the sale or distribution of the Shares to be received upon exercise thereof.

8. Delivery of Certificate. As soon as practicable after the Company receives the notice and exercise price provided for above, and determined that all conditions to exercise, including Sections 7 and 9 of this Agreement, have been satisfied, it shall deliver to the person exercising the Option, in the name of such person, a certificate or certificates representing the Shares being purchased. The Company shall pay any original issue or transfer taxes with respect to the issue or transfer of the Shares and all fees and expenses incurred by it in connection therewith. All Shares so issued shall be fully paid and nonassessable.

9. Compliance with Laws. This Option may be exercised only if the issuance of Shares upon such exercise complies with all applicable legal requirements, including compliance with the provisions of applicable federal and state securities laws. If the sale of Shares upon the exercise of this Option is not registered under the Securities Act of 1933, as amended (the “Securities Act”), you shall acknowledge at the time of exercise that (i) the Shares you are acquiring are deemed “restricted securities” for purposes of Rules 144 and 701 under the Securities Act, and you are acquiring the Shares for investment purposes and not with a view to the resale or distribution of such Shares, and (ii) the Shares you are acquiring may not be sold, pledged or otherwise transferred without (A) an effective registration or qualification thereof under the Securities Act and the securities laws of any applicable state or other jurisdiction, or (B) evidence, which may include an opinion of counsel, satisfactory to the Company and its counsel that such registration and qualification is not required.

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10. Transfer of Option. During your lifetime, only you (or your guardian or legal representative in the event of legal incapacity) may exercise this Option except in the case of a transfer described below. You may not assign or transfer this Option except (i) for a transfer upon your death in accordance with your will, by the laws of descent and distribution or pursuant to a beneficiary designation submitted in accordance with Section 6(d) of the Plan, (ii) pursuant to a qualified domestic relations order, or (iii) with the prior written approval of the Company, by gift, in a form accepted by the Company, to a transferee permitted under Rule 701 of the Securities Act. The Option held by any such transferee will continue to be subject to the same terms and conditions that were applicable to the Option immediately prior to its transfer and may be exercised by such transferee as and to the extent that the Option has become exercisable and has not terminated in accordance with the provisions of the Plan and this Agreement.

11. No Stockholder Rights Before Exercise. Neither you nor any permitted transferee of this Option will have any of the rights of a stockholder of the Company with respect to any Shares subject to this Option until a certificate evidencing such Shares has been issued (or an appropriate book entry in the Company’s stock register has been made). No adjustments shall be made for dividends or other rights if the applicable record date occurs before your stock certificate has been issued (or an appropriate book entry has been made), except as otherwise described in the Plan.

12. Governing Plan Document. This Agreement and Option are subject to all the provisions of the Plan, and to all interpretations, rules and regulations which may, from time to time, be adopted and promulgated by the Committee pursuant to the Plan. If there is any conflict between the provisions of this Agreement and the Plan, the provisions of the Plan will govern.

13. Choice of Law. This Agreement will be interpreted and enforced under the laws of the state of Minnesota (without regard to its conflicts or choice of law principles).

14. Binding Effect. This Agreement will be binding in all respects on your heirs, representatives, successors and assigns, and on the successors and assigns of the Company.

15. Other Agreements. You agree that in connection with the exercise of this Option, you will execute such documents as may be necessary to become a party to any stockholder, voting or similar agreements as the Company may require.

16. Restrictive Legends. The Company may place a legend or legends on any certificate representing Shares issued upon the exercise of this Option summarizing transfer and other restrictions to which the Shares may be subject under applicable securities laws, other provisions of this Agreement, or other agreements contemplated by Section 15 of this Agreement. You agree that in order to ensure compliance with the restrictions referred to in this Agreement, the Company may issue appropriate “stop transfer” instructions to its transfer agent.

17. Breach of Non-Disclosure, Confidential Information, Non-Competition, Non-Solicitation or Invention Assignment Agreements. Notwithstanding anything in this Agreement to the contrary, in the event you materially breach the terms of any non-disclosure, confidential information, non-competition, non-solicitation or invention assignment covenant or agreement you have with the Company or any Affiliate (regardless of how such covenant or agreement is styled or titled), whether such breach occurs before or after your termination of Service with the Company and all of its Affiliates, the Company may immediately terminate all of your rights under this Agreement without notice of any kind and the Option, both vested and unvested, shall terminate and become null and void.

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18. Drag-Along Rights. If holders of at least a majority of the outstanding Shares entitled to vote (the “Sellers”) desire to sell all of their Shares to a bona fide third party purchaser, such Sellers or the Company shall send you written notice (the “Drag-Along Notice”) setting forth the consideration to be paid by the third party purchaser and the other terms and conditions of such transaction. The Sellers or the Company may elect to require all, but not less than all, of the Shares purchased by you pursuant to this Agreement to be sold to the third party purchaser for the same consideration per share of Stock as the Sellers will receive in such transaction. To exercise such right, the Sellers or the Company shall so indicate in the Drag-Along Notice. If the Sellers or the Company so elect, then not later than 5 days following the date of the Drag-Along Notice, you shall deliver to the Company any certificates representing the Shares you hold, accompanied by duly executed instruments of conveyance. If you fail to deliver any such certificates to the Sellers or the Company, the Company shall cause the books and records of the Company to show that such Shares are bound by the provisions of this Section 18 and that such Shares shall be transferred only to the third party purchaser. In the event you fail to deliver the certificates to the Company as required herein, then the Company may execute any documents as shall be required for the purpose of transferring the Shares on the books and records of the Company, and the Company is hereby appointed the attorney-in-fact of Optionee for the purpose of effectuating the requirements of this Section 18.

19. Lock-Up.

(a) You agree that you will not offer, pledge, sell, contract to sell, sell any option, sell any contract to purchase, purchase any option, purchase any contract to sell, grant any option, right, or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any Shares (or any other Company securities) or enter into any swap, hedging, or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any Shares (or any other Company securities) held by you (other than those included in a registration statement) for a period specified by the representative of the underwriters of the Company’s Stock not to exceed 90 days (180 days in the case of an initial public offering), plus any additional periods required by the Financial Industry Regulatory Authority (including under Conduct Rule 2711), after the effective date of any Company registration statement filed under the Securities Act.

(b) You agree to execute and deliver such other agreements as may be reasonably requested by the Company or the underwriter to the extent that such agreements are consistent with the foregoing or that are necessary to give further effect to the provisions set forth in Section 19(a). In addition, if requested by the Company or the representative of the underwriters of shares of the Company’s capital stock, you will provide, within 10 days of such request, such information as may be required by the Company or such representative in connection with the completion of any public offering of the Company’s securities pursuant to a registration statement filed under the Securities Act.

(c) The obligations described in this Section 19 will not apply to a registration relating solely to employee benefit plans on Form S-8 or similar forms that may be promulgated in the future, or a registration relating solely to an SEC Rule 145 transaction on Form S-4 or similar forms that may be promulgated in the future. The Company may impose stop-transfer instructions with respect to the Shares subject to the foregoing restriction until the end of such period, as applicable.

By signing the cover page of this Agreement, you agree to all the terms and conditions described above and in the Plan document.

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EXHIBIT A

NOTICE OF EXERCISE 

Non-Statutory Stock Option

__________________, 20__

Miromatrix Medical Inc. 

[Company Address]

Ladies and Gentlemen:

I hereby exercise the following option (the “Option”) granted to me under the Miromatrix Medical Inc. 2019 Equity Incentive Plan (as amended from time to time, the “Plan”) with respect to the number of shares of common stock of Miromatrix Medical Inc. (the “Company”) indicated below:

Name:

Date of Grant of Option:

Exercise Price Per Share:

Number of Shares With Respect to Which the Option is Hereby Exercised:

Total Exercise Price:

¨ Enclosed with this Notice is a check, cashier’s check or money order in the amount of the Total Exercise Price.

¨            Enclosed with this Notice is a certificate evidencing unencumbered Shares (duly endorsed in blank) having an aggregate Fair Market Value (as defined in the Plan) equal to or in excess of the Total Exercise Price.

¨            I elect to pay the Total Exercise Price through a reduction in the number of Shares to be delivered to me upon this exercise of the Option.

In connection with this exercise, I represent, warrant and acknowledge as follows:

· I will provide for the payment to the Company, in a manner agreed to by the Company, of the amount of any required withholding taxes in connection with this exercise as provided in Section 14 of the Plan.

· I am acquiring the Shares as a result of this Option exercise for my own account, and acknowledge that the Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and are deemed to constitute “restricted securities” under Rules 144 and 701 of the Securities Act. I have no present intention of distributing or selling such Shares, and will transfer them only as permitted under applicable federal and state securities laws.

· I am the owner of all Shares delivered with this Notice free and clear of all liens, security interests and other restrictions or encumbrances.

A-1

Please issue a certificate (the “Certificate”) for the number of Shares with respect to which the Option is being exercised (or the net number of Shares if the Total Exercise Price and/or applicable withholding taxes are being paid through a reduction in the number of Shares to be delivered to me) in the name of the person indicated below and deliver the Certificate to the address indicated below:

Name in Which to Issue Certificate:

Address to Which Certificate Should be Delivered:

Principal Mailing Address for Holder of the Certificate (if different from above):

Very truly yours,

Signature

Name, please print

Social Security Number

A-2

EX-10.1

Exhibit 10.1

CONFIDENTIALITY AGREEMENT

This confidentiality agreement (“Agreement”) is effective as of February 4^th, 2010 (“Effective Date”), and is entered into by and between Miromatrix Medical Inc., a Delaware corporation, with offices located at 18683 Bearpath Trail, Eden Prairie, Minnesota 55347 (“MMI”), and the Regents of the University of Minnesota, a constitutional corporation under the laws of the state of Minnesota, having a place of business at 1000 Westgate Drive, Suite 160, St. Paul, Minnesota 55114 (the “University”).

Each of the parties is required to make available to the other certain nonpublic, confidential, proprietary information in connection with the Exclusive Patent License Agreement of even date herewith (the “License Agreement”), commercialization reports, sublicense agreements, and other information about its business, operations, business plans, programs and technical data. Unless otherwise defined in this Agreement, all capitalized terms used herein shall have the meanings given to them in the License Agreement. Each of the parties agrees that the following terms and conditions apply when one of the parties discloses (“Discloser”) Proprietary Information to the other party (“Recipient”).

1.DEFINITIONS

1.1.“Proprietary Information” means Confidential Information and Trade Secrets, whether in written, oral, electronic or other form, furnished, transmitted to, observed or obtained by one of the parties. Proprietary Information also includes any Confidential Information or Trade Secrets that are in a party’s facility and are viewable, accessible or otherwise made available to Recipient. The following information, all as reasonably substantiated by documentation, however, is not Proprietary Information and is not restricted as to its use or disclosure by Recipient:

(a) information that enters the public domain after the Effective Date through no fault of the Recipient;

(b) information lawfully furnished or disclosed to the Recipient by a non-party to this Agreement without any obligation of confidentiality;

(c) information independently developed by any party without use of any Proprietary Information; or

(d) information that is explicitly approved for release by the Discloser in writing.

1.2.“Confidential Information” means technical and non-technical information (regardless of whether such information is in tangible or intangible form) including data, ideas, concepts, formulae, methods, techniques, processes, financial and business plans and business methods (including any derivatives of any of the foregoing), other than Trade Secrets, disclosed to either party by or on behalf of the other party during the term of this Agreement or before and further means any information, including the arrangements contemplated by this Agreement, which is used, learned or contributed during the course of this Agreement, which is not generally available to the public or which could give the one who uses it a competitive advantage over the Discloser.

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1.3. “Trade Secrets” means technical and non-technical information (regardless of whether such information is in tangible or intangible form) including data, ideas, concepts, formulae, methods, techniques, processes, financial and business plans and business methods (including any derivatives of any of the foregoing) disclosed to either party by or on behalf of the other party that derive economic value, actual or potential, from not being generally known to other persons who could obtain value from the disclosure or use thereof, and which are the subject of efforts that are reasonable under the circumstances to maintain their secrecy.

1.4.“Affiliate” has the same meaning as specified in the License Agreement.

1.5.“Representatives” means any director, officer, employee, agent, advisor or consultant of either of the parties or their Affiliates.

2.PROTECTION OF PROPRIETARY INFORMATION

Recipient agrees that it shall hold Proprietary Information in confidence, agrees not to disclose such Proprietary Information to persons not having a need to know such Proprietary Information consistent with the purpose for which it was transmitted and such Proprietary Information shall not be used, directly or indirectly, for any commercial, business, nonprofit or other purpose or in any way detrimental to Discloser. Recipient shall protect the confidentiality and value of Proprietary Information to Discloser, and shall take reasonable measures to prevent loss, theft and misuse. Recipient shall immediately give notice to Discloser of any unauthorized use or disclosure of Proprietary Information. Recipient agrees to assist Discloser in remedying any unauthorized use or disclosure of Proprietary Information caused by such Recipient.

3.BUSINESS RECORD EXCEPTION

Each party acknowledges the information contained in notes, correspondence and reports prepared by a party in connection with the party’s discussions are business records of the Recipient, and hereby agrees that such copies need not be returned or destroyed, but are subject to all other terms of this Agreement.

4.RETURN OF PROPRIETARY INFORMATION

Upon written request of a party, each party shall promptly return or destroy (as directed by the Discloser) all Proprietary Information received from the other party, including all copies, except for Proprietary Information Recipient is entitled to retain under the License Agreement or under Section 3 of this agreement. Upon the request of the Discloser, the Recipient shall furnish to the Discloser an affidavit providing assurances as to the return or destruction of the Discloser’s Proprietary Information.

5.DISCLOSURE REQUIRED BY LAW

A disclosure of Proprietary Information in response to a valid order by a court or other governmental body or otherwise required by law is not considered to be a breach of this Agreement or a waiver of confidentiality for other purposes. Before any such disclosure, Recipient shall provide prompt written notice to Discloser to enable it to seek a protective order or otherwise prevent disclosure.

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6.OWNERSHIP

All materials transmitted between the parties and containing Proprietary Information are to remain the sole and exclusive property of the Discloser. This Agreement and transmission or disclosure of any Proprietary Information does not grant the Recipient a license of any type under any patents, know-how, copyrights, trade secrets or trademarks owned or controlled by the Discloser and does not obligate the Discloser to continue to treat the Proprietary Information it discloses as confidential, unless expressly required under the License Agreement.

7.EXPIRATION OF OBLIGATIONS

All obligations of confidentiality and all restrictions on the use of Proprietary Information under this Agreement are to remain in effect for a period of five (5) years following the date of disclosure for Confidential Information, and with respect to Trade Secrets under applicable law, for as long as such information remains a Trade Secret. Such time period may be extended upon written agreement of the parties.

8.RESPONSIBILITY FOR AFFILIATES AND REPRESENTATIVES

Each party is solely responsible for any breach of this Agreement by its Representatives or for any improper use or disclosure by its Representatives of the other party’s Proprietary Information. Recipient may disclose Proprietary Information to its Affiliates and Representatives who in Recipient’s reasonable judgment have the need to know such information in connection with the relationship between the parties. Recipient shall inform its Representatives of the confidential nature of such Proprietary Information, shall direct them to hold Proprietary Information in strict confidence, shall take all reasonable precautions to prevent improper use of Proprietary Information by them, and shall be responsible for any breaches by them of the terms found in this Agreement.

9.GENERAL PROVISIONS

9.1.Prohibition on Assignment. The parties agree not to assign any rights or delegate any duties under this Agreement without the other party’s prior written consent, and any attempt to do so is void and has no effect.

9.2.Binding Effect. This Agreement will be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.

9.3.Governing Law. The laws of the State of Minnesota, without giving effect to its conflicts of law principles, govern all matters arising out of or relating to this Agreement, including, without limitation, its validity, interpretation, construction, performance and enforcement. Litigation or legal proceedings which arise out of or relate to this Agreement are to be conducted before a judge and not a jury.

9.4.Venue. The parties consent to the exclusive jurisdiction of, and venue in, any state court of competent jurisdiction located in the County of Hennepin, State of Minnesota, for the purposes of adjudicating any matter arising out of or relating to this Agreement.

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9.5. No Waiver. The failure of a party to enforce a provision, exercise a right or pursue a default of this Agreement shall not be considered a waiver. The express waiver of a provision is to be effective only in the specific instance, and as to the specific purpose, for which it was given.

9.6.Severability. If any provision of this Agreement is determined to be invalid, illegal or unenforceable, the remaining provisions of this Agreement remain in full force and effect so long as the essential terms and conditions of this Agreement reflect the original intent of the parties and remain valid, legal and enforceable.

9.7.Section Headings and Captions. The section headings and captions contained in this Agreement are for convenience only and do not affect the construction or interpretation of any provision of this Agreement.

9.8.Construction. This Agreement is the result of arm’s length negotiations between the parties and each of the parties has agreed to the use of the particular language in this Agreement. The parties further acknowledge that any questions of doubtful or unclear interpretation are not to be resolved by any rule or interpretation against the drafters, and that each party has participated in drafting this Agreement. Accordingly, this Agreement is to be construed without regard to the party or parties responsible for its drafting or preparation.

9.9.Counterparts. This Agreement may be executed in counterparts and delivered to each of the parties by facsimile. Facsimile or photocopy signatures are deemed as legally enforceable as the original. Each such counterpart is deemed an original instrument, but all such counterparts taken together constitute one and the same agreement.

9.10.Compliance with Applicable Laws. Both parties represent and warrant they will comply with all applicable federal, state and local laws, rules, regulations, statutes, ordinances, codes, orders and/or programs (whether in effect as of the Effective Date of this Agreement or enacted during the term of this Agreement).

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Agreement.

Regents of the University of Minnesota Miromatrix Medical Inc.

By:	/s/ Jay W. Schrankler	By:	/s/ Robert Cohen
	Jay W. Schrankler, Executive Director		Robert Cohen, President & CEO
	Office for Technology Commercialization

Date: February 4, 2010 Date: February 4, 2010

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University of Minnesota

EXCLUSIVE PATENT LICENSE AGREEMENT

THIS EXCLUSIVE PATENT LICENSE AGREEMENT (this “Agreement”) is made by and between Regents of the University of Minnesota, a constitutional corporation under the laws of the state of Minnesota, having a place of business at 1000 Westgate Drive, Suite 160, St. Paul, Minnesota 55114 (the “University”), and the Licensee indentified below. The University and the Licensee agree that:

The Terms and Conditions of the Exclusive Patent License Agreement attached hereto as Exhibit A (the “Terms and Conditions”) are incorporated herein by reference in their entirety. In the event of a conflict between provisions of this Agreement and the Terms and Conditions, the provisions in this Agreement shall govern. Capitalized terms used in this Agreement without definition shall have the meanings given to them in the Terms and Conditions. The section numbers used in the parentheses below correspond to the section numbers in the Terms and Conditions.

1.Licensee (§I.15): Miromatrix Medical Inc., a corporation under the laws of the state of Delaware.

2.Field(s) of Use (§I.8): All for the subject matter in sections 5.1, 5.2. and 5.3. Field of Use may be less than all fields of use for University New Inventions as described in subsection 3.1.3 of the Terms and Conditions.

3.Territory (§1.25):Each country or territory in which the University has active and enforceable patent rights in the Licensed Technology, or in which the University has an active application for such rights.

4.Effective Date (§2): Date of the last signature below.

5.Technology:

      5.1.Licensed Patents(s) (§1.12): None as of the Effective Date.

     5.2.Patent Applications (§1.16):

Application No.	Country	Filing Date	Title
12/064,613	US	8/28/2006	Decellularization and Recellularization of Organs and Tissues
6790024.1	EP	8/28/2006	Decellularization and Recellularization of Organs and Tissues
2006282783	AU	8/28/2006	Decellularization and Recellularization of Organs and Tissues
2618731	CA	8/28/2006	Decellularization and Recellularization of Organs and Tissues
20060030925.4	CN	8/28/2006	Decellularization and Recellularization of Organs and Tissues
1741/DELNP/2008	IN	8/28/2006	Decellularization and Recellularization of Organs and Tissues
189418	IL	8/28/2006	Decellularization and Recellularization of Organs and Tissues
2008-528231	JP	828/2006	Decellularization and Recellularization of Organs and Tissues
10-2008-7007151	KR	8/28/2006	Decellularization and Recellularization of Organs and Tissues
MX/A/2008/002589	MX	8/28/2006	Decellularization and Recellularization of Organs and Tissues
2008111503	RU	8/28/2006	Decellularization and Recellularization of Organs and Tissues
20081197-5	SG	8/28/2006	Decellularization and Recellularization of Organs and Tissues
61/211,613	US	3/31/2009	Decellularization and Recellularization of Organs and Tissues
11/512,009	US	8/28/2006	Adult Cardiac derived Progenitor Cells
12/547,021	US	8/25/2006	Decellularization and Recellularization Apparatuses and Systems Containing the Same

5.3.Know-How (§1.10).

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6.Patent-Related Expenses (§§1.17 & 6.3): The Licensee shall reimburse the University for Patent-Related Expenses incurred before and during the Term of this Agreement as follows:

(i)Within ten (10) business days after the earlier of a Capital Infusion Event, June 30, 2011, or the termination of this Agreement, the Licensee shall reimburse the University for Patent-Related Expenses incurred by the University on or before the Capital Infusion Event, June 30, 2011, or the termination of this Agreement. Licensee shall pay such amount as follows:

(A)Company Stock for the first $300,000 of Patent Related Expenses; and

(B)Cash or Company Stock, at University’s discretion, for Patent Related Expenses in excess of $300,000.

The amount of Company Stock issued to University under (A) and (B) will be determined by the fair market value of the Company Stock, as determined in good faith by the board of directors of the Licensee.

(ii)For Patent Related Expenses incurred after the earlier of the first Capital Infusion Event or June 30, 2011 and during the Term of this Agreement, Licensee shall reimburse the University as provided in section 6.3 of the Terms and Conditions.

7.Sublicense Rights (§3.1.2): Yes.

8.Federal Government Rights (§3.2): Yes.

9.Performance Milestones (§5.1): The Licensee shall perform the following milestones:

(i)hire a vice president of business development within nine (9) months after the Effective Date;

(ii)hire a vice president of product development within twelve (12) months after the Effective Date;

(iii)raise a total of One Million Five Hundred Thousand dollars ($1,500,000) on or before June 30, 2011 from its sale and issuance of equity units in the Licensee, from the sale and issuance of debt securities of the Licensee; from Commercial Sales, Sublicense Revenues and Sublicense Royalties; and/or from the receipt of other payments from third parties;

(iv)complete the product definition for its first internally developed product within three (3) months after hiring a vice president of product development; and

(v)enter into a sublicense pursuant to subsection 3.1.2 of the Terms and Conditions within the later of one (1) year after the Effective Date or six months after hiring a vice president of product development.

10.Commercialization Reports (§5.4): The Licensee shall deliver written commercialization reports to the University as provided in section 5.4 of the Terms and Conditions, on the following schedule:

(i)Licensee shall submit commercialization reports on a quarterly basis (i.e., within thirty (30) days following March 31^St, June, 30^th, September 30^th and December 31^st) until Licensee’s cumulative annual sales of Licensed Products exceed five million dollars ($5,000,000).

(ii)After Licensee’s cumulative annual sales of Licensed Products exceed five million dollars ($5,000,000) Licensee shall submit commercialization reports annually within thirty (30) days following December 31^st.

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11. Payments (§6.1). All amounts are non-refundable, and payable as defined below or as specified in the University’s invoice. Notwithstanding the preceding sentence, however, if any amount paid is incorrectly determined, then within a reasonable period after the amount due is correctly determined, the Licensee shall pay to the University (in the case of an underpayment) or shall have the right to receive from the University (in the case of an overpayment) a credit against future payments (excluding reimbursement for patent related expenses) equal to the difference between the amount actually paid and the amount properly payable.

11.1.Upfront Payment: None.

11.2.Annual Maintenance Fee: Five thousand and no/100 dollars ($5,000), payable on each anniversary of the Effective Date.

11.3.Document Fee: None.

11.4.Running Royalties and Annual Minimums. All payments under this section are payable as provided in section 6.4 of the attached Terms and Conditions unless otherwise provided below.

11.4.1.Royalty Rates. Subject to subsection 11.4.2 below, the Licensee shall pay to the University a royalty of four percent (4%) of the Net Sales Price of the Commercial Sale of each Licensed Product by Licensee or an Affiliate until such time as a Licensed Product becomes Gross Margin Positive. At such time as such Licensed Product first becomes Gross Margin Positive, the Licensee shall pay to the University a royalty of six and one-half percent (6.5%) of the Net Sales Price of the Commercial Sale of each such Licensed Product by Licensee or an Affiliate. Once the royalty rate for a Licensed Product initially increases from 4 % to 6.5%, as described in the preceding sentence, the royalty rate for such Licensed Product will remain at 6.5%, regardless of whether such Licensed Product continues to be Gross Margin Positive.

11.4.2.Minimum Annual Cumulative Royalty Payment. Beginning on the date in which any Licensed Product first becomes Gross Margin Positive, the following minimum annual royalty obligation applies: If the total payments to the University under sections 11.4. and 11.5 do not aggregate to a minimum of $500,000 for each calendar year during the Term of this Agreement, the University may terminate the Agreement as set forth in subsection 8.1.1 of the Terms and Conditions unless the Licensee pays the University the difference between the total amounts actually paid to the University under sections 11.4 and 11.5 of this Agreement for such year the minimum sum of $500,000 within 30 days following the end of such year. If the date on which a Licensed Product first becomes Gross Margin Positive occurs other than on the first day of a calendar year, the minimum sum for that year will be prorated to the end of that year.

11.4.3.Royalty Stacking. The University and the Licensee recognize that a Licensed Product may embody Intellectual Property Rights owned or controlled by third parties, or may require the granting of consideration to third parties in order to develop, manufacture, use, or otherwise exploit Licensed Products in the Territory. In recognition of the foregoing, the amount of the royalty otherwise payable by Licensee for Commercial Sales of such Licensed Product shall be reduced by thirty percent (30%) for Commercial Sales of such Licensed Product made after the delivery to the University of a written notice, certified by the Licensee’s chief executive officer, that (i) a third party has asserted that a Licensed Product infringes such third party’s active and enforceable patent rights in the Field of Use and that, after consulting qualified legal counsel, Licensee has reason to accept the validity of the third party’s assertion; or (ii) that the Licensee has determined, after consulting with qualified legal counsel, that a license from a third party is required to develop, manufacture, use or otherwise exploit a Licensed Product in the Territory (the “Infringed Patent”); and (iii) the Licensee shall have entered into an agreement with such third party granting the Licensee a reasonable royalty—bearing license under the Infringed Patent to make, have made, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of the infringing Licensed Product in the Field of Use. Such reduction in the royalty rates shall expire on the termination or expiration of the license agreement between the Licensee and the third party. For the purposes of clarification the royalty rates paid by Licensee to the University for Sublicense Revenues and Sublicense Royalties shall not be affected or reduced by this subsection 11.4.3.

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11.4.4.Single Royalty. No more than one royalty payment shall be due with respect to a Commercial Sale of a Licensed Product. No multiple royalties shall be payable because any Licensed Product, or its manufacture, sale or use is covered by more than one valid claim of a Licensed Patent or Patent Application in any country.

11.4.5.Ro yalty Term. Royalties shall be payable under sections 11.4 and 11.5 on a product-by-product and country-by-country basis until such time as no valid claim or claim in a pending Patent Application covering the Licensed Product exists in the applicable country, provided, however, that if a pending claim of a Patent Application has not issued as a claim of an issued patent within seven (7) years after the filing date of the applicable Patent Application, then such pending claim shall not be subject to a royalty for purposes of this Agreement until such time as the claim is finally allowed as a valid claim by the applicable governmental authority. If a claim that has passed the seven (7) year limitation as described above ultimately is allowed as a valid claim by the applicable governmental authority then royalties shall be payable under sections 11.4 and 11.5 thereafter and for any prior period for which a royalty has not been paid due to the seven (7) year limitation.

11.5.Sublicense Fees:

11.5.1.Sublicense Royalties. Within thirty (30) days after the last day of each calendar quarter, during the term of this Agreement and the Post-Termination Period, the Licensee shall pay to the University twenty-five percent (25%) of all Sublicense Royalties received by the Licensee during such quarter.

11.5.2. Sublicense Revenues. Within thirty (30) days after the last day of each calendar quarter, during the term of this Agreement and the Post Termination Period, the Licensee shall issue the Company Stock to the University with a value equal to twenty-five percent (25%) of all Sublicense Revenues received by Licensee during such quarter, until such time as any Licensed Product becomes Gross Margin Positive. After such time, Licensee shall pay amounts due under this subsection 11.5.2 in either Company Stock or cash, at the discretion or the University. For the purposes of valuation of Company Stock under this subsection 11.5.2, Company Stock will be valued at the Company Stock’s then current value; provided, however, if there is no commercially reasonable valuation of the Company Stock, the payments in this subsection will be accrued until such time as there is a commercial valuation.

11.6.Intentionally Deleted.

11.7.Equity: Under the terms of the Subscription Agreement and Letter of Investment Intent attached as Exhibit B, the Licensee shall issue five-hundred sixty thousand (560,000) shares of Company Stock to the University as set forth in the table attached as Exhibit C. The Licensee represents that such shares will constitute no less than twenty four percent (24%) of the total issued and outstanding shares of the Licensee’s common stock on the Effective Date.

11.8.Transfer Payment: One hundred fifty thousand and NO/100 dollars ($150,000), payable as provided below in section 14 of the attached Terms and Conditions.

11.9.Interest Rate: Six percent (6%) per annum.

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12.Licensee’s Address for Notice (§23). Notices will be sent to the Licensee at:

Miromatrix Medical Inc.

Attention: Robert Cohen

President & CEO

18683 Bearpath Trail

Eden Prairie, MN 55347

Telephone No. 612-202-7026

Email: Robert.cohen1328@gmail.com

With a copy to:

Maslon Edelman Borman & Brand, LLP

Attention: Joseph Alexander, Esq.

90 South Seventh Street, Suite 3300

Minneapolis, MN 55402

Telephone No. 612-672-8369

Email: joseph.alexander@maslon.com

13.Licensee’s Contact Person for Patent Prosecution Consultation (§4.2.3). The University will, as set forth in the Agreement, communicate with the contact person named below with respect to patent prosecution and maintenance: (Upon ten (10) days prior written notice to the University, the Licensee may change the person designated below.)

Miromatrix Medical Inc.

Attention: Robert Cohen

President & CEO

18683 Bearpath Trail

Eden Prairie, MN 55347

Telephone No. 612-202-7026

Email: Robert.cohen1328@gmail.com

With a copy to:

Maslon Edelman Borman & Brand, LLP

Attention: Joseph Alexander, Esq.

90 South Seventh Street, Suite 3300

Minneapolis, MN 55402

Telephone No. 612-672-8369

Email: joseph.alexander@maslon.com

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14.Observer Right. The University and the Licensee will mutually agree to a representative of the University to attend and observe each regular, special or other meeting of the board of directors. Such observer shall have the right to participate in the deliberations of the board but shall have no right to vote on matters before the board. The Licensee shall cause to be delivered to such observer, in the same manner as such notice is to be delivered to the Licensee’s board of directors, true, correct and complete copies of all documents and other materials delivered to members of the Licensee’s board of directors. The Licensee may exclude such observer from all or any portion of a board meeting or committee meeting if, in the opinion of the Licensee’s legal counsel, such observer’s presence at such meeting would jeopardize the Licensee’s attorney/client privilege or expose such observer to confidential information. In addition, Licensee may exclude all confidential information from the materials distributed to such observer pursuant to this section so long as Licensee notifies such observer that confidential information has been withheld or otherwise excluded from those materials. The Licensee shall take steps, in its opinion, necessary and desirable, to cause its certificate of incorporation, bylaws, stockholder agreement or other agreement by and among the Licensee, the University and its stockholders to grant the University the rights granted in this section. Licensee hereby consents to the designation of Doug Johnson as the University’s representative. Any other designee shall be subject to Licensee’s approval, which approval shall not unreasonably be withheld. The University’s right to appoint a member to the board of directors and observer rights shall automatically terminate immediately prior to a Change of Control or a public offering of the Licensee’s securities. For purposes of clarity, references in this section 14 to “Licensee” shall apply exclusively to Miromatrix Medical Inc. and not to any successor or assign of Licensee.

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Agreement.

Regents of the University of Minnesota Miromatrix Medical Inc.

By:	/s/ Jay W. Schrankler	By:	/s/ Robert Cohen
	Jay W. Schrankler		Robert Cohen
	Executive Director		President & CEO
	Office for Technology Commercialization

Date: February 4, 2010 Date: February 4, 2010

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University of Minnesota

EXHIBIT A 

Terms and Conditions of the

Exclusive Patent License Agreement

These terms and conditions of the Exclusive Patent License Agreement (“Terms and Conditions”) govern the grant of license by Regents of the University of Minnesota (“University”) to the Licensee identified in the Exclusive Patent License Agreement (the “EPLA”). These Terms and Conditions are incorporated by reference into the EPLA. All section references in these Terms and Conditions refer to provisions in these Terms and Conditions unless explicitly stated otherwise.

1.Definitions. For purposes of interpreting the Agreement, the following terms have the following meanings:

1.1.“Affiliate” means an entity that controls the Licensee or the sublicensee, as the case may be, is controlled by the Licensee or sublicensee, or along with the Licensee or sublicensee, is under the common control of a third party. An entity shall be deemed to have control of the controlled entity if it (i) owns, directly or indirectly, fifty percent (50%) or more of the outstanding voting securities of the controlled entity, or (ii) has the right, power or authority, directly or indirectly, to direct or cause the direction of the policy decisions of the controlled entity, whether by ownership of securities, by representation on the controlled entity’s governing body, by contract, or otherwise.

1.2.“Capital Infusion Event” means the sale and issuance by Licensee, in one or more transactions, of its equity or debt securities to one or more purchasers in which the net proceeds to the Licensee equals or exceeds one million five hundred thousand dollars ($1,500,000). The calculation of net proceeds for the purpose of this section is gross proceeds, minus commercially reasonable expenses, fees and commissions payable in connection with and directly attributable to such issuance.

1.3.“Commercially Reasonable Efforts” shall mean, with respect to the development or commercialization of the Licensed Products, efforts and resources commonly used in the medical device industry for a product of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, its cost to develop, the competitiveness of alternative products, its proprietary position, the likelihood of regulatory approval, its profitability, and other relevant factors.

1.4.“Commercial Sale” means a bona fide sale, use, lease, transfer or other disposition for value of a Licensed Product by the Licensee or a sublicensee to a third party that is not an Affiliate of the Licensee. For the avoidance of doubt, the following shall not constitute a “Commercial Sale” under this Agreement:

(i)the transfer of a Licensed Product to a third party without consideration in connection with the development or testing of a Licensed Product; or

(ii)the transfer of a Licensed Product to any of Licensee’s Affiliates or sublicensees for resale;

(iii)the transfer of a Licensed Product to a third party for consideration for use in a clinical trial, so long as such clinical trial is being conducted prior to the availability of such Licensed Product for sale to the general public.

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1.5.“Company Stock” means Licensee’s fully-paid, voting, non-assessable, common stock, the rights under which are identical, in all respects, to Licensee’s outstanding common stock, issued to and in the name of the University.

1.6.“Confidentiality Agreement” means the Confidentiality Agreement by and between the Licensee and the University of even date herewith.

1.7.“Confidential Information” shall have the same meaning as set forth in the Confidentiality Agreement.

1.8.“Field of Use” means the field(s) of use described in section 2 of the EPLA.

1.9.“Gross Margin Positive” means the point in time when the Commercial Sale price of a single Licensed Product is greater than the cost of producing such single Licensed Product, as calculated in a manner consistent with US GAAP.

1.10.“Know-How” means all University proprietary information, relating to the inventions claimed in the Licensed Technology or within the Scientific Field and embodied in any laboratory notebooks, project plans or other tangible material by the Center for Cardiovascular Repair (the “CCVR”).

1.11.“Net Sales Price” means the gross amount invoiced for a Commercial Sale of a Licensed Product minus (i) all trade, quantity, and discounts actually allowed, (ii) all credits and allowances actually granted due to rejections, returns, billing errors, and retroactive price reductions, (iii) applicable duties, and (iv) applicable excise, sale and use taxes, (v) out of pocket expenses for freight and shipping of Licensed Product. Notwithstanding any provision of this Agreement to the contrary, if the Licensee or a sublicensee sells, leases, transfers or otherwise disposes of a Licensed Product to an Affiliate, the “Net Sales Price” for such transaction shall equal (a) the price the Licensee or the sublicensee, as the case may be, generally charges non-Affiliate third parties in a similar transaction for the Licensed Product or (b) if the Licensee or the sublicensee does not offer to sell the Licensed Product to the public, the price charged by the Licensee or the sublicensee for a product of similar kind, quality, and quantity.

1.12. “Licensed Patent” means the patent(s) described in section 5.1 of the EPLA, along with any active patent(s) issued during the Term that arose out of a Patent Application. “Licensed Patent” also means any reissues or reexaminations of a Licensed Patent that contain one or more claims directed to Licensed Technology.

1.13.“Licensed Product” means any product or good in the Field of Use that is made by, made for, sold, transferred, or otherwise disposed of by the Licensee or its sublicensees during the Term and the Post-termination Period and that (i) but for the granting of the rights set forth in the Agreement, would infringe (including under the doctrine of equivalents) one or more claims in a Licensed Patent; or (ii) is covered by one or more claims in a Patent Application, or any product or good that is made using a process or method that but for the granting of the rights set forth in the Agreement, would (i) infringe (including under the doctrine of equivalents) one or more claims in a Licensed Patent; or (ii) is covered by one or more claims in a Patent Application. For purposes of this Agreement, claims in a Patent Application are to be treated as if they were allowed as proposed. “Licensed Product” also means any service provided by or for the Licensee or its sublicensees that, but for the granting of the rights set forth in the Agreement, would (i) infringe (including under the doctrine of equivalents) one or more claims in a Licensed Patent; or (ii) is covered by a claim in a pending Patent Application.

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1.14.“Licensed Technology” means collectively each Licensed Patent and each Patent Application and the inventions claimed therein. For the purposes of clarification, Know-How is not to be construed to be Licensed Technology.

1.15.“Licensee” means the entity identified in section 1 of the EPLA.

1.16.“Patent Application” means the pending patent application(s) described in section 5.2 of the EPLA. “Patent Application” also means (i) any related applications including, continuations, continuations-in-part, and divisionals of a Patent Application; and (ii) patentable inventions and discoveries which are included in, or comprise all or any portion of, one or more University New Inventions, provided that, as to the subject matter covered by clause (ii), Licensee has exercised its option to license University New Inventions pursuant to subsection 3.1.3 of these Terms and Conditions.

1.17.“Patent-Related Expenses” means the reasonable attorneys’ fees of non- University personnel, patent agent fees, governmental filing fees and other out-of-pocket costs that the University incurs in searching, preparing, filing, prosecuting, and maintaining the Licensed Technology in accordance with section 4.2 below.

1.18.“Payment” means a payment to be made by the Licensee to the University specified below in section 6.1 and described in section 11 of the EPLA.

1.19.“Performance Milestone” means an act or event specified below in section 5.1 and described in section 9 of the EPLA.

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1.20. “Post-termination Period” means the one hundred eighty (180) day period commencing on the date of termination or expiration of the Term.

1.21.“Research Institution” means a non-profit entity whose primary activities are education and/or research.

1.22.“Scientific Field” means the treatment, prevention or amelioration of human or animal diseases and conditions through the decellularization or recellularization of a source material or system to generate, maturate or maintain stem cells, progenitor cells or cell phenotypes and/or functions, and all devices, processes and methods of production, modification or use related thereto.

1.23.“Sublicense Revenues” means all revenue, in whatever form, but excluding Sublicense Royalties, received by the Licensee in consideration of its granting a third party a sublicense to any of its rights under the Agreement, including, without limitation, receipt of annual milestone attainment, sublicense issuance, maintenance or up-front payments, or technology access fee; and issuance of securities or real, personal or intangible property.

1.24.“Sublicense Royalties” means a royalty paid to the Licensee that is received on Commercial Sales of Licensed Products by sublicensees.

1.25.“Territory” means the geographical area described in section 3 of the EPLA.

1.26.“Transfer Payment” means the payment to be made by the Licensee to the University specified below in section 14 and described in section 11.8 of the EPLA.

1.27.“University New Invention” means any patentable invention or discovery within the Scientific Field that meets either of the criteria in (i) or (ii) and the criteria in both (iii) and (iv):

(i)conceived and reduced to practice by Doris A. Taylor in her capacity as an employee of the University with at least a fifty percent (50%) appointment; or

(ii)conceived and reduced to practice by persons working in their capacity as a member of the CCVR during such time as Doris A. Taylor is employed by the University; and

(iii)disclosed to the University’s Office for Technology Commercialization or successor office by Doris A. Taylor or a member of her research team on or before the third (3^rd) anniversary of the Effective Date; provided, however, that, if subsequent to such date, an invention otherwise meeting the criteria of a University New Invention is disclosed to the University’s Office for Technology Commercialization or successor office that was conceived and documented after the Effective Date and before the third (3^rd) anniversary of the Effective Date, such invention will be considered as a University New Invention; and

(iv) owned solely by the University (or owned jointly with a third party and the University controls the licensing decisions and has the ability to grant a license).

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2.Term. The term of the Agreement commences on the Effective Date as defined in section 4 of the EPLA and, unless terminated earlier as provided below in section 8, expires on the date on which there is neither a Licensed Patent active in the Territory nor a Patent Application pending in the Territory (the “Term”).

3.Grants of License and Obligations.

3.1.The Licensee’s Rights.

3.1.1.Subject to the terms and conditions of this Agreement, the University hereby grants to the Licensee, and the Licensee hereby accepts, an exclusive license to make (including to have made on its behalf), use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products in the Field of Use in the Territory. No provision of the Agreement is to be construed to grant the Licensee, by implication, estoppel or otherwise, any rights (other than the rights expressly granted it in the Agreement) to the Licensed Technology, a Licensed Patent or Patent Application, or to any other University-owned technology, patent applications, or patents.

3.1.2.The Licensee may sublicense its rights under this Agreement only as follows: the Licensee shall deliver to the University a true, correct, and complete copy of the sublicense agreement or other agreement under which the Licensee purports or intends to grant such sublicense rights within ten (10) days after the execution of such agreement. The terms of each sublicense agreement shall be deemed to constitute “Confidential Information” of Licensee for all purposes of this Agreement, and the University shall not disclose the information contained in such sublicense agreement to any third party except as authorized pursuant to the Confidentiality Agreement. The Licensee shall not enter into such agreement if the terms of the agreement are inconsistent in any respect with the material terms of this Agreement, including without limitation, sections 5.2 through 5.6, 6.5, 8.4, 10.4, and 11.3. Any sublicense made in violation of this subsection is void as to any terms that cause such violation.

3.1.3.Subject to the terms and conditions of this Agreement, the University hereby grants to the Licensee a non-transferable (except in connection with the Licensee’s transfer of rights under this Agreement in accordance with section 14 of these Terms and Conditions), option to license on the terms set forth below in this subsection each University New Invention solely in the Scientific Field. The option process will occur as follows:

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(i)The University will deliver to the Licensee’s Contact Person for Patent Prosecution Consultation (as defined in section 13 of the EPLA) written notice of each University New Invention, within 30 days after the University receives an invention disclosure describing an invention or discovery that the University reasonably.determines to be a University New Invention. Each such notice shall include a description of the invention(s), and any Know-How known to the University’s Office for Technology Commercialization or successor office, at the time of such disclosure necessary for the Licensee to exploit the invention in the Scientific Field. The University shall cooperate and provide reasonable access to any information or records in its possession or control as necessary to facilitate the Licensee’s preliminary due diligence with respect to such invention, including but not limited to taking reasonable steps within University policy to facilitate the Licensee’s access to University employees having knowledge or information relevant to such invention.

(ii)To exercise its option, Licensee must deliver written notice of such exercise to the University within the forty-five (45) day period following the delivery of such notice by the University to Licensee.

(iii)If the Licensee exercises its option, the parties shall abide by the terms of section 4 of these Terms and Conditions in applying for and maintaining patent protection for such University New Invention, and the parties shall amend the terms of section 5.2 of the EPLA and other such terms of this Agreement as necessary or appropriate to record their agreement as to the University’s grant of an exclusive license to Licensee of the University’s rights in the University New Invention. The Running Royalties rates set forth in section 11.4 and Sublicense Fees in section 11.5 of the EPLA will apply to University New Inventions; provided that there will be no up-front or other fixed payments, fees or additional minimum royalties to the University for granting such license rights to the University New Invention.

(iv)During the periods set forth in subsections 3.1.3 (i) and (ii) above, the University will not (a) offer to grant or grant a license to such University New Invention to any non-Research Institution third party; or (b) disclose any information related to the University New Invention which would negatively affect a potential patent application.

(v)If the Licensee does not exercise its option as provided in subsection 3.1.3(ii), Licensee will have no rights to the University New Invention and the University will be free to license or assign its rights to that particular University New Invention. Notwithstanding any provision of this Agreement to the contrary, the Licensee’s non-exercise of its option with respect to any University New Invention shall not limit or restrict the Licensee’s option rights with respect to any other University New Invention.

3.2.The United States Government’s Rights. If the University indicated in section 8 of the EPLA that the United States federal government funded the development, in whole or in part, of the Licensed Technology, then, (i) the federal government may have certain rights in and to the Licensed Technology as those rights are described in Chapter 18, Title 35 of the United States Code and accompanying regulations, including Part 401, Chapter 37 of the Code of Federal Regulations; and (ii) the parties’ rights and obligations with respect to the Licensed Technology, including the grant of license set forth above in subsection 3.1.1, are subject to the applicable terms of these laws and regulations.

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3.3.The University’s Rights.

(i)University retains an irrevocable, world-wide, royalty-free, non-exclusive right to use the Licensed Technology solely for teaching, research and educational purposes. This right does not grant to the University any right under any patent or other intellectual property right in or to the Licensed Technology to make, use or sell any products or processes derived from or with the Licensed Technology for commercial sale without the written consent of the Licensee.

(ii)The University retains the right to sublicense the rights in subsection 3.3(i) to one or more Research Institutions with notice to the Licensee. Upon Licensee’s reasonable request, the University will make a good faith effort to secure in such sublicense either a non-exclusive, royalty-free, sublicenseable commercial license to any resulting invention or discovery based upon the Licensed Technology for Licensee in the Scientific Field, or an option for the Licensee to negotiate a license to any resulting invention or discovery on commercially reasonable terms. Notwithstanding anything to the contrary in this Agreement no sublicense granted by the University to a Research Institution shall grant any sublicenseable right or any option to any right under any patent or other intellectual property right in or to the Licensed Technology to make, use or sell any products or processes derived from or with the Licensed Technology for commercial sale without the written consent of the Licensee.

(iii)The University retains the right to use the Licensed Technology in research projects paid for in whole or significant part by for-profit or non-profit entities and has the right to grant such entities, the right to license inventions or discoveries conceived or reduced to practice in the course of such research. By way of clarification and consistent with section 1.27 of these Terms and Conditions, such invention or discovery would not constitute a University New Invention, to which Licensee would have option rights under subsection 3.1.3 of these Terms and Conditions. The University will, however, make a good faith effort to secure a non-exclusive, royalty-free, sublicenseable commercial license to such invention or discovery for Licensee.

(iv)With respect to any University New Invention for which Licensee has exercised its option rights under subsection 3.1.3(ii), the University, in addition to the rights reserved in this section 3.3, may grant licenses to any third party in any field of use other than the Scientific Field.

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(v)Licensee recognizes that, under University policy the results of any University research must be publishable and agrees that researchers using the Licensed Technology are permitted to present at symposia, national or regional professional meetings and to publish in journals, theses or dissertations, or otherwise of their own choosing, the methods and results of such research. University has the final authority to determine the scope and content of any publication; provided, however, that the University’s Office for Technology Commercialization shall provide copies of any proposed publication that it receives from a University researcher containing information relating to a University New Invention during the period set forth in subsection 3.1.3(ii) to Licensee to review and object to such publication or presentation because such draft contains Licensee’s Confidential Information or information that, if published during such period, would have an adverse effect on a patent application or a potential patent application for such University New Invention. In the event Licensee requests, by written notice to the University, a delay in publication, the University and the Researcher shall refrain from making such publication or presentation until the end of the period set forth in subsection 3.1.3(ii) or, if Licensee exercises its option under subsection 3.1.3(ii), until the University has filed for patent protection for such University New Invention; and (c) the University shall require the researcher to undertake the same obligations with respect to the Licensee’s Confidential Information relating to the applicable University New Invention as are set forth in Confidentiality Agreement. The University will not publish Licensee’s Confidential Information.

3.4.         Know-How License and Obligation. During the Term of this Agreement, beginning on the Effective Date and continuing through the fifth (5^th) anniversary of the Effective Date, the University will transfer to Licensee Know-How that has been disclosed to the University’s Office for Technology Commercialization or its successor office. The University hereby grants to Licensee a non-exclusive, royalty-free, sublicenseable, worldwide license to practice such Know-How during the Term of this Agreement. Additionally, to the extent possible under University policies and procedures, the University will use reasonable efforts to make employees available on a mutually convenient basis to provide additional information and explanation of any material provided under this section 3.4. No provision of the Agreement is to be construed to grant the Licensee, by implication, estoppel or otherwise, any rights (other than the rights expressly granted it in this Agreement) to the Know-How. For the purposes of clarification, the University is not obligated to maintain any confidentiality related to the Know-How except as set forth in subsection 3.1.3(iv).

4.Applications and Patents.

4.1.Pre-EPLA Patent Filings. The Licensee acknowledges that it has reviewed each Licensed Patent and each Patent Application and that it is not aware of any basis to challenge or dispute the inventorship, validity, or enforceability of any of the claims made in a Licensed Patent or a Patent Application. The Licensee further represents that, as of the Effective Date, it has not and does not manufacture, have manufactured, offer to sell, sell, offer to lease, lease, or import (a) any product or good that infringes (including under the doctrine of equivalents) a claim in any Licensed Patent or Patent Application, or (b) any product or good that is made using a process or machine that infringes (including under the doctrine of equivalents) a claim in a Licensed Patent or Patent Application.

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4.2.Patent Application Filings during the Term of the Agreement.

4.2.1.The University, in consultation with the Licensee, shall be responsible for: (a) the continued prosecution of all Patent Applications; (b) the maintenance of all Licensed Patents; and (c) the filing of additional Patent Applications in such additional jurisdictions as the University determines after consultation with Licensee. The University shall retain counsel of its choice to file and prosecute such patent applications, which engagement shall be subject to the Licensee’s prior written consent, which consent shall not be unreasonably withheld. Upon mutual agreement of the parties, which agreement shall not be unreasonably withheld by either party, the Licensee may elect to become a client of such patent counsel in connection with the prosecution of any Patent Applications and/or the maintenance of any Licensed Patents. If the parties mutually agree to the foregoing, the Licensee shall execute all papers and perform such acts as may be reasonably required to waive any conflict of interest in connection with such representation, in a form substantially similar to the form attached as Exhibit D.

4.2.2.The University shall diligently pursue the prosecution of all Patent Applications to issuance of the resulting patents, and shall not abandon, withdraw or discontinue prosecution of any Patent Application without first consulting with and obtaining the Licensee’s prior written consent, which consent shall not be unreasonably withheld if the parties agree that the issuance of a patent from such application is unlikely or is no longer to the benefit of the patent prosecution strategy for the Licensed Technology.

4.2.3.The Licensee shall cooperate with the University in the filing and prosecution of all patent applications with respect to the Licensed Technology. In furtherance of the foregoing, the Licensee shall notify the University, in writing, of the individual whom the Licensee has designated to consult and cooperate as provided in this subsection and is identified in section 13 of the EPLA. If possible under the circumstances, the University shall provide the Licensee’s Contact Person with drafts of all patent applications and other material submissions to and correspondence with any patent authorities to the extent such applications or submissions relate to the Licensed Technology, prior to the date a reply is required by the relevant patent authorities, to allow for review and comment by the Licensee. In addition, if possible under the circumstances, the University shall provide the Licensee’s Contact Person with an opportunity to consult with the University regarding the filing and contents of any such application, submission or correspondence. The Contact Person shall respond to the University’s request for consultation and cooperation on a pending matter within ten business days or sooner as may be required under the circumstances. If the Contact Person fails to respond in such time period, the University, exercising its own judgment and discretion, may respond to the matter as it deems appropriate. Except as provided below in subsection 4.2.7, the Licensee shall reimburse the University for all Patent-Related Expenses as provided below in section 6.3 and in section 6 of the EPLA.

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4.2.4. If following consultation pursuant to this section 4, the University intends not to pursue the filing, prosecution or maintenance of a Licensed Patent or Patent Application in a particular country, or to take any other action with respect to a Licensed Patent or Patent Application in a particular country that is necessary or useful to establish or preserve rights with respect to the Licensed Products, then the University shall so notify the Licensee promptly in writing and in good time to enable Licensee to meet any deadlines by which an action must be taken to establish or preserve any such rights. Upon receipt of any such notice by the University or if, at any time, the University fails to initiate any such action within thirty (30) days after a request by the Licensee that it do so (and thereafter diligently pursue such action), Licensee shall have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution or maintenance, of such Licensed Patent or Patent Application at its expense in such country. If the Licensee elects to pursue such filing or registration, as the case may be, or continue such support, then Licensee shall notify the University of such election and the University shall, and shall cause its agents and Affiliates to, cooperate with Licensee in this regard.

4.2.5.At the Licensee’s request, the University will provide a schedule listing all applicable filing deadlines and estimate of associated costs necessary to maintain the Licensed Patents and Patent Applications in a particular country to the Licensee in writing.

4.2.6.In the event of any dispute or disagreement among the parties as to whether the filing, prosecution, maintenance, or prosecution strategy of a Licensed Patent or Patent Application in a particular country is necessary or useful to establish or preserve rights with respect to the Licensed Technology in such country (each a “Dispute”), the Dispute, upon written request of any Party, shall first be referred to a senior executive officer of each party for decision. Such executive officers shall promptly meet in a good faith effort to resolve the dispute. Any Dispute that cannot be settled amicably by agreement with ten (10) business days shall be finally settled by a single arbitrator as provided below.

a.             To initiate the arbitration, the disputing party shall notify the other party in writing (the “Arbitration Demand”), which shall (i) describe in reasonable detail the nature of the Dispute, (ii) specify the requested relief and (iii) name a representative who (A) has been licensed to practice patent law in the U.S. for at least fifteen years, (B) has no past or present relationship with either party or their respective counsel, except as otherwise disclosed in writing to and approved by the parties, and (C) is experienced in representing clients in the filing, prosecution and maintenance of patents in the medical device industry (the “Basic Qualifications”).

b.            Within three (3) business days after its receipt of the Arbitration Demand, such other party shall serve on the Disputing Party, a written statement (i) describing in reasonable detail its position with respect to the Dispute and specifying the requested relief; and (ii) naming a second representative satisfying the Basic Qualifications.

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c.            Within three (3) business days thereafter, the two representatives so named will select a neutral arbitrator who satisfies the Basic Qualifications. The arbitrator so chosen shall issue his or her decision resolving the Dispute within five (5) days following his or her appointment, which decision will be final, conclusive and binding upon the parties with respect to the subject matter of the Dispute. All submissions, documents and information relating to the arbitration proceeding shall be deemed to be Confidential Information subject to the Confidentiality Agreement. The arbitrator will have no power or authority to relieve the parties from their obligations hereunder or otherwise to amend or disregard any provision of this Agreement, including, without limitation, the provisions of this section. To clarify, the arbitrator’s sole role is to resolve the Dispute as defined in subsection 4.2.6. Each party is responsible for its own costs in connection with arbitration and agrees to share the costs related to the fees of the arbitrator. The venue of any such arbitration under this section shall be in Minneapolis, Minnesota and the process for participation in the arbitration will be determined by the arbitrator.

d.            Each party is required to continue to perform its obligations under this Agreement pending final resolution of any Dispute.

4.2.7.The grant of license in section 3.1 and the definition of Territory in section 1.25 shall not extend to or include any country in which Licensee elects, in writing to the University, not to pay or reimburse the payment of the cost, in whole or in part, to seek or maintain intellectual property protection.

4.2.8.Except as specifically provided in this Agreement, nothing limits, conditions, or otherwise affects the University’s right to prosecute a patent application with respect to the Licensed Technology in any country, or its sole and exclusive right to file or otherwise prosecute a patent application with respect to the Licensed Technology. Except as specifically provided in this Agreement, in no event shall the Licensee file a patent application with respect to the Licensed Technology. The Licensee shall cooperate with the University in the filing and prosecution of all patent applications with respect to the Licensed Technology.

4.3.Ownership of the Licensed Patents, Patent Applications and Know-How. Except as otherwise expressly set forth in this Agreement, the University retains all rights, titles, and interests in the Licensed Patents, Patent Applications and Know-How, notwithstanding the Licensee’s payment of all or any portion of the patent prosecution, maintenance, and related costs.

5.Commercialization.

5.1.Commercialization and Performance Milestones. The Licensee shall use its Commercially Reasonable Efforts, to commercialize the Licensed Technology and to manufacture and offer to sell and sell Licensed Products as soon as practicable and to maximize sales thereof. The Licensee shall perform or cause to happen or be performed, as the case may be, all the performance milestones described in section 9 of the EPLA.

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5.2.Covenants Regarding the Manufacture of Licensed Products. The Licensee hereby warrants (i) the manufacture, use, sale, or transfer of Licensed Products will comply in all material respects with all applicable federal and state laws, including all federal export laws and regulations; and (ii) it will use reasonable efforts to ensure that no Licensed Product will be defective in design or manufacture. The Licensee hereby further covenants and agrees that it shall, and it shall cause each sublicensee, to substantially manufacture in the United States of America all products embodying or produced through the use of an invention that is subject to the rights of the federal government of the United States of America, except to the extent that a waiver of this requirement has been issued by the federal government for a Licensed Product.

5.3.Export and Regulatory Compliance. The Licensee understands that the Arms Export Control Act (AECA), including its implementing International Traffic In Arms Regulations (ITAR,) and the Export Administration Act (EAA), including its Export Administration Regulations (EAR), are some (but not all) of the laws and regulations that comprise the U.S. export laws and regulations. Licensee further understands that the U.S. export laws and regulations include (but are not limited to): (i) ITAR and EAR product/service/data-specific requirements; (ii) ITAR and EAR ultimate destination-specific requirements; (iii) ITAR and EAR end user-specific requirements; (iv) Foreign Corrupt Practices Act; and (v) antiboycott laws and regulations. The Licensee shall comply with all then-current applicable export laws and regulations of the U.S. Government (and other applicable U.S. laws and regulations) pertaining to the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information). The Licensee certifies that it shall not, directly or indirectly, export (including any deemed export), nor re-export (including any deemed re-export) the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information) in violation of U.S. export laws and regulations or other applicable U.S. laws and regulations. The Licensee shall include an appropriate provision in its agreements with its authorized sublicensees to assure that these parties comply with all then-current applicable U.S. export laws and regulations and other applicable U.S. laws and regulations.

5.4.Commercialization Reports. Throughout the Term and during the Post-termination Period, and within thirty (30) days of the date specified in the schedule set forth in section 10 of the EPLA, the Licensee shall deliver to the University written reports of the Licensee’s and its sublicensees’ efforts and plans to commercialize the Licensed Technology and to manufacture, offer to sell, or sell Licensed Products.

5.5.Use of the University’s Name and Trademarks or the Names of University Faculty, Staff, or Students. Except as permitted by law, Licensee shall not use (or authorize the use of) the name, logo, or any marks owned by or associated with the University or the names, or identities of any member of the faculty, staff, or student body of the University. No provision of this Agreement grants the Licensee any license with respect to this section 5.5. Licensee shall not and shall not authorize others to state or imply that the University endorses any products or services.

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5.6.Governmental Markings.

5.6.1. The Licensee shall mark all Licensed Products, where feasible, with patent notice appropriate under Title 35, United States Code.

5.6.2.The Licensee is responsible for obtaining all necessary governmental approvals for the development, production, distribution, sale, and use of any Licensed Product, at the Licensee’s expense, including, without limitation, any safety studies. The Licensee is responsible for including with the Licensed Product any legally required warning labels, packaging and instructions as to the use and the quality control for any Licensed Product.

5.6.3.The Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration, and the Licensee shall pay all costs and legal fees in connection with such registration. The Licensee shall comply with all foreign laws affecting the Agreement or the sale of Licensed Products.

6.Payments, Reimbursements, Reports, and Records.

6.1.Payments. The Licensee shall pay all amounts due under the Agreement by check (payable to the “Regents of the University of Minnesota” and sent to the address specified below in section 23), wire transfer, or any other mutually agreed-upon method of payment.

6.2.Interest. All amounts due under the Agreement shall bear interest as provided in section 11.9 of the EPLA on the entire unpaid balance computed from the due date until the amount is paid.

6.3.Reimbursement of Patent-Related Expenses. The Licensee shall pay invoices for Patent-Related Expenses under the Agreement within thirty (30) days of its receipt of the University’s invoice. With respect to each invoice, the University shall use reasonable efforts to specify the date on which the Patent-Related Expense was incurred and the purpose of the expense (including, as applicable, a summary of patent attorney services giving rise to the expense).

6.4.Royalty Payments/Sales Reports. Within sixty (60) days after the last day of a calendar quarter during the Term and the Post-termination Period, the Licensee shall deliver to the University a written sales report in a form provided by University that is reasonably acceptable to Licensee, recounting the number and Net Sales Price amount (expressed in U. S. dollars) of all sales, leases, or other dispositions of Licensed Products, whether made by the Licensee or a sublicensee, during such calendar quarter. The Licensee shall deliver such written report to the University even if the Licensee is not required hereunder to pay to the University a payment for sales, leases, or other dispositions of Licensed Products during the calendar quarter. The Licensee shall deliver along with such sales reports its payment for royalties owed on all Commercial Sales of Licensed Products by the Licensee and the sublicensees during such quarter.

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6.5.Records Retention and Audit Rights.

6.5.1. Throughout the Term and the Post-termination Period and for five (5) years thereafter, the Licensee, at its expense, shall keep and maintain and shall use reasonable efforts to cause each sublicensee and each non-affiliated third party that manufactures, sells, leases, or otherwise disposes of Licensed Products on behalf of the Licensee to keep and maintain accurate records of sales, leases, and other dispositions of Licensed Products during the Term and the Post-termination Period and all other records reasonably necessary for the University to verify the Licensee’s compliance with its obligations under this Agreement.

6.5.2.In connection with an audit, the Licensee, upon written request, shall make available for the University and its representatives’ inspection at a mutually agreed upon place in the continental United States, true, correct and complete copies of all documents and materials (including electronic records) reasonably relevant to the Licensee’s and sublicensees’ performance of the Agreement, including, without limitation, all sublicenses granted. Such documents and materials shall be deemed to constitute Confidential Information of Licensee for all purposes of the Confidentiality Agreement, and the University shall not disclose the information contained in such sublicense agreement to any third party except as authorized pursuant to the Confidentiality Agreement.

6.5.3.To determine the Licensee’s compliance with the terms of the Agreement, the University, at its expense (except as set forth below in this subsection) and not more than once per calendar year, and upon at least five (5) days advance written notice to Licensee, may inspect and audit the Licensee’s records referred to above in subsection 6.5.1 at the Licensee’s address as set forth in the Agreement or such other location(s) as the parties mutually agree during the Licensee’s normal business hours. The Licensee shall cooperate in the audit, including providing at no cost, reasonable space in the Licensee’s place of business for the auditor. The Licensee shall reimburse the University for all its reasonable out-of-pocket expenses to inspect and audit such records if the results of such inspection and audit demonstrate that the Licensee has underpaid amounts owed to the University by at least five percent (5%) or one fifty thousand and no/100 dollars ($50,000), whichever is greater, in a reporting period. The Licensee shall use reasonable efforts to c ause ea ch sublicensee and each non-affiliated third party that manufactures, sells, leases, or otherwise disposes of Licensed Products on behalf of the Licensee to grant the Licensee a right to inspect and audit the sublicensee’s or third party’s records substantially similar to the rights granted the University in this subsection. Any such records will be made available in connection with an audit by the University under this section. In connection with, and before the commencement of, an audit, if the Licensee requests in writing to the University, then prior to conducting such audit, the Licensee, the University and the auditor must enter into an agreement prohibiting the auditor from disclosing the Licensee’s nonpublic, proprietary information to any third party without the Licensee’s prior written consent. Terms of any such agreement shall be consistent in all material respects with the Confidentiality Agreement; provided, however, that consistent with generally accepted auditing standards and the auditor’s professional judgment, the auditor may disclose such information to the University and its agents, counsel, or consultants. The Licensee acknowledges that such an agreement is adequate to protect its legitimate interests, and the parties agree that there shall be no additional nondisclosure agreement demanded as a condition to the commencement of an audit and the University’s exercising its rights under this subsection.

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6.6.Currency and Checks. All computations and payments made under the Agreement shall be in United States dollars. To determine the dollar value of transactions conducted in non-United States dollar currencies, the parties shall use the exchange rate for the currency into dollars as reported in the Wall Street Journal as the New York foreign exchange mid-range rate on the last business day of the month in which the transaction occurred.

7.Infringement.

7.1.If a party learns of substantial, credible evidence that a third party is making, using, or selling a product in the Field of Use in the Territory that infringes a Licensed Patent, such party shall promptly notify the other party in writing of the possible infringement and in such notice describe in detail the information suggesting infringement of the Licensed Patent.

Prior to commencing any action to enforce a Licensed Patent, the parties shall enter into good faith negotiations on the desirability of bringing suit, the parties to the action, the selection of counsel, and such other matters as the parties may agree to discuss. No provision of this Agreement limits, conditions, or otherwise affects a party’s statutory and common-law rights to commence an action to enforce a Licensed Patent. In any such action, the parties agree to cooperate fully with each other and will use reasonable efforts to permit access to relevant personnel, records, papers, information, samples and specimens during regular business hours. Any amounts recovered (less amounts paid for reasonable attorneys’ fees and legal expenses) by Licensee in such action or settlement that constitute compensation for lost profits or sales will be considered subject to the royalty rate in subsection 11.4.1 of the EPLA. All other amounts recovered (less amounts paid for reasonable attorneys’ fees and legal expenses) by Licensee in such action or settlement will be considered Sublicense Revenues.

7.2.If any suit, action or proceeding is brought or commenced against the Licensee alleging the infringement of a patent or other intellectual property right owned by a third party by reason of the manufacture, use or sale of Licensed Products, the Licensee shall give the University prompt notice thereof.

7.3.If the validity of a Licensed Patent is questioned in any suit, action, or proceeding under section 7.1 or 7.2, neither party shall have the right to make any settlement or compromise which affects the scope, validity, enforceability or otherwise of the Licensed Patent without the other party’s prior written approval, which approval shall not be unreasonably withheld.

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8.Termination.

8.1.By the University.

8.1.1. If the Licensee breaches one or more of its material obligations under the Agreement, the University may deliver a written notice of default to the Licensee. Without further action by a party, the Agreement shall terminate if (a) the default has not been cured within thirty (30) days after the delivery to the Licensee of the notice of default if the default relates to a payment or reimbursement obligation under this Agreement or (b) ninety (90) days after the delivery to the Licensee of the notice of default if the default relates to any other matter.

8.1.2.The University may terminate the Agreement by delivering to the Licensee a written notice of termination at least ten (10) days before the date of termination if the Licensee (i) becomes insolvent; (ii) voluntarily files or has filed against it a petition under applicable bankruptcy or insolvency laws that the Licensee fails to have released within thirty (30) days after filing; (iii) proposes any dissolution, composition, or financial reorganization with creditors or if a receiver, trustee, custodian, or similar agent is appointed; or (iv) makes a general assignment for the benefit of creditors.

8.1.3.The University may terminate the Agreement immediately by delivering to the Licensee a written notice of termination if the Licensee or its agents or representatives commences or maintains an action in any court of competent jurisdiction or a proceeding before any governmental agency asserting or alleging, in any respect the invalidity or unenforceability of any of any of the Licensed Technology. The Licensee shall notify the University, in writing, at least thirty (30) days prior to the commencement of any such action or the institution of any such proceeding. Prior to exercising its right of termination under this section, University will discuss or attempt to discuss with Licensee’s the basis of Licensee’s actions under this section.

8.2.By the Licensee. The Licensee may terminate the Agreement by delivering to the University a written notice of termination at least thirty (30) days before the date of termination. Licensee shall pay all amounts due through the date of termination. Notwithstanding any provision of this Agreement to the contrary, if the date of termination of this Agreement is prior to a Capital Infusion Event or June 30, 2011, the Company after the date of termination shall promptly deliver to the University all shares of Common Stock to be issued to the University under section 6 of the EPLA as of such date.

8.3.If the University breaches or fails to perform one or more of its duties under the Agreement, the Licensee may deliver to the University a written notice of default. The Licensee may elect to terminate the Agreement by delivering to the University a written notice of termination if the default has not been cured in full within ninety (90) days of the delivery to the University of the notice of default.

8.4.Post-termination Period. The Licensee shall not use, or permit others to use, the Licensed Technology or manufacture or have manufactured Licensed Products after the Agreement terminates. If the Licensee terminates the Agreement under section 8.3, the Licensee may continue to offer to sell and sell, offer to lease and lease, and otherwise offer to dispose of or dispose of Licensed Products in the Territory that were manufactured before such termination. The Commercial Sales of Licensed Products during the Post-termination Period shall be governed by the terms of this Agreement, including the obligation to pay royalties on such Commercial Sales as provided in this Agreement.

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9.Indemnification, and Insurance.

9.1.The Licensee’s Indemnification. Throughout the Term and thereafter, the Licensee shall indemnify, defend, and hold the University and its regents, employees, and agents harmless from all suits, actions, claims, liabilities or demands (including investigative expenses and reasonable attorneys’ fees) by a third party (including sub-licensees), relating to or arising out of the Licensee’s exercise, enforcement or assertion of any of the rights or licenses granted it under this Agreement, including, without limitation, the manufacture, use, lease, sale, or other disposition of a Licensed Product.

9.2.The University’s Indemnification. Subject to the limitations on liability set forth below in section 11, throughout the Term and thereafter, the University shall indemnify, defend, and hold the Licensee and its directors, employees, and agents harmless from all suits, actions, claims, liabilities, demands, damages, losses, or expenses (including reasonable attorneys’ and investigative expenses) arising out of the University’s breach of any term of this Agreement.

9.3.Indemnification Procedures. The indemnified party shall give the indemnifying party prompt written notice (an “Indemnification Claim Notice”) of any matter for which the indemnified party is entitled to an indemnification hereunder. In the event that prompt notice is not given by the indemnified party, the indemnifying party shall not be liable for any losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such loss (to the extent that the nature and amount of such loss is known at such time). The indemnified party shall furnish promptly to the indemnifying party copies of all papers and official documents received in respect of any claims or losses.

9.4.Third Party Claims. The obligations of an indemnifying party under this Agreement with respect to claims of any third party that are subject to indemnification as provided for in sections 9.1 or 9.2 (a “Third Party Claim”) shall be governed by and be contingent upon the following additional terms and conditions:

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9.4.1.Control of Defense. The indemnifying party shall assume the defense of any Third Party Claim by giving written notice to the indemnified party within thirty (30) days after the indemnifying party’s receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying party shall not be construed as an acknowledgment that the indemnifying party is liable to indemnify any indemnified party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying party of any defenses it may assert against any indemnified party’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying party may appoint as lead counsel in the defense of the Third Party Claim legal counsel reasonably acceptable to the indemnified party. The indemnified party shall immediately deliver to the indemnifying party all original notices and documents (including court papers) received by any indemnified party in connection with the Third Party Claim. Once the indemnifying party assumes the defense of the third party, the indemnifying party shall not be liable to the indemnified party or any other indemnified party for any legal expenses subsequently incurred by such indemnified party in connection with the analysis, defense or settlement of the Third Party Claim. In the event that it is ultimately determined that the indemnifying party is not obligated to indemnify, defend or hold harmless an indemnified party from and against the Third Party Claim, the indemnified party shall reimburse the indemnifying party for any and all reasonable costs and expenses (including reasonable attorneys’ fees and costs of suit) and any losses incurred by the indemnifying party in its defense of the Third Party Claim asserted against the indemnified party and the indemnified party shall be exclusively liable for such losses and defense of such claim.

9.4.2.Right to Participate in Defense. Without limiting subsection 9.4.1 above, any indemnified party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the indemnified party’s own expense unless (i) the employment thereof has been specifically authorized by the indemnifying party in writing or (ii) the indemnifying party has failed to assume the defense and employ counsel in accordance with subsection 9.4.1 (in which case the indemnified party shall control the defense).

9.4.3.Settlement. With respect to any losses relating solely to the payment of money damages in connection with a Third Party Claim and that will not result in the indemnified party’s becoming subject to injunctive or other relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party shall have acknowledged in writing the obligation to indemnify the indemnified party hereunder, and for which the indemnified party receives a general release, the indemnifying party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such loss, on such terms as the indemnifying party, in its sole discretion, shall deem appropriate. With respect to all other losses in connection with Third Party Claims, where the indemnifying party has assumed the defense of the Third Party Claim in accordance with subsection 9.4.1, the indemnifying party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such loss provided it obtains the prior written consent of the indemnified party (which consent shall not be unreasonably withheld, conditioned or delayed). No indemnified party shall confess judgment to or admit any liability with respect to, or settle, compromise or discharge, any Third Party Claim without the prior written consent of the indemnifying party. Notwithstanding anything contained in the preceding sentence to the contrary, an indemnified party shall be entitled to make factually accurate statements in any court action or proceeding.

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9.4.4. Cooperation. At the request of the indemnifying party, the indemnified party shall cooperate in the defense or prosecution thereof, at the expense of the indemnifying party, and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested by indemnifying party in connection therewith at the expense of the indemnifying party. Such cooperation shall include access during normal business hours afforded to the indemnifying party to, and reasonable retention by the indemnified party of, records and information that are reasonably relevant to such Third Party Claim. The indemnified parties shall use reasonable efforts to make other employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the indemnifying party shall reimburse the indemnified party for all its reasonable out-of-pocket expenses in connection therewith.

9.5.The Licensee’s Insurance.

9.5.1.Prior to the commencement of a clinical trial using the Licensed Technology, or the sale or distribution of a Food and Drug Administration approved Product incorporating the Licensed Technology, and continuing thereafter throughout the Term, or during such other period as the parties agree in writing, the Licensee shall maintain, and shall cause each sublicensee to maintain, in full force and effect liability insurance appropriate to medical trial or medical product exposures with single and aggregate claim limits reasonably acceptable to the University based on customary practice in the U.S. medical device industry. Such insurance shall include coverage for claims that may be asserted by the University against the Licensee under section 9.1 and for claims by a third party against the Licensee or the University arising out of the purchase or use of a Licensed Product. Such insurance policy must (i) name the University as an additional insured if the University so requests in writing and (ii) require the insurer to deliver written notice to the University at the address set forth in section 23, at least thirty (30) days before the termination of the policy. Upon receipt of the University’s written request, the Licensee shall deliver to the University a copy of the certificate of insurance for such policy.

9.5.2.The provisions of subsection 9.5.1 do not apply if the University agrees in writing to accept the Licensee’s or a sublicensee’s, as the case may be, self-insurance plan as adequate insurance.

10.Warranties.

10.1.Authority. Each party represents and warrants to the other party that: (a) it has full corporate power and authority to execute, deliver, and perform the Agreement; (b) no other corporate proceedings by such party are necessary to authorize the party’s execution or delivery of the Agreement; (c) this Agreement has been duly executed and delivered by such party and constitutes the valid and binding obligation of such party, enforceable against such party in accordance with its terms; and (d) it has the right to grant the licenses granted to the other party as set forth herein, free and clear of any rights of a third party, except as provided in this agreement, including the rights of the federal government.

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10.2.Licensee’s Warranty. Licensee represents and warrants to the University that as of the Effective Date all documents effecting in any way the ownership of Licensee equity are complete and have been made available in full for review by the University.

10.3.Disclaimers.

10.3.1.EXCEPT FOR THE EXPRESS WARRANTY SET FORTH ABOVE IN SECTION 10.1, THE UNIVERSITY DISCLAIMS AND EXCLUDES ALL WARRANTIES, EXPRESS AND IMPLIED, CONCERNING THE LICENSED TECHNOLOGY, EACH LICENSED PATENT, EACH PATENT APPLICATION, ANY KNOW-HOW AND EACH LICENSED PRODUCT, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT, OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.

10.3.2.The University expressly disclaims any warranties concerning and makes no representations:

(i)that the Patent Applications will be allowed or granted or that a patent will issue from any Patent Application;

(ii)concerning the validity, enforceability, interpretation of claims or scope of any Licensed Patent; or

(iii)that the exercise of the rights or licenses granted to the Licensee under the Agreement will not infringe a third party’s patent or violate its intellectual property rights.

10.4.Sublicensees - Warranties. The Licensee shall use reasonable efforts to cause each sublicensee to accept warranties and disclaimers and exclusions of warranties substantially similar to the warranty and disclaimers and exclusions of warranties in favor of the University above in section 10.1 and subsections 10.3.1 and 10.3.2.

11.Damages.

11.1.Remedy Limitation. UNIVERSITY SHALL NOT BE LIABLE FOR PERSONAL INJURY OR PROPERTY DAMAGES (EXCEPT TO THE EXTENT OF ITS GROSS NEGLIGENCE, WILLFUL, WANTON, OR INTENTIONAL ACTS). EXCEPT FOR LICENSEE’S INDEMNIFICATION OBLIGATIONS TO THE UNIVERSITY UNDER SECTION 9.1, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR LOST PROFITS, LOST BUSINESS OPPORTUNITY, OR ANY RELIANCE, EXPECTANCY, INDIRECT, SPECIAL, INCIDENAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.

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11.2. Damage Cap. University’s total liability for its obligations under section 9.2 as well as its liability for the breach or nonperformance of any provision of this Agreement (including Exhibits) or Confidentiality Agreement shall not exceed the following: the amount of payments (including but not limited to equity or debt consideration) paid to the University by Licensee less (i) cash, equity, or debt consideration, paid under section 6 of the EPLA as reimbursement for Patent Related Expenses and (ii) any cash, equity or debt consideration paid to the University that has actually been distributed to inventors pursuant to Board of Regents Policy: Commercialization of Intellectual Property Rights, adopted December 14, 2007 or its successor policies and procedures. The University’s damage cap under this section applies to contract, tort, and any other claim of whatever nature.

11.3.Sublicensees - Damages. The Licensee shall use reasonable efforts to cause each sublicensee to agree to limitations of remedies and damages substantially similar to the limitations of remedies and damages set forth above in sections 11.1 and 11.2.

11.4.The limitations of liabilities set forth in sections 11.1 and 11.2 above shall apply with respect to the University only while it remains a party to this Agreement, and shall not extend to any assignee or successor in interest to the University’s rights or interest under this Agreement.

12.Amendment and Waiver. The Agreement may be amended from time to time only by a written instrument signed by the parties. No term or provision of the Agreement may be waived and no breach excused unless such waiver or consent is in writing and signed by the party claimed to have waived or consented. No waiver of a breach is to be deemed a waiver of a different or subsequent breach.

13.Assignment and Sublicense. Except as permitted under subsection 3.1.2, sections 3.3 or 14 of these Terms and Conditions, or as required by law under section 3.2, neither party shall assign or sublicense its interest or delegate its duties under the Agreement. Any assignment, sublicense, or delegation attempted to be made in violation of this section is void. Absent the consent of all the parties, an assignment or delegation will not release the assigning or delegating party from its obligations. The Agreement inures to the benefit of the Licensee and the University and their respective permitted sublicensees and trustees.

14.Change of Control. Notwithstanding section 13 above, the Licensee, without the prior approval of the University, may assign all, but no less than all, its rights and delegate all its duties under the Agreement to another if (i) the Licensee delivers to the University written notice of the proposed assignment (along with pertinent information about the terms of the assignment and assignee) at least ten (10) business days before the effective date of the event described below in part iii of this paragraph, (ii) pay to the University the Transfer Payment prior to the effective date of the event described below in part iii of this paragraph, and (iii) the assignment is made as a part of and in connection with (a) the sale by the Licensee of all or substantially all of its assets to a single purchaser, (b) the sale, transfer, or exchange by the shareholders, partners, or equity owners of the Licensee of a majority interest in the Licensee to a single purchaser, or (c) the merger of the Licensee into another corporation or other business entity. Any assignment attempted to be made or made in violation of this section is void.

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15.Applicable Law. The internal laws of the state of Minnesota, without giving effect to its conflict of laws principles, govern the validity, construction, and enforceability of the Agreement.

16.Access to University Information.

16.1.Data Practices Act. The parties acknowledge that the University is subject to the terms and provisions of the Minnesota Government Data Practices Act, Minnesota Statutes §13.01 et seq. (the “Act”), and that the Act requires, with certain exceptions, the University to permit the public to inspect and copy any information that the University collects, creates, receives, maintains, or disseminates.

16.2.Limited Confidentiality. To the extent permitted by law, including as provided in the Confidentiality Agreement and the Act, the University shall hold in confidence and disclose only to University employees, agents and contractors who need to know the reports described above in sections 5.4 and 6.4 and the records inspected in accordance with section 6.5 of these Terms and Conditions. No provision of the Agreement is to be construed to further prohibit, limit, or condition the University’s right to use and disclose any information in connection with enforcing the Agreement, in court or elsewhere.

16.3.In the event that any Confidential Information required to be disclosed by Licensee to the University is deemed by the University to be potentially unprotectable by the University (e.g. the terms of sublicenses), then Licensee may meet its disclosure obligation by making such information available for inspection by the University, but not permitting the removal of the information by the University in any form. In the event that the University requires any Confidential Information that has been inspected by the University for the enforcement of any term of this Agreement, then the Licensee will deliver such information to University’s Office of General Counsel as provided in section 23 and such information shall be maintained under the terms of the Confidentiality Agreement.

17.Consent and Approvals. Except as otherwise expressly provided, in order to be effective, all consents or approvals required under the Agreement must be in writing.

18.Construction. The headings preceding and labeling the sections of the Agreement are for the purpose of identification only and are not to be employed or used for the purpose of construction or interpretation of any portion of EPLA. As used herein and where necessary, the singular includes the plural and vice versa, and masculine, feminine, and neuter expressions are interchangeable.

19.Enforceability. If a court of competent jurisdiction adjudges a provision of the Agreement to be unenforceable, invalid, or void, such determination is not to be construed as impairing the enforceability of any of the remaining provisions hereof and such provisions will remain in force and shall be construed so as to give effect as fully as possible to the parties’ intent and purposes as set forth in this Agreement.

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20.Entire Agreement. The parties intend the Agreement (including all attachments, exhibits, and amendments hereto) to be the final and binding expression of their contract and agreement and the complete and exclusive statement of the terms thereof. The Agreement cancels, supersedes, and revokes all prior negotiations, representations and agreements among the parties, whether oral or written, relating to the subject matter of the Agreement.

21.No Third-Party Beneficiaries. No provision of the Agreement, express or implied, is intended to confer upon any person other than the parties to the Agreement any rights, remedies, obligations, or liabilities hereunder. No sublicensee may enforce or seek damages under the Agreement.

22.Language and Currency. Unless otherwise expressly provided in the Agreement and in order to be effective, all notices, reports, and other documents and instruments that a party elects or is required to deliver to the other party must be in English, and all notices, reports, and other documents and instruments detailing revenues and earned under the Agreement or expenses chargeable to a party must be United States dollar denominated.

23.Notices. In order to be effective, all notices, requests, and other communications that a party is required or elects to deliver must be in writing and must be delivered personally, or by electronic mail (provided such delivery is confirmed), or by a recognized overnight courier service or by United States mail, first-class, certified or registered, postage prepaid, return receipt requested, to the other party at its address set forth below or to such other address as such party may designate by notice given under this section:

If to the University: University of Minnesota Office for Technology Commercialization Attn: Contracts Manager 1000 Westgate Drive, Suite 160 St. Paul, MN 55114 Phone: 612.624.0550 Fax: 612.624.6554 E-mail: otcagree@umn.edu Web site: http://www.research.umn.edu/techcomm 

For notices sent under sections 7 or 8, with a copy to:	University of Minnesota Office for Technology Commercialization Attn: Contracts Manager 1000 Westgate Drive, Suite 160 St. Paul, MN 55114 Phone: 612.624.0550 Fax: 612.624.6554 E-mail: otcagree@umn.edu Web site: http://www.research.umn.edu/techcomm
If to the Licensee:	As indicated in section 12 of the EPLA.

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24.Publicity. The University and Licensee may disclose to the public the execution and delivery of the Agreement along with the Licensee’s name and the agreed upon name of the Licensed Technology.

25.Relationship of Parties. In entering into, and performing their duties under the Agreement, the parties are acting as independent contractors and independent employers. No provision of the Agreement creates or is to be construed as creating a partnership, joint venture, or agency relationship between the parties. No party has the authority to act for or bind the other party in any respect.

26.Security Interest. In no event may the Licensee grant, or permit any person to assert or perfect, a security interest in the Licensee’s rights under the Agreement.

27.Survival. Immediately upon the termination of the Agreement, except for certain rights granted to the Licensee during the Post-termination Period, all the Licensee’s rights under the Agreement terminate; provided, however, the Licensee’s obligations that have accrued before the effective date of termination (e.g., the obligation to report and make payments on sales, leases, or dispositions of Licensed Products and to reimburse the University for costs) and the obligations specified in section 6.1 survive. The obligations and rights set forth in sections 6.4, 8.4 and sections 9, 10, 11, 15 and 28 also survive the termination or expiration of the Agreement.

28.Forum Selection. A suit, claim, or other action to enforce the terms of the Agreement may be brought only in the state courts of Hennepin County, Minnesota. Each party hereby submits to the jurisdiction of that court and waives any objections it may have to that court asserting jurisdiction over such Party or its assets and property.

29.Equitable Relief. Notwithstanding anything in this Agreement to the contrary, in recognition of the potential irreparable harm that a violation of the covenants contained in sections 3, 4, 7, and 16.2 of this Agreement and the Confidentiality Agreement would cause to the injured party, the University and Licensee agree that each party shall have the right to enforce this Agreement by specific remedies, which shall include, among other things, temporary restraining orders and temporary and permanent injunctions. Each party acknowledges and agrees that: (i) the restrictions set forth in this Agreement are reasonable and necessary to protect the other party’s legitimate interests; and (ii) neither party would have entered into this Agreement in the absence of such restrictions. The rights provided in the immediately preceding sentence shall be cumulative and in addition to any other rights or remedies that may be available to either party. Nothing in this section is intended, or should be construed, to limit either party’s right to any other remedy for breach of any other provision of this Agreement. Under no circumstances shall any equitable relief obtained by Licensee or any action required by the University as a result of such equitable relief exceed or cause the University to expend amounts in excess of the University’s Damage Cap as defined in section 11.2.

A-24

EXHIBIT B

Exclusive Patent License Schedule

Miromatrix Medical Inc.

MIROMATRIX MEDICAL INC.

SUBSCRIPTION AGREEMENT

AND LETTER OF INVESTMENT INTENT

This subscription, submitted this 4th day of February, 2010, is between MIROMATRIX_; MEDICAL INC., a Delaware corporation (the “Company”), and REGENTS OF THE UNIVERSITY OF MINNESOTA, a Minnesota non-profit corporation (the “Subscriber”).

1.Offer to Purchase. The Subscriber hereby offers to purchase five hundred sixty thousand (560,000) shares of the Company’s Common Stock (the “Shares”). As consideration for the Shares, the Subscriber has entered into the Exclusive Patent License Agreement dated of even date herewith by and between the Subscriber and the Company.

2.Representations and Warranties of the Company. In consideration of the Subscriber’s purchase of the Shares, the Company represents and warrants to the Subscriber as follows:

(a) Organization. The Company is a validly existing corporation under the laws of the State of Delaware.

(b) Good Standing. The Company is in good standing under the laws of the State of Delaware, and there are no proceedings or actions pending to limit or impair any of its powers, rights and privileges or to dissolve it.

(c) Corporate Authorization. The execution and delivery of this Agreement and the consummation of the transaction contemplated hereby have been duly authorized by proper corporate action of the Company.

3.Representations and Warranties of Subscriber. The Subscriber hereby represents and warrants to the Company as follows:

(a) Information About the Company. The Subscriber has obtained all information about the Company as the Subscriber believes relevant to the decision to purchase the Shares. The Subscriber has also had the opportunity to ask questions of, and receive answers from the Company or an agent or a representative of the Company concerning the terms and conditions of the investment and the business and affairs of the Company and to obtain any additional information necessary to verify such information, and the Subscriber has received such information concerning the Company as the Subscriber considers necessary or advisable in order to form a decision concerning an investment in the Company.

B-1

The Subscriber understands that any business plan or similar document which he or she may have been shown or of which he or she may have been furnished a copy, is not a prospectus, placement memorandum, offering circular, offering statement, or similar document. Any such document was not prepared, and the Subscriber understands that any such document was not prepared, with the purpose of providing full and accurate disclosure to investors. The Subscriber understands that any such document has been furnished to Subscriber only as part of an overall furnishing of information about the Company and that the Subscriber has viewed the information set forth therein with a critical frame of mind and, to the extent that information contained in any such document was deemed by the Subscriber to be important information in making an investment decision, the Subscriber has discussed such information with the officers and other personnel of the Company in order to form a better judgment regarding the accuracy and adequacy of such information. The Subscriber agrees that no statement in any such document, even if framed as a factual statement, will, of itself, constitute a factual representation by the Company in light of the various purposes for which any such document may have been created.

(b) Forward-Looking Information. The Subscriber acknowledges and understands that any information provided about the Company’s future plans and prospects is uncertain and subject to all of the uncertainties inherent in future predictions.

(c) No Review by Federal or State Regulators. The Subscriber understands that this transaction has not been scrutinized by the United States Securities and Exchange Commission (the “Commission”) or by any blue sky or other authority and, because of the small number of persons solicited to invest in the Shares and the private nature of the placement, that all documents, records, and books pertaining to this investment have been made available to the Subscriber and the Subscriber’s representatives, such as attorneys, accountants and/or purchaser representatives.

(d) High Degree of Risk. The Subscriber realizes that this investment involves a high degree of risk, including the risk of loss of all investment in the Company.

(e) Ability to Bear the Risk. The Subscriber is able to bear the economic risk of the investment, including the total loss of such investment.

(f) Appropriate Investment. The Subscriber believes, in light of the information provided pursuant to paragraph 3(a) above, that investing in the Company pursuant to the terms of this Agreement is an appropriate and suitable investment for the Subscriber.

B-2

(g) Financial Condition. The Subscriber’s current financial condition is such that (and the Subscriber expects the Subscriber’s financial condition to be such that in the near future) the Subscriber does not have any present or contemplated need to dispose of any portion of the Shares to satisfy any existing or contemplated undertaking, need or indebtedness.

(h) Business Sophistication. The Subscriber is experienced and knowledgeable in financial and business matters, and is capable of evaluating the merits and risks of investing in the Company.

(i) Residency. The Subscriber is a constitutional educational corporation under the laws of the state of Minnesota.

(j) Accredited Status. The Subscriber represents and warrants as follows (INITIAL ALL APPLICABLE ITEMS):

Accredited Investor

ENTITIES:

(i) The Subscriber is an entity, and is an “Accredited Investor” as defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Act”). This representation is based on the following (initial one or more, as applicable):

(A) The Subscriber (or, in the case of a trust, the undersigned trustee) is a bank or savings and loan association as defined in sections 3(a)(2) and 3(a)(5)(A), respectively, of the Act acting either in its individual or fiduciary capacity.

(B) The Subscriber is an insurance company as defined in section 2(13) of the Act.

(C) The Subscriber is an investment company registered under the Investment Company Act of 1940 or a business development company as defined in section 2(a)(48) of that Act.

(D) The Subscriber is a Small Business Investment Company licensed by the U.S. Small Business Administration under section 301(c) or (d) of the Small Business Investment Act of 1958.

B-3

(E) The Subscriber is an employee benefit plan within the meaning of Title I of the Employee Retirement Income Security Act of 1974 and either (initial one or more, as applicable):

(1) The investment decision is made by a plan fiduciary, as defined in section 3(21) of such Act, which is either a bank, savings and loan association, insurance company, or registered investment adviser.

(2) The employee benefit plan has total assets in excess of $5,000,000.

(3) The plan is a self-directed plan with investment decisions made solely by persons who are “Accredited Investors” as defined under the Act.

(F) The Subscriber is a private business development company as defined in section 202(a)(22) of the Investment Advisers Act of 1940.

(G) The Subscriber has total assets in excess of $5,000,000, was not formed for the specific purpose of acquiring shares of the Company and is one or more of the following (initial one or more, as appropriate):

(1) An organization described in section 501(c)(3) of the Internal Revenue Code.

(2) A corporation.

(3) A Massachusetts or similar business trust.

(4) A partnership.

(H) The Subscriber is a trust with total assets exceeding $5,000,000, which was not formed for the specific purpose of investing in the Company and whose purchase is directed by a person who has such knowledge and experience in financial and business matters and that he or she is capable of evaluating the merits and risks of the investment in the Shares.

B-4

4.Investment Purpose in Acquiring the Shares. The Subscriber and the Company acknowledge that the Shares have not been registered under the Act or applicable state securities laws and that the Shares will be issued to the Subscriber in reliance on exemptions from the registration requirements of the Act and applicable state securities laws and in reliance on the Subscriber’s and the Company’s representations and agreements contained herein. The Subscriber is subscribing to acquire the Shares for the account of the Subscriber for investment purposes only and not with a view to their resale or distribution. The Subscriber has no present intention to divide his, her or its participation with others or to resell or otherwise dispose of all or any part of the Shares. In making these representations, the Subscriber understands that, in the view of the Commission, exemption of the Shares from the registration requirements of the Act would not be available if, notwithstanding the representations of the Subscriber, the Subscriber has in mind merely acquiring the Shares for resale upon the occurrence or nonoccurrence of some predetermined event.

5.Compliance with Securities Act. The Subscriber agrees that if the Shares or any part thereof are sold or distributed in the future, the Subscriber shall sell or distribute them pursuant to the requirements of the Act and applicable state securities laws. The Subscriber agrees that the Subscriber will not transfer any part of the Shares without: (i) obtaining a “no action” letter from the Commission and applicable state securities commissions; (ii) obtaining an opinion of counsel satisfactory in form and substance to the Company to the effect that such transfer is exempt from the registration requirements under the Act and applicable state securities laws; or (iii) such registration.

6.Restrictive Legend. The Subscriber agrees that the Company may place one or more restrictive legends on any certificates evidencing the Shares, containing substantially the following language:

The securities represented by this certificate have not been registered under the Securities Act of 1933, as amended, have not been registered under any state securities law, and are subject to a subscription and investment representation agreement. They may not be sold, offered for sale, or transferred in the absence of either an effective registration under the Securities Act of 1933, as amended, and under the applicable state securities laws, or an opinion of counsel for the Company that such transaction is exempt from registration under the Securities Act of 1933, as amended, and under the applicable state securities laws.

7.Stop Transfer Order. The Subscriber agrees that the Company may place a stop transfer order with its registrar and transfer agent (if any) covering all certificates representing the Shares.

8.Knowledge of Restrictions upon Transfer of the Shares. The Subscriber understands that the Shares are not freely transferable and may in fact be prohibited from sale for an extended period of time and that, as a consequence thereof, the Subscriber must bear the economic risk of an investment in the Shares for an indefinite period of time and may have extremely limited opportunities to dispose of the Shares. The Subscriber understands that Rule 144 of the Commission permits the transfer of “restricted securities” of the type here involved only under certain conditions, including a minimum one-year holding period and the availability to the public of certain information concerning the Company. The Company is not undertaking to satisfy such requirement. The Subscriber realizes that there will likely be no market for the Shares, and that there are significant restrictions on the transferability thereof.

B-5

9.Lack of Availability of Rule 144 Under the Act. The Subscriber understands and acknowledges that the Company has no obligation to undertake or complete a public offering of its securities, that even if a public offering is undertaken and successfully completed, the Shares subscribed for hereby will remain subject to the restrictions on transferability described herein, and that if a public offering is not undertaken and completed, the Subscriber may never be able to sell its Shares pursuant to Rule 144 under the Act.

The Subscriber further understands and acknowledges that the Company currently does not file periodic reports with the Commission pursuant to the requirements of sections 13 or 15(d) of the Securities Exchange Act of 1934, and may not be obligated to file such reports at any time in the future. The Subscriber also understands that the Company has not agreed to supply such other information as would be required to enable routine sales of the Shares to be made under the provisions of certain rules respecting “restricted securities,” including Rule 144 promulgated under the Act by the Commission. Thus, the Subscriber has been informed that the Company is not obligated to make publicly available or to provide the Subscriber with the information required by Rule 144.

10.Binding Effect. Neither this Agreement nor any interest herein shall be assignable by the Subscriber without the prior written consent of the Company. The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto, and their respective heirs, legal representatives, successors and assigns.

11.Delivery of Stock Certificates. Upon acceptance of this Agreement by the Company, a certificate will be registered in the name of the Subscriber and will be delivered via certified mail or overnight delivery to the address of the Subscriber set forth on the Signatures Page.

12.Representations to Survive Delivery. The representations, warranties and agreements of Company and of the Subscriber contained in this Agreement will remain operative and in full force and effect and will survive the receipt of funds pursuant to section 1 above and the issuance to the Subscriber of the Shares.

13.Indemnification. Subscriber agrees to indemnify the Company, and each current and future officer, director, employee, agent and shareholder of the Company, against and to hold them harmless from any damage, loss, liability, claim or expense including, without limitation, reasonable attorneys’ fees resulting from or arising out of the inaccuracy or alleged inaccuracy of any of the representations, warranties or statements of the Subscriber contained in this Agreement, including without limitation any violation or alleged violation of the registration requirements of the Act or applicable state law in connection with any subsequent sale of the Shares by Subscriber.

B-6

14. Arbitration. The Subscriber further agrees that any dispute regarding this Agreement or the Subscriber’s investment in the Company (including without limitation claims pursuant to federal or state securities laws), including any claim which is made against any placement agent or broker-dealer involved in the offer or sale of the Shares, shall be resolved by arbitration which shall be the sole forum for resolution of any such disputes. Unless otherwise agreed by the parties, any such proceedings shall be brought pursuant to the Rules and Code of Arbitration of the America Arbitration Association, except that if a bona fide claim is made against the Company, and a placement agent or broker-dealer is named in connection with such claim, then such claim shall be brought pursuant to the Rules and Code of Arbitration of the National Association of Securities Dealers, Inc.

The Company and the Subscriber agree that no provision of this Agreement obligates either party to arbitrate disputes arising out of the License Agreement or otherwise related to the Subscriber’s granting and the Company’s accepting a license under certain University-owned intellectual property rights.

15.Governing Law; Venue. This Agreement shall be governed by, and construed in accordance with, the substantive laws of the State of Minnesota without reference to Minnesota conflict or choice of law provisions. Actions or proceedings litigated in connection with this Agreement, if any, shall be venued exclusively in the state and federal courts located in the County of Hennepin, State of Minnesota.

16.Additional Information. Subscriber shall supply such additional information and documentation relating to Subscriber and any persons who have any rights or interest in Subscriber as may be requested by the Company in order to ensure compliance by the Company with applicable laws. If at any time prior to the Company’s acceptance of this Agreement the Subscriber an adverse change occurs with respect to the Subscriber such that the information, representations and warranties of the Subscriber set forth in this Agreement are no longer accurate, the Subscriber shall immediately notify the Company of the inaccuracy in writing and shall deliver the updated, accurate information to the Company.

17.Successors and Assigns. The representations and warranties made by the Subscriber in this Agreement are binding on the Subscriber’s successors and assigns and are made for the benefit of the Company and any other person who may become liable for violations of applicable securities laws as a result of the inaccuracy or falsity of any of the Subscriber’s representations or warranties.

18.Counterparts. This Agreement may be executed by the Company and by the Subscriber in separate counterparts, each of which shall be deemed an original.

19.Acceptance. This Agreement is not binding on the Company until accepted in writing by an authorized officer of the Company.

(signature page follows)

B-7

ENTITY SIGNATURE PAGE

THIS AGREEMENT SHALL NOT BIND THE COMPANY UNTIL IT HAS COUNTERSIGNED THIS PAGE.

1.Entity Name (please print): Regents of the University of Minnesota

2.Employer Identification Number: To be Provided

3.Business (Residence) Address: 1000 Westgate Drive, Suite 160

4.Mailing Address (if different from above): n/a

5.Business: Tel. No. (612) 624-0550 Facsimile No. (612) 624-6554

6.Total Number of Shares subscribed for: 560,000

Regents of the University of Minnesota

By:	/s/ Jay W. Schrankler
	Jay W. Schrankler
	Executive Director,
	Office for Technology Commercialization

Dated: February 4, 2010

ACCEPTANCE:

Miromatrix Medical Inc. hereby accepts the Subscriber’s offer to purchase Shares as set forth herein.

By:	/s/ Robert Cohen
	Robert Cohen
	President & CEO

Dated: February 4, 2010

B-8

EXHIBIT C

Exclusive Patent License Schedule

Miromatrix Medical, Inc.

MIROMATRIX MEDICAL CAPITALIZATION TABLE

 

C-1

EX-10.2

Exhibit 10.2

University of Minnesota

FIRST AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS FIRST AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the “Amendment 1^ST “) is entered into this 17th day of November, 2010 by and between Regents of the University of Minnesota, a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 1000 Westgate Drive, Suite 160, St. Paul, MN 55114 (the “UNIVERSITY”), and Miromatrix Medical Inc., a corporation under the laws of the state of Delaware, having a business address of 18683 Bearpath Trail, Eden Prairie, MN 55347 (the “COMPANY”).

BACKGROUND

UNIVERSITY and COMPANY entered into an Exclusive Patent License Agreement, dated and effective as of 04 February 2010, (the “EPLA”), under which the UNIVERSITY granted to COMPANY an exclusive license to UNIVERSITY’S rights in numerous patents, as described more fully in the EPLA.

The parties now wish to amend and clarify the Licensees’ rights and obligations under the EPLA.

NOW, THEREFORE, the parties agree as follows:

1. The language in Section 9(v) of the EPLA beginning with “within the latter of one (1) year after the Effective Date of six months after hiring a vice president of product development” is struck and replaced with “on or before June 30, 2013”

2. Capitalized terms not otherwise defined in this Amendment 1S^t have the meaning provided in the EPLA.

3. All other terms and conditions of the EPLA shall remain unchanged and in full effect.

4. This Amendment may be executed concurrently in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile execution and delivery of this Agreement shall be binding and enforceable for all purposes.

1 

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Fourth Amendment to License Agreement.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Jay W. Schrankler	By:	/s/ Robert Cohen
	Jay W. Schrankler		Robert Cohen
	Executive Director		President & CEO
	Office for Technology Commercialization
Date: 11/17/2010		Date: 11/20/2010

2 

University of Minnesota

FIRST AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS FIRST AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the “Amendment 1^st”) is entered into this ___ day of November, 2010 by and between Regents of the University of Minnesota, a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 1000 Westgate Drive, Suite 160, St. Paul, MN 55114 (the “UNIVERSITY”), and Miromatrix Medical Inc., a corporation under the laws of the state of Delaware, having a business address of 18683 Bearpath Trail, Eden Prairie, MN 55347 (the “COMPANY”).

BACKGROUND

UNIVERSITY and COMPANY entered into an Exclusive Patent License Agreement, dated and effective as of 04 February 2010, (the “EPLA”), under which the UNIVERSITY granted to COMPANY an exclusive license to UNIVERSITY’S rights in numerous patents, as described more fully in the EPLA.

The parties now wish to amend and clarify the Licensees’ rights and obligations under the EPLA.

NOW, THEREFORE, the parties agree as follows:

1. The language in Section 9(v) of the EPLA beginning with “within the latter of one (1) year after the Effective Date of six months after hiring a vice president of product development” is struck and replaced with “on or before June 30, 2013”

2. Capitalized terms not otherwise defined in this Amendment IS` have the meaning provided in the EPLA.

3. All other terms and conditions of the EPLA shall remain unchanged and in full effect.

4. This Amendment may be executed concurrently in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile execution and delivery of this Agreement shall be binding and enforceable for all purposes.

1 

IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Fourth Amendment to License Agreement.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Jay W. Schrankler	By:	/s/ Robert Cohen
	Jay W. Schrankler		Robert Cohen
	Executive Director		President & CEO
	Office for Technology Commercialization
Date: 11/17/10		Date: 11/20/10

2 

EX-10.3

Exhibit 10.3

University of Minnesota

SECOND AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS SECOND AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the “Amendment Second”) is entered into and effective as of the date of last signature (the “Second Amendment Effective Date”) by and between Regents of the University of Minnesota, a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 1000 Westgate Drive, Suite 160, St. Paul, MN 55114 (the “University”), and Miromatrix Medical Inc. a corporation under the laws of the state of Delaware having a business address of 18683 Bearpath Trail, Eden Prairie, MN 55347 (the “Company”) (The University or the Company may be referred to below as a “Party” or jointly as the “Parties”).

BACKGROUND

The Parties entered into an Exclusive Patent License Agreement, dated and effective as of 04 February 2010 (the “EPLA”), and as amended under the Amendment First dated and effective as of 17 November 2010) (the “Amendment First”) under which the University granted to the Company an exclusive license to the University’s intellectual property rights in the Licensed Technology, as described more fully in the EPLA and the Amendment First. The Parties now wish, inter alia, to amend the Company’s rights and obligations under the EPLA as provided in this Amendment Second.

NOW, THEREFORE, the Parties agree as follows:

1. Capitalized terms not otherwise defined in this Amendment Second have the meanings ascribed to them in the EPLA.

2. The Parties hereby amend the EPLA as of the Second Amendment Effective Date as follows:

2.1 The language in Section 5.3 of the ELPA is amended by adding the following language to the end of the Section:

“61/379,073 US 08 March 2012 Methods of Recellularizing A Tissue or Organ for Improved Transplantability”

2.2 The language in Section 9(v) of the EPLA, as amended, beginning with “on or before June 30, 2013” is deleted and replaced with “on or before June 30, 2014”

2.3 The language in the first sentence of Section 11.4.2 of the EPLA, beginning with “Beginning on the date in which” and ending with “royalty obligation applies:” is deleted and replaced with “Beginning in the calendar year in which any Licensed Product or combination of Licensed Products first achieves cumulative Commercial Sales of five million dollars ($5,000,000), the following minimum annual royalty obligation applies:”

2.4 The language in the last sentence of Section 11.4.2 of the ELPA beginning with “If the date” and ending with “end of that year.”, is deleted.

3. Except as amended in this Amendment Second, all the terms and conditions of the EPLA shall remain unchanged and in full effect.

4. This Amendment Second may be executed concurrently in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Electronic execution and delivery of this Amendment Second shall be binding and enforceable for all purposes.

1 

IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Second Amendment to the Exclusive Patent license Agreement as of the Second Amendment Date.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Jay W. Schrankler	By:	/s/ Robert Cohen
	Jay W. Schrankler		Robert Cohen
	Executive Director		President & CEO
	Office for Technology Commercialization
Date: 3/12/2013		Date: 3/12/2013

2 

EX-10.4

Exhibit 10.4

THIRD AMENDMENT

TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS THIRD AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the “Third Amendment”) is made and entered effective as of the date of the last signature (the “Third Amendment Effective Date”), by and between Regents of the University of Minnesota (the “University”), a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 200 Oak Street, SE, Suite 280, Minneapolis, Minnesota 55455, and Miromatrix Medical Inc., a corporation under the laws of the state of Delaware having a business address of 18683 Bearpath Trail, Eden Prairie, MN 55347 (the “Company”) each a “Party” and collectively, the “Parties”).

BACKGROUND

The Parties entered into an Exclusive Patent License Agreement, dated and effective as of 04 February 2010 (the “EPLA”), and as amended under the First Amendment dated and effective as of 17 November 2010 (the “First Amendment”) and under the Second Amendment dated and effective as 12 March 2013 (the “Second Amendment”), under which the University granted to the Company an exclusive license to the University’s intellectual property rights in the Licensed Technology, as described more fully in the EPLA and First Amendment and Second Amendment. The Parties now wish, inter alia, to amend the Company’s rights and obligations under the EPLA as provided in this Third Amendment.

NOW, THEREFORE, THE PARTIES AGREE THAT:

1. Capitalized terms not otherwise defined in this Third Amendment have the meanings ascribed to them in the EPLA.

2. Section 1.4 of the EPLA is hereby revised to replace subsection (i) as follows:

“(i)       the transfer of a Licensed Product to a third party for consideration for use in the development or testing of a Licensed Product, so long as such development or testing is being conducted prior to the availability of that particular Licensed Product.”

3. Section 1.4 of the EPLA is hereby revised to add a new subsection (iv) as follows:

“(iv) the transfer of a Licensed Product to a third party solely for use as a promotional tool and not usable for any medical purpose.”

4. General, Except as amended, deleted, or otherwise modified by the First Amendment, Second Amendment and this Third Amendment, the terms of the EPLA shall remain in full force and effect.

[Signature Page Follows]

1 

IN WITNESS WHEREOF, acting through their respective duly authorized representatives, the University and the Company have duly executed, delivered and entered into this Third Amendment as of the Third Amendment Effective Date.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Richard Huebsch	By:	/s/ Robert Cohen
Name:	Richard Huebsch	Name:	Robert Cohen
Title:	Assoc. Director, Office for Tech. Comm.	Title:	President & CEO
Date: 12/16/2014		Date: 12/11/14

2 

EX-10.5

Exhibit 10.5

FOURTH AMENDMENT

TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS FOURTH AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the "Fourth Amendment") is made and entered effective as of the date of the last signature (the "Fourth Amendment Effective Date"), by and between Regents of the University of Minnesota (the "University"), a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 200 Oak Street, SE, Suite 280, Minneapolis, Minnesota 55455, and Miromatrix Medical Inc., a corporation under the laws of the State of Delaware, having a business address of 10399 West 70th Street, Eden Prairie, MN 55344 (the "Company") (each a "Party" and collectively, the "Parties").

BACKGROUND

The Parties entered into an Exclusive Patent License Agreement, dated and effective as of 04 February 2010, including, without limitation, Exhibit A, Terms and Conditions of the Exclusive Patent License Agreement (the "Tunis and Conditions"), and as amended under the First Amendment dated and effective as of 17 November 2010 (the "First Amendment"), the Second Amendment dated and effective as of 12 March 2013 (the "Second Amendment"), and the Third Amendment dated and effective as of 16 December 2014 (the "Third Amendment"), under which the University granted to the Company an exclusive license to the University's intellectual property rights in the Licensed Technology, as described more fully in the Exclusive Patent License Agreement, First Amendment, Second Amendment and Third Amendment (as amended, the "EPLA"). The Parties wish to effect the transfer of ownership of the University's right, title and interest in the Licensed Patents and Patent Applications to the Company and for Company to continue to be bound by the financial terms and all other terms of the EPLA, as amended, except as set forth hereinbelow. To effect such transfer, the Parties now wish, inter alia, to amend the University's and the Company's rights and obligations under the EPLA as provided in this Fourth Amendment.

NOW, THEREFORE, THE PARTIES AGREE THAT:

EPLA

1.Definitions: Capitalized terms not otherwise defined in this Fourth Amendment have the meanings ascribed to them in the EPLA. In all instances in the EPLA (except as set forth in Section 6 hereinbelow), the use of the word(s) "Licensee", "license," "licensed," "Licensed Patent," "Licensed Product," and the like shall hereafter refer to "Assignee", "assign," "assigned," "Assigned Patent," "Assigned Product," etc. The definitions of each such capitalized tem' shall not be altered. The sole intent of the modifications of this Section 1 is to recognize that the previous license transaction now has been converted to an assignment and transfer.

2.Title: The EPLA hereby is retitled "Patent Assignment Agreement." All references in the EPLA to "Exclusive Patent License Agreement" or "EPLA" henceforth shall refer to Patent Assignment Agreement.

Fourth Amendment to Exclusive Patent License Agreement

Page 1

3. Technology: Section 5.1 of the EPLA, Licensed Patent(s) (§1.12) is hereby deleted in its entirety and replaced with the following:

Country	Serial Number	Patent Number
Australia	2006282783	2006282783
Australia	2010236855	2010236855
Australia	2013224686	2013224686
Belgium	06790024.1	1928519
Belgium	11181797.9	2431063
China	201210287455.7	ZL201210287455.7
China	200680030925.4	ZL200680030925.4
European Patent Office	06790024.1	1928519
European Patent Office	11181797.9	2431063
France	06790024.1	1928519
France	11181797.9	2431063
Germany	11181797.9	6020060451752.9/2431063
Germany	06790024.1	6020060428636.9/1928519
Hong Kong	12109340.4	HK1168565
India	1741/DELNP/2008	263193
Israel	189418	189418
Italy	06790024.1	1928519
Italy	11181797.9	2431063
Korea Rep Of	10-2013-7028378	10-1420585
Korea Rep Of	10-2008-7007151	10-1376013
Mexico	MX/a/2008/002589	320910
Mexico	MX/A/2011/010197	319353
Netherlands	06790024.1	1928519
Netherlands	11181797.9	2431063
Poland	06790024.1	1928519
Poland	11181797.9	2431063
Russia	2008111503	2463081
Singapore	2011018983	170731
Spain	11181797.9	2431063

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Country	Serial Number	Patent Number
Spain	06790024.1	1928519
Sweden	06790024.1	1928519
Sweden	11181797.9	2431063
Switzerland	06790024.1	1928519
Switzerland	11181797.9	2431063
Turkey	06790024.1	TR201203945T4/1928519
Turkey	11181797.9	2431063
United Kingdom	06790024.1	1928519
United Kingdom	11181797.9	2431063
United States	12/064,613	8,470,520

Section 5.2 of the EPLA, Patent Applications (§1.16) is hereby deleted in its entirety and replaced with the following:

Country	Serial Number
Australia	2015224503
Canada	2,618,731
Canada	2,757,457
China	201080024899.0
European Patent Office	15170077.0
European Patent Office	10723848.7
Hong Kong	12111387.4
Hong Kong	filed in July 2016 (related to HK1168565)
India	5160/DELNP/2014
India	7719/DELNP/2011
Israel	233821
Israel	215463
Japan	2012-248398
Japan	2008-528231
Japan	2015-164446
Japan	2012-503673
Japan	2015-094591
Korea Rep Of	10-2014-7007674

Fourth Amendment to Exclusive Patent License Agreement

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Country	Serial Number
Korea Rep Of	10-2011-7025607
Mexico	MX/a/2014/006778
PCT	PCT/US2006/033415
PCT	PCT/US2010/046644
PCT	PCT/US2010/029463
Russia	2012122055
Russia	2011143730
Singapore	200801197-5
Singapore	.10201401131W
Singapore	10201603074Q
Singapore	201107081-0
United States	13/725,030
United States	60/815,242
United States	60/711,501
United States	13/913,974
United States	60/711,509
United States	11/512,009
United States	12/547,021
United States	13/262,286
United States	61/211,613

4.Sublicense Rights (§3.1.2): Section 7 of the EPLA is deleted in its entirety.

5.Federal Government Rights (§3.2): Section 7 of the EPLA is deleted in its entirety and replaced as follows:

Federal Government Rights (§3.5): Yes.

6.Performance Milestones (§ 5.1): The parties agree that the Company has satisfactorily performed each of the Milestones listed in Section 9, Performance Milestones (§ 5.1) of the EPLA.

7.Payments (§6.1): Section 11.4.2 of the EPLA is deleted in its entirety and replaced as follows:

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     11.4.2 Minimum Annual Cumulative Royalty Payment. Beginning in the calendar year in which any Assigned Product or combination of Assigned Products first achieves cumulative Commercial Sales of five million dollars ($5,000,000), the following minimum annual royalty obligation applies: If the total payments to the University under sections 11.4. and 11.5 do not aggregate to a minimum of $500,000 for each calendar year during the Term of this Agreement, the Licensee shall pay the University the difference between the total amounts actually paid to the University under sections 11.4 and 11.5 of this Agreement for such year and the minimum sum of $500,000 within 30 days following the end of such year.

In Section 11.5 of the EPLA only, the word "License" shall be substituted for the word "Sublicense" and "Licensee" shall refer to Company as "Assignee" in each instance.

8.Licensee's Address for Notice (p3): Section 12 of the EPLA is hereby amended to change Licensee's address for notice to:

Miromatrix Medical Inc.

Attention: Robert Cohen

10399 West 70th Street

Eden Prairie, MN 55344

Telephone No. 612-202-7026

Email: rcohen@miromatrix.com

9.Licensee's Contact Person for Patent Prosecution Consultation (§4.2.3): Section 13 of the EPLA is hereby amended to change Licensee's contact person to:

Miromatrix Medical Inc.

Attention: Robert Cohen

10399 West 70th Street

Eden Prairie, MN 55344

Telephone No. 612-202-7026

Email: rcohen@miromatrix.com

10.Observer Rights: Section 14 of the EPLA is hereby amended to change the designation of the University's representative from "Doug Johnson" to "Jay Schrankler."

TERMS AND CONDITIONS

11.Definitions. In all instances, the use of the word(s) "Licensee", "license," "licensed," "Licensed Patent," "Licensed Product," and the like shall hereafter refer to "Assignee", "assign," "assigned," "Assigned Patent," "Assigned Product," etc. except in Section 5.5 no change to the word "license" is intended. The sole intent of the modifications of this Section 11 is to recognize that the previous license transaction now has been converted to an assignment and transfer.

In Section 1.1 of the Terms and Conditions, the word "Licensee" shall be understood to refer to Company as "Assignee" the word "Licensee" shall be substituted for the word "sublicensee" in each instance.

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Section 1.10 of the Terms and Conditions shall be deleted in its entirety.

In Sections 1.23, 1.24 and 6.5.2 of the Terms and Conditions, the word "License" shall be substituted for the word "Sublicense" in each instance, whether in its uppercase or lowercase form and "Licensee(s) of the Assignee" shall be substituted for "sublicensees" in Section 1.24 and 6.5.2.

12.            Grant of License and Obligations. Section 3 of the Terms and Conditions is hereby deleted in its entirety and replaced with the following:

3.             Assignment:

3.1       In consideration of the premises and the terms and conditions contained in the EPLA and this Fourth Amendment, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the University hereby unconditionally and irrevocably assigns to the Company, and the Company hereby accepts, 100% of the University's right, title, and interest in the Licensed Patents and Patent Applications (as well as such rights in any divisions, continuations in whole or part, substitute applications, reissues, reexaminations, extensions, supplementary protection certificates, certificates of invention, utility models, related patent applications and the like) (collectively, the "IP") for the entire term of any issued patent(s) deriving from the IP, and for the entire terms of any and all patents, patent applications and patents that may ultimately issue from such applications (as well as such rights in any divisions, continuations in whole or part, substitute applications, reissues, reexaminations, extensions, supplementary protection certificates, certificates of invention, utility models, related patent applications and the like) anywhere in the world that, at any time, claim benefit or priority from any of the IP. Notwithstanding the foregoing, University retains an irrevocable, world-wide, royalty-free, non-exclusive right to use each Licensed Patent and Licensed Patent Application for teaching, research and educational purposes, but not to include any commercial purposes. The University shall have the right to sublicense its rights under this section to one or more non-profit academic or research institutions, but only in the event that such non-profit academic or research institution signs a contemporaneous agreement in a form reasonably acceptable to Company that grants Company a non-exclusive, royalty-free license under any patents or patent applications issued or filed by such non¬profit academic or research institution that, if practiced, would infringe the Licensed Technology.

3.2       The University hereby assigns to the Company all of the rights, privileges (including the benefit of any attorney-client privilege or attorney work product privilege), title and interest in and to the IP being assigned and set over to the Company hereunder, including, without limitation, all income, royalties, damages, right to sue, right to enforce and any and all payments now or hereafter due or payable with respect thereto (excluding any payments due the University from the Company pursuant to the EPLA), and the right to bring any claim, suit, counterclaim, and recover for the past, present and future infringement of the rights assigned hereunder.

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3.3       The University authorizes the United States Patent and Trademark Office and all foreign patent offices to issue any patents resulting from the IP to the Company and to transfer ownership of any existing patents resulting from the IP to the Company. The right, title and interest in the IP transferred hereunder is to be held and enjoyed by the Company and the Company's successors and assigns as fully and exclusively as it would have been held and enjoyed by the University had this assignment not been made.

3.4       The University further agrees to: (a) sign and cause to be signed the form of assignment of patent right attached hereto as Exhibit A transferring University's entire right, title and interest in the Licensed Patents and Patent Applications to the Company and cause, or cooperate with Company in causing, such assignment to be filed and recorded with the United States Patent and Trademark Office; (b) cooperate with the Company in the prosecution of any patent applications derived from the IP; (c) execute, verify, acknowledge and deliver all such further papers reasonably necessary to effect the intent of this Fourth Amendment, including patent applications and instruments of transfer; and (d) perform such other acts as the Company lawfully and reasonably may request to obtain or maintain any patents derived from the IP in any and all countries.

3.5       Company acknowledges that the United States federal government funded the development, in whole or in part, the applications and patents in UMN Z08174 (collectively, the "NIH-Funded IP") and, therefore, as it relates to the NIH Funded IP:, (i) the federal government may have certain rights in and to such intellectual property rights as those rights are described in Chapter 18, Title 35 of the United States Code and accompanying regulations, including Part 401, Chapter 37 of the Code of Federal Regulations, and (ii) the Parties' rights and obligations with respect to such intellectual property rights, including the assignments set forth herein, are subject to the applicable terms of these laws and regulations. University will use good faith efforts to secure National Institutes of Health ("NIH") approval for the assignment to Company of the NIH-Funded IP in a timely manner. Company shall be responsible for drafting all required documents for submission to NIH and University shall have final approval of the content of such documents. Until such time as the NIH-Funded IP is assigned to Company, or in the event that NIH makes a final determination that the NIH-Funded IP cannot be assigned to Company, such NIH-Funded IP shall continue to be subject to the terms and conditions of the EPLA as if this Fourth Amendment was not effective.

The applications in UMN Z08174 are shown below:

Canada	2809990
China	201180052952.2
Hong Kong	14100212.6
India	2789/DELNP/2013
Israel	224964
Korea Rep of	10-2013-7008118
Mexico	MX/a/2013/002372

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Page 7

PCT	PCT/US2011/050266
Russia	2013114382
United States	61/379,073
United States	13/820,079

The granted/issued patents in UMN Z08174are shown below:

Country	Serial Number	Patent Number
Australia	2011295779	2011295779
Belgium	117796927.3	2611472
European Patent Office	11776927.3	2611472
France	11776927.3	2611472
Germany	11776927.3	602011023264.9/2611472
Italy	11776427.3	2611472
Japan	2013527329	5931878
Netherlands	11776927.3	2611472
Poland	11776927.3	2611472
Singapore	2013015706	188369
Spain	11776927.3	2611472
Sweden	11776427.3	2611472
Switzerland	11776927.3	2611472
Turkey	11776427.3	TR20 I 602464T4/2611472
United Kingdom	11776927.3	2611472

Company agrees that it will not assign any rights under the Licensed Technology, the Licensed Patent Applications or the Licensed Patents granted in this Section 3 including, but not limited to, the rights granted under Section 3.1 and Section 3.2 (collectively, the "Transferred Rights") to any third party unless the third party intended assignee agrees to assume all obligations of Company with respect to the Transferred Rights to be assigned and the third party assignee provides such assurance to the University in a form reasonably acceptable to the University.

13.Applications and Patents. Section 4 of the Terms and Conditions is hereby deleted in its entirety and replaced with the following:

4.             Applications and Patents:

4.1       The Company shall diligently pursue the prosecution of all Licensed Patent Applications to issuance of the resulting patents, and shall not abandon, withdraw or discontinue prosecution of any Patent Application without first consulting with and obtaining the University's prior written consent, which consent shall not be unreasonably withheld, if the parties agree that the issuance of a patent from such application is unlikely or is no longer to the benefit of the patent prosecution strategy for the Licensed Technology.

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Page 8

4.2       If the Company intends not to pursue the prosecution or maintenance of a Licensed Patent or Patent Application in a particular country, or to take any other action with respect to a Licensed Patent or Patent Application in a particular country that is useful or necessary to establish or preserve rights with respect to the Licensed Products, the Company shall so notify the University in writing and in good time to enable the University to meet any deadlines by which an action must be taken to establish or preserve any such rights. Upon receipt of any such notice, the University shall have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution or maintenance, of such Licensed Patent or Patent Application at its expense in such country. If the University elects to pursue such filing or registration, as the case may be, or continue such support, then the University shall notify the Company of such election and the Company shall, and shall cause its agents and Affiliates to, cooperate with the University in this regard.

4.3       At the University's request, the Company will provide a schedule listing all applicable filing deadlines and estimate of associated costs necessary to maintain the Licensed Patents and Patent Applications in a particular country to the University in writing.

14.Infringement. Section 7 of the Terms and Conditions is hereby deleted in its entirety and replaced with the following:

7.       Infringement.

7.1       If a party learns of substantial, credible evidence that a third party is making, using, or selling a product in the Field of Use in the Territory that infringes a Licensed Patent, such party shall promptly notify the other party in writing of the possible infringement and in such notice describe in detail the information suggesting infringement of the Licensed Patent. No provision of this Agreement limits, conditions, or otherwise affects Company's statutory and common-law rights to commence an action to enforce a Licensed Patent.

7.2       Any amounts recovered (less amounts paid for reasonable attorneys' fees and legal expenses) by Licensee in such action or settlement that constitute compensation for lost profits or sales will be considered subject to the royalty rate in subsection 11.4.1 of the EPLA. All other amounts recovered (less amounts paid for reasonable attorneys' fees and legal expenses) by Licensee in such action or settlement will be considered Sublicense Revenues subject to Section 11.5.2 of the EPLA.

15.Termination: Section 8 of the Terms and Conditions is hereby deleted in its entirety.

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Page 9

16. Warranties: Section 10.4 of the Terms and Conditions is hereby deleted in its entirety.

17.Damages: Section 11.3 of the Terms and Conditions is hereby deleted in its entirety.

18.Assignment and Sublicense: Section 13 of the Terms and Conditions is hereby deleted in its entirety.

19.Payments (§6.1): In Section 11.5 of the EPLA, the word "License" shall be substituted for the word "Sublicense" in each instance.

20.Change of Control: Section 14 of the Terms and Conditions is hereby deleted in its entirety.

21.Security Interest: Section 26 of the Terms and Conditions is hereby deleted in its entirety.

22.Survival: Section 27 of the Terms and Conditions is hereby deleted in its entirety and replaced as follows:

"Licensee's obligations that have accrued before the effective date of termination, purported termination or expiration of this Agreement (e.g., the obligation to report and make payments on sales, leases, or dispositions of Licensed Products and to reimburse the University for costs) and the obligations specified in section 6.1 survive. The obligations and rights set forth in sections 6.4, 9, 10, 11, 15 and 28 also survive termination, purported termination or expiration of this Agreement.

23.Administration Fee. Within thirty (30) days of the signing of the assignments pursuant to Sections 3.5 to 3.8 of the EPLA (as amended) by University, Miromatrix will pay University an Administration Fee fifty thousand ($50,000).

24.Definitions: Section 1.23 of the Terms and Conditions shall be replaced in its entirety as follows:

1.23 "Sublicense Revenues" means all revenue, in whatever form, but excluding Sublicense Royalties, received by the Licensee in consideration of its granting a third party a license or assignment to any of its rights under the Agreement, including, without limitation, receipt of annual milestone attainment, license issuance, maintenance or up-front payments, or technology access fee; and issuance of securities or real, personal or intangible property.

Fourth Amendment to Exclusive Patent License Agreement

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25.University Address for Notice Purposes:

In Section 23 of the Terms and Conditions, notice to the University should be given to the Office for Technology Commercialization as follows:

University of Minnesota

Office for Technology Commercialization

Attn: Contracts Manager

200 Oak St. SE, Suite 280

Minneapolis, MN 55455

Phone: 612.624.0550

Fax: 612.624.6554

E-mail: otcagree@umn.edu

Web site: http://www.research.umn.edu/techcomm

26.General. Except as amended, deleted, or otherwise modified by this Fourth Amendment, the terms of the EPLA, including, without limitation, the Terms and Conditions and including in particular the payment obligations of the Company to the University, shall remain in full force and effect and enforceable against and legally binding upon the Parties. If there is any conflict between the terms of this Fourth Amendment and the terms of the EPLA, the terms of this Fourth Amendment shall control.

IN WITNESS WHEREOF, acting through their respective duly authorized representatives, the University and the Company have duly executed, delivered and entered into this Fourth Amendment as of the Fourth Amendment Effective Date.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Jay Schrankler	By:	/s/ Robert Cohen
Name: Jay Schrankler		Name: Robert Cohen
Title: Executive Director		Title: President and CEO
Office for Technology
Commercialization
Date: 9/15/2016		Date: 9/21/2016

Fourth Amendment to Exclusive Patent License Agreement

Page 11

EXHIBIT A

Form of Assignment of Patent and Patent Application recordable with the United States Patent and Trademark Office

[ATTACHED HEREINBELOW]

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UNIVERSITY OF MINNESOTA

ASSIGNMENT

WHEREAS, REGENTS OF THE UNIVERSITY OF MINNESOTA ("Assignor"), having offices at 600 McNamara Alumni Center, 200 Oak Street SE, Minneapolis, Minnesota 55455-2020, possesses the entire right, title and interest in and to the applications and patents listed in attached Exhibit A (collectively, the "University Patents and Applications"); and

WHEREAS, Miromatrix Medical Inc. ("Assignee"), a corporation under the laws of the State of Delaware, having a business address of 10399 West 70th Street, Eden Prairie, MN 55344, desires to acquire the entire right, title and interest in and to the University Patents and Applications and any and all additional Letters Patent that may emanate therefrom.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Assignor hereby sells, assigns, transfers and sets over unto Assignee, its successors and assigns, the entire right, title and interest in the University Patents and Applications and to any and all Letters Patent of the United States and any foreign countries that may emanate from the University Patents and Applications, including rights under the International Convention for the Protection of Industrial Property, and in and to any and all extensions, divisions, continuations, continuations-in-part or reissues of said University Patents and Applications and Letters Patent that may be granted, the same to be held and enjoyed by Assignee for its own use and benefit and use and benefit of its successors and assigns through the latest expiration date of any patent or application comprising the University Patents and Applications, as fully and entirely as the same would have been held and enjoyed by Assignor had this assignment not been made. This assignment specifically includes the exclusive right to enforce all rights under the University Patents and Applications in the name of Assignee and to recover damages for past infringement of the rights conveyed herein.

Assignor hereby authorizes said Assignee, its successors and assigns, or anyone it may properly designate, to continue prosecution of the University Patents and Applications, to apply for additional Letters Patent, in its own name if desired, in any and all foreign countries, and additionally to claim the filing date of said University Patents and Applications and/or otherwise take advantage of the provisions of the International Convention.

Assignor does hereby covenant and agree with said Assignee, its successors and assigns, that Assignor will not execute in writing or do any act whatsoever conflicting with these presents, and that Assignor at any time upon request, without further or additional consideration, but at the expense of said Assignee, its successors and assigns, execute such additional writings and do such additional acts as said Assignee, its successors and assigns, may deem necessary or desirable to perfect the Assignee's enjoyment of this assignment, and render all assistance necessary or appropriate in making application for and obtaining original, divisional, reissues or extended Letters Patent of the United States, or of any and all foreign countries on said invention, and in enforcing any rights occurring as a result of such application or patents, by giving testimony in any proceedings or transactions involving such applications or patents.

Fourth Amendment to Exclusive Patent License Agreement

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Assignor hereby requests the Honorable Commissioner of Patents and Trademarks to issue all Letters Patent to Assignee in accordance with the University Patents and Applications set forth this instrument.

IN WITNESS WHEREOF, I have hereunto set my hand on this 15th day of September, 2016 on behalf of Assignor:

REGENTS OF THE UNIVERSITY OF MINNESOTA

/s/ Jay Schrankler

STATE OF MINNESOTA

COUNTY OF HENNEPIN

On this 15th day of September, 2016, before me personally appeared Jay Schrankler, to me known to be the person described in and who executed the foregoing instrument and acknowledged that s/he executed the same as his/her free act and deed.

IN WITNESS WHEREOF, I have hereunto affixed my official signature with the seal of my office, the day and year above written.

/s/ Resa M. Gilats

Notary Public

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Page 14

UNIVERSITY OF MINNESOTA

ASSIGNMENT

WHEREAS, REGENTS OF THE UNIVERSITY OF MINNESOTA ("Assignor"), having offices at 600 McNamara Alumni Center, 200 Oak Street SE, Minneapolis, Minnesota 55455-2020, possesses the entire right, title and interest in and to the applications and patents listed in attached Exhibit A (collectively, the "University Patents and Applications"); and

WHEREAS, Miromatrix Medical Inc. ("Assignee"), a corporation under the laws of the State of Delaware, having a business address of 10399 West 70th Street, Eden Prairie, MN 55344, desires to acquire the entire right, title and interest in and to the University Patents and Applications and any and all additional Letters Patent that may emanate therefrom.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Assignor hereby sells, assigns, transfers and sets over unto Assignee, its successors and assigns, the entire right, title and interest in the University Patents and Applications and to any and all Letters Patent of the United States and any foreign countries that may emanate from the University Patents and Applications, including rights under the International Convention for the Protection of Industrial Property, and in and to any and all extensions, divisions, continuations, continuations-in-part or reissues of said University Patents and Applications and Letters Patent that may be granted, the same to be held and enjoyed by Assignee for its own use and benefit and use and benefit of its successors and assigns through the latest expiration date of any patent or application comprising the University Patents and Applications, as fully and entirely as the same would have been held and enjoyed by Assignor had this assignment not been made. This assignment specifically includes the exclusive right to enforce all rights under the University Patents and Applications in the name of Assignee and to recover damages for past infringement of the rights conveyed herein.

Assignor hereby authorizes said Assignee, its successors and assigns, or anyone it may properly designate, to continue prosecution of the University Patents and Applications, to apply for additional Letters Patent, in its own name if desired, in any and all foreign countries, and additionally to claim the filing date of said University Patents and Applications and/or otherwise take advantage of the provisions of the International Convention.

Assignor does hereby covenant and agree with said Assignee, its successors and assigns, that Assignor will not execute in writing or do any act whatsoever conflicting with these presents, and that Assignor at any time upon request, without further or additional consideration, but at the expense of said Assignee, its successors and assigns, execute such additional writings and do such additional acts as said Assignee, its successors and assigns, may deem necessary or desirable to perfect the Assignee's enjoyment of this assignment, and render all assistance necessary or appropriate in making application for and obtaining original, divisional, reissues or extended Letters Patent of the United States, or of any and all foreign countries on said invention, and in enforcing any rights occurring as a result of such application or patents, by giving testimony in any proceedings or transactions involving such applications or patents.

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Assignor hereby requests the Honorable Commissioner of Patents and Trademarks to issue all Letters Patent to Assignee in accordance with the University Patents and Applications set forth this instrument.

IN WITNESS WHEREOF, I have hereunto set my hand on this 15th day of September, 2016 on behalf of Assignor

REGENTS OF THE UNIVERSITY OF MINNESOTA

/s/ Jay Schrankler

STATE OF MINNESOTA

COUNTY OF HENNEPIN

On this 15th day of September, 2016, before me personally appeared Jay Shrankler, to me known to be the person described in and who executed the foregoing instrument and acknowledged that s/he executed the same as his/her free act and deed.

IN WITNESS WHEREOF, I have hereunto affixed my official signature with the seal of my office, the day and year above written.

/s/ Resa M. Gilats

Notary Public

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Patents

Exhibit A

Country	Serial Number	Patent Number
Australia	2006282783	2006282783
Australia	2010236855	2010236855
Australia	2013224686	2013224686
Belgium	06790024.1	1928519
Belgium	11181797.9	2431063
China	201210287455.7	ZL201210287455.7
China	200680030925.4	ZL200680030925.4
European Patent Office	06790024.1	1928519
European Patent Office	11181797.9	2431063
France	06790024.1	1928519
France	11181797.9	2431063
Germany	11181797.9	6020060451752.9/2431063
Germany	06790024.1	6020060428636.9/1928519
Hong Kong	12109340.4	HK1168565
India	1741/DELNP/2008	263193
Israel	189418	189418
Italy	06790024.1	1928519
Italy	11181797.9	2431063
Korea Rep Of	10-2013-7028378	10-1420585
Korea Rep Of	10-2008-7007151	10-1376013
Mexico	MX/a/2008/002589	320910
Mexico	MX/A/2011/010197	319353
Netherlands	06790024.1	1928519
Netherlands	11181797.9	2431063
Poland	06790024.1	1928519
Poland	11181797.9	2431063
Russia	2008111503	2463081

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Page 17

Country	Serial Number	Patent Number
Singapore	2011018983	170731
Spain	11181797.9	2431063
Spain	06790024.1	1928519
Sweden	06790024.1	1928519
Sweden	11181797.9	2431063
Switzerland	06790024.1	1928519
Switzerland	11181797.9	2431063
Turkey	06790024.1	TR201203945T4/1928519
Turkey	11181797.9	2431063
United Kingdom	06790024.1	1928519
United Kingdom	11181797.9	2431063
United States	12/064,613	8,470,520

Patent Applications

Australia	2015224503
Canada	2,618,731
Canada	2,757,457
China	201080024899.0
European Patent Office	15170077.0
European Patent Office	10723848.7
Hong Kong	12111387.4
Hong Kong	filed in July 2016 (related to
India	HK1168565)
India	5160/DELNP/2014
Israel	7719/DELNP/2011
Israel	233821
Japan	215463
Japan	2012-248398
Japan	2008-528231
Japan	2015-164446
Japan	2012-503673
Korea Rep Of	2015-094591

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Page 18

Korea Rep Of	10-2014-7007674
Mexico	10-2011-7025607
PCT	MX/a/2014/006778
PCT	PCT/US2006/033415
PCT	PCT/US2010/046644
Russia	PCT/US2010/029463
Russia	2012122055
Singapore	2011143730
Singapore	200801197-5
Singapore	10201401131W
Singapore	10201603074Q
United States	201107081-0
United States	13/725,030
United States	60/815,242
United States	60/711,501
United States	13/913,974
United States	60/711,509
United States	11/512,009
United States	12/547,021
United States	13/262,286

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EX-10.6

Exhibit 10.6

FIFTH AMENDMENT

TO EXCLUSIVE PATENT LICENSE AGREEMENT

THIS FIFTH AMENDMENT TO EXCLUSIVE PATENT LICENSE AGREEMENT (the “Fifth Amendment”) is made and entered effective as of the date of the last signature (the “Fifth Amendment Effective Date”), by and between Regents of the University of Minnesota (the “University”), a Minnesota constitutional corporation under the laws of the state of Minnesota, having a place of business at 200 Oak Street, SE, Suite 280, Minneapolis, Minnesota 55455, and Miromatrix Medical Inc., a corporation under the laws of the State of Delaware, having a business address of 10399 West 70th Street, Eden Prairie, MN 55344 (the “Company”) (each a “Party” and collectively, the “Parties”).

BACKGROUND

The Parties entered into that certain Exclusive Patent License Agreement, dated and effective as of 04 February 2010, including, without limitation, Exhibit A, Terms and Conditions of the Exclusive Patent License Agreement (the “Terms and Conditions”), and as amended under the First Amendment dated and effective as of 17 November 2010 (the “First Amendment”), the Second Amendment dated and effective as of 12 March 2013 (the “Second Amendment”), the Third Amendment dated and effective as of 16 December 2014 (the “Third Amendment”) and the Fourth Amendment dated and effective as of 21 September 2016 (the “Fourth Amendment”), under which the University transferred ownership of the University’s right, title and interest in the Licensed Patents and Patent Applications to the Company, as described more fully in the Exclusive Patent License Agreement, First Amendment, Second Amendment, Third Amendment and Fourth Amendment (as amended, the “EPLA”). The Parties wish to amend the Company’s rights and obligations under the EPLA as provided in this Fifth Amendment.

NOW, THEREFORE, THE PARTIES AGREE THAT:

1.            Capitalized terms not otherwise defined in this Fifth Amendment have the meanings ascribed to them in the EPLA (and as amended by prior Amendments).

2.            The Parties hereby amend Section 11.4.2 of the EPLA to read in its entirety as follows:

“11.4.2 Minimum Annual Cumulative Royalty Payment. Beginning in the calendar year in which any Assigned Product or combination of Assigned Products first achieves cumulative Commercial Sales of five million dollars ($5,000,000), Company shall assume a minimum annual royalty obligation as follows:

The Parties agree that an Assigned Product or combination of Assigned Products first achieved cumulative Commercial Sales of five million dollars ($5,000,000) in calendar year 2018. Therefore, if the total payments to the University under sections 11.4. and 11.5 do not aggregate to a minimum sum of $500,000 for each calendar year during the Term of this Agreement, Company shall pay the University the difference between the total amounts actually paid to the University under sections 11.4 and 11.5 of this Agreement for such year and the minimum sum of $500,000 (the “Difference”) within 30 days following the end of such year, subject to the provisions of the following sentence. The Parties agree that the payment of such Difference for each of calendar years 2020 and 2021 may be deferred by Company and such year’s Difference added to the $500,000 minimum sum required for calendar years 2022 and 2023, respectively. For example, if Company pays University $125,000 in royalties for 2020, Company shall be obligated to pay minimum sum of $875,000 in 2022. Beginning in 2024, Company will thereafter pay the $500,000 minimum sum within 30 days following the end of such year.

3.            Amendment Fee: $0. One time waiver of the license amendment fee.

IN WITNESS WHEREOF, acting through their respective duly authorized representatives, the University and the Company have duly executed, delivered and entered into this Fifth Amendment as of the Fifth Amendment Effective Date.

Regents of the University of Minnesota		Miromatrix Medical Inc.
By:	/s/ Richard Huebsch	By:	/s/ Jeff Ross
Name:	Richard Huebsch	Name:	Jeff Ross
Title:	Executive Director	Title:	President and CEO
	Office for Technology
	Commercialization
Date:	February 18, 2021 | 8:57 PM CST	Date:	February 21, 2021 | 8:39 AM PST

EX-10.7

Exhibit 10.7

LICENSE AGREEMENT

THIS AGREEMENT is entered into as of the 1st day of January 2011 (the "Effective Date"), by and between Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 18683 Bearpath Trail, Eden Prairie, MN 55347, ("Miromatrix"), and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo").

WHEREAS, Miromatrix and Mayo wish to enter a relationship whereby Mayo performs certain services for Miromatrix relating to Miromatrix decellularization/recellularization technology (the "Services");

WHERAS, Mayo wishes to acquire certain convertible promissory notes from Miromatrix and Miromatrix wishes to provide such convertible promissory notes to Mayo;

WHEREAS, Dr. Allan Dietz of Mayo's Human Cellular Therapy Laboratory (the "Laboratory") shall be Mayo's principal provider of services for Miromatrix (the "Principal Investigator").

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, and intending to be legally bound hereby, the parties agree as follows:

1. Scope of Work.

1.1 Mayo agrees to use its best efforts to perform the Services in accordance with the Statement of Work attached hereto as Exhibit A (the "Project").

1.2 Mayo shall perform the Project in accordance with standards applicable to work of similar type and scope to the Project performed by those skilled in the relevant art, as well as all laws and regulations that apply to such type of work. For the avoidance of doubt, the work under this agreement will not be to GMP standards.

2. Term. The parties shall perform their respective obligations for the Project commencing with the Effective Date of this Agreement and terminating on March 1, 2012 (the "Term").

3. Payment.

3.1 The Project will be funded by $200,000.00 (the "Project Cost") in ILP funds from Mayo, as approved on December 16, 2010. The Project Cost will be allocated as described in the Budget with funds supporting efforts at both Mayo and Miromatrix.

3.2 Mayo and Miromatrix agree to conduct the Project pursuant to the budget attached hereto as Exhibit B (the "Budget").

3.3 Mayo and Miromatrix may reasonably reallocate funds within categories of the Budget to complete the Project.

3.4 In consideration of the Project Cost, Miromatrix, within ten (10) days following the delivery of a Subscription Agreement by Mayo in the form attached hereto as Exhibit D, will deliver to Mayo a $200,000.00 Convertible Promissory Note and 30% warrant coverage in the form of the documents attached hereto as Exhibits E and F, respectively.

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

4. Materials Provided.

4.1 Miromatrix shall provide certain materials in order to support Mayo's efforts associated with the Project. These materials shall consist primarily of decellularized organs (the "Materials").

4.2 All Materials shall remain the property of Miromatrix and will be used by Mayo solely for the Project. The Materials shall be returned to Miromatrix or destroyed by Mayo, as requested by Miromatrix, at the end of the Term of this Agreement or upon early termination of this Agreement.

4.3 The Materials shall be used with prudence and appropriate caution in any experimental work. THE MATERIALS ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Miromatrix agrees to defend and indemnify Mayo from any and all claims and damages in any way arising from the acquisition, use, storage or disposal of the Materials by Mayo, unless such claim is due to negligence on the part of Mayo.

4.4 No option, license, or conveyance of rights, express or implied, is granted by Miromatrix to Mayo in connection with any Materials provided under this Agreement, except the right to use the Materials strictly in accordance with the terms of this Agreement.

5. Principal Investigator. If, for any reason, the Principal Investigator is unable to continue to serve as Principal Investigator, Mayo shall be entitled to designate another individual who is reasonably acceptable to Miromatrix to serve as Principal Investigator of the Project.

6. Independent Contractor.

6.1 Mayo is an independent contractor of Miromatrix.

6.2 Nothing in this Agreement shall be construed to create a partnership or joint venture between Mayo and Miromatrix, nor shall either party's employees, servants, agents or representatives be considered the employees, servants, agents or representatives of the other. Neither party shall have any express or implied right or authority to assume or create any obligation on behalf of, or in the name of, the other party; or to bind the other party to any contract, agreement or undertaking with any third party.

Page 2

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

7. Reports and Records.

7.1 Mayo shall provide Miromatrix with periodic progress reports on the Project, detailing, for example, work completed and results achieved.

7.2 Mayo shall provide Miromatrix with a final written report within thirty (30) days following completion of the Project or upon earlier termination of this Agreement.

7.3 Mayo shall, at mutually agreed upon times, meet with Miromatrix' representatives to discuss Project results and reports.

8. Intellectual Property Rights.

8.1 Ownership of inventions and/or discoveries developed under this Agreement shall follow inventorship under U.S. Patent law:

(a) Mayo shall own all right, title and interest in and to inventions and/or discoveries whether patentable, copyrightable or otherwise developed solely by Mayo employees under this Agreement, except that Miromatrix shall retain a worldwide, irrevocable, non-exclusive, royalty-free right to use such inventions and/or discoveries developed under this Agreement for non-commercial, internal research activities. Mayo shall disclose such inventions and/or discoveries to Miromatrix in writing before the end of the Term of this Agreement.

(b) Mayo and Miromatrix shall jointly own inventions and/or discoveries developed by employees of both parties. Miromatrix shall have a right of first offer to license Mayo's interest in such inventions and/or discoveries in accordance with the provisions of this Section 8.

(c) Miromatrix shall own all right, title and interest in and to inventions and/or discoveries. whether patentable, copyrightable or otherwise, developed solely by Miromatrix' employees or agents.

8.2 During the Term of this Agreement, Mayo grants to Miromatrix an option to acquire an exclusive license to inventions and/or discoveries developed by Mayo as a result of work on the Project. Such option shall remain in effect for ninety (90) days after the date of detailed written disclosure to Miromatrix. If Miromatrix has not notified Mayo in writing of its desire to enter into license negotiations within such ninety (90) day period, Mayo shall have the right, but not the obligation, to license such rights to a third party.

8.3 Should a mutually acceptable license agreement not be executed and delivered within ninety (90) days from the date Mayo provides Miromatrix with a draft license agreement, Mayo shall have the right, but not the obligation, to license its rights to inventions and discoveries described in Section 8.1(a) and (b) to a third party on terms no less favorable in the aggregate to Mayo than those offered by Miromatrix for the same or substantially similar rights. It shall be within Mayo's sole reasonable discretion to deteulline the relative favorability of different offers.

Page 3

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

8.4 This Agreement does not grant any right, title or interest in or to any tangible or intangible property right of either party, including any improvements thereon, that is not expressly stated in Section 8.2. All such rights, titles and interests are expressly reserved by owner and the other party agrees that in no event will this Agreement be construed as a sale, an assignment, or an implied license of any such tangible or intangible property rights.

8.5 Mayo's proprietary Platelet Lysate media supplement will specifically NOT be used in the work performed under this agreement and as such any developments incorporating this supplement will specifically not be subject to the option granted to Miromatrix in this agreement.

9. Termination.

9.1 This Agreement may be terminated prior to the expiration of the Term should either party materially breach this Agreement, the non-breaching party provides the breaching party with thirty (30) days advance written notice of termination, and such breach is not remedied within such thirty (30) day period.

9.2 In the event of termination pursuant to Section 9.1 by Miromatrix, Mayo shall return to Miromatrtix the Consideration paid under Section 3.4 of this Agreement and Miromatrix waives all rights and options to data, results and Mayo inventions and discoveries as granted hereunder.

9.3 In the event of termination pursuant to Section 9.1 by Mayo, Miromatrix shall reimburse Mayo for the amount of the Budget corresponding to the percent of the Budget "Specific Aims" already completed as of the date of termination.

10. Warranty Disclaimers. MAYO SERVICES AND INVENTIONS PROVIDED OR CREATED PURSUANT TO THIS AGREEMENT ARE "AS IS", "WITH ALL FAULTS, AND "WITH ALL DEFECTS" AND MAYO DISCLAIMS AND MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, INCLUDING BUT NOT LIMITED TO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, PATENTABILITY OR THAT MIROMATRIX' USE OF THE PROJECT RESULTS WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS OR OTHER RIGHTS OF THIRD PARTIES.

Page 4

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

11. LIMIT OF LIABILITY COMPANY AGREES THAT MAYO AND ITS AFFILIATES WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY OR ARISING OUT OF ANY RIGHTS GRANTED OR PERFORMANCE MADE UNDER THIS AGREEMENT, WHETHER TO OR BY COMPANY OR A THIRD PARTY. IN NO EVENT WILL MAYO'S LIABILITY OF ANY KIND INCLUDE ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE LOSSES OR DAMAGES, EVEN IF MAYO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR EXCEED THE TOTAL AMOUNT OF CONSIDERATION WHICH HAS ACTUALLY BEEN PAID TO MAYO BY COMPANY AS OF THE DATE OF FILING AN ACTION AGAINST MAYO WHICH RESULTS IN THE SETTLEMENT OR AWARD OF DAMAGES TO COMPANY.

12. Confidentiality. Mayo and Miromatrix have executed Confidentiality and Non-Disclosure Agreement dated November 5, 2010, and attached as Exhibit C (the "CDA") that is hereby incorporated by reference in this Agreement. All results relating to the Project are hereby included in the definition of Confidential Information in the CDA.

13. Publicity. Miromatrix will not use for publicity, promotion, or otherwise, any logo, name, trade name, service mark, or trademark of Mayo or its Affiliates, including, but not limited to, the terms "Mayo®," "Mayo Clinic®," and the triple shield Mayo logo, or any simulation, abbreviation, or adaptation of the same, or the name of any Mayo employee or agent, without Mayo's prior, written, express consent. Mayo may withhold such consent in Mayo's absolute discretion. With regard to the use of Mayo's name, all requests for approval pursuant to this Section must be submitted to the Mayo Clinic Public Affairs Business Relations Group, at the following e-mail address: PublieAffairsBRMayo.edu at least five business days prior to the date on which a response is needed.

14. Notice. Any notice or communication pursuant to this Agreement shall be sufficiently made or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed to the address below or as either party shall designate by written notice to the other party.

In the case of Mayo:

Tim Argo

Mayo Clinic Office of Intellectual Property

200 First Street S.W.

Rochester MN 55905

Telephone No.: (507) 284-1839

In the case of Miromatrix:

Robert Cohen

President & CEO

Miromatrix Medical, Inc.

18683 Bearpath Trail

Eden Prairie, MN 55347

Telephone No.: (612) 202-7026

Page 5

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

15. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Minnesota exclusive of choice of law except interpretation of patent rights.

16. Entire Agreement. This Agreement, together with all attachments and exhibits, constitutes the entire agreement and understanding between the parties and supersedes any prior or contemporaneous negotiations, agreements, understandings, or arrangements of any nature or kind with respect to the subject matter herein. In the event of any inconsistency between this Agreement or any attachments and exhibits, the terms of this Agreement shall govern.

17. Waiver. Neither party waives its right to enforce any and all provisions of the Agreement at any time during the Term. Either party's failure to enforce any provision shall not prejudice such party from later enforcing or exercising the same or any other provision of the Agreement.

18. Modifications. This Agreement may not be changed, altered, modified, amended, rescinded, canceled or waived except by a writing executed by authorized representatives of the parties.

19. Binding Agreement on Successors. This Agreement shall be binding upon each party's successors and assigns.

20. Headings. Headings are for convenience of reference only, and not for interpreting the provisions of the Agreement.

21. Counterparts. This Agreement may be executed in counterparts, and by either party on separate counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Remainder of this page intentionally left blank]

Page 6

Mayo/Miromatrix Medical, Inc.

License Agreement

June 21, 2011

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized representatives as of the date first above written.

MIROMATRIX MEDICAL, INC.
By:	/s/ Robert Cohen
Name: Robert Cohen
Title: President & CEO
Date:	6/28/11

MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
/s/ Steven P. VanNurden
Name: Steven P. VanNurden
Title: Assistant Treasurer
Date:	6/21/2011
Principal Investigator confirms that he has read and understands this Agreement and agrees to abide by its terms.
/s/ Alan Dietz
Aran Dietz, Ph.D.
Date:	6/23/2011

Page 7

EXHIBIT A

SCOPE OF WORK

Create a perfusable cardiac patch from porcine cardiac tissue using perfusion decellularization. Characterize the ability to source and grow an autologous source of endothelial cells capable of re-endothealizing a 5 x 5 cm decellularized cardiac patch in a contained bioreactor.

1. Define cardiac patch overall geometry and vascular supply [Miromatrix/Mayo]

a. Define ability to create a self-contained vascularized patch and technology to seal edges

b. Define and design appropriate bioreactor to support growth of a vascularized cardiac patch

c. Perfect vascular anastomosis procedure

2. Optimize revascularization [Mayo/Miromatrix]

a. Build bioreactor for revascularization experiments

b. Screen multiple endothelial cell sources (arterial and venous/peripheral and aortic compared to coronary endothelial cells) for ability to achieve >95% re-endothelialization

3. Define autologous endothelial cell source based on specific aim #2 [Mayo]

a. Define initial autologous endothelial isolation and determine biopsy protocol

b. Define growth protocol to achieve reseeding of the cardiac patch in a controlled bioreactor

c. Achieve >95% re-endothelialization in 4 cardiac patch constructs capable of supporting preclinical implantations

EXHIBIT B

BUDGET

Specific Aim	Description	Miromatrix		Mayo		Timeframe (Months)
1	Define Cardiac Patch	$	22,000.00	$	0		2
2	Revascularization/Cell Source	$	15,000.00	$	70,000.00		6
3	Pre-clinical Scale Up	$	15,000.00	$	78,000.00		4
Total		$	52,000.00	$	148,000.00		12

EXHIBIT C

CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT

EXHIBIT D

SUBSCRIPTION AGREEMENT

EXHIBIT E

CONVERTIBLE PROMISSORY NOTE

EXHIBIT F

WARRANT AGREEMENT

EX-10.8

Exhibit 10.8

LICENSE AGREEMENT

THIS AGREEMENT is entered into as of the 15th day of September 2013 (the “Effective Date”), by and between Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 18683 Bearpath Trail, Eden Prairie, MN 55347, (“Miromatrix”), and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 (“Mayo”).

WHEREAS, Miromatrix and Mayo wish to enter a relationship whereby Mayo performs certain services for Miromatrix relating to Miromatrix decellularization/recellularization technology (the “Services”);

WHERAS, Mayo wishes to acquire certain Series A Preferred Stock (the “Stock”) from Miromatrix and Miromatrix wishes to provide such Stock to Mayo;

WHEREAS, Dr. Allan Dietz of Mayo’s Human Cellular Therapy Laboratory (the “Laboratory”) shall be Mayo’s principal provider of services for Miromatrix (the “Principal Investigator”).

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, and intending to be legally bound hereby, the parties agree as follows:

1. Scope of Work.

1.1 Mayo agrees to use its best efforts to perform the Services in accordance with the Statement of Work attached hereto as Exhibit A (the “Project”).

1.2 Mayo shall perform the Project in accordance with standards applicable to work of similar type and scope to the Project performed by those skilled in the relevant art, as well as all laws and regulations that apply to such type of work. For the avoidance of doubt, the work under this agreement will not be to GMP standards.

2. Term. The parties shall perform their respective obligations for the Project commencing with the Effective Date of this Agreement and terminating on December 31, 2014 (the “Term”).

3. Payment.

3.1 The Project will be funded by $200,000.00 (the “Project Cost”) in ILP funds from Mayo, as approved on October 1, 2012. The Project Cost will be allocated as described in the Budget with funds supporting efforts at both Mayo and Miromatrix.

3.2 Mayo and Miromatrix agree to conduct the Project pursuant to the budget attached hereto as Exhibit B (the “Budget”).

3.3 Mayo and Miromatrix may reasonably reallocate funds within categories of the Budget to complete the Project.

3.4 In consideration of the Project Cost, Miromatrix will deliver to Mayo a certificate representing 83,333 shares of Stock (calculated by dividing $200,000 by the $2.40/share discounted price for investments of at least $100,000).

4. Materials Provided.

4.1 Miromatrix shall provide certain materials in order to support Mayo’s efforts associated with the Project. These materials shall consist primarily of decellularized organs (the “Materials”).

4.2 All Materials shall remain the property of Miromatrix and will be used by Mayo solely for the Project. The Materials shall be returned to Miromatrix or destroyed by Mayo, as requested by Miromatrix, at the end of the Term of this Agreement or upon early termination of this Agreement.

4.3 The Materials shall be used with prudence and appropriate caution in any experimental work. THE MATERIALS ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Miromatrix agrees to defend and indemnify Mayo from any and all claims and damages in any way arising from the acquisition, use, storage or disposal of the Materials by Mayo, unless such claim is due to negligence on the part of Mayo.

4.4 No option, license, or conveyance of rights, express or implied, is granted by Miromatrix to Mayo in connection with any Materials provided under this Agreement, except the right to use the Materials strictly in accordance with the terms of this Agreement.

5. Principal Investigator. If, for any reason, the Principal Investigator is unable to continue to serve as Principal Investigator, Mayo shall be entitled to designate another individual who is reasonably acceptable to Miromatrix to serve as Principal Investigator of the Project.

6. Independent Contractor.

6.1 Mayo is an independent contractor of Miromatrix.

6.2 Nothing in this Agreement shall be construed to create a partnership or joint venture between Mayo and Miromatrix, nor shall either party’s employees, servants, agents or representatives be considered the employees, servants, agents or representatives of the other. Neither party shall have any express or implied right or authority to assume or create any obligation on behalf of, or in the name of, the other party; or to bind the other party to any contract, agreement or undertaking with any third party.

7. Reports and Records.

7.1 Mayo shall provide Miromatrix with periodic progress reports on the Project, detailing, for example, work completed and results achieved.

7.2 Mayo shall provide Miromatrix with a final written report within thirty (30) days following completion of the Project or upon earlier termination of this Agreement.

7.3 Mayo shall, at mutually agreed upon times, meet with Miromatrix’ representatives to discuss Project results and reports.

8. Intellectual Property Rights.

8.1 Ownership of inventions and/or discoveries developed under this Agreement shall follow inventorship under U.S. Patent law:

(a) Mayo shall own all right, title and interest in and to inventions and/or discoveries whether patentable, copyrightable or otherwise developed solely by Mayo employees under this Agreement, except that Miromatrix shall retain a worldwide, irrevocable, non-exclusive, royalty-free right to use such inventions and/or discoveries developed under this Agreement for non-commercial, internal research activities. Mayo shall disclose such inventions and/or discoveries to Miromatrix in writing before the end of the Term of this Agreement.

(b) Mayo and Miromatrix shall jointly own inventions and/or discoveries developed by employees of both parties. Miromatrix shall have a right of first offer to license Mayo’s interest in such inventions and/or discoveries in accordance with the provisions of this Section 8.

(c) Miromatrix shall own all right, title and interest in and to inventions and/or discoveries, whether patentable, copyrightable or otherwise, developed solely by Miromatrix’ employees or agents.

8.2 During the Term of this Agreement, Mayo grants to Miromatrix an option to acquire an exclusive license to inventions and/or discoveries developed by Mayo as a result of work on the Project. Such option shall remain in effect for ninety (90) days after the date of detailed written disclosure to Miromatrix. If Miromatrix has not notified Mayo in writing of its desire to enter into license negotiations within such ninety (90) day period, Mayo shall have the right, but not the obligation, to license such rights to a third party.

8.3 Should a mutually acceptable license agreement not be executed and delivered within ninety (90) days from the date Mayo provides Miromatrix with a draft license agreement, Mayo shall have the right, but not the obligation, to license its rights to inventions and discoveries described in Section 8.1(a) and (b) to a third party on terms no less favorable in the aggregate to Mayo than those offered by Miromatrix for the same or substantially similar rights. It shall be within Mayo’s sole reasonable discretion to determine the relative favorability of different offers.

8.4 This Agreement does not grant any right, title or interest in or to any tangible or intangible property right of either party, including any improvements thereon, that is not expressly stated in Section 8.2. All such rights, titles and interests are expressly reserved by the owner and the other party agrees that in no event will this Agreement be construed as a sale, an assignment, or an implied license of any such tangible or intangible property rights.

8.5 Mayo’s proprietary Platelet Lysate media supplement will specifically NOT be used in the work performed under this agreement and as such any developments incorporating this supplement will specifically not be subject to the option granted to Miromatrix in this agreement.

9. Termination.

9.1 This Agreement may be terminated prior to the expiration of the Term should either party materially breach this Agreement, the non-breaching party provides the breaching party with thirty (30) days advance written notice of termination, and such breach is not remedied within such thirty (30) day period.

9.2 In the event of termination pursuant to Section 9.1 by Miromatrix, Mayo shall return to Miromatrix the Consideration paid under Section 3.4 of this Agreement and Miromatrix waives all rights and options to data, results and Mayo inventions and discoveries as granted hereunder.

9.3 In the event of termination pursuant to Section 9.1 by Mayo, Miromatrix shall reimburse Mayo for the amount of the Budget corresponding to the percent of the Budget “Specific Aims” already completed as of the date of termination.

10. Warranty Disclaimers. MAYO SERVICES AND INVENTIONS PROVIDED OR CREATED PURSUANT TO THIS AGREEMENT ARE “AS IS”, “WITH ALL FAULTS, AND “WITH ALL DEFECTS” AND MAYO DISCLAIMS AND MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, INCLUDING BUT NOT LIMITED TO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, PATENTABILITY OR THAT MIROMATRIX’ USE OF THE PROJECT RESULTS WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS OR OTHER RIGHTS OF THIRD PARTIES.

11. LIMIT OF LIABILITY. MIROMATRIX AGREES THAT MAYO AND ITS AFFILIATES WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY OR ARISING OUT OF ANY RIGHTS GRANTED OR PERFORMANCE MADE UNDER THIS AGREEMENT, WHETHER TO OR BY COMPANY OR A THIRD PARTY. IN NO EVENT WILL MAYO’S LIABILITY OF ANY KIND INCLUDE ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE LOSSES OR DAMAGES, EVEN IF MAYO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR EXCEED THE TOTAL AMOUNT OF CONSIDERATION WHICH HAS ACTUALLY BEEN PAID TO MAYO BY MIROMATRIX AS OF THE DATE OF FILING AN ACTION AGAINST MAYO WHICH RESULTS IN THE SETTLEMENT OR AWARD OF DAMAGES TO MIROMATRIX.

12. Confidentiality. Mayo and Miromatrix have executed a Confidentiality and Non-Disclosure Agreement dated October 15, 2012 and attached as Exhibit C (the “CDA”) that is hereby incorporated by reference in this Agreement. All results relating to the Project are hereby included in the definition of Confidential Information in the CDA.

13. Publicity. Miromatrix will not use for publicity, promotion, or otherwise, any logo, name, trade name, service mark, or trademark of Mayo or its Affiliates, including, but not limited to, the terms “Mayo®,” “Mayo Clinic®,” and the triple shield Mayo logo, or any simulation, abbreviation, or adaptation of the same, or the name of any Mayo employee or agent, without Mayo’s prior, written, express consent. Mayo may withhold such consent in Mayo’s absolute discretion. With regard to the use of Mayo’s name, all requests for approval pursuant to this Section must be submitted to the Mayo Clinic Public Affairs Business Relations Group, at the following e-mail address: PublicAffairsBR@Mayo.edu at least five business days prior to the date on which a response is needed.

14. Notice. Any notice or communication pursuant to this Agreement shall be sufficiently made or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed to the address below or as either party shall designate by written notice to the other party.

In the case of Mayo:

Tim Argo
Mayo Clinic Office of Intellectual Property
200 First Street SW
Rochester MN 55905
Telephone No: (507) 284-1839

In the case of Miromatrix:

Robert Cohen
President & CEO
Miromatrix Medical Inc.
18683 Bearpath Trail
Eden Prairie, MN 55347
Telephone No: (612) 202-7026

15. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Minnesota exclusive of choice of law except interpretation of patent rights.

16. Entire Agreement. This Agreement, together with all attachments and exhibits, constitutes the entire agreement and understanding between the parties and supersedes any prior or contemporaneous negotiations, agreements, understandings, or arrangements of any nature or kind with respect to the subject matter herein. In the event of any inconsistency between this Agreement or any attachments and exhibits, the terms of this Agreement shall govern.

17. Waiver. Neither party waives its right to enforce any and all provisions of the Agreement at any time during the Term. Either party’s failure to enforce any provision shall not prejudice such party from later enforcing or exercising the same or any other provision of the Agreement.

18. Modifications. This Agreement may not be changed, altered, modified, amended, rescinded, canceled or waived except by a writing executed by authorized representatives of the parties.

19. Binding Agreement on Successors. This Agreement shall be binding upon each party’s successors and assigns.

20. Headings. Headings are for convenience of reference only, and not for interpreting the provisions of the Agreement.

21. Counterparts. This Agreement may be executed in counterparts, and by either party on separate counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Remainder of this page intentionally left blank]

IN WITNESS ‘WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized representatives as of the date first above written.

MIROMATRIX MEDICAL INC.
By:	/s/ Robert Cohen

Name:	Robert Cohen
Title:	President & CEO
Date:9/29/2013

MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Daniel Estes

Name:	Daniel D. Estes
Title:	Assistant Treasurer
Date:9/19/2013

Principal Investigator confirms that he has read and understands this Agreement and agrees to abide by its terms.

/s/ Allan B. Dietz

Allan Dietz, Ph.D.

Date:9/24/2013

EXHIBIT A
SCOPE OF WORK

Specific Aim 1: Acute transplantation to demonstrate hemocompatibility

[Goal: Demonstrate the ability to anastomose the revascularized liver graft onto the liver and maintain blood flow >50% of initial output after 30 minutes of perfusion]

1. Isolate and determine source of porcine endothelial cells (n=4)

a. Autologous versus Allogeneic porcine vein harvest and outgrowth

b. Outgrowth kinetics will be determined from autologous, if outgrowth is >4 weeks then allogeneic porcine cord endothelial cells will used as defined in previous ILP award

2. Production of revascularized liver grafts (n=12, 2 per animal)

a. Perform vein harvest on n=6 animals if autologous model is used, and perform outgrowth

b. Growth of allogenic endothelial cells if deemed necessary in Specific Aim 1-A

c. Seeding of endothelial cells according to defined SOP and monitoring growth via metabolic assays (7 days) resulting in 12 transplantable grafts

3. Acute Transplantation (n=6 animals, n=12 grafts) [+/- Heparin in graft]

a. Perform anastomosis of the revascularized liver graft to the portal vein for 30 minutes (n=3- heparin, n=3 +heparin)

b. In the same animal, perform partial liver resection followed by anastomosis of liver graft via the identified portal vein in the graft (n=3 -heparin, n=3 +heparin)

c. Monitor pressure and output perfusion with a target to achieve continuous perfusion for 30 minutes

d. Determine optimal location for long-term transplantation for Specific Aim 2

Specific Aim la: Hepatocyte Isolation and Seeding Development

[Goal: Determine the optimal hepatocyte isolation efficiencies to isolate >50 million hepatocytes and define the seeding protocol for use in Specific Aim 2 that results in >50% viable hepatocytes after 7 days in culture]

1. Isolation and protocol development for porcine hepatocytes (n=6)

a. Protocol development and isolation of porcine hepatocytes from resected porcine or human liver tissue (n=6)

b. Goal of isolating 50 million viable hepatocytes

2. Seeding isolated hepatocytes via injection versus perfusion into liver grafts (n=6)

a. Perform n=3 direct injection (n=3) into a revascularized liver graft

b. Perform n=3 perfusion of hepatocytes into a revascularized liver graft

c. Measure metabolic output of liver grafts for 7 days during cell culture

d. Perform histology, viability staining and proliferation staining on seeded grafts

e. Perform hepatocyte metabolic activity assays on seeded grafts

3. Finalize hepatocyte seeding protocol

a. Based on Specific Aim 1 a-B, an optimized protocol will be drafted for use in Specific Aim 2

b. Based on Specific Aim la-B, an optimized protocol will be drafted for use in Specific Aim 2

Specific Aim 2: 45 Day Transplantation to Demonstrate Efficacy of Revascularized Liver Graft

[Goal: Determine the ability of the revascularized liver graft to become recellularized by the native liver or the ability to be seeded with hepatocytes resulting in the detection of viable hepatocytes within the graft at 45 days]

1. Production of transplantable liver grafts (n=20)- 14 days

a. Production of two liver grafts per selected animal (1-implant and 1-characterization)

b. Seeding of endothelial cells according to defined SOP and monitoring growth via monitoring metabolic activity

c. Transplantation of one liver graft and histological analysis of the remaining graft as a control

2. Long-term transplantation (45 day transplantation, n=10) [+ immunosuppression if allogeneic endothelial cells are use]

a. Revascularized liver grafts (n=5)

i. Partial liver resection followed by anastomosis of hepatic and portal vein to exposed liver surface

b. Revascularized + Isolated Hepatocytes (n=5)

i. Partial liver resection followed by anastomosis of hepatic and portal vein to exposed liver surface

ii. Hepatocyte isolation and added to graft based on Specific Aim la-C

c. Control (n=4)

i. Partial liver resection followed without anastomosis of an liver acellular graft on adjacent lobe

3. Post Transplant Analysis

a. Histology 24 slides per transplant

i. Isolation of 3 blocks per graft (proximal and distal to transplantation site) and 8 sections (4 serial-200um-4 serial)

ii. H&E staining

iii. Albumin staining for the characterization of hepatocytes

iv. Ki67 staining for the characterization of hepatocyte proliferation

v. Extra slides for endothelial or epithelial staining if needed

-2-

EXHIBIT B
BUDGET

Specific Aim	Description	Miromatrix		Mayo (Dietz)		Mayo (Nyberg/ Heimbach)		Indirects		Timeframe (Months)
1	Acute Hemocompatibility Study	$	15,000	$	30,000	$	25,000			6
2	45 Day Long-Term Transplantation	$	15,000	$	25,000	$	45,000			6
Total		$	30,000	$	55,000	$	70,000	$	45,000	12

EXHIBIT C
CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT

[NEEDS TO BE ADDED - OLD AGREEMENT HAS EXPIRED]

EX-10.9

Exhibit 10.9

LICENSE AGREEMENT

THIS AGREEMENT is entered into as of the 1st day of December 2014 (the “Effective Date”), by and between Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 18683 Bearpath Trail, Eden Prairie, MN 55347, (“Miromatrix”), and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 (“Mayo”).

WHEREAS, Miromatrix and Mayo previously entered into License Agreements dated January 1, 2011 and September 15, 2013;

WHEREAS, Miromatrix and Mayo wish to further this relationship whereby Mayo Performs certain services for Miromatrix relating to Miromatrix decellularization/recellularization technology (the “Services”);

WHEREAS, Mayo wishes to acquire certain Series B Preferred Stock (the “Stock”) from Miromatrix and Miromatrix wishes to provide such Stock to Mayo;

WHEREAS, Dr. Allan Dietz of Mayo’s Human Cellular Therapy Laboratory (the “Laboratory”) shall be Mayo’s principal provider of services for Miromatrix (the “Principal Investigator”).

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, and intending to be legally bound hereby, the parties agree as follows:

1. Scope of Work.

1.1 Mayo agrees to use its best efforts to perform the Services in accordance with the Statement of Work attached hereto as Exhibit A (the “Project”).

1.2 Mayo shall perform the Project in accordance with standards applicable to work of similar type and scope to the Project performed by those skilled in the relevant art, as well as all laws and regulations that apply to such type of work. For the avoidance of doubt, the work under this agreement will not be to GMP standards.

2. Term. The parties shall perform their respective obligations for the Project commencing with the Effective Date of this Agreement and terminating on December 31, 2016 (the “Term”).

3. Payment.

3.1 The Project will be funded by $200,000.00 (the “Mayo Project Cost”) in ILP funds from Mayo, as approved on July 16, 2014, and $764,700.00 in funds to be provided by Miromatrix (the “Miromatrix Project Cost”). The Mayo Project Cost and the Miromatrix Project Cost (cumulatively, the “Project Cost”) will be allocated as described in the Budget with funds supporting efforts at both Mayo and Miromatrix.

3.2 Mayo and Miromatrix agree to conduct the Project pursuant to the budget attached hereto as Exhibit B (the “Budget”).

3.3 Mayo and Miromatrix may reasonably reallocate funds within categories of the Budget to complete the Project.

3.4 In consideration of the Mayo Project Cost, Miromatrix will deliver to Mayo a certificate representing 26,667 shares of Stock (calculated by dividing $200,000 by the $7.50/share price) (the “Consideration”).

4. Materials Provided.

4.1 Miromatrix shall provide certain materials in order to support Mayo’s efforts associated with the Project. These materials Shall consist primarily of decellularized organs and certain recellularized organs (the “Materials”).

4.2 All Materials shall remain the property of Miromatrix and will be used by Mayo solely for the Project. The Materials shall be returned to Miromatrix or destroyed by Mayo, as requested by Miromatrix, at the end of the Term of this Agreement or upon early termination of this Agreement

4.3 The Materials shall be used with prudence and appropriate caution in any experimental work. THE MATERIALS ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Miromatrix agrees to defend and indemnify Mayo from any and all claims and damages in any way arising from the acquisition, use, storage or disposal of the Materials by Mayo, unless such claim is due to negligence on the part of Mayo.

4.4 No option, license, or conveyance of rights, express or implied, is granted by Miromatrix to Mayo in connection with any Materials provided under this Agreement, except the right to use the Materials strictly in accordance with the terms of this Agreement

5. Principal Investigator. If, for any reason, the Principal Investigator is unable to continue to serve as Principal Investigator, Mayo shall be entitled to designate another individual who is reasonably acceptable to Miromatrix to serve as Principal Investigator of the Project.

6. Independent Contractor.

6.1 Mayo is an independent contractor of Miromatrix.

6.2 Nothing in this Agreement shall be construed to create a partnership or joint venture between Mayo and Miromatrix, nor shall either party’s employees, servants, agents or representatives be considered the employees, servants, agents or representatives of the other. Neither party shall have any express or implied right or authority to assume or create any obligation on behalf of, or in the name of, the other party; or to bind the other party to any contract, agreement or undertaking with any third party.

7. Reports and Records.

7.1 Mayo shall provide Miromatrix with periodic progress reports on the Project, detailing, for example, work completed and results achieved.

7.2 Mayo shall provide Miromatrix with a final written report within thirty (30) days following completion of the Project or upon earlier termination of this Agreement.

7.3 Mayo shall, at mutually agreed upon times, meet with Miromatrix’ representatives to discuss Project results and reports.

8. Intellectual Property Rights.

8.1 Ownership of inventions and/or discoveries developed under this Agreement shall follow inventorship under U.S. Patent law:

(a) Mayo shall own all right, title and interest in and to inventions and/or discoveries whether patentable, copyrightable or otherwise developed solely by Mayo employees under this Agreement, except that Miromatrix shall retain a worldwide, irrevocable, non-exclusive, royalty-free right to use such inventions and/or discoveries developed under this Agreement for non-commercial, internal research activities. Mayo shall disclose such inventions and/or discoveries to Miromatrix in writing within one (1) month of their invention and/or discovery.

(b) Mayo and Miromatrix shall jointly own inventions and/or discoveries developed by employees of both parties. Miromatrix shall have a right of first offer to license Mayo’s interest in such inventions and/or discoveries in accordance with the provisions of this Section 8.

(c) Miromatrix shall own all right, title and interest in and to inventions and/or discoveries, whether patentable, copyrightable or otherwise, developed solely by Miromatrix’ employees or agents.

8.2 During the Term of this Agreement, Mayo grants to Miromatrix an option to acquire an exclusive license to inventions and/or discoveries developed by Mayo as a result of work on the Project. Such option shall remain in effect for ninety (90) days after the date of detailed written disclosure to Miromatrix. If Miromatrix has not notified Mayo in writing of its desire to enter into license negotiations within such ninety (90) day period, Mayo shall have the right, but not the obligation, to license such rights to a third party.

8.3 Should a mutually acceptable license agreement not be executed and delivered within ninety (90) days from the date Mayo provides Miromatrix with a draft license agreement, Mayo shall have the right, but not the obligation, to license its rights to inventions and discoveries described in Section 8.1(a) and (b) to a third party on terms no less favorable in the aggregate to Mayo than those offered by Miromatrix for the same or substantially similar rights. It shall be within Mayo’s sole reasonable discretion to determine the relative favorability of different offers.

8.4 This Agreement does not grant any right, title or interest in or to any tangible or intangible property right of either party, including any improvements thereon, that is not expressly stated in Section 8.2. All such rights, titles and interests are expressly reserved by the owner and the other party agrees that in no event will this Agreement be construed as a sale, an assignment, or an implied license of any such tangible or intangible property rights.

8.5 Mayo’s proprietary Platelet Lysate media supplement will specifically NOT be used in the work performed under this agreement and as such any developments incorporating this supplement will specifically not be subject to the option granted to Miromatrix in this agreement.

9. Termination.

9.1 This Agreement may be terminated prior to the expiration of the Term should either party materially breach this Agreement, the non-breaching party provides the breaching party with thirty (30) days advance written notice of termination, and such breach is not remedied within such thirty (30) day period.

9.2 In the event of termination pursuant to Section 9.1 by Miromatrix, at Miromatrix’ option, Mayo shall return to Miromatrix the Consideration paid under Section 3.4 of this Agreement and Miromatrix shall waive all rights and options to data, results and Mayo inventions and discoveries as granted hereunder..

9.3 In the event of termination pursuant to Section 9.1 by Mayo, Miromatrix shall reimburse Mayo for the amount of the Mayo Project Cost corresponding to the percent of the Budget “Specific Aims” already completed as of the date of termination.

10. Warranty Disclaimers. MAYO SERVICES AND INVENTIONS PROVIDED OR CREATED PURSUANT TO THIS AGREEMENT ARE “AS IS”, “WITH ALL FAULTS, AND “WITH ALL DEFECTS” AND MAYO DISCLAIMS AND MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, INCLUDING BUT NOT LIMITED TO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, PATENTABILITY OR THAT MIROMATRIX’ USE OF THE PROJECT RESULTS WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS OR OTHER RIGHTS OF THIRD PARTIES.

11. LIMIT OF LIABILITY. MIROMATRIX AGREES THAT MAYO AND ITS AFFILIATES WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY OR ARISING OUT OF ANY RIGHTS GRANTED OR PERFORMANCE MADE UNDER THIS AGREEMENT, WHETHER TO OR BY COMPANY OR A THIRD PARTY. IN NO EVENT WILL MAYO’S LIABILITY OF ANY KIND INCLUDE ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE LOSSES OR DAMAGES, EVEN IF MAYO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR EXCEED THE TOTAL AMOUNT OF CONSIDERATION WHICH HAS ACTUALLY BEEN PAID TO MAYO BY MIROMATRIX AS OF THE DATE OF FILING AN ACTION AGAINST MAYO WHICH RESULTS IN THE SETTLEMENT OR AWARD OF DAMAGES TO MIROMATRIX.

12. Confidentiality. Mayo and Miromatrix have executed a Confidentiality and Non-Disclosure Agreement dated August 1, 2014 and attached as Exhibit C (the “CDA”) that is hereby incorporated by reference in this Agreement. All results relating to the Project are hereby included in the definition of Confidential Information in the CDA.

13. Publicity. Miromatrix will not use for publicity, promotion, or otherwise, any logo, name, trade name, service mark, or trademark of Mayo or its Affiliates, including, but not limited to, the terms “Mayo®,” “Mayo Clinic®,” and the triple shield Mayo logo, or any simulation, abbreviation, or adaptation of the same, or the name of any Mayo employee or agent, without Mayo’s prior, written, express consent. Mayo may withhold such consent in Mayo’s absolute discretion. With regard to the use of Mayo’s name, all requests for approval pursuant to this Section must be submitted to the Mayo Clinic Public Affairs Business Relations Group, at the following e-mail address: PublicAffairsBR@Mayo.edu at least five business days prior to the date on which a response is needed. Mayo will not use for publicity, promotion, or otherwise, any logo, name, trade name, service mark, or trademark of Miromatrix or its Affiliates, or the name of any Miromatrix employee or agent, without Miromatrix’ prior, written, express consent. Miromatrix may withhold such consent in Miromatrix’ absolute discretion.

14. Notice. Any notice or communication pursuant to this Agreement shall be sufficiently made or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed to the address below or as either party shall designate by written notice to the other party.

In the case of Mayo:

Tim Argo
Mayo Clinic Ventures
200 First Street SW
Rochester MN 55905
Telephone No: (507) 284-1839

In the case of Miromatrix:

Robert Cohen
President & CEO
Miromatrix Medical Inc.
18683 Bearpath Trail
Eden Prairie, MN 55347
Telephone No: (612) 202-7026

15. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Minnesota exclusive of choice of law except interpretation of patent rights.

16. Entire Agreement. This Agreement, together the agreements signed on January 1, 2011 and September 15, 2013 with all attachments and exhibits, constitutes the entire agreement and understanding between the parties and supersedes any prior or contemporaneous negotiations, agreements, understandings, or arrangements of any nature or kind with respect to the subject matter herein. In the event of any inconsistency between this Agreement or any attachments and exhibits, the terms of this Agreement shall govern.

17. Waiver. Neither party waives its right to enforce any and all provisions of the Agreement at any time during the Term. Either party’s failure to enforce any provision shall not prejudice such party from later enforcing or exercising the same or any other provision of the Agreement.

18. Modifications. This Agreement may not be changed, altered, modified, amended, rescinded, canceled or waived except by a writing executed by authorized representatives of the parties.

19. Binding Agreement on Successors. This Agreement shall be binding upon each party’s successors and assigns.

20. Headings. Headings are for convenience of reference only, and not for interpreting the provisions of the Agreement.

21. Counterparts. This Agreement may be executed in counterparts, and by either party on separate counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

22. Potential New Organ Prize. In the event that the $1,000,000.00 New Organ Liver Prize offered by the Methuselah Foundation (http://www.neworgan.org/prize.php) is awarded to Miromatrix based upon the Project, Miromatrix shall grant $1,000,000.00 of Miromatrix stock from the then-most recently open financing round to Mayo at the price/share then in effect.

23. Payment Schedule. Miromatrix shall pay Mayo for the Project pursuant to the schedule incorporated in the Budget. At the conclusion of each noted portion of the project, Mayo shall submit an invoice to Miromatrix for the amount due.

[Remainder of this page intentionally left blank]

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized representatives as of the date first above written.

MIROMATRIX MEDICAL INC.
By:	/s/ Robert Cohen
Name:	Robert Cohen
Title:	President & CEO
Date: 12/19/2014
MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:
Name:
Title:
Date: 12/10/2014

Miromatrix/Mayo Transplantable Liver Project

Exhibit A- Statement of Work

The Transplantable Liver Program “Project” is divided into three Specific Aims consisting of work being performed at Miromatrix and the Mayo Clinic over a continuous 24 calendar months period. Included in the specific aim budget (Exhibit B) below are funds for a dedicated Post-Doc in Dr. Allan Dietz’s Lab ($75,000) and a dedicated Scientist in Dr. Scott Nyberg’s Lab ($160,000). Below is a summary of each specific aim and the desired outcome.

Summary of Project Specific Aims/Milestones - 2 year program:

1. Characterization of Re-Endothelialization Liver Seeded In-Vivo with Hepatocytes Seeding [18 months]

1. Demonstrate continuous perfusion of transplanted re-endothelialized liver for 30 days

2. Characterize seeding with hepatocytes at time of implantation at 7 days

3. Characterize seeding with hepatocytes at time of implantation at 30 days

2. Optimization of Hepatocyte Seeding in Liver Matrix [13 months]

1. Optimization of hepatocyte seeding condition (perfusion versus injection, single cells versus spheroids)

2. Optimization of culturing media conditions

3. Final culturing optimization

3. Characterization of Transplanted Recellularized Liver [11 months]

1. Characterize fully recellularized liver at 7 days

2. Characterize fully recellularized liver at 30 days

Detailed Statement of Work

Specific Aim #1-1 (6 months- January 2015-June 2015)

The goal of specific aim 1-1 is to first demonstrate the ability of a re-endothelialized (revascularized) liver graft to be transplanted into a recipient large animal and remain perfused for 30 days. Four (4) pigs will be successfully transplanted with a re-endothelialized graft and monitored for 30 days to characterize the hemodynamics of the transplanted graft during this time. Success will be determined by the degree of open vascularity during the duration.

Responsibilities/budget:

Miromatrix:

Miromatrix is responsible for the decellularization, recellularization including endothelial cell seeding optimization, and the delivery of the graft to Mayo.

Mayo:

Dr. Scott Nyberg is responsible for the transplantation, a minimum of weekly hemodynamic characterization via ultrasound, explantation, and histological evaluation of the graft.

Dr. Allan Dietz is responsible for the isolation and characterization of the pig endothelial cells which will be transferred to Miromatrix. Allogeneic endothelial cells will be used unless an immune rejection is detected and then autologous endothelial cells will be used.

Specific Aim #1-2 (6 months- June 2015-December 2015)

The goal of specific aim 1-2 is to utilize the successful results from Specific Aim 1-1 and then seed the graft with autologous hepatocytes at the time of implantation of the re-endothelialized liver graft. This specific aims explores the ability of hepatocytes and accessory liver cells to proliferate in-vivo when seeded into a fully revascularized liver construct. A total of six (6) pigs will be successfully transplanted with a re-endothelialized graft with three (3) receiving autologous hepatocytes via direct injection and three (3) receiving autologous hepatocytes via perfusion (utilizing results from Specific Aim 2-1) for 7 days. Histological characterization will include H&E, pig albumin, Ki67, and a specific endothelial and bile duct cell marker. Successful results are defined by the detection of viable hepatocytes in the transplanted liver graft after 7 days.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization, recellularization including endothelial cell seeding optimization, and the delivery of the graft to Mayo.

Mayo:

Dr. Scott Nyberg is responsible for the transplantation, autologous hepatocyte isolation, injection or perfusion of hepatocytes, animal care, and general histological evaluation of the graft.

Dr. Allan Dietz is responsible for the isolation and characterization of the pig endothelial cells which will be transferred to Miromatrix and the immunohistochemical staining of the explanted liver sections for pig albumin, Ki67, and a specific endothelial and bile duct cell marker.

Specific Aim #1-3 (6 months- January 2016-June 2016)

The goal of specific aim 1-3 utilizes the successful results from Specific Aim 1-2 to seed the graft with autologous hepatocytes at the time of implantation of the revascularized liver graft for 30 days. This specific aim further characterizes the ability of hepatocytes and accessory liver cells to proliferate and function in-vivo when seeded into a fully revascularized liver construct. The results of Specific Aim 1-2 will be used to define the desired seeding technique. A total of six (6) pigs will be successfully transplanted with a re-endothelialized graft with the defined method from Specific Aim 1-2. Histological characterization will include H&E, pig albumin, Ki67, and a specific endothelial and bile duct cell marker.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization, recellularization including endothelial cell seeding optimization, and the delivery of the graft to Mayo.

Mayo:

Dr. Scott Nyberg is responsible for the transplantation, autologous hepatocyte isolation, injection or perfusion of hepatocytes, animal care, and general histological evaluation of the graft.

Dr. Allan Dietz is responsible for the isolation and characterization of the pig endothelial cells which will be transferred to Miromatrix and the immunohistochemical staining of the explanted liver sections for pig albumin, Ki67, and a specific endothelial and bile duct cell marker.

Specific Aim #2-1 (5 months- January 2015-May 2015)

The goal of specific aim 2-1 is the optimization of hepatocyte seeding conditions with endothelial and bile duct epithelial cells to define the optimal seeding conditions to support hepatocyte engraftment into the matrix. For each seeding condition (perfusion, direct injection, or the combination) five (5) liver constructs will be seeded with isolated hepatocytes or five (5) liver constructs will be seeded with spheroids for seven (7) to fourteen (14) days of in-vitro cell culture in a Miromatrix -designed bioreactor system. Characterization of engraftment, viability and functionality will be achieved through the media characterization of glucose, albumin and urea levels. In addition, histological analysis including staining for hepatocytes, endothelial and bile duct epithelial cells, and SEM will be performed to evaluate the spatial orientation of the seeded hepatocytes. Success will be defined by the percent of viable hepatocyte after the defined cell culture duration and the level of metabolic activity.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization, hepatocyte and endothelial cell seeding optimization, isolation of media, and fixation of the liver graft.

Mayo:

Dr. Scott Nyberg is responsible for the isolation of the hepatocytes, growth of spheroids and their shipment/transfer to Miromatrix.

Dr. Allan Dietz is responsible for the histological submission of the samples, media analysis and immunohistochemical staining.

Specific Aim #2-2 (5 months- June 2015-October 2015)

The goal of specific aim 2-2 is the optimization of cell culture media to maximum hepatocyte function, endothelial and bile duct epithelial cell proliferation. Six (6) cell culture media conditions, to be defined by Miromatrix and Mayo, will be evaluated on five (5) recellularized liver constructs for a total of thirty (30) constructs for seven plus (7+) days of in-vitro cell culture in a Miromatrix designed bioreactor system. Each construct will be characterized by glucose, albumin and urea analysis. In addition, histological analysis including staining for hepatocytes, endothelial cells, epithelial cell, and proliferation will be performed to define the optimal condition. Success will be defined by the percent of viable hepatocyte after the defined cell culture duration and the level of metabolic activity, the percent endothelial cell coverage within the vasculature, and the percent bile duct cell coverage within the bile duct system.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization, media screening of half of the conditions, isolation of media and fixation of the liver graft.

Mayo:

Dr. Scott Nyberg is responsible for the isolation of the hepatocytes and/or the growth of spheroids depending on the defined seeding protocol from Specific Aim 2-1.

Dr. Allan Dietz is responsible for media screening of half of the conditions to be defined by Miromatrix, isolation of media, and fixation of the liver graft. In addition, Dr. Dietz’ group will coordinate histological submission of the samples, media analysis, and immunohistochemical staining.

Specific Aim #2-3 (3 months- November 2015-Janurary 2016)

The goal of specific aim 2-3 is the final optimization of cell culture conditions to maximize the successful complete recellularization of the liver construct for transplantation in Specific Aim 3. Utilizing the defined seeding protocol for Specific Aim 2-1 and the media condition from Specific Aim 2-2, Specific Aim 3-3 will involve the further optimization of cell seeding, culturing duration, bioreactor modification and whole liver construct characterization through the culturing of ten (10) liver constructs. Success will be defined by the increased percent of viable hepatocytes after the defined cell culture duration and the level of metabolic activity, the increased percent endothelial cell coverage within the vasculature, and the increased percent bile duct cell coverage within the bile duct system.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization, cell seeding and final optimization of half of the conditions, isolation of media, and fixation of the liver graft.

Mayo:

Dr. Scott Nyberg is responsible for the isolation of the hepatocytes and/or the growth of spheroids depending on the defined seeding protocol from Specific Aim 2-2.

Dr. Allan Dietz is responsible for cell seeding and final optimization of half of the conditions to be defined by Miromatrix, isolation of media, and fixation of the liver graft. In addition, Dr. Dietz’ group will coordinate histological submission of the samples, media analysis and immunohistochemical staining of all liver samples.

Specific Aim #3-1(6 months- February 2016-July 2016)

The goal of specific aim 3-1 utilizes the successful results from Specific Aim 2-3 to provide an optimized recellularized liver graft for transplantation. A total of five (5) pigs will be successfully transplanted with a recellularized liver graft with the defined seeding and culture method from Specific Aim 2-3 for 7 days. Hepatocyte seeding will involve the autologous isolation of hepatocytes, possible endothelial cells and bile duct cells from the recipient pig prior to transplantation depending on earlier results. Following transplantation, the hemodynamics of the transplanted graft will be evaluated via ultrasound to assess perfusion of the graft. Following explantation, histological characterization will include H&E, pig albumin, Ki67, and a specific endothelial and bile duct cell marker. Success will be defined by the successful transplantation, vascular flow after 7 days, and the percent of viable hepatocytes after 7 days.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization , recellularization of half of the grafts, and the delivery of the graft to Mayo.

Mayo:

Dr. Scott Nyberg is responsible for the autologous hepatocyte isolation, transfer of cells to Miromatrix or Dr. Dietz’ group, transplantation of the recellularized graft, animal care, and general histological evaluation of the graft.

Dr. Allan Dietz is responsible for the recellularization of half of the grafts (defined by Miromatrix) and immunohistochemical staining of the explanted liver sections for pig albumin, Ki67 and a specific endothelial and bile duct cell marker.

Specific Aim #3-2 (5 months- August 2016-December 2016)

The goal of specific aim 3-1 utilizes the successful results from Specific Aim 3-1 to characterize longterm transplantation of the recellularized liver graft. A total of six (6) pigs will be successfully transplanted with a recellularized liver graft with the defined seeding and culture method from Specific Aim 3-1 for 30 days. Hepatocyte seeding will involve the autologous isolation of hepatocytes, possible endothelial cells and bile duct cells from the recipient pig prior to transplantation depending on earlier results. Following transplantation, the hemodynamics of the transplanted graft will be evaluated via ultrasound to assess perfusion of the graft. Following explantation, histological characterization will include H&E, pig albumin, Ki67, and a specific endothelial and bile duct cell marker. Success will be defined by the successful transplantation, vascular flow after 30 days, and the percent of viable hepatocytes after 30 days.

Responsibilities:

Miromatrix:

Miromatrix is responsible for the decellularization , recellularization of half of the grafts, and the delivery of the graft to Mayo.

Mayo:

Dr. Scott Nyberg is responsible for the autologous hepatocyte isolation, transfer of cells to Miromatrix or Dr. Dietz’ group, transplantation of the recellularized graft, animal care, and general histological evaluation of the graft.

Dr. Allan Dietz is responsible for the recellularization of half of the grafts (defined by Miromatrix) and immunohistochemical staining of the explanted liver sections for pig albumin, Ki67, and a specific endothelial and bile duct cell marker.

Exhibit B

Mayo Cost

	Cost Each		Qty		Total		Lab
7 Day Implant Animal Costs	$	2,500		16	$	40,000	Nyberg
30 Day Implant Animal Costs	$	3,500		16	$	56,000	Nyberg
Hepatocyte Isolation	$	2,500		23	$	57,500	Nyberg
In-Vitro Liver Culture	$	1,600		32	$	51,200	Dietz
Histological Analysis (Immuno)					$	30,000	Dietz
Analysis (ELISA, media ETC)					$	40,000	Nyberg/Dietz
FTE Support
Nyberg (24 months)					$	160,000
Dietz					$	75,000
Total Mayo Direct Costs					$	509,700
Indirect Costs					$	152,910
Total Mayo Direct + Indirect Costs					$	662,610
Mayo ILP Funds					$	200,000
Miromatrix Funds Payable to Mayo					$	462,610

	Nyberg Funds		Dietz Funds		Miromatrix Funds			Project Total
Specific Aim #1	$	106,333	$	35,000	$	97,333
Specific Aim #2	$	110,833	$	93,400	$	113,033
Specific Aim #3	$	116,333	$	47,800	$	91,723
Total Direct Costs	$	333,500	$	176,200	$	302,090
Indirect Costs	$	100,050	$	52,860
Total Direct + Indirect Costs	$	433,550	$	229,060	$	302,090
							$	964,700

Payment Schedule

	Percent			Estimated Date	Amount		Minus ILP Funds			Total Due
Specific Aim #1
Miromatrix authorization of initiation of Specific Aim		85	%	1/1/2015	$	156,172.00	$	(100,000.00	)	$	56,172.00
Delivery of Final Report by Mayo to Miromatrix		15	%	7/1/2016	$	27,561.00				$	27,561.00
Specific Aim #2
Miromatrix authorization of initiation of Specific Aim		85	%	1/1/2015	$	225,677.00	$	(100,000.00	)	$	125,677.00
Delivery of Final Report by Mayo to Miromatrix		15	%	2/1/2016	$	39,826.00				$	39,826.00
Specific Aim #3
Miromatrix authorization of initiation of Specific Aim		85	%	2/1/2016	$	181,367.00				$	181,367.00
Delivery of Final Report by Mayo to Miromatrix		15	%	12/31/2016	$	32,006.00				$	32,006.00

EXHIBIT C

CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT

MUTUAL CONFIDENTIALITY AGREEMENT

This Agreement is made this 28th day of October, 2014 (“Effective Date”) by and between Mayo Foundation for Medical Education and Research, with offices at 200 First Street SW, Rochester, Minnesota 55905 (“Mayo”) and Miromatrix Medical Inc. with offices at 18683 Bearpath Trail, Eden Prairie, MN 55347 (“Company”). As used herein, a party disclosing Information (as defined below) shall be defined as the “Disclosing Party”, and the party to whom the Disclosing Party discloses such information shall be defined as the “Recipient.” In order to protect certain confidential information that may be disclosed between Mayo and Company, the parties agree as follows:

1. Definition. Confidential information (“Information”) shall consist of all unpublished or nonpublic information or materials including, but not limited to, written, oral or virtually presented information and such items as electronic media products, trade secrets, financial information, equipment, databases and the like (a) for Mayo, clinical and developmental know-how associated with the culturing of stem cells and the transplantation of decellularized organs (Mayo file # 2010-315); and (b) for Company, developmental, scientific, market, and clinical know-how and information associated with decellularization, recellularization, maturation, and utilization of animal and human organs and other vascularized tissue, that is provided in the course of discussions between Mayo and Company or in the performance of services by Mayo for Company (“Relationship”).

The Recipient’s duties under this Agreement shall apply only to Information that is:

(a) disclosed by the Disclosing Party in writing and is marked at the time of disclosure to indicate it is confidential;

(b) disclosed by the Disclosing Party in any other manner and is indicated at the time of disclosure to be confidential and thereafter is also summarized and designated as confidential in written form and delivered to Recipient within one month of the disclosure; or

(c) disclosed in the form of tangible materials transmitted to Recipient with an accompanying written notification indicating the confidential nature of the materials.

2. Non-Disclosure and Non-Use. Information shall not:

(a) be used for any purpose other than the Relationship; or

(b) be disclosed in any manner to any third party without the prior written consent of the Disclosing Party. Recipient may disclose Information to its employees and those of its legal affiliates, attorneys and accountants (“Recipient Representatives”) who have a need to know exclusively for purposes of the Relationship, provided that Recipient Representatives are bound by Recipient to maintain the confidentiality of the Information in compliance with this Agreement.

3. Exceptions. This Agreement imposes no obligation upon Recipient with respect to Information that Recipient can prove to a court of competent jurisdiction:

(a) was at the time of receipt, in the public domain, which means information that is generally known among or readily accessible to persons that normally deal with the kind of information in question; or

(b) became, after its receipt, part of the public domain through no fault of Recipient; or

(c) was in the possession of Recipient before its receipt from the Disclosing Party or its representatives; or

(d) is received in good faith by Recipient from a third party and is not subject to an obligation of confidentiality owed to the third party; or

(e) is independently developed by Recipient without reference to Information received hereunder, as established by competent proof; or

(f) is disclosed pursuant to a requirement or request of a government agency, subpoena or other legal proceeding, provided that in the event that Recipient becomes legally compelled (by deposition, interrogatory, request for documents, subpoena, civil investigation demand, other demand or request by government agency or the application of statutes, rules and regulations under the federal securities laws or similar process) to disclose any of the Information, Recipient shall provide the Disclosing Party with prompt written notice of such requirement prior to such disclosure to allow the Disclosing Party to seek a protective order or other remedy. In the event that a protective order or other remedy is not obtained, or that the Disclosing Party waives compliance with the provisions hereof, Recipient agrees to furnish only that portion of the Information that Recipient reasonably believes is legally required to be furnished.

4. Standard of Care. Each party shall protect Information using the same degree of care, but no less than a reasonable degree of care, as the party uses to protect its own confidential information. In the event that Recipient becomes aware of any use or disclosure not consistent with the purpose of this Agreement, Recipient shall immediately notify the Disclosing Party and endeavor to prevent any further unauthorized disclosure or use. The owners of Information may seek equitable and legal remedies as appropriate in the event of a threatened or actual disclosure.

5. Term. This Agreement controls only Information that is disclosed to Recipient during the period between the Effective date and three (3) years later. However either party may terminate this period earlier by prior written notice to the other party. The obligations of Recipient under this Agreement shall survive and continue for four (4) years after the expiration or termination of this Agreement.

6. Termination. Upon the termination or completion of the Negotiations, all documents in each party’s possession that incorporate the other party’s Information shall be returned to the Disclosing Party. Each party may retain one copy of the Information in its legal offices for archival purposes.

7. Export Control. The parties agree not to use or otherwise export or re-export anything exchanged or transferred between them pursuant to this agreement except as authorized by United States law and the laws of the jurisdiction in which it was obtained. In particular, but without limitation, items exchanged may not be exported or re-exported (a) into any U.S. embargoed countries or (b) to anyone on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Department of Commerce Denied Person’s List or Entity List. By entering into this Agreement, each party represents and warrants that it is not located in any such country or on any such list. Each party also agrees that it will not use any item exchanged for any purposes prohibited by United States law. In the event either party becomes aware of any suspected violations of this paragraph that party will promptly inform the other party of such suspected violation, and cooperate with the other party in any subsequent investigation and defense, be they civil or criminal.

8. No License. Under this Agreement neither party (a) acquires any license under intellectual property rights of the other party; or (b) has an obligation to purchase from or sell to the other party any service or item.

9. Amendment. This Agreement may not be amended or modified except by a writing signed by both parties and identified as an amendment to this Agreement.

10. Binding Effect. This Agreement shall be binding upon and inure to the benefit of the parties, their heirs, legal representatives, successors and assigns.

11. Complete Agreement. This Agreement constitutes the final, complete and exclusive agreement between the parties with respect to its subject matter and supercedes all past and contemporaneous agreements, promises and understandings, whether oral or written, between the parties.

12. Relationship. It is mutually understood and agreed that the relationship between the parties is that of independent contractors. Neither party is the agent, employee or servant of the other. Except as specifically set forth herein, neither party shall have nor exercise any control or direction over the methods by which the other party performs work or obligations under this Agreement. Further, nothing in this Agreement is intended to create any partnership, joint venture, lease or equity relationship, expressly or by implication, between the parties.

13. Severability. In the event any provision of this Agreement is held to be invalid or unenforceable, the remainder of this Agreement shall remain in full force and effect as if the invalid or unenforceable provision had never been a part of the Agreement.

14. Waiver. The failure of either party to complain of any default by the other party or to enforce any of such party’s rights, no matter how long such failure may continue, will not constitute a waiver of the party’s rights under this Agreement. The waiver by either party of any breach of any provision of this Agreement shall not be construed as a waiver of any subsequent breach of the same or any other provision. No part of this Agreement may be waived except by the further written agreement of the parties.

15. Use of Name. Except as provided in Paragraph 3(f) above, neither party shall, without the prior written consent of the other party, directly or indirectly, make any public or private comment, statement or communication with respect to, or otherwise disclose or permit the disclosure of the existence of discussions regarding a possible transaction between the parties or any of the terms, conditions or other aspects of any such transaction or any other Information. Neither party will use the name or trademarks of the other party in any news release, publicity, advertising, endorsement or commercial communication without the prior written approval of the other party. All requests for approval of the use of Mayo’s name pursuant to this Paragraph must be submitted to the Mayo Clinic Public Affairs Business Relations Group, at the following E-mail address: publicaffairsbr@mayo.edu at least five (5) business days prior to the date on which a response is needed.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate by proper person there unto duly authorized.

MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH		MIROMATRIX MEDICAL INC.
By:	/s/ James A. Rogers III	By:	/s/ Robert Cohen
Date:	11/4/2014	Date:	11/4/2014
Name:	James A. Rogers III	Name:	Robert Cohen

Printed Title:   Chair, Mayo Clinic Ventures Printed Title:   President & CEO

EX-10.10

Exhibit 10.10

LICENSE AGREEMENT
AMENDMENT #1

WHEREAS, effective as of December 1, 2014, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 18683 Bearpath Trail, Eden Prairie, MN 55347 ("Miromatrix") and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo") executed a License Agreement (the "Agreement") for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1. The Term of the Agreement shall be extended for an additional one year period. Accordingly, the new expiration date of the Agreement shall be December 31, 2017.

2. Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.		MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Robert Cohen	By:	/s/ Randall S. Jones
Name:	Robert Cohen	Name:	Randall S. Jones
Title:	President & CEO	Title:	Operations Manager
Date:	September 16, 2016	Date:	9/20/2016

EX-10.11

Exhibit 10.11

LICENSE AGREEMENT

AMENDMENT #2

WHEREAS, effective as of December 1, 2014, and as further amended September 20, 2016, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 10399 West 70th Street, Eden Prairie, MN 55344 ("Miromatrix") and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo") executed a License Agreement (the "Agreement") for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1. The Term of the Agreement shall be extended for an additional one year period. Accordingly, the new expiration date of the Agreement shall be December 31, 2018.

2. Miromatrix has agreed to provide additional funding of $60,000 for year three of the Project. Accordingly, the attached Exhibit B-1 shall amend Section 3 of the Agreement.

3. Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.		MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Jeff Ross	By:	/s/ Randall S. Jones
Name:	Jeff Ross	Name:	Randall S. Jones
Title:	CEO	Title:	Operations Manager
Date:	9/5/2017	Date:	9/12/2017

Budget - Exhibit B-1

TT MAYO CLINIC

PI Name:     Stott Nyberg, MD, PhD 

MCR Funding Proposal Number: FP86573-41-A1-41 

Sponsor; Miromatrix Medical Inc. 

Date: 8/2/17

Study Title: Amendment #2: Miromatrix/Mayo Transplantable Liver Project (Nyberg}

	1/1/18-12/31/18**
Personnel: (Includes salary and benefits"):
Dr. Scott Nyberg, PI		23,076
Lab Supplies:
Hapatccyte Isolation		7,693
Large Animal Care - Chronic		15,385
Sub-Total		46,154
Indirects (30%)		13,846
BUDGET TOTAL		60,000

Payment Terms: 100% due upon execution of contract

*Salary and benefit rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against Mayo policy

' This budget only reflects the budget for year 3 which is being added with amendment 2.

Years 1-2 have already been negotiated.

NOTE: This is only a budget estimate, budget ay be adjusted due to the following changes: salaries, fees, procedures, etc.

Prepared by:

Sherry Foster, Sponsored Projects Specialist

EX-10.12

Exhibit 10.12

AMENDMENT NO. 3
TO
LICENSE AGREEMENT
BETWEEN
MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
AND
MIROMATRIX MEDICAL INC.

THIS Amendment No. three (“Amendment No. 3”), effective as of February, 21, 2017, to the License Agreement (“Agreement”) with an effective date of December 1, 2014, between Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation having its principal place of business at 200 pt Street S W, Rochester, Minnesota 55905-0001 (“MAYO”) and Miromatrix Medical Inc., a corporation having its principal place of business at 18683 Bearpath Trail, Eden Prairie, Minnesota 55347 (“COMPANY”) is hereby amended under the following terms:

1. The following invention disclosure and provisional patent application are determined to be jointly owned Intellectual Property, under the terms of Section 8. Intellectual Property Rights in the Agreement: Mayo Invention Disclosure # 2017-266: “Use of Resected Liver Serum for Whole Liver-Engineering”, Mayo Inventor - Scott L. Nyberg M.D., Ph.D. and Provisional Patent Application Docket No.: 3242.007PRV Title: Use of Resected Liver Serum for Whole Liver-Engineering.

The terms of this Amendment No. 3 supersede any conflicting or inconsistent tem1s in the Agreement. All other provisions of the original Agreement remain in full force and effect.

This Agreement may be executed in any number of counterparts which, when taken together, will constitute an original, and photocopy, facsimile, electronic or other copies shall have the same effect for all purposes as an ink-signed original. Each Party hereto consents to be bound by photocopy or facsimile signatures of such Party’s representative hereto.

Mayo Foundation for Medical Education and Research			Miromatrix Medical Inc.
By	/s/Daniel D. Estes		By	/s/ Jeff Ross
	Name:	Daniel D. Estes		Name:	Jeff Ross
	Title:	Assistant Treasurer		Title:	CEO
Date: 9/15/2017			Date:	9/25/2017

EX-10.13

Exhibit 10.13

LICENSE AGREEMENT
AMENDMENT #4

WHEREAS, effective as of December 1, 2014, and as further amended September 20, 2016, September 12, 2017, and February 21, 2017, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office 10399 West 70th Street, Eden Prairie, MN 55344 ("Miromatrix") and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo") executed a License Agreement (the "Agreement") for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1. The Term of the Agreement shall be extended for an additional 6 month period. Accordingly, the new expiration date of the Agreement shall be June 30, 2019.

2. Miromatrix has agreed to provide additional funding of $444,448 for year three of the Project. Accordingly, the attached Exhibit B-2 shall amend Section 3 of the Agreement.

3. The parties wish to add an additional project to the Statement of Work. Accordingly, the attached Exhibit A-1 shall hereby amend the Statement of Work/the Project.

4. Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.		MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Jeff Ross	By:	/s/ Virginia M. Bruce
Name:	Jeff Ross	Name:	Virginia M. Bruce
Title:	CEO	Title:	Director, Legal Contract Adminis-tration
Date:	1/23/2018	Date:	1/24/2018

Budget - Exhibit B-2

U MAYO CLINIC  

PI Name:          Scott Nyberg, MD, PhD  

MCR Funding Proposal Number: FP86573-A1-A1-A1-A1  

Sponsor: Miromatrix Medical Inc.
Date: 12/27/07              

Study Title: Amendment #4: Miromatrix/Mayo Transplantable Liver Project (Nyberg)

	1/1/18-12/31/18**
Personnel: (Includes salary and benefits*):	$	77,683
Dr. Scott Nyberg, PI
Bruce Amiot, Business Analyst
Lab Supplies:
Media	$	108,000
ICP Probes	$	29,000
Internal Services:
Cr scans	$	7,200
Pigs + OR	$	72,000
Pig Harvests	$	24,000
Auto Transplants	$	24,000
Sub-Total	$	341,883
lndirects (30%)	$	102,565
BUDGET TOTAL	$	444,448

Payment Terms: The total budget above will be payable in four quarterly payments of $111,112 each. The first payment of $111,112 will be payable upon execution of the contract amendment. The remaining three payments will be invoiced at 3 months, 6 months, and 12 months after contract amendment execution.

*Salary and benefit rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against Mayo policy

** This budget only reflects the additional funds that are being added with amendment #4.

Exhibit A-1

Project 1: Implantation of a revascularized decellularized liver graft with autologous portal hepatocyte seeding post transplantation.

Project 2: The model development and testing of a recellularized liver grafts to provide functional support in a pig model for 48 hours.

EX-10.14

Exhibit 10.14

LICENSE AGREEMENT

AMENDMENT #5

WHEREAS, effective as of December 1, 2014, and as further amended, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office 10399 West 70th Street, Eden Prairie, MN 55344 (“Miromatrix”) and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 (“Mayo”) executed a License Agreement (the “Agreement”) for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1. The Term of the Agreement shall be extended to March 31, 2020.

2. Miromatrix has agreed to provide additional funding of $200,000 for extension described in #1 above. Accordingly, the attached Exhibit B-3 shall amend Section 3 of the Agreement.

3. Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.		MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Jeff Ross	By:	/s/ Brenda L. Burns
Name:	Jeff Ross	Name:	Brenda L. Burns
Title:	CEO	Title:	Sr. Contract Manager
Date:	5/12/2019	Date:	5/7/2019

Budget – Exhibit B-3

EX-10.15

Exhibit 10.15

LICENSE AGREEMENT
AMENDMENT #6

WHEREAS, effective as of December 1, 2014, and as further amended, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office 10399 West 70th Street, Eden Prairie, MN 55344 (“Miromatrix”) and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 (“Mayo”) executed a License Agreement (the “Agreement”) for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1.          The Term of the Agreement shall be extended to February 28, 2021.

2.          Miromatrix has agreed to provide additional funding of $400,000 for

extension described in #1 above. Accordingly, the attached Exhibit B-4 shall amend Section 3 of the Agreement.

Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.		MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
By:	/s/ Jeff Ross	By:	/s/ Randall S. Jones
Name:	Jeff Ross	Name:	Randall S. Jones
Title:	CEO	Title:	Operations Manager
Date:	2/27/2020	Date:	2/28/2020

Budget

Pl Name: Scott Nyberg, MD, PhD
MCR Funding Proposal Number: FP86573-Al-Al-Al-Al-Al-Al

Sponsor: Miromatrix Medical Inc.
Date: 2/27 /20

Study Title: Amendment #6: Miromatrix/Mayo Transplantable Liver Project (Nyberg)

	Additional funding to extend project through 2/28/21 **
Personnel: $	$	206,744
Dr. Scott Nyberg, Pl
Bruce Amiot, Business Analyst
Lab Supplies & Internal Services: $	$	100,949
Sub-Total $	$	307,693
Indirects (30%) $	$	92,307
BUDGET TOTAL $	$	400,000

Payment Terms: The total budget above will be payable in 4 payments of $100,000 each. The first payment of $100,000 will be payable upon execution of contract amendment #6. The remaining payments will be invoiced at the beginning of each quarter thereafter. In addition to the $100,000 per quarter, if more than 6 liver transplants are performed per quarter then an additional $16,667 per transplant will be added to the invoice in the subsequent quarter.

* Salary and benefit rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against Mayo policy

** This budget only reflects the additional funds that are being added with amendment #6.

EX-10.16

Exhibit 10.16

LICENSE AGREEMENT

AMENDMENT #7

WHEREAS, effective as of December 1, 2014, and as further amended, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office 10399 West 70th Street, Eden Prairie, MN 55344 ("Miromatrix") and Mayo Foundation for Medical Education and Research, a not for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo") executed a License Agreement (the "Agreement") for Services as outlined in the Agreement.

WHEREAS, Miromatrix and Mayo wish to amend said Agreement.

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

1. The Term of the Agreement shall be extended to December 31, 2021.

2. Miromatrix has agreed to provide additional funding of $317,600 for extension described in #1 above. Accordingly, the attached Exhibit B-5 shall amend Section 3 of the Agreement.

3. Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

IN WITNESS WHEREOF, the Parties have executed this Amendment which shall be effective as of the last dated signature below.

MIROMATRIX MEDICAL INC.	MAYO FOUNDATION FOR MEDICAL
	EDUCATION AND RESEARCH

By:	/s/ Jeff Ross	By:
Name:	Jeff Ross	Name:
Title:	CEO	Title:
Date:	2/26/21	Date:

 

Budget - Exhibit B-5

Budget

PI Name:     Scott Nyberg, MD, PhD

MCR Funding Proposal Number: FP86573-A1-A1-A1-A1-A1-A1

Sponsor: Miromatrix Medical Inc.

Date: 2/25/21

Study Title: Amendment #7: Miromatrix/Mayo Transplantable Liver Project (Nyberg)

	Additional funding to extend project through 12/31/21**
Personnel:	$	137,485
Dr. Scott Nyberg, PI
Bruce Amiot, Business Analyst
Lab Supplies & Internal Services:	$	105,284
Sub-Total	$	242,769
Indirects (30%)	$	72,831
BUDGET TOTAL (excluding fees)	$	315,600
One-time, non-refundable fees:
IACUC Initial Review Fee	$	2,000.00
Total Fees:	$	2,000.00
BUDGET TOTAL	$	317,600.00

Payment Terms: The total budget will be payable in four payments. The first payment of $80,900, which includes the $2,000 non-refundable Initial IACUC Review Fee, will be due upon the execution of this contract for amendment #7; the second payment of $78,900 will be due on June 12021, the third payment of $78,900 will be due on August 12021, and the fourth payment of $78,900 will be due on November 1, 2021. Milestones of this sponsored research will include a minimum of 16 experiments according to two Mayo IACUC approved protocols [A0005683-evaluation of the ELAP device in a reversible model of ALF (12 experiments), A00003996-liver transplantation in pigs to compare donor grafts (4 experiments)] before the end of 2021.

*Salary and benefit rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against Mayo policy

**This budget only reflects the additional funds that are being added with amendment #7.

EX-10.17

Exhibit 10.17

SUB-LICENSE AGREEMENT

THIS SUB-LICENSE AGREEMENT is made as of the 1st day of October 2013 (the “Effective Date”) by and between Miromatrix Medical Inc., a Delaware corporation with a principal place of business at 18683 Bearpath Trail, Eden Prairie, MN 55347 USA (hereinafter “Miromatrix”), and Texas Heart Institute, a Texas non-profit corporation with a principal place of business at 6770 Bertner, Suite C 550, Houston, Texas 77030 (hereinafter “THI”). Miromatrix and THI may be referred to as a “Party” or, collectively, as “Parties.”

RECITALS

WHEREAS, THI is engaged in the research and development of medical products for the prevention and treatment of cardiovascular disease;

WHEREAS, Miromatrix is engaged in the research, development, manufacture and marketing of perfusion decellularization and recellularization technology and the products that are created utilizing such technology, including that under Miromatrix Patents;

WHEREAS, Miromatrix is the licensee of certain patents and patent applications described in Exhibit A annexed hereto (the “Licensed Miromatrix Patents”) pursuant to an Exclusive License Agreement with the University of Minnesota dated February 4, 2010, (the “License Agreement”);

WHEREAS, THI wishes to sub-license Miromatrix Patents (as defined herein) for use in the Product Area for research in the Product Area and development of Products; and

WHEREAS, Miromatrix is willing to grant such a sub-license under the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound thereby, the Parties agree as follows:

ARTICLE I
DEFINITIONS

1.1Definitions. The following terms, as used herein, have the following meanings:

“Act” means the United States Federal Food Drug and Cosmetic Act and applicable regulations.

“Affiliate” means, when used with reference to a Party, any person directly or indirectly Controlling, Controlled by or under common Control with a Party.

“Bankruptcy Event” means the person in question becomes insolvent, or voluntary or involuntary proceedings by or against such person are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for such person, or proceedings are instituted by or against such person for corporate reorganization or the dissolution of such person, which proceedings, if involuntary, will not have been dismissed within ninety days after the date or filing, or such person makes an assignment for the benefit of creditors, or substantially all of the assets of such person are seized or attached and not released within ninety days thereafter.

“Commercial Sale” means a bona fide sale, use., lease, transfer or other disposition for value of Product by a Party, or any Affiliate or any sub-licensee of a Party, to a third party that is not an Affiliate of such Party, except that the following shall be excluded from the definition of a Commercial Sale: (a) the transfer of Product to a third party without consideration in connection with the development or testing of a Product, (b) transfer of a Product by a Party to such Party’s Affiliates or sub-licensees for resale; or (c) the transfer of a Product to a third party for consideration for use in a clinical trial, so long as such clinical trial is being conducted prior to the availability of the Product for sale to the general public.

“Control,” “Controlling,” and “Controlled by” mean the direct or indirect ownership of over 50% of the outstanding voting securities of a Person, or the right to receive over 50% of the profits or earnings of a Person, or the right to control the policy decisions of a Person.

“Effective Date” means the date of this Agreement first written hereinabove.

“FDA” means the United States Food and Drug Administration or any successor regulatory agency.

“Intellectual Property” means patents, copyrights, trademarks, trade secrets, trade dress, know-how or other intellectual property rights, whether patented, patentable, pending or granted.

“Miromatrix Patents” means the Licensed Miromatrix Patents listed in the License Agreement and all present or future patents and patent applications owned or controlled by, or subject to an obligation of assignment to, Miromatrix necessary or required (i) for research in the Product Area or development of the Products; or (ii) to make, have made, supply, use, sell, offer to sell, or import the Products; and any and all applications and patents owned or controlled by Miromatrix that claim priority, in whole or in part, directly or indirectly, to one or more of the foregoing, including but not limited to continuations, continuations-in-part, additions, divisions, renewals, extensions, re-examinations and reissues of the foregoing and any and all foreign counterparts of the foregoing.

“Net Sales Price” means the amount invoiced for a Commercial Sale of a Product minus (i) all trade, quantity and discounts actually allowed, (ii) all credits and allowances granted due to rejections, returns, billing errors and retroactive price reductions, (iii) applicable duties, (iv) applicable excise, sale and use taxes, and (v) out of pocket expenses for freight and shipping of Products.

“Person” or “Persons” means any corporation, partnership, joint venture or natural person.

“Product Area” means the whole heart organ (as differentiated from parts of the heart including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like) for transplantation into human beings, whereby perfusion decellularization and/or perfusion recellularization has been utilized in any portion of the creation or manufacture of such whole heart organ.

2

“Products” means any and all products in the Product Area, the manufacture, use, sale, offer for sale, supply, or import of which, but for the sub-license granted hereunder, would infringe a Valid Claim of one or more of the Miromatrix Patents.

“Regulatory Approval” means regulatory authorizations required to sell Products in the geographic location where such Products are being sold.

“Term” has the meaning set forth in Article VIII.

“Territory” means all countries of the world.

“THI Patents” means any present or future patents and patent applications owned or controlled by THI necessary or required to make, have made, supply, use, sell, offer to sell, or import the Products and any and all continuations, continuations-in-part, additions, divisions, renewals, extensions, re-examinations and reissues thereof and any and all foreign counterparts of the foregoing.

“Valid Claim” means a claim of an issued and unexpired patent right which can be reasonably asserted against a Party manufacturing, using., offering for sale, selling or importing a Product absent a license and whose validity or enforceability has not been adversely affected by any of the following: (i) lapse, revocation, or abandonment, (ii) a determination by a court or other governmental agency of competent jurisdiction, which is unappealable, has not been appealed within the time allowed for appeal, or for which all possible appeals have been exhausted, that the patent is unenforceable or the infringed claims are invalid and/or (iii) a disclaimer or admission of invalidity or unenforceability through reissue, re-examination, opposition, nullity action or invalidation suit response, disclaimer or otherwise.

ARTICLE II
GRANT OF SUB-LICENSE

2.1Grant of Sub-License. Subject to the terms and conditions contained in this Agreement, and in consideration for the research and development of Products by THI for commercialization by Miromatrix, Miromatrix grants to THI an exclusive, even as to Miromatrix, non-transferrable, non-sub-licensable, worldwide license under the Miromatrix Patents for performance of research in the Product Area and the development of Products in accordance with the terms and conditions hereinafter set forth. The Parties agree that the foregoing license to THI includes the right to research and develop parts of the heart, including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like, provided THI is conducting such research and development of parts of the heart solely in furtherance of THI’s research and development of Products; provided, that this shall not be construed as a license to conduct clinical trials of, or sell, offer to sell, have sold, supply or import or otherwise commercialize or have commercialized, parts of the heart (including, without limitation, heart valves, cardiac patches, blood vessels, AV node and the like). The foregoing license shall be retroactive to the first publication date of a patent application falling within the Miromatrix Patents. Miromatrix represents and warrants that it possesses all rights to bring demands, claims, and causes of action against the THI, and THI’s representatives, officers, shareholders, directors, employees, subsidiaries, affiliates, divisions, successors and assigns (collectively the “Released Parties”) for infringement of the Miromatrix Patents, and that such demands, claims, and causes of action are within the scope of the license set forth in this Section 2.1.

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2.2Sub-License. THI agrees that the grant of the license by Miromatrix to THI as to Licensed Miromatrix Patents is a sub-license governed by the terms and subject to the conditions of the License Agreement. Miromatrix agrees that it shall not grant, or consent to the grant of, any right, title, or license to any Person in or to the Miromatrix Patents if such grant would permit another Person to make use, sell, offer to sell, supply, or import a Product.

2.3Research and Development Activities. THI agrees to use reasonable commercial efforts, consistent with sound and reasonable judgment and practices as customary in the medical device and biological products industries, at its cost and expense, to perform product development in the Product Area and to develop the Products. THI shall perform, or shall cause to happen or be performed as the case may be, all of Milestones 1, 2, 3, 4, 5 and 6 as set forth in Exhibit B annexed hereto (each a “THI Milestone” and collectively, “THI Milestones”). Failure by THI to meet any THI Milestone in a timely manner shall be grounds for termination of this Agreement. After written notice by Miromatrix to THI of failure to timely meet any THI Milestone and the failure by THI to cure such defaults within sixty (60) days thereafter, this Agreement shall terminate. All fees, costs, and expenses associated with achieving the THI Milestones shall be the sole responsibility of THI; Miromatrix shall not be obligated to provide or pay and such fees, costs, or expenses.

2.4Conversion of Sub-License Into Royalty Right. Upon achievement of THI Milestone #6, the sub-license granted by Miromatrix to THI pursuant to Section 2.1 shall terminate and Miromatrix shall continue the development and commercialization of the Products, subject to the right of THI to royalties from the sale of Products as set forth in Section 3.1. Miromatrix shall perform, or shall cause to happen or be performed, as the case may be, all of Milestones 7, 8, and 9 set forth in Exhibit B (each a “Miromatrix Milestone” and collectively, “Miromatrix Milestones”). All fees, costs; and expenses associated with achieving the Miromatrix Milestones shall be the sole responsibility of Miromatrix; THI shall not be obligated to provide or pay any such fees, costs, or expenses. Failure by Miromatrix to meet any Miromatrix Milestone in a timely manner shall be grounds for THI exercising its rights to revive its sub-license as hereinafter set forth.

2.5Revival of Sub-License Rights of THI. After written notice by THI to Miromatrix of failure to timely meet any Miromatrix Milestone and the failure by Miromatrix to cure such default within sixty (60) days, the sub-license set forth in Section 2.1 shall be back into full force and effect and shall be expanded to include the license to make, have made, supply, use, offer to sell, sell, have sold, and import Products, with the right to grant sub-licenses in the Territory, subject to the right of Miromatrix to receive royalties for sales of Products as set forth in Section 3.2 and the license rights of Miromatrix set forth in Section 2.7 hereof shall terminate and be of no further and effect. THI shall perform, or shall cause to happen or be performed, as the case may be, all of the Miromatrix Milestones, provided, however, the Miromatrix Milestones shall be extended for an aggregate of one year beginning with the defaulted Miromatrix Milestone in order to take into consideration Miromatrix’s prior non-performance. Failure by THI to meet any Miromatrix Milestone in a timely manner shall be grounds for Miromatrix terminating the sub-license set forth in Sections 2.1 and 2.5 hereof as hereinafter set forth.

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2.6 Termination of Sub-license by Miromatrix. After notice by Miromatrix to THI of failure to timely meet any Miromatrix Milestone and the failure by THI to cure such default within sixty (60) days, (i) the sub-license rights of THI set forth in Sections 2.1 and 2.5 hereof shall terminate and be of no further and effect, (ii) the license to Miromatrix in Section 2.7 shall be back into full force and effect, and (iii) Miromatrix shall be given an additional three (3) years following the end of the foregoing sixty (60) day period to begin to again attempt to achieve the Miromatrix Milestones. All of the foregoing subject to the right of THI to receive royalties for sales of Products as set forth in Section 3.1. Should Miromatrix not achieve the Miromatrix Milestones in accordance with this Section 2.6, then Miromatrix shall thereafter not be required to achieve any of the Miromatrix Milestones and all licenses, sublicenses and royalty obligations granted by one Party to another Party, and all sublicenses granted by a Party to a third party, pursuant to this Agreement shall immediately terminate, and shall no longer have any force or effect.

2.7THI License. Subject to the terms and conditions contained in this Agreement, THI grants to Miromatrix an exclusive, even as to THI, worldwide royalty bearing license under the THI Patents to develop, make, have made, use, supply, offer to sell, sell, have sold, and import Products, with the right to grant sub-licenses. THI will promptly notify Miromatrix of any inventions or discoveries in the Product Area that lead to the filing of THI Patent applications. THI shall retain nontransferable and non-sublicensable rights to the THI Patents in the Product Area solely for education, research, and product development purposes only; such retained right in the Product Area shall not include the right to supply, conduct clinical trials of, offer to sell, sell, have sold, import or otherwise commercialize or have commercialized any Products, other than as permitted by this Agreement.

2.8License for Product Improvements. If THI completes THI Milestone #6, and if Miromatrix desires additional research and development in an effort to improve the Products that exist after completion of THI Milestone #6 beyond what is required to comply with Milestones #7, #8 and #9 (“Improvements”), then Miromatrix shall notify THI in writing of the desire to research and develop the Improvements. Miromatrix shall provide such written notice to THI at least ninety (90) days before Miromatrix notifies any other Person of the desire for the Improvements. During that ninety (90) day period, the Parties shall negotiate in good faith a license or other rights in the Miromatrix Patents that may be needed for THI to research and/or development the Improvements.

2.9Ownership of Other Intellectual Property. Subject to the license grants set forth in this Agreement, neither Party grants to the other Party any right, title, or interest in and to such Party’s Intellectual Property.

2.10Prosecution and Maintenance. During the term, Miromatrix and THI shall each prosecute and maintain their respective patents and patent applications that are the subject of this Agreement.

2.11Patent Marking. Each Party shall comply with all legal patent marking requirements for the Products.

2.12Information. Each Party (“Disclosing Party”) agrees in a timely fashion to provide the other Party (“Receiving Party”), at the Disclosing Party’s cost and expense, such information, documentation and data which may from time to time exist, including research data, clinical data, technical information and other documentation and information, that is necessary or useful in connection with the performance by the Receiving Party of its obligations under this Agreement including, without limitation, achievement by the Receiving Party of the Milestones set forth in Exhibit B. The Receiving Party shall comply with Article VII pertaining to Confidential Information with respect to such information, documentation and data received from the Disclosing Party.

2.13Expenses. Each Party will perform their obligations under this Agreement, including, but not limited to, obtaining Regulatory Approvals and/or preparing or processing any required documentation, without the right for reimbursement from the other Party.

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ARTICLE III
ROYALTIES

3.1Miromatrix Royalty Payments. Pursuant to Sections 2.4 and 2.6, Miromatrix shall pay to THI a royalty of five percent (5%) of the Net Sale Price from the Commercial Sales of Products by Miromatrix or its Affiliates or sub-licensees. Additionally, in the event that Miromatrix receives monies as a result of a lawsuit based on allegations of infringement of, or in exchange for a license to, any of the Miromatrix Patents in the Product Area, Miromatrix shall notify THI of such monies and agrees such monies shall be subject to a royalty payment under this Section 3.1. The Parties agree to negotiate the amount of such payment in good faith.

3.2THI Royalty Payments. Pursuant to Section 2.5, THI shall pay to Miromatrix a royalty of ten percent (10%) of the Net Sales Price from the Commercial Sales of Products by THI or its Affiliates or sub-licensees.

3.3Royalty Payments and Sales Reports. Within sixty (60) days after the last day of a calendar quarter during the Term, the applicable Party shall deliver to the other Party a written sales report reasonably acceptable to the other Party, recounting the number and Net Sales Price amount (expressed in U.S. dollars) of all sales, supplies, leases, or other disposition of Products, whether made by such Party or a sublicensee, during such calendar quarter. Such Party shall deliver along with such sales reports its payment for royalties owed on all Commercial Sales of Licensed Products by such Party and the sublicensees during such quarter.

3.4Records and Audit. Each Party, as applicable, shall keep good and accurate books of account sufficient to permit determination of the royalty and should make such books of account available for inspection by the other Party or an accountant designed by the other Party. Such inspections shall be conducted during normal business hours, with at least seven (7) days advance notice from the other Party and no more frequent than once per calendar year and once within five (5) years after termination or expiration of this Agreement. The inspecting Party or its designated accountant shall retain in confidence the information in the books of account. The inspecting Party’s failure to inspect shall not constitute a waiver of its right to object to the accuracy of the payments made under this Agreement.

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ARTICLE IV

WARRANTIES AND REPRESENTATIONS

4.1Mutual Representations. Each of the Parties hereto represents, warrants and covenants:

(a)Miromatrix is a corporation and THI is a non-profit corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation, organization or formation.

(b)The execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate or entity action.

(c)It has the power and authority to execute and deliver this Agreement and perform its obligations hereunder.

(d)The execution, delivery and performance by such Party of this Agreement does not and will not conflict with or result in breach of the terms and provisions of any other agreement or constitute a default under (a) a loan agreement, guaranty, financing agreement, affecting a product or other agreement or instrument binding or affecting it or its property; (b) the provisions of its charter or operative documents or bylaws; or (c) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound.

(e)The execution, delivery and performance of this Agreement by such Party does not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or regulatory authority in the Territory and the execution, delivery and performance of this Agreement does not violate any law, rule or regulation applicable to such Party.

(f)This Agreement has been duly authorized, executed and delivered and constitutes such Party’s legal, valid, and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors’ rights and to the availability of particular remedies under general equity principles.

(g)Each Party will comply with all applicable laws and regulations relating to its activities under this Agreement; including, without limitations, the Act and regulations of the FDA and United States export laws and regulations, including without limitation the Foreign Corrupt Practices Act, Arms Export Control Act, Export Administration Act, Patriot Act and anti-bribery laws.

(h)Each Party is not debarred and has not and will not use in any capacity the services of any person debarred by the FDA under 21 U.S.C. §335a. If at any time during the term of this Agreement this warranty is no longer accurate, the affected Party will immediately notify the other Party.

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4.2 Licensed Miromatrix Patents. Miromatrix represents and warrants that: (a) Miromatrix is the licensee of the Licensed Miromatrix Patents governed by the terms and subject to the conditions contained in the License Agreement; and (b) Miromatrix has not received any written notice that the Miromatrix Patents with respect to the Products infringes the proprietary rights of any third party; (c) Miromatrix is not aware of any third party proprietary rights that would be infringed by the development and commercialization of the Products in the Product Area; and (d) there are no claims, demands, judgments or settlements against or owed by Miromatrix, or pending or, to Miromatrix’s knowledge, threatened claims, demands, or litigation, relating to the Miromatrix Patents.

4.3License Agreement. Conditioned upon THI’s agreement in Section 2.2 that this Sub-License Agreement is governed by the terms and subject to the conditions of the License Agreement, Miromatrix represents and warrants that this sub-license Agreement, as well as the terms and conditions herein, is in full compliance with the License Agreement and that Miromatrix is in full compliance with the License Agreement and has met all milestones set forth in the License Agreement. Miromatrix shall notify THE if Miromatrix fails, after the Effective Date, to meet a milestone in the License Agreement.

ARTICLE V
INDEMNIFICATION AND RELEASE

5.1Indemnification by Miromatrix. Miromatrix will indemnify and hold THI, its directors, officers, employees and agents harmless against any and all liability, damage, loss, cost or expense (including reasonable attorney’s fees) resulting from any third party claims, demands, suits, and/or causes of action made or asserted against, or suits brought against, THI which arise from (a) an act or failure to act by Miromatrix or (b) Miromatrix’s breach of any of its representations, warranties or agreements contained herein; or (c) the manufacture, use, lease, sale, offer to sell, supply, importation, or other disposition of the Products by Miromatrix or its sub-licensees (other than THI).

5.2Indemnification by THI. THI will indemnify and hold Miromatrix, its directors, officers, employees and agents harmless against any and all liability, damage, loss, cost or expense (including reasonable attorney’s fees) resulting from any third party claims, demands, suits, and/or causes of action made or asserted against, or suits brought against, Miromatrix which arise from (a) an act or failure to act by THI, (b) THI’s breach of any of its representations, warranties or agreements contained herein or (c) the rights granted to THI under this Agreement, including, without limitation, if applicable, the manufacture, use, lease, sale, offer to sell, supply, importation, or other disposition of the Products by THI or its sub-licensees.

5.3Procedures. The indemnified Party will notify the indemnifying Party of any claim, demand, cause of action, or suit that may give rise to a liability within fifteen (15) days after receipt of knowledge of the claim, demand, cause of action, or suit. If notice is not given within fifteen (15) days, the indemnifying Party will maintain its obligation to indemnify unless such failure to timely notify has a material, adverse effect on the outcome of the claim, demand, cause of action, or suit. The indemnifying Party will control the defense or settlement of the claim, demand, cause of action, or suit. However, the indemnifying Party will not settle or compromise any such claim, demand, cause of action, or suit in a manner that imposes any restrictions or obligations on the indemnified Party without the indemnified Party’s written consent. The indemnified Party will cooperate reasonably, assist and give all necessary authority and reasonably required information.

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ARTICLE VI
INTELLECTUAL PROPERTY

6.1Trademarks. This Agreement is not intended to confer any rights of ownership or use to THI relating to the use of Miromatrix’s name or trademarks and THI shall not use Miromatrix’s name, trademarks or trade names without the prior written consent of Miromatrix. This Agreement is not intended to confer any rights of ownership or use to Miromatrix relating to the use of THI’ s name or trademarks and Miromatrix shall not use THI’ s name, trademarks or trade names without the prior written consent of THI.

6.2Prosecution of Patents. Miromatrix will be solely responsible, at its own cost, for preparing, prosecuting and maintaining the Miromatrix Patents. THI will be solely responsible, at its own cost, for preparing, prosecuting and maintaining the THI Patents. Miromatrix will retain all right, title and interest in and to the Miromatrix Patents subject to the express sublicense granted to THI under this Agreement. THI will retain all right, title and interest in and to the THI Patents subject to the express sub-license granted to Miromatrix under this Agreement.

ARTICLE VII
CONFIDENTIALITY

7.1Confidentiality.

The Parties will maintain in confidence and will not disclose to any third party and will not use any trade secrets or confidential or proprietary information disclosed by the disclosing Party to the receiving Party, including, without limitation, patent applications not yet in the public domain (the “Confidential Information”), except that the Confidential Information may be used in connection with the performance this Agreement and may be disclosed only to those third parties and employees who have a need to know the Confidential Information in connection with the performance of this Agreement and who agree in writing to keep the information confidential to the same extent as is required of each Party under this Section 7.1. The Parties also agree that the terms and conditions of this Agreement shall be considered Confidential Information. Each Party will take all reasonable steps to protect the Confidential Information of the other Party with the same degree of care it uses to protect its own confidential proprietary information. The confidentiality provisions of this Section 7.1 shall not apply to any part of such information, which:

(a)is known to the receiving Party at the time it was obtained from the disclosing Party pursuant to documentary evidence thereof that existed with the receiving Party at the time such information was obtained from the disclosing Party;

(b)is acquired by the receiving Party from a third party, and such third party did not obtain such information directly or indirectly from the disclosing Party under an obligation not to disclose;

(c)is or becomes published or otherwise in the public domain other than by violation of this Agreement by the receiving Party;

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(d) is independently developed by the receiving Party without reference to or reliance upon the information provided by the disclosing Party pursuant to documentary evidence thereof; or

(e)is required to be disclosed by the receiving Party to comply with applicable laws or governmental regulations; provided that the receiving Party provides prompt written notice of such disclosure to the disclosing Party and cooperates with the disclosing Party’s reasonable and lawful actions to avoid and/or minimize the extent of such disclosure.

7.2Injunctive Relief. The receiving Party agrees that any breach of this Article VII may cause the disclosing Party substantial and irreparable injury and therefore, in the event of any such breach, in addition to other remedies which may be available, the disclosing Party shall have the right to seek specific performance and other injunctive and equitable relief.

7.3Survival. The obligations of confidentiality set forth in this Article VII will survive the termination or expiration of this Agreement for a period of five (5) years.

ARTICLE VIII
TERM AND TERMINATION

8.1Term. The Term of this Agreement will commence on the Effective Date and, unless otherwise terminated in accordance with the Agreement, remain in force and effect for the life of each patent wherein, but for this Agreement, Valid Claims of the Miromatrix Patents or the THI Patents would be infringed by the applicable Party exercising its rights under this Agreement.

8.2Termination Rights.

(a)If any Party breaches one or more of its material obligations under the Agreement, the non-breaching Party may deliver written notice of default to the breaching Party. This Agreement shall terminate if the default has not been cured within (i) thirty (30) days after notice of default to the defaulting Party if the default relates to a payment obligation under this Agreement or (ii) sixty (60) days after notice of default to the defaulting Party if the default related to any other matter; or

(b)In the event either Party becomes subject to a Bankruptcy Event.

(c)The failure to meet a Miromatrix Milestone or a THI Milestone shall be governed by Article II hereof, not by Section 8.2

8.3Failure to Achieve Performance Milestones. Notwithstanding anything to the contrary stated in Section 8.2 above, a default arising out of failure to perform a Milestone set forth in Exhibit B shall be governed by Article II hereof.

8.4Waiver. No failure by Miromatrix or THI to exercise any right of termination will constitute a waiver of any right of Miromatrix or THI for recovery of any monies then due to it hereunder or any other right or remedy Miromatrix or THI may have at law or under this Agreement.

8.5 Sub-License Grant. If the Agreement is terminated by THI pursuant to Section 8.2(a) based on Miromatrix’s material breach and failure to timely cure, then THI shall possess the sub-license set forth in Section 2.5, which shall remain in full force and effect, along with THI’s obligation to pay the royalties set forth in Section 3.2.

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ARTICLE IX
DISCLAIMER AND LIMITATION OF LIABILITY

9.1EXCEPT FOR THE EXPRESS WARRANTY SET FORTH IN THIS AGREEMENT, EACH PARTY DISCLAIMS AND EXCLUDES ALL WARRANTIES, EXPRESS OR IMPLIED, CONCERNING ANY PATENTS, ANY RELATED INTELLECTUAL PROPERTY, AND/OR THE PRODUCTS, INCLUDING WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT (INCLUDING THE UNIFORM COMMERCIAL CODE WARRANTY OF TITLE AGAINST INFRINGEMENT), OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE. EACH PARTY’S TOTAL LIABILITY FOR ITS OBLIGATIONS UNDER ARTICLE IV HEREOF AS WELL AS FOR BREACH OR NON-PERFORMANCE OF THIS AGREEMENT SHALL BE LIMITED TO THE CONSIDERATION PAID TO BY THE OTHER PARTY UNDER THIS AGREEMENT, LESS ANY AMOUNTS PAID BY MIROMATRIX TO THE UNIVERSITY OF MINNESOTA PURSUANT TO THE LICENSE AGREEMENT. EACH PARTY AGREES THAT IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES RESULTING FROM A DEFAULT OR BREACH OF THIS AGREEMENT.

ARTICLE X
ADDITIONAL PROVISIONS

10.1Arbitration. All disputes arising between Miromatrix and THI under this Agreement will be settled by arbitration conducted in accordance with the Rules of the American Arbitration Association. The Parties will cooperate with each other in causing the arbitration to be held in as efficient and expeditious a manner as practicable. Any such arbitration will be held in Minneapolis, Minnesota USA. Notwithstanding the foregoing, the dispute resolution procedures set forth herein will not limit a court from granting a temporary restraining order or a preliminary injunction in order to preserve the status quo of the Parties pending arbitration or to protect a Party’s trademark, other Intellectual Property or Confidential Information. Further, the arbitrator will have power to enter such orders by way of interim award, and such orders will be enforceable in court.

10.2Assignment. No rights hereunder may be assigned by either Party, directly or by merger or other operation of law, except assignment to an Affiliate, without the express written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned; provided, however, without such consent, either Party may assign this Agreement in connection with the sale of all or substantially all of its assets or business related to the subject matter of this Agreement or its merger or consolidation with another company. Any prohibited assignment of this Agreement or the rights hereunder will be null and void. No assignment will relieve THI or Miromatrix of responsibility for the performance of any accrued obligations which they have prior to such assignment. This Agreement will inure to the benefit of permitted assigns.

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10.3 Force Majeure. In the event a Party fails to perform any of its obligations under this Agreement (other than a payment obligation) due to a cause that such party could not have prevented through the exercise of commercially reasonable efforts, then such Party shall promptly give written notice of such occurrence to the other Party. The affected party’s performance shall be excused and the time for performance shall be extended for the period of delay or inability to perform due to such occurrence; but in no event shall such extension exceed ninety (90) days.

10.4No Waiver. A waiver by either Party of a breach or violation of any provision of this Agreement will not constitute or be construed as a waiver of any subsequent breach or violation of that provision or as a waiver of any breach or violation of any other provision of this Agreement.

10.5Independent Contractor. Nothing herein will be deemed to establish a relationship of principal and agent between Miromatrix and THI, nor any of their agents or employees for any purpose whatsoever. This Agreement will not be construed as constituting Miromatrix and THI as partners, or as creating any other foul’ of legal association or arrangement which could impose liability upon one Party for the act of the other Party.

10.6Notices. All notices or other communications required or permitted to be given under this Agreement shall be in writing and addressed to the other Party as set forth below, or as otherwise designated by a party, and shall be deemed effectively given on the earliest of: (i) when delivered, if personally delivered; (ii) on the first day following delivery to an overnight courier; (iii) on the 3rd business day following the date of mailing if delivered by certified or registered mail, return receipt requested; (iv) on the date of transmission, if delivered by email transmission; or (v) when received by the Party to whom notice is intended or required to be given:

If to Miromatrix, to:

Miromatrix Medical Inc.
18683 Bearpath Trail
Eden Prairie, Minnesota 55347

Attention: President and CEO

With a copy to:

Maslon Edelman Borman & Brand, LLP
3300 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402

Attention: Joseph Alexander, Esq.

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If to the THI, to:

Texas Heart Institute
6770 Bertner, Suite C 550
Houston, TX 77030

Attention: Chief Executive Officer

With a copy to:

Porter Hedges LLP
1000 Main Street, 36th Floor
Houston, Texas 77002

Attention: Eric D. Wade, Esq.

or to such other addresses as may be designated from time to time by notice given in accordance with the terms of this Section.

10.7Severability. Any of the provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction will be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof or affecting the validity or unenforceability of any of the terms of this Agreement in any other jurisdiction.

10.8Survival. In addition to any rights that have accrued as of the date of expiration or termination, provisions which by their very nature are intended to survive such event shall remain in force.

10.9Headings and Titles. Any headings and titles used in this Agreement are for convenience or reference only and will not affect its construction or interpretation.

10.10No Third Party Benefits. Nothing in this Agreement, express or implied, is intended to confer on any person other than the Parties hereto or their permitted assigns, any benefits, rights or remedies.

10.11Governing Law. This Agreement will be construed, governed, interpreted and applied in accordance with the laws of the State of Minnesota, without giving effect to conflict of law provisions.

10.12Counterparts. This Agreement will become binding when any one or more counterparts hereof, individually or taken together, will bear the signatures of each of the parties hereto. This Agreement may be executed in any number of counterparts, each of which will be deemed an original as against the party whose signature appears thereon, but all of which taken together will constitute but one and the same instrument.

10.13Entire Agreement. This Agreement is the entire agreement between the parties regarding the subject matter herein and supersedes all prior existing understandings between the Parties relating to the subject matter hereof. This Agreement may not be modified except in writing signed by both Parties.

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IN WITNESS WHEREOF, the parties hereto have duly executed this Sub-license Agreement as of the date first above written.

MIROMATRIX MEDICAL INC.		TEXAS HEART INSTITUTE
By	/s/ Robert Cohen	By	/s/ Marc C. Mattsson
	Robert Cohen President & CEO		Marc C. Mattsson Chief Executive Officer

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EXHIBIT A

LICENSED MIROMATRIX PATENTS

All “Licensed Patents” and “Patent Applications” as defined in the Exclusive License Agreement between Miromatrix and the University of Minnesota dated February 4, 2010, as well as all future patent applications and patents that, in the future, fall under or become covered by the foregoing Exclusive License Agreement.

EXHIBIT B

WHOLE HEART MAJOR MILESTONES

Milestone 1- Cardiac Source and Characterization (.75 years, complete 9/30/2014)

· Define cardiac decellularization process from porcine sources

· Characterize the cardiac matrix and identify key process

· Define cardiac decellularization production process

Milestone 2 - Porcine Whole Heart Recellularization (4 years, complete 9/30/2018)

Recellularization of the Whole Heart (2.5 years)

· Evaluate vascular and parenchymal human cell sources including for example iPS cells for cardiac recellularization

· Identify human cell sources and define regulatory strategy in consultation with Miromatrix

Functional Characterization of Porcine Heart with Human Cells (1.5 years)

· Demonstrate functional whole heart recellularization in three separate hearts as defined by:

o contractile coordination between chambers

o an ejection fraction of > or equal to 45%

Milestone 3 - Preclinical Large Animal Safety/Efficacy Studies of Porcine Hearts with Human Cells (2 years, complete 9/30/2020)

· Complete acute large animal preclinical studies

o Whole heart transplantation that successfully demonstrates cardiac function and acute stability for 6 hours in three animals

· Complete chronic large animal preclinical studies

o Whole heart transplantation that successfully demonstrates sustained cardiac function for 45 days following transplantation in three animals

Milestone 4 - Whole Porcine Heart with Human Cells Production, and GLP Preclinical Studies (1 year, complete 9/30/2021 or at end of follow-up period required by FDA)

· Complete GLP preclinical studies for follow up period required by FDA to demonstrate efficacy and to support IND submission

· Define release criteria to demonstrate safety for IND application

Milestone 5 - IND Submission (1.5 year, complete 3/31/2023)

· Validate product SOPs for GLP and make available all data and documentation to Miromatrix

· File FDA regulatory submission for Phase I safety trials

Milestone 6 - First in Human Clinical Trial (THI will send data from 3 patient trials within 3 months following the end of the FDA specified follow-up period for 3 patients enrolled.).

· Complete first in human clinical study (3 patients)

Milestone 7 - Phase I/II Clinical Trials (complete 2 years after end of FDA specified follow-up period for patients enrolled)

· Complete within 18 months or timeline designated by FDA for Phase II clinical trials (5(0 patients)

· Potential for Phase I/II initial study and compassionate use

Milestone 8 - Phase III Pivotal Clinical Trial (complete 3 years after end of FDA specified follow-up period for patients enrolled)

· Complete pivotal trial to demonstrate efficacy of whole heart transplantation

· Shortened clinical trial period to reflect potential for orphan status

Milestone 9 - PMA Approval (1 year after Milestone 81

· File PMA submission with FDA

2 

 Subscriber Full Name: Texas Heart Institute

Number of Shares Subscribed For: 666 666.67 State TX

MIROMATRIX MEDICAL INC.

SUBSCRIPTION AGREEMENT AND LETTER OF INVESTMENT INTENT

FOR ENTITIES

This subscription, submitted as of the date set forth on the Signature Page, is between Miromatrix Medical Inc., a Delaware corporation (the “Company”), and the undersigned subscriber (the “Subscriber”).

1. Offer to Purchase. The Subscriber hereby offers to purchase that number of shares of the Company’s Series B Preferred Stock set forth on the Signature Page (the “Shares”) and hereby agrees to tender to the Company an aggregate purchase price for the Shares equal to Five Million Dollars ($5,000,000.00), representing a per Share purchase price of Seven and 50/100 Dollars ($7.50), as set forth on the Signature Page. The rights, preferences and privileges of the Series B Preferred Stock, and the qualifications, limitations and restrictions thereof, are summarized on the “Summary of Series B Preferred Stock Terms” attached as Exhibit A to the Subscription Agreement and Letter of Investment Intent. The Subscriber’s check payable to “Miromatrix Medical Inc.” in the amount of the aggregate purchase price is being tendered herewith, or such aggregate purchase price is being delivered pursuant to a wire transfer of immediately available funds to an account designated by the Company. By execution of this Agreement, the Subscriber acknowledges that the Company is relying upon the accuracy and completeness of the representations contained in this Agreement in complying with its obligations under applicable securities laws. In lieu of fractional shares, the Shares to be issued by the Company to Subscriber hereunder shall be rounded up to the nearest whole share.

2. Representations and Warranties of the Company. In consideration of the Subscriber’s purchase of the Shares, upon acceptance of the Subscription the Company represents and warrants to the Subscriber as follows:

a. Organization. The Company is a validly existing corporation under the laws of the State of Delaware.

b. Good Standing. The Company is in good standing under the laws of the State of Delaware, and there are no proceedings or actions pending to limit or impair any of its powers, rights and privileges, or to dissolve it.

c. Corporate Authorization. The execution and delivery of this Agreement and the consummation of the transaction contemplated hereby have been duly authorized by proper corporate action of the Company.

d. Valid Issuance. The Shares have been duly authorized and, when issued, delivered and paid for in the manner contemplated in this Subscription Agreement and Letter of Investment Intent, will be validly issued, fully paid and nonassessable, and will conform in all material respects to the description thereof set forth in Exhibit A attached hereto.

3. Representations and Warranties of Subscriber. The Subscriber hereby represents and warrants to the Company and its officers, directors, shareholders, employees and agents as follows:

a. Information About the Company. The Subscriber acknowledges that the Subscriber has received and reviewed all information about the Company that the Subscriber considers necessary or appropriate to assess the merits and risks of the investment made hereby.

b. Additional Information. The Subscriber has also had the opportunity to ask questions of, and to receive answers from, the Company concerning the terms and conditions of the investment and the business and affairs of the Company, and to obtain any additional information necessary to verify this information, and has utilized such access to Subscriber’s satisfaction for the purpose of obtaining information regarding the Company, and the Subscriber has received such information concerning the Company as the Subscriber considers necessary or advisable in order to form a decision concerning an investment in the Company.

[MISSING PAGE]

part. The Subscriber understands that if the Company determines to reject this subscription, any funds returned to the Subscriber will be without deduction therefrom or interest thereon.

m. No General Solicitation. The Subscriber’s purchase of the Shares is not the result of any general solicitation or general advertising, including, but not limited to (i) any advertisement, article, notice or other communication published in any newspaper, magazine or similar media or broadcast over television or radio; and (ii) any seminar or meeting whose attendees have been invited by any general solicitation or general advertising.

n. Legal Age. The Subscriber or, if applicable, the authorized signatory signing this Subscription Agreement and Letter of Investment Intent on behalf of the Subscriber, is of legal age (as established in the Subscriber’s state of residence) and is under no disability with respect to entering into a contractual relationship.

o. Entity Subscribers. If an entity, the Subscriber was not formed for the purpose of investing in the Shares.

p. Not Subject to Backup Withholding. The Subscriber certifies, under penalty of perjury, that the Subscriber is not subject to the backup withholding provisions of the Internal Revenue Code of 1986, as amended. (Note: The Subscriber is subject to backup withholding if: (i) the Subscriber fails to furnish its Social Security Number or Taxpayer Identification Number herein; (ii) the Internal Revenue Service notifies the Company that the Subscriber furnished an incorrect Social Security Number or Taxpayer Identification Number; (iii) the Subscriber is notified that it is subject to backup withholding; or (iv) the Subscriber fails to certify that it is not subject to backup withholding or the Subscriber fails to certify the Subscriber’s Social Security Number or Taxpayer Identification Number.)

q. Legal Representation. The Subscriber understands that: (i) the Company has engaged legal counsel to provide assistance to the Company in connection with the offer and sale of securities contemplated herein; (ii) legal counsel engaged by the Company does not represent the Subscriber or the Subscriber’s interests; (iii) this legal counsel did not prepare any Company disclosure documents and has not conducted due diligence in connection with the Subscriber’s investment; and (iv) the Subscriber is not relying on legal counsel engaged by the Company. The Subscriber has had the opportunity to engage, and obtain advice from, the Subscriber’s own legal counsel with respect to the investment contemplated herein.

r. Subscriber Not Listed in Restricted Lists. That the Subscriber (i) is not listed in the Annex to the Executive Order No. 13224 of September 23, 2001 — Blocking Property and Prohibiting Transactions With Persons who Commit, Threaten to Commit or Support Terrorism (the “Executive Order”) or is otherwise subject to the provisions of the Executive Order, (ii) is not listed on the “Specially Designated Nationals and Blocked Persons” list maintained by the Office of Foreign Assets Control (“OFAC”) of the United States Department of the Treasury, as updated or amended from time to time, or any similar list issued by OFAC, (iii) is not listed on any similar restricted list maintained by any United States Department of Commerce, Department of State or any other U.S., State or Federal governmental official or entity, and (iv) does not have any property blocked, or subject to seizure, forfeiture or confiscation, by any order relating to terrorism or money laundering issued by the President, Attorney General, Secretary of State, Secretary of Defense, Secretary of the Treasury or any other U.S. State or Federal governmental official or entity (in any case, a “Restricted Party”).

s. Source of Subscriber’s Funds. That the funds used by the Subscriber exclude any funds received or derived from a Restricted Party or from any person or entity involved in the violation of any U.S. State or Federal law relating to terrorism, including, without limitation (i) the Executive Order, (ii) the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, Public Law 107-56, and (iii) the Money Laundering Control Act of 1986, Public Law 99-570.

t. Accredited Status. The Subscriber represents and warrants as follows (please INITIAL or CHECK all applicable items):

ENTITIES (Please provide a copy of the entity’s charter documents):

x	(i)	The Subscriber is a (initial or check one):
	¨	(A)	General Partnership

	¨	(B)	Limited Liability Partnership
	¨	(C)	Limited Partnership
	¨	(D)	Limited Liability Company
	¨	(E)	Corporation
	¨	(F)	Business Trust
	x	(G)	Other Entity (please specify): _nonprofit corporation_
¨	(ii)	The Subscriber is an entity, and is an “Accredited Investor” as defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Act”).  This representation is based on the following (initial or check one or more, as applicable):
	¨	(A)	The Subscriber (or, in the case of a trust, the undersigned trustee) is a bank or savings and loan association as defined in Sections 3(a)(2) and 3(a)(5)(A), respectively, of the Act acting either in its individual or fiduciary capacity.
	¨	(B)	The Subscriber is a broker or dealer registered pursuant to the Securities Exchange Act of 1934.
	¨	(C)	The Subscriber is an insurance company as defined in Section 2(13) of the Act.
	¨	(D)	The Subscriber is an investment company registered under the Investment Company Act of 1940 or a business development company as defined in Section 2(a)(48) of that Act.
	¨	(E)	The Subscriber is a Small Business Investment Company licensed by the U.S. Small Business Administration under Section 301(c) or (d) of the Small Business Investment Act of 1958.
	¨	(F)	The Subscriber is an employee benefit plan within the meaning of Title I of the Employee Retirement Income Security Act of 1974 and either (initial one or more, as applicable):

¨	(1)	The investment decision is made by a plan fiduciary, as defined in Section 3(21) of such Act, which is either a bank, savings and loan association, insurance company, or registered investment adviser.
¨	(2)	The employee benefit plan has total assets in excess of $5,000,000.
¨	(3)	The plan is a self-directed plan with investment decisions made solely by persons who are “Accredited Investors” as defined under the Act.

¨	(G)	The Subscriber is a private business development company as defined in Section 202(a)(22) of the Investment Advisers Act of 1940.
x	(H)	The Subscriber has total assets in excess of $5,000,000, was not formed for the specific purpose of acquiring shares of the Company and is one or more of the following (initial one or more, as appropriate):
	x	(1)An organization described in Section 501(c)(3) of the Internal Revenue Code.
	¨	(2)A corporation.
	¨	(3)A Massachusetts or similar business trust.
	¨	(4)A partnership.

		¨	(5)A limited liability company.
	¨	(I)	The Subscriber is a trust with total assets exceeding $5,000,000, which was not formed for the specific purpose of investing in the Company and whose purchase is directed by a person described in Rule 506(b)(2)(ii) under the Act.
	¨
		(J)	The Subscriber is an entity, all of whose equity owners are accredited investors. (Please provide written representation of accredited investor status from each equity owner.)
If you have not initialed or checked any of the foregoing tests set forth above, you are not an accredited investor and cannot purchase any Shares.
x	(iii)	Entities.  A Representative of an Entity Subscriber must initial here.  If the Subscriber is an entity, the individual(s) signing on behalf of the Subscriber and the Subscriber, jointly and severally, agree and certify that this Agreement has been duly authorized by all necessary action on the part of the Subscriber, has been duly executed by an authorized representative of the Subscriber, and is a legal, valid, and binding obligation of the Subscriber enforceable in accordance with its terms.

4. Investment Purpose in Acquiring the Shares. The Subscriber and the Company acknowledge that the Shares have not been registered under the Act or applicable state securities laws and that the Shares will be issued to the Subscriber in reliance on exemptions from the registration requirements of the Act and applicable state securities laws and in reliance on the Subscriber’s and the Company’s representations and agreements contained herein. The Subscriber is subscribing to acquire the Shares for the account of the Subscriber for investment purposes only and not with a view to their resale or distribution. The Subscriber has no present intention to divide his, her or its participation with others or to resell or otherwise dispose of all or any part of the Shares. In making these representations, the Subscriber understands that, in the view of the Commission, exemption of the Shares from the registration requirements of the Act would not be available if, notwithstanding the representations of the Subscriber, the Subscriber has in mind merely acquiring the Shares for resale upon the occurrence or non-occurrence of some predetermined event.

5. Compliance with Securities Act. The Subscriber agrees that if the Shares or any part thereof are sold or distributed in the future, the Subscriber will sell or distribute them pursuant to the requirements of the Act and applicable state securities laws. The Subscriber agrees that the Subscriber will not transfer any part of the Shares unless: (i) the Subscriber obtains an opinion of counsel satisfactory in form and substance to the Company to the effect that such transfer is exempt from the registration requirements under the Act and applicable state securities laws; or (ii) the Shares have been registered under the Act and other applicable state law.

6. Up to 180-Day Restriction on Transfer After a Public Offering. The Subscriber understands that the Company at a future date may file a registration or offering statement (the “Registration Statement”) with the Commission to facilitate a public offering of its securities. The Subscriber agrees, for the benefit of the Company, that should such an initial public offering be made and should the managing underwriter of such offering require, the undersigned will not, without the prior written consent of the Company and such underwriter, during the “Lockup Period” as defined herein: (i) sell, transfer or otherwise dispose of, or agree to sell, transfer or otherwise dispose of any of the Shares beneficially held by the undersigned during the Lockup Period; (ii) sell, transfer or otherwise dispose of, or agree to sell, transfer or otherwise dispose of any options, rights or warrants to purchase any of the Shares beneficially held by the undersigned during the Lockup Period; or (iii) sell or grant, or agree to sell or grant, options, rights or warrants with respect to any of the Shares. The foregoing does not prohibit gifts to donees or transfers by will or the laws of descent to heirs or beneficiaries, but these donees, heirs and beneficiaries will be bound by the restrictions set forth in the paragraph. The term “Lockup Period” means the lesser of (x) 180 days or (y) the shortest period during which any of the Company’s officers, directors, and shareholders holding 5% or more of the Company’s common stock are restricted by the managing underwriter from effecting any sales or transfers of the Company’s securities. The Lockup Period will commence on the effective date of the Registration Statement or such earlier date that the other Lockups begin.

7. Restrictive Legend. The Subscriber agrees that the Company may place one or more restrictive legends on any certificates evidencing the Shares, containing substantially the following language:

The securities represented by this certificate have not been registered under the Securities Act of 1933, as amended, have not been registered under any state securities law, and are subject to a subscription and investment representation agreement. They may not be sold, offered for sale, or transferred in the absence of either an effective registration under the Securities Act of 1933, as amended, and under the applicable state securities laws, or an opinion of counsel for the Company that such transaction is exempt from registration under the Securities Act of 1933, as amended, and under the applicable state securities laws.

Sale or other transfer of these securities is further restricted for up to 180 days following an initial public offering of securities of the Company by the terms of a Subscription Agreement, a copy of which is available for inspection at the offices of the Company.

8. Stop Transfer Order. The Subscriber agrees that the Company may place a stop transfer order with its registrar and transfer agent (if any) covering all certificates representing the Shares.

9. No Public Information. The Subscriber understands and acknowledges that the Company currently does not file periodic reports with the Commission pursuant to the requirements of Sections 13 or 15(d) of the Securities Exchange Act of 1934, and may not be obligated to file such reports at any time in the future.

10. Lack of Availability of Rule 144 Under the Act. The Subscriber understands and acknowledges that the Company has no obligation to undertake or complete a public offering of its securities, that even if a public offering is undertaken and successfully completed, the Shares subscribed for hereby will remain subject to the restrictions on transferability described herein, and that if a public offering is not undertaken and completed, the Subscriber may never be able to sell its Shares pursuant to Rule 144 under the Act.

11. Relationship to Brokerage Firms. (Please answer the following questions by initialing or checking the appropriate response, or if answer to each is no, circle “NO” here):

¨	YES	x	NO:	Is the Subscriber a director, officer, partner, branch manager, registered representative, employee, shareholder of, or similarly related to or employed by, a brokerage firm?
¨	YES	x	NO	Does the Subscriber own voting securities of any brokerage firm?
¨	YES	x	NO	Is any director, officer, partner or 5% owner of the Subscriber also a director, officer, partner, branch manager, registered representative, employee, shareholder of, or similarly related to or employed by a brokerage firm?

(If the Subscriber answered YES to any of the foregoing questions, please contact the Company to provide additional information before the subscription can be considered.)

12. Binding Effect. Neither this Agreement nor any interest herein is assignable by the Subscriber without the prior written consent of the Company. The provisions of this Agreement are binding upon and inure to the benefit of the parties hereto, and their respective heirs, legal representatives, successors and assigns.

13. Representations to Survive Delivery. The representations, warranties and agreements of the Company and of the Subscriber contained in this Agreement will remain operative and in full force and effect and will survive the receipt of funds by the Company, and the issuance to the Subscriber of the Shares.

14. Indemnification. Subscriber agrees to indemnify the Company, and each current and future officer, director, employee, agent and shareholder of the Company, against and to hold them harmless from any damage, loss, liability, claim or expense including, without limitation, reasonable attorneys’ fees resulting from or arising out of the inaccuracy or alleged inaccuracy of any of the representations, warranties or statements of the Subscriber contained in this Agreement, including without limitation any violation or alleged violation of the registration requirements of the Act or applicable state law in connection with any subsequent sale of the Shares by Subscriber.

15. Revocation. Subscriber hereby acknowledges and agrees that Subscriber is not entitled to cancel, terminate or revoke this Agreement and that it will survive any bankruptcy of Subscriber.

16. Arbitration. The Subscriber further agrees that any dispute regarding this Agreement or the Subscriber’s investment in the Company (including without limitation claims pursuant to federal or state securities laws), including any claim which is made against any Offering agent or broker dealer involved in the offer or sale of the Shares, will be resolved by arbitration which will be the sole forum for resolution of any such disputes. Unless otherwise agreed by the parties, any such proceedings shall be brought in the State of Delaware, pursuant to the Rules and Code of Arbitration of the American Arbitration Association, except that if a bona fide claim is made against the Company, and an Offering agent or broker-dealer is named in connection with the claim, then the claim must be brought pursuant to the Rules and Code of Arbitration of the Financial Industry Regulatory Authority.

17. Governing Law; Venue. This Agreement is governed by, and construed in accordance with, the substantive laws of the State of Delaware without reference to Delaware conflict or choice of law provisions. Actions or proceedings litigated in connection with this Agreement, if any, will be venued exclusively in the state and federal courts located in the County of Hennepin, State of Minnesota.

18. Additional Information. Subscriber will supply any additional information and documentation relating to Subscriber and any persons who have any rights or interest in Subscriber as may be reasonably requested by the Company in order to ensure compliance by the Company with applicable laws. If at any time prior to the Company’s acceptance of this Agreement, an adverse change occurs with respect to the Subscriber so that the information, representations and warranties of the Subscriber set forth in this Agreement are no longer accurate, the Subscriber will immediately notify the Company of the inaccuracy in writing and shall deliver the updated, accurate information to the Company.

19. Successors and Assigns. The representations and warranties made by the Subscriber in this Agreement are binding on the Subscriber’s successors and assigns and are made for the benefit of the Company and any other person who may become liable for violations of applicable securities laws as a result of the inaccuracy or falsity of any of the Subscriber’s representations or warranties.

20. Counterparts. This Agreement may be executed by the Company and by the Subscriber in separate counterparts, each of which will be deemed an original.

21. Acceptance. This Agreement is not binding on the Company until accepted in writing by an authorized officer of the Company.

SIGNATURE PAGE

I. The number of shares and total dollar value of Series B Preferred Stock of Miromatrix Medical. Inc. that I hereby subscribe for is:

666,666.66* *	X	$7.50	=	$5,000,000.00
(Number of Shares)		(Per Share Purchase Price)		(Aggregate Purchase Price)

** In lieu of fractional shares, the Shares to be issued by the Company to Subscriber hereunder are being rounded up to the nearest whole share (i.e., 666,667 Shares).

Make checks payable to “Miromatrix Medical Inc. or deliver purchase price pursuant to a wire transfer of immediately available funds to an account designated by the Company.

II. Manner in which title is to be held (check the correct box):

¨	Limited Partnership	¨	Partnership
¨	Sole Proprietorship	¨	Corporation
¨	Investment Company	¨	Pension/Profit Sharing Plan
¨	LLC	¨	Business Trust
¨	Family Partnership	¨	Other (Nonprofit Corporation)

III.	Name in which title is to be held (Please Print--the Shares will be issued in this name):
	Texas Heart Institute

IV. Addresses

(A) Address of Subscriber’s Domicile:

6770 Bertner, C550

Street Address or PO Box

Houston, Texas 77030

City, State and Zip Code

832-355-3792

Telephone Number

mmattsson@texasheart.org

E-Mail Address

(B) Address to Which Correspondence Should be Directed (if different from above):

Street Address or PO Box

City, State and Zip Code

Telephone Number

V. Tax ID Number

74-6053200

Tax ID or Social Security Number

VI. Signatures:

(A) Corporate, Partnership, Trust and other Entities

Texas Heart Institute
Printed Name of Entity

/s/ Marc C. Mattsson
By (signature of person signing)

CEO
Its (title of person signing)

October 8, 2013
Date

This Subscription Agreement and Letter of Investment Intent is accepted as of October 8, 2013 .
                                                                                                                                          (day, month, year)

Miromatrix Medical Inc.
By	/s/ Robert Cohen
Name	Robert Cohen
Title	President and CEO

CERTIFICATE OF SIGNATORY

I, Marc C. Mattsson, am the   CEO  of   Texas Heart Institute   the “Entity”).
(name of person signing)      (title)        (name of the Subscriber)

I certify that I am empowered and duly authorized by the Entity to execute and carry out the terms of the Subscription Agreement and Letter of Investment Intent and to purchase and hold the Series B Preferred Stock, and certify further that the Subscription Agreement and Letter of Investment Intent has been duly and validly executed on behalf of the Entity and constitutes a legal and binding obligation of the Entity.

IN WITNESS WHEREOF, I have hereto set my hand this 8 day of the month of   October   in the year 2013.

/s/ Marc C. Mattsson

(Signature)

EXHIBIT A

SUMMARY OF SERIES B PREFERRED STOCK TERMS

(All information is as of ________________, 2013)

Authorized and Outstanding Capital Stock

The Company has 50,000,000 authorized shares of capital stock, comprised of 30,000,000 shares of common stock and 20,000,000 shares of preferred stock, of which 3,000,000 have been designated as Series A Preferred Stock (“Series A Preferred”), and (2) the Company has issued and outstanding:

· 1,819,797 shares of common stock; and

· 2,887,847 shares of Series A Preferred.

In addition, the Company has 1,196,888 shares of common stock that are issuable upon exercise of outstanding stock options and 551,082 shares of common stock that are issuable upon the exercise of outstanding warrants.

The following summary of certain provisions of the Company’s capital stock does not purport to be complete and is subject to, and qualified in its entirety by, the provisions of its Articles of Incorporation and Bylaws, and by the provisions of applicable law.

Series B Preferred Stock Terms

Ranking: The Series B Preferred Stock will rank pari passu with the Series A Preferred with respect to any liquidation or winding up of the Company. See “Liquidation preference” below.

Liquidation preference:	In the event of any liquidation or winding up of the Company, the holders of Series B Preferred Stock and Series A Preferred will be entitled to receive, in preference to the holders of common shares, an amount equal to the price paid per Series A or Series B share, as applicable, plus all unpaid distributions on such shares (if any). A merger or sale of all or substantially all of the Company’s assets will be treated as a liquidation or winding up for purposes of the liquidation preference.
Conversion rights:	Series B Preferred Stock holders will have the right to convert their shares, at their option, at any time into common shares, at the initial rate of one Series B share for one common share. The conversion rate will be adjusted in the event of any stock splits, stock combinations, reorganizations or similar events. The Series B shares will automatically convert into common shares, at the then applicable conversion rate, (i) in the event of the closing of an underwritten public offering of the Company’s securities in which the aggregate gross proceeds to the Company equals or exceeds $20,000,000, or (ii) upon the election of the holders of a majority of the shares of Series A Preferred and Series B Preferred Stock.
Voting rights:	Each share of Series B Preferred Stock will entitle the holder thereof to that number of votes equal to the number of shares of common stock issuable upon conversion of the Series B Preferred Stock. The holders of Series B Preferred Stock vote together with the holders of common and Series A Preferred shares on all matters.

EXHIBIT A

SUMMARY OF SERIES B PREFERRED STOCK TERMS

(All information is as of ________________, 2013)

Authorized and Outstanding Capital Stock

The Company has 50,000,000 authorized shares of capital stock, comprised of 30,000,000 shares of common stock and 20,000,000 shares of preferred stock, of which 3,000,000 have been designated as Series A Preferred Stock (“Series A Preferred”), and (2) the Company has issued and outstanding:

· 1,819,797 shares of common stock; and

· 2,887,847 shares of Series A Preferred.

In addition, the Company has 1,196,888 shares of common stock that are issuable upon exercise of outstanding stock options and 551,082 shares of common stock that are issuable upon the exercise of outstanding warrants.

The following summary of certain provisions of the Company’s capital stock does not purport to be complete and is subject to, and qualified in its entirety by, the provisions of its Articles of Incorporation and Bylaws, and by the provisions of applicable law.

Series B Preferred Stock Terms

Ranking: The Series B Preferred Stock will rank pari passu with the Series A Preferred with respect to any liquidation or winding up of the Company. See “Liquidation preference” below.

Ranking:	The Series B Preferred Stock will rank pari passu with the Series A Preferred with respect to any liquidation or winding up of the Company. See “Liquidation preference” below.
Liquidation preference:	In the event of any liquidation or winding up of the Company, the holders of Series B Preferred Stock and Series A Preferred will be entitled to receive, in preference to the holders of common shares, an amount equal to the price paid per Series A or Series B share, as applicable, plus all unpaid distributions on such shares (if any). A merger or sale of all or substantially all of the Company’s assets will be treated as a liquidation or winding up for purposes of the liquidation preference.
Conversion rights:	Series B Preferred Stock holders will have the right to convert their shares, at their option, at any time into common shares, at the initial rate of one Series B share for one common share. The conversion rate will be adjusted in the event of any stock splits, stock combinations, reorganizations or similar events. The Series B shares will automatically convert into common shares, at the then applicable conversion rate, (i) in the event of the closing of an underwritten public offering of the Company’s securities in which the aggregate gross proceeds to the Company equals or exceeds $20,000,000, or (ii) upon the election of the holders of a majority of the shares of Series A Preferred and Series B Preferred Stock.
Voting rights:	Each share of Series B Preferred Stock will entitle the holder thereof to that number of votes equal to the number of shares of common stock issuable upon conversion of the Series B Preferred Stock. The holders of Series B Preferred Stock vote together with the holders of common and Series A Preferred shares on all matters.

PROMISSORY NOTE

$4,000,000.00 Houston, Texas October 8, 2013

FOR VALUE RECEIVED, Texas Heart Institute, a Texas non-profit corporation (“Maker”), promises to pay to the order of Miromatrix Medical, Inc., a Delaware corporation (together with any subsequent holder of this note, “Payee”), at 18683 Bearpath Trail, Eden Prairie, Minnesota, 55347 or such other location as Payee may direct in writing to Maker, the sum of FOUR MILLION DOLLARS AND NO/100 ($4,000,000.00) (or such lesser sum as shall then be outstanding hereunder), together with interest on the unpaid principal balance from time to time outstanding at a per annum rate equal to the greater of (a) one percent (1.00%) and (b) the Applicable Federal Rate, calculated on the basis of actual days elapsed and a 365-day year. For purposes hereof, the “Applicable Federal Rate” means, when determined, the short-term applicable federal rate published by the Internal Revenue Service then in effect at the time of determination; provided that, the interest non-default rate of interest under this note is intended to equal or exceed the short-term applicable federal rate as prescribed by Section 7872 of the Internal Revenue Code, and if the non-default rate of interest contracted for and charged hereunder is less than the applicable rates as prescribed under Section 7872 of the Internal Revenue Code, such rate of interest shall be adjusted accordingly automatically to an amount that is equal to the short-term applicable federal rate in effect for the period for which the amount of such interest is being determined.

1.Payments. An installment of principal in the amount of $2,000,000.00 plus accrued and unpaid interest on this note is due and payable on each of December 31, 2013 and March 31, 2014, when all outstanding principal and all accrued but unpaid interest is due and payable. If any payment is due on a day which is not a Business Day, Maker shall be entitled to delay such payment until the next Business Day, but interest shall continue to accrue until the payment is in fact made. Upon and during the continuance of a Default (as defined in paragraph 4 below), interest shall accrue hereon at the lesser of (a) 3.00% per annum and (b) the Highest Lawful Rate. Each payment or prepayment hereon must be paid at the address of Payee set forth above in lawful and freely transferable money of the United States of America and in funds which are or will be available for immediate use by Payee, without setoff or counterclaim. For purposes of this note, “Business Day” means every day on which banks in Texas are open for banking business

2.Prepayments. Maker may prepay the principal of and accrued interest on this note from time to time and at any time, in whole or in part, without premium or penalty, but amounts prepaid may not be reborrowed hereunder.

3.Order of Application. All payments and prepayments on this note shall be applied as indicated by Maker or as otherwise provided in this note. Otherwise, such payments and prepayments shall be applied as follows: first, to accrued and unpaid interest; second, to expenses, if any, for which Payee is due to be reimbursed; and third, to principal.

4.Default. The term “Default” means: (a) The failure or refusal of Maker to make any payment hereunder when due or to comply with any provision herein and such failure or refusal continues beyond five (5) Business Days after such due date; (b) the discovery by Payee that any statement by Maker herein or in connection herewith is false or misleading; (c) Maker or any guarantor becomes insolvent, fails to pay its debts generally as they become due or becomes the subject of any proceeding under any debtor relief law; or (d) a default occurs under the Pledge Agreement (as defined below) beyond any applicable grace period. In the event of a Default, Payee may (i) declare the entire unpaid balance of this note, or any part hereof, immediately due and payable, whereupon it shall be due and payable; (ii) offset against this note any sum or sums owed by Payee to Maker; (iii) declare a default (and a default thereunder shall be deemed to have occurred) under that certain Sub-License Agreement dated as of October 1, 2013 between Maker and Payee, and thereupon, Payee may exercise its termination rights under (but subject to the notice procedures set out therein) Section 8.2 of such Sub-License Agreement and/or (iv) proceed to protect and enforce any other legal or equitable right or remedy of Payee. No delay on the part of Payee in the exercise of any power or right or single or partial exercise of any such power or right, under this note or any other instrument executed in connection herewith, shall operate as a waiver thereof.

5.Pledge Agreement. Maker’s obligations and indebtedness under this note and the are secured by that certain Pledge Agreement dated as of even date with this Note executed by Maker in favor of Payee (as amended, the “Pledge Agreement”), executed and delivered in connection with the closing of the Subscripton Agreement and the issuance of this note. Reference is hereby made to such Pledge Agreement (which is incorporated herein by reference) for terms, provisions and conditions applicable to this note and the subject matter covered thereby.

6.Notices. Any notice or demand given hereunder by Payee shall be deemed to have been given and received (a) when actually received by Maker, if delivered in person, or (b) if mailed to the address below (whether ever received or not), two Business Days after deposit in the U.S. Mail, postage prepaid.

7.Governing Law. This note is intended to be performed in Texas and the laws of Texas shall govern its validity, enforcement and interpretation.

8.Headings. The headings herein are for convenience only and shall not be deemed a part hereof

9.Successors and Assigns. All of Maker’s agreements in this note shall bind its successors and assigns.

10.Maximum Interest Rate. Regardless of any provision contained herein or in any document related hereto, Payee shall never be entitled to receive, collect or apply as interest any amount in excess of the Highest Lawful Rate. In the event Payee ever receives, collects or applies as interest any such excess, it shall be deemed a partial prepayment of principal and treated hereunder as such and, if the principal hereof is paid in full, any remaining excess shall be refunded to Maker. In determining whether or not the interest paid or payable, under any specific contingency, exceeds the Highest Lawful Rate, Maker and Payee shall (a) characterize any nonprincipal payment as an expense, fee or premium rather than as interest, (b) exclude voluntary prepayments and the effects thereof, and (c) spread the total amount of interest throughout the entire contemplated term hereof (provided that if the indebtedness evidenced hereby is paid and performed in full prior to the end of the full contemplated term thereof, and if the interest received for the actual period of existence exceeds the Highest Lawful Rate, Payee shall apply or refund such excess as provided above, and shall not be subject to any penalties provided by any laws for contracting for, charging or receiving interest in excess of the Highest Lawful Rate). “Highest Lawful Rate” means the maximum rate of interest which Payee is allowed to contract for, charge, take, reserve or receive under applicable law after taking into account, to the extent required by applicable law, any and all relevant payments or charges hereunder.

11.Subscription Agreement. This note is executed in connection with, and is issued pursuant to, that certain Subscription Agreement and Letter of Investment Intent dated as of even date with this Note between Maker (as the Subscriber) and Payee (as the Company) (the “Subscription Agreement”). Reference is hereby made to such Subscription Agreement (which is incorporated herein by reference) for terms, provisions and conditions applicable to this note and the subject matter covered thereby.

12.Costs of Collection. Maker agrees to pay all costs of collection of this note, including reasonable attorneys’ fees, paid or incurred by Payee on account of such collection, whether or not suit is filed with respect thereto and whether incurred prior to or after entry of judgment.

13.Waiver. Demand, presentment, protest and notice of nonpayment and dishonor of this note are hereby waived.

14.ENTIRETY AND AMENDMENTS. THIS NOTE, THE PLEDGE AGREEMENT, AND THE SUBSCRIPTION AGREEMENT REPRESENT THE FINAL AGREEMENT BETWEEN THE PARTIES AND MAY NOT BE CONTRADICTED BY EVIDENCE OF PRIOR, CONTEMPORANEOUS OR SUBSEQUENT ORAL AGREEMENTS BY THE PARTIES. THERE ARE NO UNWRITTEN ORAL AGREEMENTS BETWEEN THE PARTIES. THIS NOTE, THE GUARANTY, AND THE SETTLEMENT AGREEMENT EMBODY THE ENTIRE WRITTEN AGREEMENT BETWEEN THE PARTIES, SUPERSEDE ALL PRIOR WRITTEN AGREEMENTS AND UNDERSTANDINGS, IF ANY, RELATING TO THE SUBJECT MATTER HEREOF, AND MAY BE AMENDED ONLY BY AN INSTRUMENT IN WRITING EXECUTED BY MAKER AND PAYEE.

EXECUTED as of the date first written above.

ADDRESS:	“MAKER”
6770 Bertner, Suite C 550	TEXAS HEART INSTITUTE, a Texas non-profit corporation
Houston, Texas 77030
	By:	/s/ Marc C. Mattsson
	Name: Marc C. Mattsson
	Title: Chief Executive Officer

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PLEDGE AGREEMENT

THIS PLEDGE AGREEMENT (as amended, restated, or supplemented, this “Agreement”) is executed as of October 8, 2013, by Texas Heart Institute, a Texas non-profit corporation (“Pledgor”) for the benefit of Miromatrix Medical, Inc., a Delaware corporation (the “Secured Party”).

RECITALS

A.       Pledgor and Secured Party have entered into that certain Subscription Agreement and Letter of Investment Intent dated as of even date herewith (as amended or restated, the “Subscription Agreement”), under which Pledgor has offered to purchase certain shares of the Secured Party’s Series B Preferred Stock (herein, the “Subscription Shares”).

B.       In consideration for the purchase by Pledgor of the Subscription Shares, at the closing of the Subscription Agreement Pledgor will (i) pay a certain amount of cash consideration, and (ii) issue a Promissory Note in the original principal amount of $4,000,000.00 (as renewed, extended, modified or replaced, the “Note”).

C.       To secure the obligations of Pledgor under the Note, Secured Party requires that Pledgor execute and deliver this Agreement.

D.       It is expressly understood between Pledgor and Secured Party that the execution and delivery of this Agreement is a condition precedent to Secured Party’s obligations to extend credit under the Note.

NOW, THEREFORE, for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties agree as follows:

1.       Certain Definitions. Capitalized terms used but not defined in this Agreement have the meanings given them in the Note or in the UCC. If the definition given a term in the Note conflicts with the definition given that term in the UCC, the Note definition shall control to the extent allowed by Law. Terms used in this Agreement which are not capitalized but which are defined in the UCC, shall have the meaning given them in the UCC. If the definition given a term in Chapter 9 of the UCC conflicts with the definition given that term in any other chapter of the UCC, the Chapter 9 definition shall control. As used in this Agreement:

“Agreement” means this Pledge Agreement together with all schedules and annexes attached to this Pledge Agreement, and all amendments, restatements, and supplements to this Pledge Agreement, the schedules and exhibits.

“Collateral” is defined in Section 3.

“Default” means a “Default” under, and as defined in, the Note.

“Note” is defined in the Recitals.

“Obligation” means the indebtedness under the Note.

“Pledged Equity” is defined Section 3.

“Pledgor” includes, without limitation, Pledgor as a debtor-in-possession, and any receiver, trustee, liquidator, conservator, custodian, or similar party hereafter appointed for Pledgor or all or substantially all of Pledgor’s assets pursuant to any liquidation, conservatorship, bankruptcy, moratorium, rearrangement, receivership, insolvency, reorganization, or similar Law from time to time in effect affecting the rights of creditors generally.

“Security Interest” means the security interests granted and the transfers, pledges and collateral assignments made under Section 3 of this Agreement.

“UCC” means (a) generally, and with respect to the definitions above, the Uniform Commercial Code, as adopted in Texas, as amended from time to time, and (b) with respect to rights in states other than Texas, the Uniform Commercial Code as enacted in the applicable state, as amended from time to time.

2.       Note. This Agreement is being executed and delivered pursuant to the terms and conditions of the Note.

3.       Security Interest. In order to secure the full and complete payment and performance of the Obligation when due, Pledgor hereby grants to Secured Party a security interest in, and pledges and assigns to Secured Party the following (collectively, the “Collateral”):

(a)the equity interests described in attached Schedule 1 (the “Pledged Equity”), whether or not evidenced or represented by any stock certificate, certificated security or other instrument, issued by Pledged Issuer and described in such Schedule 1, the certificates representing the Pledged Equity, all options and other rights, contractual or otherwise, in respect thereof and all dividends, distributions, cash, instruments, investment property and other property (including, but not limited to, any stock dividend and any distribution in connection with a stock split) from time to time received, receivable or otherwise distributed in respect of or in exchange for any or all of the Pledged Equity;

(b)the equity interests at any time and from time to time acquired by Pledgor in the Pledged Issuer, the certificates representing such equity interests, all options and other rights, contractual or otherwise, in respect thereof and all dividends, distributions, cash, instruments, investment property and other property (including, but not limited to, any stock dividend and any distribution in connection with a stock split) from time to time received, receivable or otherwise distributed in respect of or in exchange for any or all of the foregoing;

(c)all investment property, financial assets, securities, capital stock, other equity interests, stock options and commodity contracts of Pledgor, all notes, debentures, bonds, promissory notes or other evidences of indebtedness of Pledgor, and all other assets now or hereafter received or receivable with respect to the foregoing;

(d)all security entitlements of Pledgor in any and all of the foregoing; and

(e)all proceeds (including proceeds of proceeds) of any and all of the foregoing;

in each case, whether now owned or hereafter acquired by Pledgor and howsoever his interest therein may arise or appear (whether by ownership, security interest, Lien, claim or otherwise). Notwithstanding the foregoing, at Secured Party’s sole cost and expense, Secured Party will release any and all Liens on the Collateral upon payment in full of the Obligations, including delivering the originals of any Collateral held by Secured Party (with any necessary endorsements) and filing of UCC-3 amendments to give effect to the full releases hereby.

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4.       No Assumption or Modification. The Security Interest is given to secure the prompt, unconditional and complete payment and performance of the Obligation when due, and is given as security only. Secured Party does not assume and shall not be liable for any liabilities, duties, or obligations of Pledgor under or in connection with the Collateral. Secured Party’s acceptance of this Agreement, or its taking any action in carrying out this Agreement, does not constitute Secured Party’s approval of the Collateral or Secured Party’s assumption of any obligation under or in connection with the Collateral. This Agreement does not affect or modify Pledgor’s obligations with respect to the Collateral.

5.       Fraudulent Conveyance. Notwithstanding anything contained in this Agreement to the contrary, Pledgor agrees that if, but for the application of this Section 5, the Obligation or any Security Interest would constitute a preferential transfer under 11 U.S.C. § 547, a fraudulent conveyance under 11 U.S.C. § 548 (or any successor section) or a fraudulent conveyance or transfer under any state fraudulent conveyance or fraudulent transfer Law or similar Law in effect from time to time (each a “Fraudulent Conveyance”), then the Obligation and each affected Security Interest will be enforceable against Pledgor to the maximum extent possible without causing the Obligation or any Security Interest to be a Fraudulent Conveyance, and shall be deemed to have been automatically amended to carry out the intent of this Section 5.

6.       Representations and Warranties. Pledgor hereby represents and warrants to Secured Party as follows:

(a)Pledgor owns the Collateral free arid clear of all Liens except for the Liens created hereunder.

(b)The information contained in Schedule 1 attached to this Agreement is true and accurate and sufficiently describes all of the Collateral.

7.       Covenants. Pledgor shall:

(a)Promptly notify Secured Party of any material change in any fact or circumstances represented or warranted by Pledgor with respect to any of the Collateral.

(b)Promptly notify Secured Party of any claim, action or proceeding materially affecting the security interest granted and the pledge and assignment made under Section 3 or title to any of the Collateral and, at the request of Secured Party, appear in and defend, at Pledgor’s expense, any such action or proceeding.

(c)Not create, incur or suffer to exist any other Lien upon any of the Collateral.

(d)Not assign, dispose of, sell or otherwise transfer any of the Collateral.

(e)At Pledgor’s expense and Secured Party’s reasonable request, file or cause to be filed such applications and take such other actions to obtain the consent or approval of any Governmental Authority to Secured Party’s rights hereunder, including, without limitation, the right to sell all the Collateral upon a Default without additional consent or approval from such Governmental Authority (and, because Pledgor agrees that Secured Party’s remedies at law for failure of Pledgor to comply with this provision would be inadequate and that such failure would not be adequately compensable in damages, Pledgor agrees that his covenants in this provision may be specifically enforced).

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(f) From time to time promptly execute and deliver to Secured Party all such other stock powers, assignments, certificates, supplemental documents, and financing statements (if appropriate), and do all other acts or things as Secured Party may reasonably request in order to more fully create, evidence, perfect, continue and preserve the priority of the Security Interest.

8.       Default; Remedies. Should a Default occur and be continuing, Secured Party may, at its election, exercise any and all rights available to a secured party under the UCC, in addition to any and all other rights afforded by this Agreement, the Note, at law, in equity, or otherwise, including, without limitation, applying by appropriate judicial proceedings for appointment of a receiver for all or part of the Collateral (and Pledgor hereby consents to any such appointment).

9.       Notice. Reasonable notification of the time and place of any public sale of the Collateral, or reasonable notification of the time after which any private sale or other intended disposition of the Collateral is to be made, shall be sent to Pledgor and to any other person entitled to notice under the UCC; provided that if any of the Collateral threatens to decline speedily in value or is of the type customarily sold on a recognized market, Secured Party may sell or otherwise dispose of the Collateral without notification, advertisement, or other notice of any kind. It is agreed that notice sent or given not less than ten calendar days prior to the taking of the action to which the notice relates is reasonable for the purposes of this Section 9.

10.       Sales of Securities.

(g)In the event that the Secured Party determines to exercise its right to sell all or any part of the Collateral, Pledgor will, at Pledgor’s expense and upon request by the Secured Party: (i) execute and deliver, and cause each issuer of such Collateral and the directors and officers thereof to execute and deliver, all such instruments and documents, and do or cause to be done all such other acts and things, as may be necessary or, in the opinion of the Secured Party, advisable to register such Collateral under the provisions of the Securities Act of 1933, as amended (the “Securities Act”), and to cause the registration statement relating thereto to become effective and to remain effective for such period as prospectuses are required by law to be furnished, and to make all amendments and supplements thereto and to the related prospectus which, in the opinion of the Secured Party, are necessary or advisable, all in conformity with the requirements of the Securities Act and the rules and regulations of the Securities and Exchange Commission applicable thereto, (ii) cause each issuer of such Collateral to qualify such Collateral under the state securities or “Blue Sky” laws of each jurisdiction, and to obtain all necessary governmental approvals for the sale of the Collateral, as requested by the Secured Party, (iii) cause Pledged Issuer to make available to its securityholders, as soon as practicable, an earnings statement which will satisfy the provisions of Section 11(a) of the Securities Act, and (iv) do or cause to be done all such other acts and things as may be necessary to make such sale of such Collateral valid and binding and in compliance with applicable law. Pledgor acknowledges the impossibility of ascertaining the amount of damages which would be suffered by the Secured Party by reason of the failure by Pledgor to perform any of the covenants contained in this Section 10(a) and, consequently, agrees that, if Pledgor fails to perform any of such covenants, he shall pay, as liquidated damages and not as a penalty, an amount equal to the value of the Collateral on the date the Secured Party demands compliance with this Section 10(a); provided that the payment of such amount shall not release Pledgor from any of its obligations under this Agreement or the Note.

(h)Notwithstanding the provisions of Section 10(a) hereof, Pledgor recognizes that the Secured Party may deem him impracticable to effect a public sale of all or any part of the Pledged Equity or any other securities constituting Collateral. Secured Party is authorized, but not obligated, to limit prospective purchasers to the extent deemed necessary or desirable by Secured Party to render such sale exempt from the registration requirements of the Securities Act, and any applicable state securities laws, and no sale so made in good faith by Secured Party shall be deemed not to be “commercially reasonable” because so made. Secured Party may make one or more private sales of any such securities to a restricted group of purchasers who will be obligated to agree, among other things, to acquire such securities for their own account, for investment and not with a view to the distribution or resale thereof. Pledgor acknowledges that any such private sale may be at prices and on terms less favorable to the seller than the prices and other terms which might have been obtained at a public sale and, notwithstanding the foregoing, agrees that such private sales shall be deemed to have been made in a commercially reasonable manner and that the Secured Party shall have no obligation to delay the sale of any such securities for the period of time necessary to permit the issuer of such securities to register such securities for public sale under the Securities Act. Pledgor further acknowledges and agrees that any offer to sell such securities which has been (i) publicly advertised on a bona fide basis in a newspaper or other publication of general circulation in the financial community of Houston, Texas (to the extent that such an offer may be so advertised without prior registration under the Securities Act) or (ii) made privately in the manner described above to not less than ten (10) bona fide offerees shall be deemed to involve a “public disposition” for the purposes of Section 9-610(c) of the UCC, notwithstanding that such sale may not constitute a “public offering” under the Securities Act, and that the Secured Party may, in such event, bid for the purchase of such securities.

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11.       Application of Proceeds. Secured Party shall apply the proceeds of any sale or other disposition of the Collateral in the following order: first, to the payment of all its expenses incurred in retaking, holding and preparing any of the Collateral for sale(s) or other disposition, in arranging for such sale(s) or other disposition, and in actually selling or disposing of the same (all of which are part of the Obligation); second, toward repayment of amounts expended by Secured Party under this Agreement; third, toward payment of the balance of the Obligation in accordance with the Note. Any surplus remaining shall be delivered to Pledgor or as a court of competent jurisdiction may direct.

12.       Other Rights of Secured Party.

(a)Performance. In the event Pledgor shall fail to perform any of his obligations hereunder with respect to the Collateral, then Secured Party may, at its option, but without being required to do so, take such action which Pledgor is required, but has failed or refused, to take. Any sum which may be expended or paid by Secured Party under this Section 12(a) (including, without limitation, court costs and reasonable attorneys’ fees) shall bear interest from the dates of expenditure or payment at the default rate under the Note until paid and, together with such interest, shall be payable by Pledgor upon demand and shall be part of the Obligation.

(b)Collection. Upon notice from Secured Party, each Person obligated with respect to any of the Collateral, whether as an issuer, account debtor or otherwise (an “Obligor”) is hereby authorized and directed by Pledgor to make payments on any of the Collateral (including, without limitation, dividends and other distributions) directly to Secured Party, regardless of whether Pledgor was previously making collections thereon. Subject to Section 12(e) hereof, until such notice is given, Pledgor is authorized to retain and expend all payments made on Collateral. Secured Party shall have the right in its own name or in the name of Pledgor to compromise or extend time of payment with respect to all or any portion of the Collateral for such amounts and upon such terms as Secured Party may determine; to demand, collect, receive, receipt for, sue for, compound and give acquittances for any and all amounts due or to become due with respect to Collateral; to take control of cash and other proceeds of any Collateral; to endorse the name of Pledgor on any notes, acceptances, checks, drafts, money orders or other evidences of payment on Collateral that may come into the possession of Secured Party; to send requests for verification of obligations to any Obligor; and to do all other acts and things necessary to carry out the intent of this Agreement. If any Obligor fails or refuses to make payment on any Collateral when due, Secured Party is authorized, in its sole reasonable discretion, either in its own name or in the name of Pledgor, to take such action as Secured Party shall deem appropriate for the collection of any such amounts. Regardless of any other provision hereof, Secured Party shall never be liable for its failure to collect, or for its failure to exercise diligence in the collection of, any amounts owed with respect to Collateral, nor shall it be under any duty whatever to anyone except Pledgor to account for funds that it shall actually receive hereunder. Without limiting the generality of the foregoing, Secured Party shall have no responsibility for ascertaining any maturities, calls, conversions, exchanges, offers, tenders or similar matters relating to any Collateral, or for informing Pledgor with respect to any of such matters (irrespective of whether Secured Party actually has, or may be deemed to have, knowledge thereof). The receipt of Secured Party to any Obligor shall be a full and complete release, discharge and acquittance to such Obligor, to the extent of any amount so paid to Secured Party. The rights granted Secured Party under this Section 12(b) may be exercised at any time, whether or not a Default has occurred and is continuing.

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(c)Record Ownership of Securities. When a Default has occurred and is continuing, Secured Party at any time may have the Collateral registered in its name, or in the name of its nominee or nominees, as pledgee; and Pledgor shall execute and deliver to Secured Party all such proxies, powers of attorney, dividend coupons or orders and other documents as Secured Party may reasonably request for the purpose of enabling Secured Party to exercise the voting rights and powers which it is entitled to exercise hereunder and to receive the dividends and other payments which it is authorized to receive and retain hereunder.

(d)Voting of Securities. So long as no Default has occurred, Pledgor shall be entitled to exercise all voting rights pertaining to the Collateral. After the occurrence and during the continuance of a Default, the right to vote the Collateral shall be vested exclusively in Secured Party. To this end, Pledgor irrevocably appoints Secured Party the proxy and attorney-in-fact of Pledgor, with full power of substitution, to vote and to act with respect to the Collateral, subject to the understanding that such proxy may not be exercised unless a Default has occurred and is continuing. The proxy herein granted is coupled with an interest, is irrevocable, and shall continue until the Obligation has been paid and performed in full.

(e)Certain Proceeds. Any and all stock or dividends or distributions, or distributions in property made on or in respect of the Collateral, and any proceeds of the Collateral, whether such dividends, distributions, or proceeds result from a subdivision, combination or reclassification of the outstanding capital stock or equity owned by Pledgor or as a result of any merger, consolidation, acquisition or other exchange of assets to which Pledgor may be a party, or otherwise, shall be part of the Collateral hereunder, shall, if received by Pledgor, be held in trust for the benefit of Secured Party, and shall forthwith be delivered to Secured Party (accompanied by proper instruments of assignment and/or stock and/or bond powers executed by Pledgor in accordance with Secured Party’s instructions) to be held subject to the terms hereof. Prior to the occurrence and continuation of a Default, any cash proceeds of Collateral which come into the possession of Secured Party may, at Secured Party’s option, be applied in whole or in part to the Obligation, or be released in whole or in part to or on the written instructions of Pledgor for any general or specific purpose not in violation of the Note, or be retained in whole or in part by Secured Party as additional Collateral. Upon the occurrence and continuation of a Default, any cash proceeds of Collateral shall be applied to the Obligation.

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13.       Miscellaneous.

(a)Term. Upon full and final payment of the Obligation and final termination of Secured Party’s commitment to lend under the Note without Secured Party having exercised its rights under this Agreement, this Agreement shall terminate; provided that no Obligor on any of the Collateral shall be obligated to inquire as to the termination of this Agreement, but shall be fully protected in making payment directly to Secured Party, which payment shall be promptly paid over to Pledgor after termination of this Agreement.

(b)Notice. Any notice or communication required or permitted under this Agreement must be given as prescribed in the Note. Any notice or communication required or permitted to be given to Pledgor hereunder may be given to Pledgor in the manner prescribed in the Note, and such notice shall constitute notice to Pledgor.

(c)Governing Law. This Agreement is to be construed, and its performance enforced, under Texas law.

(d)Note. In the event of any conflict or inconsistency between the terms hereof and the Note, the terms of the Note shall be controlling.

(e)Multiple Counterparts and Facsimile Signatures. This Agreement may be executed in any number of counterparts with the same effect as if all signatories had signed the same document. All counterparts must be construed together to constitute one and the same instrument. This Agreement may be transmitted and signed by facsimile and portable document format (PDF), and any such facsimile or PDF signatures shall have the same effect as manually-signed originals and shall be binding on Pledgor and Secured Party.

(f)Binding Effect; Survival. This Agreement is binding upon, the parties hereto and their respective and successors and permitted assigns, as applicable.

(g)Amendments. This Agreement may be amended, modified, supplemented or be the subject of a waiver only by a writing executed by Secured Party and Pledgor.

(h)Entirety. THIS AGREEMENT, THE NOTE, AND THE SUBSCRIPTION AGREEMENT REPRESENT THE FINAL AGREEMENT AMONG THE PARTIES AND MAY NOT BE CONTRADICTED BY EVIDENCE OF PRIOR, CONTEMPORANEOUS, OR SUBSEQUENT ORAL AGREEMENTS BY THE PARTIES. THERE ARE NO UNWRITTEN ORAL AGREEMENTS AMONG THE PARTIES.

[Signatures are on the following page.]

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EXECUTED as of the date set forth in the preamble.

PLEDGOR:
TEXAS HEART INSTITUTE, a Texas non-profit corporation
By:	/s/ Marc C. Mattsson
Name: Marc C. Mattsson
Title: Chief Executive Officer
SECURED PARTY:
MIROMATRIX MEDICAL, INC., a Delaware corporation
By:	/s/ Robert Cohen
Name:	Robert Cohen
Title:	President and CEO

Signature Page to Pledge Agreement

SCHEDULE 1
Pledged Equity

Issuer	Shares of Series B Preferred		Certificate Number		Percentage Owned by Pledgor			Other Liens
Miromatrix Medical, Inc.		666,667		1		100	%	none

Schedule1 

 

Marc C. Mattsson

Chief Executive Officer

October 8, 2013

Miromatrix Medical Inc. (“Miromatrix”) and Texas Heart Institute (“THI”) have entered into a Sub-License Agreement dated October 8, 2013, related to research, development, and commercialization of whole heart products using perfusion based decellularization and recellularization technology licensed to or owned by Miromatrix (“Agreement”). The Agreement restricts the ability of Miromatrix and THI to assign the Agreement to another person or entity. Section 10.2 of the Agreement states that consent to an assignment will not be unreasonably withheld.

Catholic Health Initiatives (“CHI”) and THI recently announced a letter of intent for exclusive negotiations toward a new partnership over the next decade for research and education in cardiovascular diseases. As part of this new partnership, THI and CHI may enter into a joint venture arrangement or form a new entity with CHI for research and development purposes, including but not limited to research and development of the type of technology licensed to THI under the Agreement.

THI may request a transfer of the Agreement from THI to the THI/CHI joint venture or new entity, if consummated. Based on discussions between THI and Miromatrix to date, Miromatrix is not presently aware of any reason to deny such a request. THI will keep Miromatrix seasonably informed of its plans with CHI and any need in THI’s opinion to assign the Agreement to further the goals of both THI and Miromatrix.

Please sign where indicated below to acknowledge that Miromatrix has been made aware of the potential transfer issue and to acknowledge that the foregoing represents Miromatrix’s present understanding of the potential transfer request.

Sincerely yours,

/s/ Marc C. Mattson

Marc C. Mattsson

Miromatrix Medical, Inc.

/s/ Robert Cohen

Robert Cohen

President & CEO

Texas Heart Institute • Texas Medical Center • MC 3-117 • Post Office Box 20345 • Houston, Texas 77225-0345

(832) 355-3792 • Fax (832) 355-3089 • www.texasheart.org

EX-10.18

Exhibit 10.18

FIRST AMENDMENT TO SUB-LICENSE AGREEMENT

THIS FIRST AMENDMENT (“First Amendment”) is made to the Sub-License Agreement by and between Miromatrix Medical Inc., a Delaware corporation with a principal place of business at 18683 Bearpath Trail, Eden Prairie, MN 5534 7 USA (hereinafter “Miromatrix”), and Texas Heart Institute, a Texas non-profit corporation with a principal place of business at 6770 Bertner, Suite C 550, Houston, Texas 77030 (hereinafter “THI”), which has an effective date of October 2013 (“Agreement”). Miromatrix and THI may be referred to as a “Party” or, collectively, as “Parties.”

RECITALS

WHEREAS, the Parties desire to amend the Agreement as set forth below;

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound thereby, the Parties agree as follows:

Section 2.1 of the Agreement is deleted and replaced with amended Section 2.1 below. Amended Section 2.1 is effective as of the __ day of April, 2014 (“First Amendment Effective Date”). All other Sections, terms, and provisions of the Agreement remain unchanged and in full effect:

Amended Section 2.1 Grant of Sub-License. Subject to the terms and conditions contained in this Agreement, and in consideration for the research and development of Products by THI for commercialization by Miromatrix, Miromatrix grants to THI an exclusive, even as to Miromatrix, non-transferrable, non-sub-licensable, worldwide license under the Miromatrix Patents for performance of research in the Product Area and the development of Products in accordance with the terms and conditions hereinafter set forth. Notwithstanding the foregoing or any other term or provision of this Agreement, subject to, in each instance, prior written approval by Miromatrix (which it may withhold in its sole and absolute discretion) THI may grant sub- licenses under the Miromatrix Patents to third parties (“Authorized Sub-Licensees”), provided: (i) the sub-license extends solely to research performed in the Product Area for the benefit of THI and does not extend to any clinical or commercialization activities; (ii) the Authorized Sub- Licensees agree in a separate agreement to be executed by Miromatrix, THI, and the respective Authorized Sub-licensee, in substantially the form attached to this First Amendment as Exhibit 1, that all intellectual property in the Product Area conceived in the performance of such research is assigned to THI with no rights remaining in the Authorized Sub-Licensees (the “Sub-License IP”) and the results and data from such research shall be provided solely to THI and Miromatrix, both of which may use and license such results and data in the Product Area as provided for in the Agreement; and (iii) all patents and patent applications issued or filed on the Sub-License IP shall automatically be included in the definition of THI Patents. The Parties agree that the foregoing license to THI includes the right to research and develop parts of the heart, including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like, provided THI is conducting such research and development of parts of the heart solely in furtherance of THI’s research and development of Products; provided, that this shall not be construed as a license to conduct clinical trials of, or sell, offer to sell, have sold, supply or import or otherwise commercialize or have commercialized, parts of the heart (including, without limitation, heart valves, cardiac patches, blood vessels, AV node and the like). The foregoing license shall be retroactive to the first publication date of a patent application falling within the Miromatrix Patents. Miromatrix represents and warrants that it possesses all rights to bring demands, claims, and causes of action against the THI, and THI’s representatives, officers, shareholders, directors, employees, subsidiaries, affiliates, divisions, successors and assigns (collectively the “Released Parties”) for infringement of the Miromatrix Patents, and that such demands, claims, and causes of action are within the scope of the license set forth in this Section 2.1.

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IN WITNESS WHEREOF, the parties hereto have duly executed this First Amendment to the Agreement.

MIROMATRIX MEDICAL INC.		TEXAS HEART INSTITUTE
By	/s/ Robert Cohen	By	/s/ Marc C. Mattsson
	Robert Cohen		Marc C. Mattsson
	President & CEO		Chief Executive Officer

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SUB-LICENSE AGREEMENT

THIS SUB-LICENSE AGREEMENT is entered into by and between Miromatrix Medical Inc., a Delaware corporation with a principal place of business at 18683 Bearpath Trail, Eden Prairie, MN 55347 USA (hereinafter “Miromatrix”), Texas Heart Institute, a Texas non-profit corporation with a principal place of business at 6770 Bettner, Suite C 550, Houston, Texas 77030 (hereinafter “THI”), and _____________________________ (“Sub-Licensee”), and has an Effective Date of _______________________ (“Agreement”). Miromatrix, THI, and Sub-Licensee may be referred to as a “Party” or, collectively, as “Parties.”

RECITALS

WHEREAS, Miromatrix is engaged in the research, development, manufacture and marketing of perfusion decellularization and recellularization technology and the products that are created utilizing such technology;

WHEREAS, Miromatrix and THI have executed a license agreement that grants THI a sub-license in and to certain patents and patent applications owned and/ or licensed by Miromatrix, including a first amendment to the license agreement ( collectively the “THI License Agreement”);

WHEREAS, THI desires to grant to Sub-Licensee a sub-license under the THI License Agreement for research to be performed by Sub-Licensee at the request of THI; and

WHEREAS, THI believes the Research may foster developments in the Product Area (as defined below).

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound thereby, the Parties agree as follows:

DEFINITIONS

SECTION 1 

1.1 “Intellectual Property” means patents, copyrights, trademarks, trade secrets, trade dress, know-how or other intellectual property rights, whether patented, patentable, pending or granted.

1.2 “Material” means decellularized animal hearts.

1.3 “Miromatrix Patents” means all patents and patent applications license to THI under the THI License Agreement.

1.4 “Product Area” means the whole heart organ (as differentiated from parts of the heart including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like) for transplantation into human beings, whereby perfusion decellularization and/ or perfusion recellularization has been utilized in any portion of the creation or manufacture of such whole heart organ and parts of the heart, including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like, provided any research related to parts of the heart solely furthers research and development of the while heart organ.

1.5 “Research” means research and testing by Sub-Licensee for THI in the Product Area using the Material. The Research shall be limited strictly to the activities set forth in Attachment A hereto.

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SUB-LICENSE GRANT

SECTION 2 

2.1 Subject to the terms and conditions contained in this Agreement, THI grants to Sub-Licensee a non-transferrable, non-sub-licensable sub-license under the Miromatrix Patents for performance of the Research only. Sub-Licensee agrees that:

2.1.1 the sub-license granted herein is for the Research only and does not extend to any commercialization or other activities;

2.1.2 all Intellectual Property conceived by Sub-Licensee and its officers, employees, and personnel in the performance of the Research (“Sub-License IP”) shall be, and is hereby, assigned to THI with no rights remaining in the Sub-Licensee;

2.1.3 all results and data from the Research (“Research Data”) shall be, and is hereby, assigned to THI with no rights remaining in the Sub-Licensee; and

2.1.4 Sub-Licensee shall not maintain copies of the Sub-License IP or the Research Data.

2.2 The sub-license granted to Sub-Licensee shall terminate at the earliest of conclusion of the Research, the date set forth in Section 4.4 hereinbelow for the completion of the Research, or termination of this Sub-License Agreement by any Party for any reason.

2.3 Except for the sub-license grant in this Agreement, no right, title, or interest in and to any Intellectual Property owned, controlled, or licensed by THI or by Miromatrix is granted to Sub-Licensee.

FEE AND EXPENSES

SECTION 3 

3.1 THI shall pay to Sub-Licensee the amount of                                                       (“Fee”).

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3.2 The Fee shall be the only compensation owed by THI to Sub-Licensee. The costs of all facilities equipment, and expenses required to perform the Research shall be borne by Sub-Licensee.

3.3 Miromatrix shall not owe any compensation, fee, or monies to Sub-Licensee.

MATERIAL AND RESEARCH

SECTION 4 

4.1 THI will transfer the Material to the Sub-Licensee solely for the limited purpose of the Research. Sub-Licensee agrees that all Research shall be conducted under the supervision of                                                       (“Investigator”).

4.2 Ownership of the Material shall at all times remain with THI. All restrictions and obligations of this Agreement relate to the Material, including Material contained or incorporated in unmodified derivatives and progeny, (as those selected terms are defined in the under the Uniform Material Transfer Agreement as published in the Federal Register, on March 8, 1995, (“UBMTA”) and incorporated by reference herein), mutants, or replicated forms thereof, and all cells and tissues containing the Material, including any replicated forms and unmodified derivatives thereof.

4.3 Sub-Licensee agrees and acknowledges that the Material:

4.3.1 will be used solely for the Research and shall not be disclosed or distributed to any other person or entity;

4.3.2 will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects;

4.3.3 will be used only at the Sub-Licensee’s facilities and only in the care and under the direction of the Investigator; and

4.3.4 will be used in compliance with all applicable statutes and regulations.

4.4 The Research shall be completed on or before ____________. The Research Data shall be provided to THI within three (3) business days after completion of the Research or within three (3) business days after termination of this Agreement, whichever occurs earlier.

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CONFIDENTIAL INFORMATION

SECTION 5 

5.1 The Parties agree that the Material and all information exchanged between the Parties concerning the Research or any Miromatrix confidential information shall be held in strict confidence, hereinafter “Confidential Information,” provided Confidential Information shall not include information that:

5.1.1 was previously known to the receiving Party as evidenced by information in possession of receiving Party before its receipt of the Confidential Information from the other Party;

5.1.2 has been publicly disclosed by another person or entity that is not under an obligation of confidentiality to the disclosing Party;

5.1.3 is publicly available at time of disclosure or becomes publicly available after disclosure by no fault of the receiving Party; or

5.1.4 is required by law, subpoena, court order or other governmental order or request to be disclosed provided that the receiving Party provides prompt written notice of such disclosure to the disclosing Party and cooperates with the disclosing Party’s reasonable and lawful actions to avoid and/ or minimize the extent of such disclosure.

5.2 The obligations of confidentiality under this Section 5 shall survive until the information ceases to fall under the definition of Confidential Information.

TERM AND TERMINATION

SECTION 6 

6.1 Any Party may terminate this Sub-License Agreement for a material breach by another Party. The terminating Party shall provide written notice to the breaching Party that explains in detail the nature of the material breach and the Sections that have been breached. The breaching Party shall have ten (10) days after receipt of the termination notice to fully cure the material breach. If the material breach has not been fully cured within those ten (10) days, then this Agreement shall automatically terminate.

6.2 THI may terminate this Agreement without cause by providing Sub-Licensee five (5) days written notice. If THI provides such notice, it shall pay Sub-Licensee any unpaid portion of the Fee and shall not be entitled to reimbursement of any portion of the Fee previously paid to Sub-Licensee.

MISCELLANEOUS

SECTION 7 

7.1 This Agreement (i) may not be assigned or transferred, in whole or in part, by Sub-Licensee without the prior written consent of THI and Miromatrix, which either THI or Miromatrix may withhold in its sole and absolute discretion, and (ii) may not be amended or modified, by course of conduct or otherwise, except in a writing duly executed by authorized signatories of each of the Parties.

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7.2 Nothing contained in this Agreement shall be construed or implied to create a partnership, joint venture, or an agency relationship between the Parties. No Party shall have the authority to incur expenses on behalf of another Party. Employees of one Party shall not be deemed to be employees of any other Party.

7.3 A Party may be excused from performance under this Agreement in the event that unforeseen conditions arise rendering the Party unable to perform its respective duties including, but not limited to, natural disasters, Acts of God, labor disputes, government actions, wars, terrorism, or any other cause(s) beyond the reasonable control of such Party.

7.4 This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of Minnesota (without regard to the conflicts or choice of law principles thereof). The Parties irrevocably consent to the jurisdiction of the State of Minnesota, County of Hennepin, Minneapolis, and agree that any court of competent jurisdiction sitting therein shall be an appropriate and convenient place of venue to resolve any dispute with respect to this Agreement. In the event either Party commences any proceeding against the other Party with respect to this Agreement, the Parties agree that the prevailing party (as determined by the authority before whom such proceeding is commenced) shall be entitled to recover reasonable attorneys’ fees and costs as may be incurred in connection therewith in addition to any such other relief as may be granted.

7.5 Any notice, consent or payment permitted or required by this Agreement shall be considered made on the date personally delivered in writing or mailed by certified mail, postage prepaid, return receipt requested to the party at the addresses set forth:

If to THI, to:

Texas Heart Institute, Inc.

Attention: Chief Executive Officer and Medical Director

6770 Bettner, Mail Code 3-116

Houston, Texas 77030

With a Copy to:

Eric Wade, Esq.

Porter Hedges, LLP

1000 Main Street, 36th Floor

Houston, Texas 77002

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If to Miromatrix, to:

Miromatrix Medical Inc.

Attention: President and CEO

18683 Bearpath Trail

Eden Prairie, Minnesota 55347

With a copy to:

Joseph Alexander, Esq.

Maslon Edelman Borman & Brand, LLP

3300 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402

If to Sub-Licensee, to:

7.6 If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.

7.7 The section and other headings in this Agreement are for convenience of reference only and shall not affect, expressly or by implication, the meaning or interpretation of any of the provisions hereof. This Agreement may be executed in counterparts (including facsimile counterparts) each of which shall be an original, but all of which together shall constitute one instrument.

IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement.

MIROMATRIX MEDICAL INC.		TEXAS HEART INSTITUTE
By		By
	Robert Cohen		Marc C. Mattsson
	President & CEO		Chief Executive Officer

SUB-LICENSEE

By

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EX-10.19

Exhibit 10.19

SECOND AMENDMENT TO SUB-LICENSE AGREEMENT

THIS SECOND AMENDMENT (“Second Amendment”) is made to the Sub-License Agreement by and between Miromatrix Medical Inc., a Delaware corporation with .a principal place of business at 10399 West 70th Street, Eden Prairie; MN 55334 USA (hereinafter “Miromatrix”), and Texas. Heart Institute, a Texas non-profit corporation with a principal place of business 01_.6770 Bertner, Suite C 550, Houston, Texas 77030 (hereinafter “THI”), which has an effective date of October 1, 2013 (“Agreement”). Miromatrix and THI may be referred to as a “Party” or, collectively, as “Parties.”

RECITALS

WHEREAS, on or about April 1, 2014, the Parties executed a First Amendment to the Agreement (“First Amendment”); and

WHEREAS, the Parties desire to execute this Second Amendment to the Agreement.

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound thereby, the Parties agree as follows:

The attached Exhibit B (Milestones) hereby supersedes and replaces original. Exhibit B to the Agreement in its entirety. The original Exhibit B to the Agreement shall no longer have any force or effect. All other Sections, terms, and provisions of the Agreement remain unchanged by this Second Amendment. All Sections, terms, and provisions of the First Amendment remain unchanged by this Second Amendment.

IN WITNESS WHEREOF, the Parties hereto have duly executed this Second Amendment to the Agreement, effective as of the date of the last signature of a Party set forth below.

MIROMATRIX MEDICAL INC.		TEXAS HEART INSTITUTE
By:	/s/ Jeff Ross	By:	/s/ Fred Zeidman
	Jeff Ross		Fred Zeidman
	President & CEO		Chief Financial Officer
Date:	9/25/2018	Date:	9/25/2018

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EXHIBIT B

WHOLE HEART MAJOR MILESTONES

Milestone 1 - Cardiac Source and Characterization (.75 years, complete 9/30/2014)

· Define cardiac decellularization process from porcine sources

· Characterize the cardiac matrix and identify key process

· Define cardiac decellularization production process

Milestone 2:- Human Sized Whole Heart Recellularization (5 years, complete 9/30/2019)

Recellularization of the Whole Heart (3.5 years)

· Evaluate vascular and parenchymal human cell sources including for example iPS cells for cardiac recellularization

· Identify human cell sources and define regulatory strategy in consultation with

· Miromatrix

Functional Characterization of Human Sized Heart with Human Cells (1.5 years)

· Demonstrate functional whole heart recellularization in three separate hearts as defined by:

o Contractile function and drug responsiveness consistent with human physiology.

Milestone 3 - Preclinical Lame Animal Safety/Efficacy Studies of Human Sized Hearts with Human Cells (3 years, complete 9/30/2021)

· Complete acute large animal preclinical studies

o Whole heart transplantation that successfully demonstrates cardiac function and acute stability for 6 hours in three animals

· Complete chronic large animal preclinical studies

o Whole heart transplantation that successfully demonstrates sustained cardiac function for 45 days following transplantation in three animals

Milestone 4 - Whole Human Sized Heart with Human Cells Productions and GLP Preclinical Studies (2 year, complete 9/30/2022 or at end of follow-up period required by FDA)

· Complete GLP preclinical studies for follow up period required by FDA to demonstrate efficacy and to support IND submission

· Define release criteria to demonstrate safety for IND application

B-1

Milestone 5 - IND Submission (1.5 year. complete 3/31/2023)

· Validate product SOPs for GLP and make available all data and documentation to Miromatrix

· File FDA regulatory submission for Phase I safety trials

Milestone 6 - First in Human Clinical Trial (THI will send data from 3 patient trials within 3 months following the end of the FDA specified follow-up period for 3 patients enrolled.).

· Complete first in human clinical study (3 patients)

Milestone 7 - Phase I/II Clinical Trials (complete 2 years after end of FDA specified follow-up period for patients enrolled)

· Complete within 18 months or timeline designated by FDA for Phase II clinical trials (5-10 patients)

· Potential for Phase I/11 initial study and compassionate use

Milestone 8 - Phase III Pivotal Clinical Trial (complete 3 years after end of FDA specified follow-up period for patients enrolled)

· Complete pivotal trial to demonstrate efficacy of whole heart transplantation

· Shortened clinical trial period to reflect potential for orphan status

Milestone 9 - PMA Approval (1 Year after Milestone 8)

· File PMA submission with FDA

B-2

EX-10.20

Exhibit 10.20

STOCK PURCHASE AGREEMENT

THIS STOCK PURCHASE AGREEMENT (this “Agreement”), dated as of October 14, 2020, is entered into between Reprise Biomedical, Inc., a Minnesota corporation (the “Company”), and Miromatrix Medical Inc., a Delaware corporation (“Seller”).

WHEREAS, Seller owns 4,500,000 shares of common stock, $0.001 par value per share (the “Shares”), of the Company; and

WHEREAS, Seller wishes to sell to the Company, and the Company wishes to purchase from Seller, the Shares, subject to the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1.Purchase and Sale. Subject to the terms and conditions set forth herein:

(a)At the First Closing (as defined below), Seller shall sell, transfer and assign to the Company, and the Company shall purchase from Seller, all of Seller's right, title and interest in and to 2,700,000 Shares (the “First Closing Shares”). The aggregate purchase price for the First Closing Shares shall be $3,000,000 (the “First Closing Purchase Price”).

(b)At the Second Closing (as defined below), Seller shall sell, transfer and assign to the Company, and the Company shall purchase from Seller, all of Seller's right, title and interest in and to the remaining 1,800,000 Shares (the “Second Closing Shares”). The aggregate purchase price for the Second Closing Shares shall be $2,000,000 (the “Second Closing Purchase Price”).

2.Closings.

(a)Subject to the terms and conditions contained in this Agreement, the initial closing for the purchase and sale of the First Closing Shares contemplated hereby (the “First Closing”) shall take place at 10:00 a.m., local time, on November 15, 2020 (the “First Closing Date”) at the offices of Faegre Drinker Biddle & Reath LLP in Minneapolis, Minnesota, or at such other place or on such other date as the Company and Seller may mutually agree upon in writing. At the First Closing, Seller shall deliver to the Company the stock certificate representing the First Closing Shares, free and clear of all Encumbrances (as defined herein), duly endorsed in blank, and the Company shall deliver to Seller the First Closing Purchase Price by wire transfer of immediately available funds to an account designated in writing by Seller to the Company no later than two business days before the First Closing. Promptly following the First Closing, the Company will cancel the First Closing Shares on the stock register of the Company and will issue to Seller a new stock certificate evidencing the Second Closing Shares.

(b)Subject to the terms and conditions contained in this Agreement, the closing for the purchase and sale of the Second Closing Shares contemplated hereby (the “Second Closing,” and together with the First Closing, the “Closings” and each individually a “Closing”) shall take place at 10:00 a.m., local time, on March 15, 2021 (the “Second Closing Date,” and together with the First Closing Date, the “Closing Dates” and each individually a “Closing Date”) at the offices of Faegre Drinker Biddle & Reath LLP in Minneapolis, Minnesota, or at such other place or on such other date as the Company and Seller may mutually agree upon in writing. At the Second Closing, Seller shall deliver to the Company the stock certificate evidencing the Second Closing Shares, free and clear of all Encumbrances, duly endorsed in blank, and the Company shall deliver to Seller the Second Closing Purchase Price by wire transfer of immediately available funds to an account designated in writing by Seller to the Company no later than two business days before the Second Closing.

3.Closing Conditions.

(a)The obligation of Seller to sell, transfer and assign the applicable Shares at each Closing Date to the Company hereunder is subject to the satisfaction of the following conditions as of each Closing:

(i)the representations and warranties of the Company in Section 5 hereof shall be true and correct on and as of the applicable Closing Date with the same effect as though made at and as of such date;

(ii)the Company shall have performed and complied in all material respects with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or on the applicable Closing Date;

(iii)the Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary or appropriate for consummation of the transactions contemplated herein;

(iv)Seller shall have received a certificate, dated as of the applicable Closing Date and signed by a duly authorized officer of the Company, that each of the conditions set forth in this Section 3(a) have been satisfied; and

(v)Seller shall have received a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of the Company certifying that attached thereto are true and complete copies of all resolutions adopted by the board of directors of the Company authorizing the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby, and that all such resolutions are in full force and effect and are all the resolutions adopted in connection with the transactions contemplated hereby.

(b)The obligation of the Company to purchase the applicable Shares from Seller is subject to the satisfaction of the following conditions as of each Closing:

(i)the representations and warranties of Seller in Sections 4(a), 4(b), 4(c) and 4(d) shall be true and correct on and as of each Closing Date with the same effect as though made at and as of such date;

(ii)Seller shall have performed and complied in all material respects with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or on the applicable Closing Date;

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(iii) Seller shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for consummation of the transactions contemplated herein;

(iv)the Company shall have received a certificate, dated the applicable Closing Date and signed by a duly authorized officer of Seller, that each of the conditions set forth in this Section 3(b) have been satisfied; and

(v)the Company shall have received a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of Seller certifying that attached thereto are true and complete copies of all resolutions adopted by the board of directors of Seller authorizing the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby, and that all such resolutions are in full force and effect and are all the resolutions adopted in connection with the transactions contemplated hereby.

4.Representations and Warranties of Seller. Seller hereby represents and warrants to the Company as follows:

(a)Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

(b)Seller has all requisite power and authority to execute and deliver this Agreement, to carry out its obligations hereunder, and to consummate the transactions contemplated hereby. Seller has obtained all necessary corporate approvals for the execution and delivery of this Agreement, the performance of its obligations hereunder, and the consummation of the transactions contemplated hereby. This Agreement has been duly executed and delivered by Seller and (assuming due authorization, execution and delivery by the Company) constitutes Seller's legal, valid and binding obligation, enforceable against Seller in accordance with its terms.

(c)The Shares have been duly authorized, are validly issued, fully paid and non-assessable, and are owned of record and beneficially by Seller, free and clear of all liens, pledges, security interests, charges, claims, encumbrances, agreements, options, voting trusts, proxies and other arrangements or restrictions of any kind (“Encumbrances”). Upon consummation of the transactions contemplated by this Agreement, the Company shall own the Shares, free and clear of all Encumbrances.

(d)The execution, delivery and performance by Seller of this Agreement do not conflict with, violate or result in the breach of, or create any Encumbrance on the Shares pursuant to, any agreement, instrument, order, judgment, decree, law or governmental regulation to which Seller is a party or is subject or by which the Shares are bound.

(e)No material governmental, administrative or other third-party consents or approvals are required by or with respect to Seller in connection with the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby.

(f)There are no actions, suits, claims, investigations or other legal proceedings pending or, to the knowledge of Seller, threatened against or by Seller that challenge or seek to prevent, enjoin or otherwise delay the transactions contemplated by this Agreement.

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(g) No broker, finder or investment banker is entitled to any brokerage, finder's or other fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of Seller.

5.Representation and Warranties of the Company.

(a)The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Minnesota.

(b)The Company has all requisite power and authority to enter into this Agreement, to carry out its obligations hereunder and to consummate the transactions contemplated hereby. The execution and delivery by the Company of this Agreement, the performance by the Company of its obligations hereunder and the consummation by the Company of the transactions contemplated hereby have been duly authorized by all requisite corporate action on the part of the Company. This Agreement has been duly executed and delivered by the Company and (assuming due authorization, execution and delivery by Seller) this Agreement constitutes a legal, valid and binding obligation of the Company enforceable against the Company in accordance with its terms.

(c)No material governmental, administrative or other third-party consents or approvals are required by or with respect to the Company in connection with the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby.

(d)There are no actions, suits, claims, investigations or other legal proceedings pending or, to the knowledge of the Company, threatened against or by the Company that challenge or seek to prevent, enjoin or otherwise delay the transactions contemplated by this Agreement.

(e)No broker, finder or investment banker is entitled to any brokerage, finder's or other fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of the Company.

6.Survival. All representations and warranties contained herein shall survive the execution and delivery of this Agreement and the Closing hereunder.

7.Guaranty. Howard Root and Ronald Eibensteiner (each a “Guarantor” and collectively, “Guarantors”) irrevocably, unconditionally and absolutely jointly and severally guarantee to Seller the full and prompt performance by the Company of any and all of its obligations under Section 1 and the related payment obligations under Section 2 of this Agreement. Each Guarantor waives any and all defenses, claims, setoffs and discharges with respect to such obligations, except the defense of discharge by payment and performance in full and any defense available to the Company provided for in this Agreement. Neither Guarantor will exercise or enforce any right of contribution, reimbursement, recourse or subrogation as to any such obligations against the Company until all such obligations have been fully paid and performed. If Seller commences litigation to enforce this Section 7 and is the prevailing party as determined by a final order of a court of competent jurisdiction, Guarantors will pay all reasonable costs incurred by Seller, including reasonable attorneys’ fees and expenses, in connection with the enforcement of this Section 7.

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8.Indemnification.

(a) Seller shall indemnify the Company and hold the Company harmless against and in respect of any and all losses, liabilities, damages, obligations, claims, Encumbrances, costs and expenses (including, without limitation, reasonable attorneys' fees) incurred by the Company resulting from any breach of any representation, warranty, covenant or agreement made by Seller herein.

(b)The Company shall indemnify Seller and hold Seller harmless against and in respect of any and all losses, liabilities, damages, obligations, claims, Encumbrances, costs and expenses (including, without limitation, reasonable attorneys' fees) incurred by Seller resulting from any breach of any representation, warranty, covenant or agreement made by the Company herein.

(c)Subject to Section 12, the parties acknowledge and agree that their sole and exclusive remedy with respect to any and all claims (other than claims arising from intentional fraud on the part of a party hereto in connection with the transactions contemplated by this Agreement) for any breach of any representation, warranty, covenant, agreement or obligation set forth herein or otherwise relating to the subject matter of this Agreement, shall be pursuant to the indemnification provisions set forth in this Section 7.

9.Further Assurances. Following the Closing, each of the parties hereto shall execute and deliver such additional documents, instruments, conveyances and assurances, and take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions contemplated by this Agreement.

10.Termination. This Agreement may be terminated at any time prior to the applicable Closing (a) by the mutual written consent of the Company and Seller or (b) by Seller if (i) a breach of any provision of this Agreement has been committed by the Company and such breach has not been cured within 10 days following receipt by the Company of written notice of such breach, or (ii) (x) the First Closing does not occur by November 25, 2020 or (y) the Second Closing does not occur by March 25, 2021. Upon termination, all further obligations of the parties under this Agreement shall terminate without liability of any party to the other parties to this Agreement, except that no such termination shall relieve any party from liability for any fraud or willful breach of this Agreement.

11.Expenses. All costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be paid by the party incurring such costs and expenses.

12.Specific Performance. The parties agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy to which they are entitled at law or in equity.

13.Notices. All notices, requests, consents, claims, demands, waivers and other communications hereunder (each, a “Notice”) shall be in writing and addressed to the parties at the addresses set forth on the first page of this Agreement (or to such other address that may be designated by the receiving party from time to time in accordance with this section). All Notices shall be delivered by personal delivery, nationally recognized overnight courier (with all fees pre- paid), facsimile or e-mail of a PDF document (with confirmation of transmission) or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in this Agreement, a Notice is effective only (a) upon receipt by the receiving party, and (b) if the party giving the Notice has complied with the requirements of this Section.

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14.Entire Agreement. This Agreement constitutes the sole and entire agreement of the parties to this Agreement with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

15.Successor and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. No party may assign any of its rights or obligations hereunder without the prior written consent of the other parties hereto, which consent shall not be unreasonably withheld or delayed.

16.Headings. The headings in this Agreement are for reference only and shall not affect the interpretation of this Agreement.

17.Amendment and Modification; Waiver. This Agreement may only be amended, modified or supplemented by an agreement in writing signed by each party hereto. No waiver by any party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

18.Severability. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon such determination that any term or other provision is invalid, illegal or unenforceable, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.

19.Governing Law; Submission to Jurisdiction. This Agreement shall be governed by and construed in accordance with the internal laws of the State of Minnesota without giving effect to any choice or conflict of law provision or rule (whether of the State of Minnesota or any other jurisdiction). Any legal suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated hereby may be instituted in the federal courts of the United States or the courts of the State of Minnesota in each case located in the city of Minneapolis and County of Hennepin, and each party irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action or proceeding. Service of process, summons, notice or other document by mail to such party's address set forth herein shall be effective service of process for any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or any proceeding in such courts and irrevocably waive and agree not to plead or claim in any such court that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum.

20.Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

[Signature Page Follows]

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the date first written above.

REPRISE BIOMEDICAL, INC.
By:	/s/ Howard Root
Name:	Howard Root
Title:	Chairman
MIROMATRIX MEDICAL INC.
By:	/s/ Paul Buckman
Name:	Paul Buckman
Title:	Chairman

Solely with respect to Section 7:

/s/ Howard Root

Howard Root

/s/ Ronald Eibensteiner

Ronald Eibensteiner

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EX-10.21

Exhibit 10.21

Execution Version

Patent and Know-How License Agreement

This Patent and Know-How License Agreement ("Agreement"), dated as of June 30, 2019 (the "Effective Date"), is by and between Miromatrix Medical Inc., a Delaware corporation ("Licensor"), and Reprise Biomedical, Inc., a Minnesota corporation ("Licensee") (collectively, the "Parties" or each, individually, a "Party").

WHEREAS, Licensor owns the entire right, title, and interest in and has the right to license to Licensee the Licensed Patents and Licensed Know-How; and

WHEREAS, Licensee wishes to practice the Licensed Patents and Licensed Know-How in the Field of Use in connection with the Licensed Products and the development of new products, and Licensor is willing to grant to Licensee a license to and under the Licensed Patents and Licensed Know-How on the terms and conditions set out in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Definitions. For purposes of this Agreement, the following terms have the following meanings:

1.1 "Action" has the meaning set forth in Section 12.1.

1.2 "Agreement" has the meaning set forth in the preamble.

1.3 "Auditor" has the meaning set forth in Section 5.2(a).

1.4 "Business Day" means a day other than a Saturday, Sunday, or other day on which commercial banks in Minneapolis, Minnesota are authorized or required by Law to be closed for business.

1.5 "Change of Control" means with respect to a Person: (a) an acquisition, reorganization, merger, or consolidation of such Person by or with any other Person in which the holders of the voting securities of such Person outstanding immediately before such transaction cease to beneficially own at least fifty percent (50%) of the combined voting power of the surviving entity, directly or indirectly, immediately after such transaction; (b) a transaction or series of related transactions in which any other Person, together with its affiliates (if applicable), becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Person; or (c) the sale or other transfer to any other Person of all or substantially all of such Person’s assets.

1.6 "Clinical Use" means use for treatment of patients and specifically not, for research and development purposes.

1.7 "Confidential Information" means all non-public, confidential, or proprietary information of Licensor or its affiliates, whether in oral, written, electronic, or other form or media, whether or not such information is marked, designated, or otherwise identified as "confidential" and includes the terms and existence of this Agreement and any information that, due to the nature of its subject matter or circumstances surrounding its disclosure, would reasonably be understood to be confidential or proprietary, including, specifically: (a) the Licensed Know-How; (b) Licensor’s other unpatented inventions, ideas, methods, discoveries, know-how, trade secrets, unpublished patent applications, invention disclosures, invention summaries, and other confidential intellectual property; and (c) all notes, analyses, compilations, reports, forecasts, studies, samples, data, statistics, summaries, interpretations, and other materials prepared by or for Licensee or its affiliates that contain, are based on, or otherwise reflect or are derived from any of the foregoing in whole or in part.

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Confidential Information does not include information that Licensee can demonstrate by documentation: (x) was or is independently developed by Licensee or its affiliates without reference to or use of any Confidential Information; (y) was or becomes generally known by the public other than by breach of this Agreement by, or other wrongful act of, Licensee or its affiliates; or (z) was received by Licensee or its affiliates from a third party who was not, at the time, under any obligation to Licensor or any other Person to maintain the confidentiality of such information.

1.8	"Effective Date" has the meaning set forth in the preamble.
1.9	"Existing Products" means the products listed Schedule 2.
1.10	"Field of Use" means acellular extracellular matrix products derived from perfusion decellularization but excluding: (i) decellularized Whole Organs; (ii) all non-clinical applications; and (iii) use in three-dimensional printing applications including but not limited to mapping associated therewith. For the avoidance of doubt, under no circumstances does the Field of Use include the addition of cells to the extracellular matrix.
1.11	"GAAP" means United States generally accepted accounting principles consistently applied.
1.12	"Governmental Authority" means any federal, state, national, supranational, local, or other government, whether domestic or foreign, including any subdivision, department, agency, instrumentality, authority (including any regulatory authority), commission, board, or bureau thereof, or any court, tribunal, or arbitrator.
1.13	"Improvement" means any patent or patent application filed within (or having a priority date within) the period beginning on the Effective Date and ending on the earlier of (a) the fifth anniversary of the Effective Date or (b) the effective date of a Change of Control that are (x) owned or controlled by Licensee or its affiliates and (y) specifically relate to perfusion decellularization.
1.14	"Law" means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, decree, other requirement or rule of law of any federal, state, local, or foreign government or political subdivision thereof, or any arbitrator, court, or tribunal of competent jurisdiction.
1.15	"Licensed Know-How" means any and all technical information, trade secrets, formulas, prototypes, specifications, directions, instructions, test protocols, procedures, results, studies, analyses, raw material sources, data, manufacturing data, formulation or production technology, conceptions, ideas, innovations, discoveries, inventions, processes, methods, materials, machines, devices, formulae, equipment, enhancements, modifications, technological developments, techniques, systems, tools, designs, drawings, plans, software, documentation, data, programs, and other knowledge, information, skills, and materials owned or controlled by Licensor directly related to the Existing Products existing as of the Effective Date.
1.16	"Licensed Patent(s)" means collectively the patents and patent applications listed in Schedule 1 together with all patents that issue therefrom, substitutions, reissues, re-examinations, and renewals of any of the foregoing.

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1.17	"Licensed Product(s)" means all products within the Field of Use, including but not limited to the Existing Products, that (a) the manufacture, use, offer for sale, sale, or importation of which by Licensee would, but for this Agreement, infringe a Valid Claim or (b) incorporate or use any element of the Licensed Know-How in its design or manufacture.
1.18	"Licensee" has the meaning set forth in the preamble.
1.19	"Licensor" has the meaning set forth in the preamble.
1.20	"Losses" means all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including reasonable attorneys’ fees and the cost of enforcing any right to indemnification hereunder, and the cost of pursuing any insurance providers.
1.21	"Minimum Royalty" means the minimum amount payable for each year during the Term as set forth in Schedule 3.
1.22	"Miromatrix Origin Patents" means the Licensed Patents listed in Schedule 1 under the heading Miromatrix Origin Patents.
1.23	"Net Sales" means the gross amount invoiced for a bona fide sale or disposition for value to a party not an affiliate of the Licensee of a Licensed Product minus (i) all trade, quantity, and discounts actually allowed, (ii) all credits and allowances actually granted due to rejections, returns, billing errors, and retroactive price reductions, (iii) applicable duties, and (iv) applicable excise, sale and use taxes, (v) out of pocket expenses for freight and shipping of Licensed Product.
	No deductions from Net Sales may be made for commissions paid to individuals whether they are with independent sales agencies or regularly employed by Licensee and on its payroll, or for cost of collections. Licensed Products will be considered "sold" at the earlier of: (x) when such Licensed Product is shipped to the third-party purchaser or (y) when billed or invoiced.
	All calculations of Net Sales must be in accordance with GAAP and based on, or valued as if based on, bona fide arms’ length transactions and not on any bundled, loss-leading, or other blended or artificial selling or transfer price. Net Sales do not include sales or transfers by Licensee to its affiliates for resale; provided that the Net Sales calculation will include the amounts invoiced by such affiliate on the resale of such Licensed Products.

1.24 "New Licensed Patent" means the Licensed Patent listed in Schedule 1 under the heading New Licensed Patent.

1.25 "Other Licensed Patents" means the Licensed Patents listed in Schedule 1 under the heading Other Licensed Patents.

1.26 "Party" has the meaning set forth in the preamble.

1.27 "Payment Statement" has the meaning set forth in Section 4.4(c).

1.28 "Person(s)" means an individual, corporation, partnership, joint venture, limited liability company, governmental authority, unincorporated organization, trust, association, or other entity.

1.29 "Quarterly Period" means each period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31.

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1.30 "Representatives" means a Party’s and its affiliates’ employees, officers, directors, consultants, and legal advisors.

1.31 "Royalty" has the meaning set forth in Section 4.1.

1.32 "Royalty End Date" has the meaning set forth in Section 4.2.

1.33 "Sell-Off Period" has the meaning set forth in Section 14.3(b).

1.34 "Subsidiary" of a Person means a corporation, partnership, limited liability company, or other business entity that is controlled by such Person, and "control" has the meaning given to it in the definition of "affiliate."

1.35 "Term" has the meaning set forth in Section 14.1

1.36 "Territory" means world-wide.

1.37 "University Agreement" has the meaning set forth in Section 4.1.

1.38 "Valid Claim" means, on a country-by-country basis, a claim of an unexpired issued or granted Licensed Patent as long as the claim has not been admitted by Licensor or otherwise caused to be invalid or unenforceable through reissue, disclaimer, or otherwise, or held invalid or unenforceable by a Governmental Authority of competent jurisdiction from whose judgment no appeal is allowed or timely taken.

1.39 "Whole Organ" means intact decellularized organs, where for the avoidance of doubt, intact is defined as an organ that retains >75% of the original volume of the starting organ including, as applicable, but not limited to, upon complete inflation or a liver lobe or lung lobe capable of being recellularized for function.

2. Grant/Patents.

2.1 Licensed Patents License. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the Term a nontransferable, nonsublicensable, exclusive right and license under the Licensed Patents in the Field of Use to make, use, offer to sell, sell, and import Licensed Products in the Territory. For the avoidance of doubt, no "have made" rights are granted hereunder and Licensee has no right to permit any third party to make any Licensed Products. Further, for the avoidance of doubt, Licensor may make, use, sell, offer for sale and/or import products outside the Field of Use using the Licensed Patents.

2.2 Know-How License. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the Term a nontransferable, nonsublicensable, exclusive right and license in the Field of Use under the Licensed Know-How to make, use, offer to sell, sell, and import Licensed Products. For the avoidance of doubt, no "have made" rights are granted hereunder and Licensee has no right to permit any third party to make any Licensed Products. Further, for the avoidance of doubt, Licensor may make, use, sell, offer for sale and/or import products outside the Field of Use using the Licensed Know-how.

2.3 No Laundering. The right and license granted to Licensee hereunder are intended to cover only bona fide products or services of Licensee and do not cover any activity of or arrangement with any third party for the primary purpose of extending rights under the Licensed Patents and Licensed Know-How to such third party or to cover such third party’s products. Without limiting the foregoing, Licensee shall not "have made" any Licensed Products from designs owned by any unlicensed third party solely for resale to or on behalf of such third party.

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2.4 Limited Grant. Except for the rights and licenses granted by Licensor under this Section 2, this Agreement does not grant to Licensee or any other Person any right, title, or interest by implication, estoppel, or otherwise. Without limiting the foregoing, nothing in this Agreement grants by implication, estoppel, or otherwise, any right, title, or interest in, to, or under any patents owned or controlled by Licensor other than Licensed Patents. All rights, titles, and interests not specifically and expressly granted by Licensor hereunder are hereby reserved.

3. Improvements/Prosecution of Miromatrix Origin Patents.

3.1 Licensee Improvements. Licensee hereby grants to Licensor a non-exclusive, nonsublicensable, nontransferable, worldwide, royalty-free, license to all Improvements for use by Licensor to make, use, sell, offer for sale and/or import Licensor's products solely outside the Field of Use. Licensee shall disclose each Improvement to Licensor in writing within thirty (30) Business Days of the filing of the relevant Improvement patent application, including a summary of the subject matter claimed in such Improvement patent application. Licensee agrees that it will enter into appropriate agreements with its employees and contractors such that Licensee owns the right to Improvements made by them and is able to grant the license being granted by this Section 3.1. For the avoidance of doubt, use of the Licensee Improvements in the process of making products for import, use, offering for sale and sale outside the Field of Use shall not be precluded because one or more steps in the process of making such products falls within the Field of Use.

3.2 Licensee, in consultation with Licensor, shall be responsible for: (a) the continued prosecution of the Miromatrix Origin Patents; and (b) the maintenance of the Miromatrix Origin Patents. Licensee shall retain counsel of its choice to file and prosecute such patent applications, which engagement shall be subject to Licensor's prior written consent, which consent shall not be unreasonably withheld. Upon mutual agreement of the parties, which agreement shall not be unreasonably withheld by either party, Licensor may elect to become a client of such patent counsel in connection with the prosecution and/or the maintenance of any Miromatrix Origin Patents.

3.3 If following consultation between the Parties, Licensee intends not to pursue the prosecution or maintenance of a Miromatrix Origin Patent in a particular country or to take any other action with respect to a Miromatrix Origin Patent in a particular country, then Licensee shall so notify Licensor promptly in writing and in good time to enable Licensor to meet any deadlines by which an action must be taken to establish or preserve any such rights. Upon receipt of any such notice by Licensee or if, at any time, Licensee fails to initiate any such action within thirty (30) days after a request by the Licensor that it do so (and thereafter diligently pursue such action), Licensor shall have the right, but not obligation, to pursue filing or registration, or support the continued prosecution or maintenance, of such Miromatrix Origin Patent at its expense in such country. If Licensor elects to pursue such filing or registration, as the case may be, or continue such support, then Licensor shall notify Licensee of such election and Licensee shall, and shall cause its agents and Affiliates to, cooperate with Licensor in this regard. If Licensee either chooses to not to take action or fails to take a required action as required by this Section 3.3 on a Miromatrix Origin Patent issued or pending in the United States, then such patent or patent application will be removed from the list of Miromatrix Origin Patents.

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4. Royalties/Payments.

4.1 Royalty. In consideration of the rights and licenses granted under this Agreement, Licensee shall pay to Licensor a royalty of six and one-half percent (6.5%) of Net Sales of all Licensed Products sold between the Effective Date and the earlier of the expiration of the Term and the Royalty End Date ("Royalty"). For the avoidance of doubt, the Royalty is the same in amount and term as the royalty owed by Licensor for the Net Sales of all Licensed Products under a Patent Assignment Agreement with the University of Minnesota originally effective as of February 4, 2010 (the “University Agreement”), and Licensor shall be entitled to no additional Royalty from Licensee under this Agreement beyond that what is owed to the University of Minnesota from the Licensed Products. If at any time during the Term the royalty owed by Licensor to the University of Minnesota for the Net Sales of the Licensed Products is reduced, then the Royalty shall be reduced by a corresponding amount.

4.2 Minimum Royalty. If the Royalty for any calendar year is less than the Minimum Royalty, Licensee shall pay Licensor the Royalty plus the difference between the Minimum Royalty and the Royalty for that calendar year. If Licensee fails to pay any shortfall in the Minimum Royalty within five (5) Business Days after the date when such Minimum Royalty is due, Licensor may terminate this Agreement on five (5) Business Days prior written notice. No Royalty shall apply to Net Sales after November 28, 2028 (the “Royalty End Date”), provided that Licensee will pay in by January 5, 2029 any shortfall in achieving the Minimum Royalty in the year 2028.

4.3 Taxes. Royalties and other sums payable under this Agreement are exclusive of taxes. Licensee will be responsible for all sales, use, excise, and value added taxes, and any other similar taxes, duties, and charges of any kind imposed by any federal, state, or local Governmental Authority on any amounts payable by Licensee hereunder, other than any taxes imposed on, or with respect to, Licensor’s income and shall pay all such royalties and other sums payable hereunder free and clear of all deductions and withholdings whatsoever, unless the deduction or withholding is required by law. If any deduction or withholding is required by law, Licensee shall pay to Licensor such sum as will, after the deduction or withholding has been made, leave Licensor with the same amount as it would have been entitled to receive without any such requirement to make a deduction or withholding.

4.4 Payment Terms and Royalty Statements.

(a) Licensee shall pay all Royalties, Minimum Royalties, and any other sums payable under this Agreement for each Quarterly Period within thirty (30) days of the end of such Quarterly Period. Licensee shall make all payments in US dollars by wire transfer of immediately available funds to a bank account to be designated in writing by Licensor. Licensor shall use Licensee’s payments of Royalties and Minimum Royalties solely and fully to pay the royalties owed to the University of Minnesota with respect to the Licensed Products and shall make such payment within five (5) days of receipt of payment from Licensee. If, after notice of breach and a ten (10) day opportunity to cure, Licensor has not cured a breach of the preceding sentence, then Licensee may pay (at its sole option) the University of Minnesota directly for any amounts owed to them and offset such amounts paid against any other amounts due to Licensor hereunder for the remainder of the Term.

(b) If Licensee is prohibited by a Governmental Authority in any country from making any payment due under this Agreement, then within the prescribed period for making the payment, Licensee shall promptly request permission from the Governmental Authority to make the payment and shall make the payment within thirty (30) days after receiving permission. If permission is not received within sixty (60) days after Licensee’s request then Licensee, at the option of Licensor, shall either deposit the payment in the currency of the relevant country in a bank account within that country designated by Licensor or make the payment to an affiliate of Licensor designated by Licensor and having an office in the relevant country or in another country designated by Licensor.

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(c) On or before the due date for all payments to Licensor pursuant to Section 4.1, Licensee shall provide Licensor with a statement ("Payment Statement") showing for the relevant Quarterly Period:

(i) the gross amount invoiced by Licensor to any third party for the sale to such third party of Licensed Products;

(ii) the type and amount of all deductions and offsets allocated with respect to such sale of Licensed Products;

(iii) the calculation of Net Sales, including the applicable Royalty rate;

(iv) the exchange rate used for calculating any Royalties; and

(v) such other particulars as are necessary for an accurate accounting of the payments due pursuant to this Agreement.

(d) If payments are not received by Licensor within five (5) Business Days after becoming due, Licensee shall pay to Licensor interest on the overdue payment from the date such payment was due to the date of actual payment at a rate of one and one-half percent (1.5%) per month, or if lower, the maximum amount permitted under applicable Law

4.5 Patent-Related Expenses. The Licensee shall pay invoices for patent-related expenses incurred under Section 3.2 for the Miromatrix Origin Patents within thirty (30) days of its receipt of the Licensor’s invoice. With respect to each invoice, the Licensor shall use reasonable efforts to specify the date on which the patent-related expense was incurred and the purpose of the expense (including, as applicable, a summary of patent attorney services giving rise to the expense).

5. Records and Audit.

5.1 Records. Licensee shall keep complete and accurate records of its sales, transfers, and other dispositions of Licensed Product necessary for the calculation of payments to be made to Licensor hereunder. Licensee shall maintain such records for the longer of: (a) the period of time required by applicable Law, or (b) three (3) years following expiration or termination of this Agreement.

5.2 Audit.

(a) Licensor, at its own expense, may at any time within two (2) years after receiving any Payment Statement from Licensee, nominate an independent certified public accountant ("Auditor") whom Licensee shall permit to have access to Licensee’s records during Licensee’s normal business hours for the purpose of verifying all payments made under this Agreement.

(b) Licensor shall provide to Licensee a copy of the Auditor’s audit report within seven (7) Business Days of Licensor’s receipt of the report. If the report shows that payments made by Licensee are deficient, Licensee shall pay Licensor the deficient amount plus interest on the deficient amount, as calculated pursuant to Section 4.4(c), within five (5) Business Days after Licensee’s receipt of the audit report. If payments made by Licensee are found to be deficient by more than five percent (5%), Licensee shall pay for the cost of the audit.

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6. Challenges to Licensed Patents. If, during the Term, Licensee or any of its affiliates institutes or actively participates as an adverse party in, or otherwise provides material support to, any action, suit, or other proceeding to invalidate or limit the scope of any Licensed Patent claim or obtain a ruling that any Licensed Patent claim is unenforceable or not patentable or that any Licensed Products would not, but for the licenses granted hereunder, infringe one or more claims of any Licensed Patent, Licensor may, after notice of breach of this Section 6 and a ten (10) Business Day opportunity to cure such breach, upon written notice to Licensee, increase the amount of the Royalty to be paid by Licensee to Licensor under Section 4.1 to $300,000 per month during the pendency of such action, suit or proceeding and that such payment shall not be paid into any escrow or other similar account.

7. Enforcement; Third-Party Infringement Claims.

7.1 Notice of Infringement or Third-Party Claims. If (a) either Party believes that any Licensed Patent or Licensed Know-How is being infringed or misappropriated by a third party in the Field of Use, or (b) if a third party alleges that any Licensed Patent is invalid or unenforceable, or claims that a Licensed Product, or its use, development, manufacture, or sale infringes such third party’s intellectual property rights in the Field of Use, the Party possessing such belief or awareness of such claims shall promptly provide written notice to the other Party and provide it with all details of such infringement or claim, as applicable, that are known by such Party.

7.2 Right to Bring Action or Defend.

(a) Licensor has the sole right and discretion to prevent or abate any actual or threatened misappropriation or infringement and attempt to resolve any claims relating to the Other Licensed Patents, New Licensed Patent and Licensed Know-How, including by (a) prosecuting or defending any inter partes review, post-grant review, covered business method patent review, opposition, derivation, interference, declaratory judgment, federal district court, US Patent and Trademark Office, US International Trade Commission, or other proceeding of any kind, and (b) taking any other lawful action that Licensor, in its sole discretion, believes is reasonably necessary to protect, enforce, or defend any Other Licensed Patent, New Licensed Patent or Licensed Know-How. Licensor has the right to prosecute or defend any such proceeding in Licensor’s own name or, if required by applicable Law or otherwise necessary or desirable for such purposes, in the name of Licensee and may join Licensee as a party if a court of competent jurisdiction determines Licensee is an indispensable party to such proceeding. Licensor shall bear its own costs and expenses in all such proceedings and have the right to control the conduct thereof and be represented by counsel of its own choice therein.

(b) Licensee shall and hereby does irrevocably and unconditionally waive any objection to Licensor’s joinder of Licensee to any proceeding described in Section 7.2(a) on any grounds whatsoever, including on the grounds of personal jurisdiction, venue, or forum non conveniens. If Licensor brings or defends any such proceeding, Licensee shall cooperate in all respects with Licensor in the conduct thereof, and assist in all reasonable ways, including having its employees testify when requested, and make available for discovery or trial exhibit relevant records, papers, information, samples, specimens, and the like, at Licensee’s own cost, subject to Licensor’s reimbursement of all out-of-pocket expenses incurred by Licensee in providing Licensee such assistance.

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(c) If requested to do so by Licensee, Licensor may (in its sole right and discretion) attempt to prevent or abate any actual or threatened misappropriation or infringement and attempt to resolve any claims relating to the Miromatrix Origin Patents, including by (a) prosecuting or defending any inter partes review, post-grant review, covered business method patent review, opposition, derivation, interference, declaratory judgment, federal district court, US Patent and Trademark Office, US International Trade Commission, or other proceeding of any kind, and (b) taking any other lawful action that Licensor, in its sole discretion, believes is reasonably necessary to protect, enforce, or defend any Miromatrix Origin Patents. Licensor has the right to prosecute or defend any such proceeding in Licensor’s own name or, if otherwise necessary or desirable for such purposes, in the name of Licensee and may join Licensee as a party. Licensor shall have the right to control the conduct thereof, subject to Licensee having the option to provide input to Licensor. Licensor shall bear its own costs and expenses in all such proceedings and have the right to control the conduct thereof and be represented by counsel of its own choice therein.

7.3 Recovery and Settlement. If Licensor undertakes the enforcement or defense of any Licensed Patent or Licensed Know-How:

(a) any recovery, damages, or settlement derived from such suit, action, or other proceeding will be retained in its entirety by Licensor; and

(b) Licensor may settle any such suit, action, or other proceeding, whether by consent order, settlement, or other voluntary final disposition, without the prior written approval of Licensee provided that Licensor shall not settle any such suit, action, or other proceeding in a manner that adversely affects the rights of Licensee concerning the Other Licensed Patents, New Licensed Patent and Licensed Know-How without Licensee’s prior written consent, which consent may not be unreasonably withheld, conditioned or delayed.

7.4 Intervention. If any suit, action, or other proceeding alleging invalidity or non-infringement of any Licensed Patent is brought against Licensee, Licensor, at its option, will have the right to intervene and take over the sole defense of the suit, action, or other proceeding at its own expense.

7.5 Abandonment. Notwithstanding anything to the contrary in this Agreement, Licensor has no obligation to maintain or enforce any patent in the Licensed Patents and may abandon any patent application or patent in the Licensed Patents at any time.

8. Compliance with Laws.

8.1 Patent Marking. Licensee shall comply with the patent marking provisions of 35 USC § 287(a) by marking the labelling of all Licensed Products with the word "patent" or the abbreviation "pat." and either the numbers of the relevant Licensed Patents or a web address that is freely accessible to the public and that associates the Licensed Products with the relevant Licensed Patents. Licensee shall also comply with patent marking Laws.

8.2 Regulatory Clearance. Licensee shall, at Licensee’s expense, comply with all applicable Laws and safety standards concerning Licensed Products developed and commercialized by or under the authority of Licensee and obtain all necessary Governmental Authority approvals for the development, production, distribution, sale, and use of Licensed Products developed and commercialized by or under the authority of Licensee, including any safety or clinical studies. Licensee will have responsibility for and provide suitable warning labels, packaging, and instructions as to the use for such Licensed Products.

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8.3 Export Compliance. Licensee shall not, directly or indirectly, export or re-export the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information) in violation of any applicable Laws.

9. Confidentiality.

9.1 Confidentiality Obligations. Each Party (the "Receiving Party") acknowledges that in connection with this Agreement it will gain access to Confidential Information of the other Party (the "Disclosing Party"). As a condition to being provided with Confidential Information, the Receiving Party shall, during the Term and for twenty (20) years thereafter:

(a) not use the Disclosing Party’s Confidential Information other than as strictly necessary to perform its obligations under this Agreement; and

(b) maintain the Disclosing Party’s Confidential Information in strict confidence and, subject to Section 9.2, not disclose the Disclosing Party’s Confidential Information without the Disclosing Party’s prior written consent, provided, however, the Receiving Party may disclose the Confidential Information to its Representatives who:

(i) have a need to know the Confidential Information for purposes of the Receiving Party’s performance, or exercise of its rights concerning the Confidential Information, under this Agreement;

(ii) have been apprised of this restriction; and

(iii) are themselves bound by written nondisclosure agreements at least as restrictive as those set forth in this Section 9.1, provided further that the Receiving Party will be responsible for ensuring its Representatives’ compliance with, and will be liable for any breach by its Representatives of, this Section 9.1.

The Receiving Party shall use reasonable care, at least as protective as the efforts it uses for its own confidential information, to safeguard the Disclosing Party’s Confidential Information from use or disclosure other than as permitted hereby.

9.2 Exceptions. If the Receiving Party becomes legally compelled to disclose any Confidential Information, the Receiving Party shall:

(a) provide prompt written notice to the Disclosing Party so that the Disclosing Party may seek a protective order or other appropriate remedy or waive its rights under Section 9; and

(b) disclose only the portion of Confidential Information that it is legally required to furnish.

If a protective order or other remedy is not obtained, or the Disclosing Party waives compliance under Section 9, the Receiving Party shall, at the Disclosing Party’s expense, use reasonable efforts to obtain assurance that confidential treatment will be afforded the Confidential Information.

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10. Representations and Warranties.

10.1 Mutual Representations and Warranties. Each Party represents and warrants to the other party that as of the Effective Date:

(a) it is duly organized, validly existing, and in good standing as a corporation or other entity as represented herein under the laws and regulations of its jurisdiction of incorporation, organization, or chartering;

(b) it has the full right, power, and authority to enter into this Agreement and to perform its obligations hereunder;

(c) the execution of this Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of the Party; and

(d) when executed and delivered by such Party, this Agreement will constitute the legal, valid, and binding obligation of that Party, enforceable against that Party in accordance with its terms.

10.2 Licensee Representation and Warranties. Licensee represents and warrants that it has not received any notice or threat of any claim, suit, action, or proceeding, and has no knowledge or reason to know of any information, that could: (a) invalidate or render unenforceable any claim of any Licensed Patent; (b) prove that the Licensed Products are not covered by any claim of any Licensed Patent; or (c) cause any claim of any Licensed Patent to fail to issue or be materially limited or restricted as compared with its currently pending scope.

10.3 Licensor Representations and Warranties.

(a) Licensor represents and warrants that, to Licensor’s knowledge, Licensor is the owner of the entire right, title, and interest in and to the Licensed Patents and Licensed Know-How. For purposes of this Section 10.3, "Licensor’s knowledge" means to the actual knowledge of Licensor regarding the facts and information in the possession of Licensor’s officers as of the Effective Date, but without any duty to conduct any investigation with respect to such facts and information

(b) Licensor further represents and warrants that the Licensed Patents represent all of Licensor’s patents for the Licensed Products in the Field of Use.

10.4 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 10.3, LICENSOR DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN, ORAL, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, CONCERNING THE VALIDITY, ENFORCEABILITY, AND SCOPE OF THE LICENSED PATENTS, THE ACCURACY, COMPLETENESS, SAFETY, USEFULNESS FOR ANY PURPOSE, OR LIKELIHOOD OF SUCCESS (COMMERCIAL, REGULATORY OR OTHER) OF THE LICENSED PRODUCTS, LICENSED KNOW-HOW, AND ANY OTHER TECHNICAL INFORMATION, TECHNIQUES, MATERIALS, METHODS, PRODUCTS, PROCESSES, OR PRACTICES AT ANY TIME MADE AVAILABLE BY LICENSOR, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY, QUALITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND WARRANTIES ARISING FROM A COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE, OR TRADE PRACTICE. WITHOUT LIMITATION TO THE FOREGOING, LICENSOR WILL HAVE NO LIABILITY WHATSOEVER TO LICENSEE OR ANY OTHER PERSON FOR OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE, SUSTAINED BY, OR ANY DAMAGE ASSESSED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY INCURRED BY OR IMPOSED ON LICENSEE OR ANY OTHER PERSON, ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM (A) THE MANUFACTURE, USE, OFFER FOR SALE, SALE, OR IMPORT OF A LICENSED PRODUCT, OR THE PRACTICE OF THE LICENSED PATENTS; (B) THE USE OF OR ANY ERRORS OF OMISSIONS IN ANY KNOW-HOW, TECHNICAL INFORMATION, TECHNIQUES, OR PRACTICES DISCLOSED BY LICENSOR; OR (C) ANY ADVERTISING OR OTHER PROMOTIONAL ACTIVITIES CONCERNING ANY OF THE FOREGOING.

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11. Exclusion of Consequential and Other Indirect Damages. TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR WILL NOT BE LIABLE TO LICENSEE OR ANY OTHER PERSON FOR ANY INJURY TO OR LOSS OF GOODWILL, REPUTATION, BUSINESS, PRODUCTION, REVENUES, PROFITS, ANTICIPATED PROFITS, CONTRACTS, OR OPPORTUNITIES (REGARDLESS OF HOW THESE ARE CLASSIFIED AS DAMAGES), OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE, OR ENHANCED DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE (INCLUDING THE ENTRY INTO, PERFORMANCE, OR BREACH OF THIS AGREEMENT), REGARDLESS OF WHETHER SUCH LOSS OR DAMAGE WAS FORESEEABLE OR THE PARTY AGAINST WHOM SUCH LIABILITY IS CLAIMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.

12. Indemnification.

12.1 Licensee Indemnification. Licensee shall indemnify, defend, and hold harmless Licensor and its affiliates, and each of Licensor’s and its affiliates’ respective officers, directors, employees, agents, successors, and assigns against all Losses arising out of or resulting from any third party claim, suit, action, or other proceeding related to or arising out of or resulting from (a) Licensee’s breach of any representation, warranty, covenant, or obligation under this Agreement, or (b) use by Licensee of Licensed Patents or Licensed Know-How, or (c) any use, sale, transfer, or other disposition by Licensee of Licensed Products or any other products made by use of Licensed Patents or Licensed Know-How (each an "Action").

12.2 Licensor Indemnification. Licensor shall indemnify, defend, and hold harmless Licensor and its affiliates, and each of Licensor’s and its affiliates’ respective officers, directors, employees, agents, successors, and assigns against all Losses arising out of or resulting from any third party claim, suit, action, or other proceeding related to or arising out of or resulting from Licensor’s breach of any representation, warranty, covenant, or obligation under this Agreement, including breach of the University Agreement with respect to the Licensed Patents.

12.3 Indemnification Procedure. The party claiming indemnification (the “Indemnified Party”) shall notify the other party (the “Indemnifying Party”) in writing of any Action and cooperate with the Indemnifying Party at the Indemnifying Party’s sole cost and expense. Subject to Section 7, the Indemnifying Party shall immediately take control of the defense and investigation of the Action and shall employ counsel reasonably acceptable to the Indemnified Party to handle and defend the Action, at the Indemnifying Party’s sole cost and expense. The Indemnifying Party shall not settle any Action in a manner that adversely affects the rights of the Indemnified Party or its affiliates without the Indemnified Party’s or its affiliates’ prior written consent. The Indemnified Party’s or its affiliates’ failure to perform any obligations under this Section 12.3 will not relieve the Indemnifying Party of its obligation under Section 12 except to the extent the Indemnifying Party can demonstrate that it has been materially prejudiced as a result of the failure. The Indemnified Party and its affiliates may participate in and observe the proceedings at their own cost and expense with counsel of their own choosing.

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13. Insurance.

13.1 Licensee Insurance. Throughout the Term and for a period of three (3) years after the Term, Licensee shall, at its sole cost and expense, obtain, pay for, and maintain in full force and effect commercial general liability and professional liability (Errors and Omissions) insurance in commercially reasonable and appropriate amounts that (a) provides product liability coverage concerning the Licensed Products and contractual liability coverage for Licensee’s defense and indemnification obligations under this Agreement, and (b) in any event, provide commercial general liability limits of not less than two million US dollars ($2,000,000) and product liability insurance limits of not less than ten million US dollars ($10,000,000), in each case as an annual aggregate for all claims each policy year. To the extent any insurance coverage required under this Section 13.1 is purchased on a "claims-made" basis, such insurance must cover all prior acts of Licensee during the Term. Licensee shall have Licensor named in each policy as an additional insured. Upon request by Licensor, Licensee shall provide Licensor with certificates of insurance or other reasonable written evidence of all coverages described in this Section 13.1. Additionally, Licensee shall provide Licensor with written notice at least thirty (30) Business Days prior to Licensee cancelling, not renewing, or materially changing the insurance.

13.2 Licensor Insurance. Throughout the Term and for a period of three (3) years after the Term, Licensor shall, at its sole cost and expense, obtain, pay for, and maintain in full force and effect commercial general liability and professional liability (Errors and Omissions) insurance in commercially reasonable and appropriate amounts that (a) provides product liability coverage concerning versions of the Licensed Products sold by the Licensor prior to the Effective Date and contractual liability coverage for Licensor’s defense and indemnification obligations under this Agreement, and (b) in any event, provide commercial general liability limits of not less than two million US dollars ($2,000,000) and product liability insurance limits of not less than ten million US dollars ($10,000,000), in each case as an annual aggregate for all claims each policy year. To the extent any insurance coverage required under this Section 13.2 is purchased on a "claims-made" basis, such insurance must cover all prior acts of Licensor prior to the Term. Licensor shall have Licensee named in each policy as an additional insured. Upon request by Licensee, Licensor shall provide Licensee with certificates of insurance or other reasonable written evidence of all coverages described in this Section 13.2. Additionally, Licensor shall provide Licensee with written notice at least thirty (30) Business Days prior to Licensor cancelling, not renewing, or materially changing the insurance.

14. Term and Termination.

14.1 Term. This Agreement is effective as of the Effective Date and, unless terminated earlier in accordance with Section 14.2, will continue in full force and effect for each Licensed Product and country on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of the last to expire Valid Claim of a Licensed Patent (the "Term").

14.2 Termination for Cause. Licensor may terminate this Agreement immediately by giving written notice to Licensee if:

(a) Licensee fails to pay any amount due under this Agreement on the due date for payment and remains in default not less than five (5) Business Days after Licensor’s written notice to make such payment, including the payment of interest in accordance with Section 4.5(d);

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(b) Licensee breaches this Agreement (other than through a failure to pay any amounts due under this Agreement) and, if such breach is curable, fails to cure such breach within thirty (30) days of Licensor’s written notice of such breach; or

(c) Licensee: (i) is dissolved or liquidated or takes any corporate action for such purpose; (ii) becomes insolvent or is generally unable to pay, or fails to pay, its debts as they become due; (iii) files or has filed against it a petition for voluntary or involuntary bankruptcy or otherwise becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law; (iv) makes or seeks to make a general assignment for the benefit of creditors; or (v) applies for or has a receiver, trustee, custodian, or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.

14.3 Effect of Termination.

(a) Within thirty (30) Business Days after termination or expiration of this Agreement, Licensee shall: (i) submit a Payment Statement to Licensor, and any payments due Licensor will become immediately payable with submission of the final Payment Statement; (ii) if termination was due to breach by the Licensee, immediately cease all activities concerning, including all practice and use of, the Licensed Patents and Licensed Know-How, except as expressly permitted under Section 14.3(b); and (iii) within thirty (30) Business Days after termination or expiration: (A) return to Licensor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Licensor’s Confidential Information; (B) permanently erase such Confidential Information from its computer systems; and (C) certify in writing to Licensor that it has complied with the requirements of this Section 14.3(a).

(b) For a period of ninety (90) Business Days after the effective date of the termination of this Agreement (other than termination by Licensor pursuant to Section 14.2(a), (b) or (d) ) (the "Sell-Off Period"), Licensee will have the right to sell or otherwise dispose of all existing Licensed Products in its possession and to complete the manufacture of and sell all Licensed Products in the course of manufacture as of the effective date of such expiration or termination. Licensee shall ensure that all sales of Licensed Products during the Sell-Off Period are in accordance with the applicable terms and conditions of this Agreement, including the Royalty and reporting obligations under Section 4. For the avoidance of doubt, this Section 14.3(b) shall not apply if the Agreement expires at the end of the Term in which event Licensee may continue to manufacture and sell all Licensed Products.

14.4 Survival.

(a) The rights and obligations of the Parties set forth in this Section 14.4 and Section 1 (Definitions), Section 4 (Royalties/Payments), Section 6 (Challenges to Licensed Patents), Section 9 (Confidentiality), Section 10 (Representations and Warranties), Section 12 (Indemnification), Section 14.3 (Effect of Termination), and Section 15 (Miscellaneous), and any right, obligation, or required performance of the Parties in this Agreement which, by its express terms or nature and context is intended to survive termination or expiration of this Agreement, will survive any such termination or expiration.

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(b) If the Agreement expires at the end of the Term (and isn’t terminated before the end of the Term under Section 14.2), then Section 2.2 (Know-How License) shall survive the expiration of the Agreement.

15. Miscellaneous.

15.1 Force Majeure. Licensor will not be in default by reason of any failure or delay in the performance of its obligations hereunder, except for Licensee’s payment obligations, where such failure or delay is due to any circumstance or cause beyond its reasonable control, including strikes, labor disputes, civil disturbances, riot, rebellion, invasion, epidemic, hostilities, war, terrorist attack, embargo, natural disaster, acts of God, flood, fire, sabotage, fluctuations or non-availability of electrical power, heat, light, air conditioning.

15.2 Further Assurances. Each Party shall, upon the reasonable request, and at the sole cost and expense, of the other party, promptly execute such documents and take such further actions as may be necessary to give full effect to the terms of this Agreement.

15.3 Independent Contractors. The relationship between the Parties is that of independent contractors. Nothing contained in this Agreement creates any agency, partnership, joint venture, or other form of joint enterprise, employment, or fiduciary relationship between the parties, and neither Party has authority to contract for or bind the other party in any manner whatsoever.

15.4 Use of Trademarks/names. Unless expressly permitted under this Agreement or a separate agreement between the Parties, neither Party may use the other party’s trademarks, service marks, trade names, logos, domain names, or other indicia of source, association, or sponsorship, in each case, without the prior written consent of the other party.

15.5 Notices. All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next business day if sent after normal business hours of the recipient; or (d) on the third day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section):

If to Licensor:	Miromatrix Medical, Inc. 10399 West 70th Street Eden Prairie, Minnesota 55344 Attention: President E-mail: jross@miromatrix.com With a copy to
	Faegre Baker Daniels LLP 2200 Wells Fargo Center 90 South Seventh Street Minneapolis, Minnesota 55402 Attention: Steven Kennedy E-mail: Steven.Kennedy@FaegreBD.com
If to Licensee:	Reprise Biomedical, Inc. 10399 West 70th Street Eden Prairie, Minnesota 55344 Attention: President E-mail: cpowers@reprisebio.com

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15.6 Interpretation. For purposes of this Agreement: (a) the words "include," "includes," and "including" will be deemed to be followed by the words "without limitation"; (b) the word "or" is not exclusive; and (c) the words "herein," "hereof," "hereby," "hereto," and "hereunder" refer to this Agreement as a whole. Unless the context otherwise requires, references herein: (x) to Sections and Schedules refer to the Sections of and Schedules attached to this Agreement; (y) to an agreement, instrument, or other document means such agreement, instrument or other document as amended, supplemented, and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This Agreement will be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted.

15.7 Headings. The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.

15.8 Entire Agreement. This Agreement, together with all Schedules and any other documents incorporated herein by reference, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings and agreements, both written and oral, with respect to such subject matter. In the event of any conflict between the terms and provisions of this Agreement and those of any Schedule or other document, the following order of precedence will govern: (a) first, this Agreement, excluding its Schedules; (b) second, the Schedules to this Agreement as of the Effective Date; and (c) third, any other documents incorporated herein by reference.

15.9 Assignment. Neither Party shall assign or otherwise transfer any of its rights, or delegate or otherwise transfer any of its obligations or performance, under this Agreement, in each case whether voluntarily, involuntarily, by operation of law, or otherwise. Notwithstanding the preceding sentence, either Party may assign, delegate or transfer its obligations or performance under this Agreement in connection with a sale of all or substantially all of its assets without the other Party's prior written consent. Further, Licensor may sell the assets of any product or product line (including a license to or a partial assignment of the rights granted to Licensor under Section 3.1) without the prior approval of the Licensee. No delegation or other transfer will relieve a Party of any of its obligations or performance under this Agreement. Any purported assignment, delegation, or transfer in violation of this Section 15.9 is void. This Agreement is binding upon and inures to the benefit of the Parties and their respective permitted successors and assigns.

15.10 No Third-Party Beneficiaries. This Agreement is for the sole benefit of the Parties and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or will confer upon any other Person any legal or equitable right, benefit, or remedy of any nature whatsoever, under or by reason of this Agreement.

15.11 Amendment; Modification; Waiver. This Agreement may only be amended, modified, or supplemented by an agreement in writing signed by each Party. No waiver by any Party of any of the provisions hereof will be effective unless explicitly set forth in writing and signed by the waiving Party. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power, or privilege arising from this Agreement will operate or be construed as a waiver thereof; nor will any single or partial exercise of any right, remedy, power, or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power, or privilege.

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15.12 Severability. If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or other provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.

15.13 Governing Law; Submission to Jurisdiction.

(a) This Agreement and all related documents, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the laws of the State of Minnesota, United States of America, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Minnesota.

(b) Any action, suit, or other proceeding arising out of or related to this Agreement or the licenses granted hereunder must be instituted exclusively in the federal courts of the United States or the courts of the State of Minnesota, and each Party irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action, or proceeding. Service of process, summons, notice, or other document by mail to such Party’s address set forth herein will be effective service of process for any action, suit, or other proceeding brought in any such court.

15.14 Waiver of Jury Trial. Each Party irrevocably and unconditionally waives any right it may have to a trial by jury for any legal action arising out of or relating to this Agreement or the transactions contemplated hereby.

15.15 Equitable Relief. Each Party acknowledges that a breach by the other Party of this Agreement may cause the non-breaching Party irreparable harm, for which an award of damages would not be adequate compensation and, in the event of such a breach or threatened breach, the non-breaching Party will be entitled to equitable relief, including in the form of a restraining order, orders for preliminary or permanent injunction, specific performance, and any other relief that may be available from any court, and the Parties hereby waive any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such relief. These remedies are not exclusive but are in addition to all other remedies available under this Agreement at law or in equity, subject to any express exclusions or limitations in this Agreement to the contrary.

15.16 Attorneys’ Fees. In the event that any action, suit, or other legal or administrative proceeding is instituted or commenced by either Party against the other Party arising out of or related to this Agreement, the prevailing Party will be entitled to recover its reasonable attorneys’ fees and court costs from the non-prevailing Party.

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15.17 Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, but all of which together will be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, email, or other means of electronic transmission (to which assigned PDF copy is attached) will be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

[Signature page follows]

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first written above by their respective officers thereunto duly authorized.

LICENSOR – Miromatrix Medical, Inc.
By	/s/ Jeff Ross
Name: Jeff Ross
Title: Chief Executive Officer
LICENSEE – Reprise Biomedical, Inc.
By	/s/ Carrie Powers
Name: Carrie Powers
Title: President and Chief Executive Officer

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SCHEDULE 1

LICENSED PATENTS

Miromatrix Origin Patents

Title:	Matter Type	Country	Status	Application #
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Australia	Issued	2013274322
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Brazil	Pending	BR1120140312249
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Canada	Pending	2,876,648
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	China	Issued	201380041965.9
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	European Patent Office	Pending	13732752.4
METHODS OF DECELLULARIZING BONE	Utility - ORG	Hong Kong	Pending	15109884.3
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	India	Pending	11201/DELNP/2014
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Japan	Pending	2015-517391
METHODS OF DECELLULARIZING BONE	Utility - DIV	Japan	Pending	2018-248452
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Republic of Korea	Pending	10-2015-7000492
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Mexico	Issued	MX/a/2014/015270
METHODS OF DECELLULARIZING BONE	Utility - NSPCT	Singapore	Issued	11201408337P
METHODS OF DECELLULARIZING BONE	Utility - NPREG	United States of America	Issued	13/787,625

GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - NSPCT	Australia	Pending	2016235074
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - NSPCT	China	Pending	201680027075.6
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - NSPCT	European Patent Office	Pending	16730926.9
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - ORG	Hong Kong	Pending	18109873.3
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - NSPCT	Japan	Pending	2018-502040
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Prov - ORG	United States of America	Issued	62/138,850
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - NSPCT	Singapore	Pending	11201707924V
GAS FILLED DECELLULARIZED EXTRACELLULAR MATRIX	Utility - ORG	PCT	Pending	PCT/US2016/024032

U.S. Provisional Patent Application entitled FISTULA FILLER AND DEPLOYMENT SYSTEM, Application No.: 62/684,426; Filing Date: June 13, 2018, U.S. PROVISIONAL CONVERSION/ PARIS CONVENTION DEADLINE: JUNE 13, 2019

New Licensed Patent

U.S. Provisional Patent Application entitled IMPROVED DECELLULARIZATION OF ISOLATED ORGANS, Application No.: 62/821,620

U.S. Provisional Patent Application entitled NON-DESTRUCTIVE METHOD OF DEHYDRATION OF EXTRACELLULAR MATRIX OF DECELLULARIZED ORGANS AND PARTICLES FORMED THEREFROM, Application No.: 62/789,218

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Other Licensed Patents

Title:	Matter Type	Country	Status	Application #
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	Australia	Issued	2006282783
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Australia	Issued	2013224686
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Australia	Pending	2017272168
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Belgium	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Belgium	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Switzerland	Issued	067900241
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Switzerland	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	China	Issued	200680030925.4
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	China	Issued	201210287455.7
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Germany	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Germany	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Germany	Issued	15170077.0
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	European Patent Office	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	European Patent Office	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	European Patent Office	Issued	15170077.0
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Spain	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Spain	Issued	111817979
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	France	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	France	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	France	Issued	15170077.0
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	United Kingdom	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	United Kingdom	Issued	11181797.9

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DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	United Kingdom	Issued	15170077.0
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - ORG	Hong Kong	Issued	12109340.4
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - ORG	Hong Kong	Pending	16108222.5
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	Israel	Issued	189418
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Israel	Issued	233821
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Italy	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Italy	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	Republic of Korea	Issued	10-2008-7007151
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Republic of Korea	Issued	10-2013-7028378
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	Mexico	Issued	MX/a/2008/002589
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Mexico	Issued	MX/a/2014/006778
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Mexico	Pending	MX/a/2017/011107
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Netherlands	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Netherlands	Issued	111817979
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Poland	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Poland	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Sweden	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Sweden	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Singapore	Issued	201101898-3
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - DIV	Singapore	Pending	10201603074Q
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Turkey	Issued	06790024.1
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - EPPAT	Turkey	Issued	11181797.9
DECELLULARIZATION AND RECELLULARIZATION OF ORGANS AND TISSUES	Utility - NSPCT	United States of America	Issued	12/064,613

 22

SCHEDULE 2

EXISTING PRODUCTS

Miromesh™ and Miroderm^TM products

and the following products in development or previously considered:

Tendon Wrap

Wound Particulate

Nerve Wrap

Void Filler

Fistula

 23

SCHEDULE 3

MINIMUM ROYALTY

Five Hundred Thousand Dollars ($500,000.00) per calendar year (prorated to the Effective Date for the first year of the Term).

 24

EX-10.22

Exhibit 10.22

Amendment No. 1

to

Patent and Know-How License Agreement

This Amendment No. 1 to the Patent and Know-How License Agreement (this “Amendment”), amending that certain Patent and Know-How License Agreement (the “License Agreement”), dated as of June 30, 2019, by and between Miromatrix Medical Inc., a Delaware corporation (“Licensor”), and Reprise Biomedical, Inc., a Minnesota corporation (“Licensee”), is made as of October 3, 2019.

WHEREAS, Licensor and Licensee desire to amend the License Agreement to as provided below.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and by their signatures to this Amendment, Licensor and Licensee hereby amend the License Agreement in the following manner:

1. Definitions. Capitalized terms used but not otherwise defined herein shall have the meaning assigned to them in the License Agreement. The term “Agreement” as used in the License Agreement shall at all times refer to the License Agreement as modified by this Amendment.

2. Amendment to Section 4.1 of the License Agreement. Section 4.1 is hereby amended and restated in its entirety to read as follows:

“4.1 Royalty. In consideration of the rights and licenses granted under this Agreement, Licensee shall pay to Licensor a royalty of six and one-half percent (6.5%) of Net Sales of all Licensed Products sold between the Effective Date and the earlier of the expiration of the Term and the Royalty End Date (“Royalty”). For the avoidance of doubt, the Royalty is to be calculated the same in amount and term as the royalty that would have been owed by Licensor for the Net Sales of all Licensed Products under a Patent Assignment Agreement with the University of Minnesota originally effective as of February 4, 2010 (the “University Agreement”) if made by the Licensor directly, and Licensor shall be entitled to no additional Royalty from Licensee under this Agreement beyond that what would have been owed to the University of Minnesota from sale of the Licensed Products if made by the Licensor directly. If at any time during the Term the royalty that would otherwise have been so owed by Licensor to the University of Minnesota for the Net Sales of the Licensed Products is reduced, then the Royalty shall be reduced by a corresponding amount.”

1

3. Amendment to Section 4.4(a) of the License Agreement. Section 4.4(a) is hereby amended and restated in its entirety to read as follows:

“4.4 Payment Terms and Royalty Statements.

(a)Licensee shall pay all Royalties, Minimum Royalties, and any other sums payable under this Agreement for each Quarterly Period within thirty (30) days of the end of such Quarterly Period. Licensee shall make all payments in US dollars by wire transfer of immediately available funds to a bank account to be designated in writing by Licensor. Licensor shall use Licensee’s payments of Royalties and Minimum Royalties to fully pay the royalties owed to the University of Minnesota with respect to the Licensed Products and shall make such payment within five (5) days of receipt of payment from Licensee. If, after notice of breach and a ten (10) day opportunity to cure, Licensor has not cured a breach of the preceding sentence, then Licensee may pay (at its sole option) the University of Minnesota directly for any amounts owed to them and offset such amounts paid against any other amounts due to Licensor hereunder for the remainder of the Term.”

4. Continued Validity of License Agreement. Unless otherwise modified or supplemented by the terms of this Amendment, all terms and conditions of the License Agreement, including the Schedules thereto, shall continue in full force and effect.

5. Governing Law; Submission to Jurisdiction.

(a)This Amendment and all related documents, and all matters arising out of or relating to this Amendment, are governed by, and construed in accordance with, the laws of the State of Minnesota, United States of America, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Minnesota.

(b)Any action, suit, or other proceeding arising out of or related to this Amendment must be instituted exclusively in the federal courts of the United States or the courts of the State of Minnesota, and each Party (as defined in the License Agreement) irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action, or proceeding. Service of process, summons, notice, or other document by mail to such Party’s address set forth in the License Agreement will be effective service of process for any action, suit, or other proceeding brought in any such court.

6. Counterparts. This Amendment may be executed in counterparts, each of which will be deemed an original, but all of which together will be deemed to be one and the same agreement. A signed copy of this Amendment delivered by facsimile, email, or other means of electronic transmission (to which assigned PDF copy is attached) will be deemed to have the same legal effect as delivery of an original signed copy of this Amendment.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment No. 1 to the Patent and Know-How License Agreement as of the date first written above.

2

LICENSOR - Miromatrix Medical Inc.
By	/s/ Jeff Ross
Name:	Jeff Ross
Title:	Chief Executive Officer
LICENSEE - Reprise Biomedical, Inc.
By	/s/ Carrie Powers
Name:	Carrie Powers
Title:	President and Chief Executive Officer

3

EX-10.23

Exhibit 10.23

Amendment No. 2

to

Patent and Know-How License Agreement

This Amendment No. 2 to the Patent and Know-How License Agreement (this “Amendment”), amending that certain Patent and Know-How License Agreement (the “License Agreement”), dated as of June 30, 2019, by and between Miromatrix Medical Inc., a Delaware corporation (“Licensor”), and Reprise Biomedical, Inc., a Minnesota corporation (“Licensee”), is made as of February 22, 2021.

WHEREAS, Licensor and Licensee desire to amend the License Agreement as provided below.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and by their signatures to this Amendment, Licensor and Licensee hereby amend the License Agreement in the following manner:

1. Definitions. Capitalized terms used but not otherwise defined herein shall have the meaning assigned to them in the License Agreement. The term “Agreement” as used in the License Agreement shall at all times refer to the License Agreement as modified by this Amendment.

2. Amendment to Section 4.2 of the License Agreement. Section 4.2 is hereby amended and restated in its entirety to read as follows:

“4.2 If the Royalty for any calendar year is less than the Minimum Royalty, Licensee shall pay Licensor the Royalty plus the difference between the Minimum Royalty and the Royalty for that calendar year (the “Difference”), subject to the provisions of the following sentence. The Parties agree that the payment of such Difference for each of calendar years 2020 and 2021 may be deferred by Licensee and such year’s Difference added to the $500,000 minimum payment sum required for calendar years 2022 and 2023, respectively. For example, if Licensee pays Licensor $125,000 in royalties for 2020, Licensee shall be obligated to pay a minimum sum of $875,000 in 2022. Beginning in 2024, Licensee shall thereafter pay the $500,000 minimum sum. If Licensee fails to pay any shortfall in the Minimum Royalty within five (5) Business Days after the date when such Minimum Royalty is due, Licensor may terminate this Agreement on five (5) Business Days prior written notice. No Royalty shall apply to Net Sales after November 28, 2028 (the “Royalty End Date”), provided that Licensee will pay in by January 5, 2029 any shortfall in achieving the Minimum Royalty in the year 2028.”

3. Continued Validity of License Agreement. Unless otherwise modified or supplemented by the terms of this Amendment, all terms and conditions of the License Agreement, including the Schedules thereto, shall continue in full force and effect.

4. Governing Law; Submission to Jurisdiction.

(a)            This Amendment and all related documents, and all matters arising out of or relating to this Amendment, are governed by, and construed in accordance with, the laws of the State of Minnesota, United States of America, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Minnesota.

1 

(b)            Any action, suit, or other proceeding arising out of or related to this Amendment must be instituted exclusively in the federal courts of the United States or the courts of the State of Minnesota, and each Party (as defined in the License Agreement) irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action, or proceeding. Service of process, summons, notice, or other document by mail to such Party’s address set forth in the License Agreement will be effective service of process for any action, suit, or other proceeding brought in any such court.

5. Counterparts. This Amendment may be executed in counterparts, each of which will be deemed an original, but all of which together will be deemed to be one and the same agreement. A signed copy of this Amendment delivered by facsimile, email, or other means of electronic transmission (to which assigned PDF copy is attached) will be deemed to have the same legal effect as delivery of an original signed copy of this Amendment.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment No. 2 to the Patent and Know-How License Agreement as of the date first written above.

LICENSOR – Miromatrix Medical Inc.
By	/s/ Jeff Ross
Name:	Jeff Ross
Title:	Chief Executive Officer
LICENSEE – Reprise Biomedical, Inc.
By	/s/ Carrie Powers
Name:	Carrie Powers
Title:	President and Chief Executive Officer

2 

EX-10.24

Exhibit 10.24

Execution Version

SERIES C CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT

THIS SERIES C CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT (this “Agreement”), is made as of May 3, 2021, by and among Miromatrix Medical Inc., a Delaware corporation (the “Company”), and the investors listed on Exhibit A attached to this Agreement (each a “Purchaser” and together the “Purchasers”).

The parties hereby agree as follows:

1.               Purchase and Sale of Preferred Stock.

1.1            Sale and Issuance of Preferred Stock.

(a)         The Company shall have adopted and filed with the Secretary of State of the State of Delaware on or before the Initial Closing (as defined below) the Amended and Restated Certificate of Incorporation in the form of Exhibit B attached to this Agreement (the “Restated Certificate”).

(b)         Subject to the terms and conditions of this Agreement, each Purchaser, severally and not jointly, agrees to purchase at the applicable Closing (as defined below) and the Company agrees to sell and issue to each Purchaser at the applicable Closing that number of shares of Series C Convertible Preferred Stock, $0.00001 par value per share (the “Series C Preferred Stock”), set forth opposite each Purchaser’s name on Exhibit A, at a purchase price of $7.50 per share. The shares of Series C Preferred Stock issued to the Purchasers pursuant to this Agreement shall be referred to in this Agreement as the “Shares.”

1.2            Closing; Delivery.

(a)         The initial purchase and sale of the Shares shall take place remotely via the exchange of documents and signatures on the second business day following the satisfaction or waiver of the conditions set forth in Section 4 below (other than conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of such conditions), or at such other time and place as the Company and the Purchasers mutually agree upon, orally or in writing (which time and place are designated as the “Initial Closing”). In the event there is more than one closing, the term “Closing” shall apply to each such closing unless otherwise specified.

(b)         At or promptly following each Closing, the Company shall deliver to each Purchaser a certificate representing the Shares being purchased by such Purchaser at such Closing against payment of the purchase price therefor by check payable to the Company, by wire transfer to a bank account designated by the Company, by cancellation or conversion of indebtedness or other convertible securities of the Company to Purchaser, including interest, or by any combination of such methods.

1.3            Sale of Additional Shares of Series C Preferred Stock. After the Initial Closing, the Company may sell, on the same terms and conditions as those contained in this Agreement, any additional shares (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or similar recapitalization affecting such shares) of Series C Preferred Stock authorized in the Restated Certificate and not sold during the Initial Closing (the “Additional Shares”), to Cheshire MD Holdings, LLC (“Cheshire”) or any Affiliate thereof, CareDx, Inc. or any Affiliate thereof, or one or more purchasers reasonably acceptable to Baxter (defined below) (the “Additional Purchasers”); provided that (i) such subsequent sale is consummated prior to 90 days after the Initial Closing and (ii) each Additional Purchaser becomes a party to this Agreement, by executing and delivering a counterpart signature page to this Agreement. Exhibit A to this Agreement shall be updated to reflect the number of Additional Shares purchased at each such Closing and the parties purchasing such Additional Shares.

1.4            Consent to Conversion and Termination of Convertible Instruments.

(a)             By executing and delivering this Agreement, each Purchaser holding one or more convertible instruments (including convertible promissory notes) issued by the Company prior to the Initial Closing listed on Exhibit A (each, a “Convertible Security” and, collectively, the “Convertible Securities”), if any, hereby irrevocably agrees that:

(i)         all of such Purchaser’s Convertible Securities listed on Exhibit A will automatically and without any action on the part of such Purchaser convert into shares of Series C Preferred Stock at the Initial Closing in the amount for such Purchaser as set forth on Exhibit A, regardless of whether any such Convertible Securities or an affidavit of loss therefor is actually delivered in original or other form to the Company;

(ii)       the shares of Series C Preferred Stock in the amount set forth opposite such Purchaser’s name on Exhibit A are issued in full and complete discharge and satisfaction of all obligations of the Company (including outstanding principal, interest or any other amounts) under such Purchaser’s Convertible Securities, and such Convertible Securities will be terminated and of no further force or effect automatically immediately prior to the Initial Closing; and

(iii)      such Purchaser’s Convertible Securities listed on Exhibit A hereby are and will be deemed for all purposes to have been amended and modified by virtue hereof to the full extent necessary to permit and facilitate their conversion into the shares of Series C Preferred Stock, and, immediately prior to the Initial Closing, such Convertible Securities shall be deemed terminated in full and null, void and of no further force or effect; provided that the foregoing will not impair the right of such Purchaser to receive the applicable number of shares of Series C Preferred Stock shown opposite his, her or its name on Exhibit A as provided above.

(b)             Such Purchaser hereby represents, warrants and confirms to the Company that: (i) Purchaser is the sole owner of all right, title and interest in and to the Convertible Securities corresponding to the amounts shown on Exhibit A opposite such Purchaser’s name and converting into the shares of Series C Preferred Stock shown on Exhibit A; and (ii) Purchaser has reviewed Exhibit A and agrees that his, her or its ownership of shares of Series C Preferred Stock after giving effect to the Initial Closing is fully and accurately reflected on Exhibit A.

(c)             Aside from such Purchaser’s right to receive the shares of Series C Preferred Stock set forth opposite such Purchaser’s name on Exhibit A at the Initial Closing and to receive rights provided for in this Agreement and as a holder of shares of Series C Preferred Stock under the Restated Certificate, such Purchaser hereby waives any and all demands, claims, suits, actions, causes of actions, proceedings, assessments and rights in respect of such Purchaser’s Convertible Securities listed on Exhibit A, including, without limitation, (i) any principal or interest payments in excess of the amounts to be converted into the shares of Series C Preferred Stock as provided on Exhibit A, (ii) any right to formal notice of the conversion of the Convertible Securities and (iii) any rights arising from any past or present actual or alleged default or event of default under the Convertible Securities. The Purchasers further confirm and agree that any original Convertible Securities held by (or delivered to) the Company may be cancelled (and marked cancelled) by the Company upon or following the Initial Closing.

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1.5            Use of Proceeds. In accordance with the directions of the Company’s Board of Directors, the Company will use the proceeds from the sale of the Shares for product development, working capital and other general corporate purposes. The Company shall not use the proceeds from the sale of the Shares for the repayment of any indebtedness or to fund any payments to any stockholder, officer or employee, other than compensation in the ordinary course consistent with past practice.

1.6            Defined Terms Used in this Agreement. In addition to the terms defined above, the following terms used in this Agreement shall be construed to have the meanings set forth or referenced below.

(a)            “Affiliate” means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common control with such Person, including, without limitation, any general partner, managing member, officer, director or trustee of such Person, or any venture capital fund or registered investment company now or hereafter existing that is controlled by one or more general partners, managing members or investment advisers of, or shares the same management company or investment adviser with, such Person.

(b)            “Board” means the Company’s board of directors.

(c)            “Code” means the Internal Revenue Code of 1986, as amended.

(d)            “Company Covered Person” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any Person listed in the first paragraph of Rule 506(d)(1).

(e)            “Company Intellectual Property” means all patents, patent applications, registered and unregistered trademarks, trademark applications, registered and unregistered service marks, service mark applications, tradenames, copyrights, trade secrets, domain names, mask works, information and proprietary rights and processes, similar or other intellectual property rights, subject matter of any of the foregoing, tangible embodiments of any of the foregoing, licenses in, to and under any of the foregoing, and in any and all such cases that are owned or used by the Company in the conduct of the Company’s business as now conducted and as presently proposed to be conducted.

(f)             “Key Employee” means any executive-level employee, as well as any employee or consultant who either alone or in concert with others develops, invents, programs or designs any Company Intellectual Property.

(g)            “Knowledge” including the phrase “to the Company’s knowledge” shall mean the actual knowledge after reasonable investigation and assuming such knowledge as the individual would have as a result of the reasonable performance of his or her duties in the ordinary course of the following officers: Jeff Ross, Brian Niebur and Mason Macenski. Additionally, for purposes of Section 2.8 below, the Company shall be deemed to have “knowledge” of a patent right if the Company has actual knowledge of the patent right or would be found to be on notice of such patent right as determined by reference to United States patent laws.

(h)            “Material Adverse Effect” means a material adverse effect on the business, assets (including intangible assets), liabilities, financial condition, property or results of operations of the Company.

(i)             “Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

3 

(j)             “Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

(k)            “Side Letter” means the agreement between the Company and Baxter Healthcare Corporation (“Baxter”) as of the date of the Initial Closing, in the form of Exhibit D attached to this Agreement.

(l)             “Transaction Agreements” means this Agreement and the Side Letter.

2.              Representations and Warranties of the Company. The Company hereby represents and warrants to each Purchaser that, except as set forth on the Disclosure Schedule attached as Exhibit C to this Agreement, which exceptions shall be deemed to be part of the representations and warranties made hereunder, the following representations are true and complete as of the date of the date of this Agreement, except as otherwise indicated. The Disclosure Schedule shall be arranged in sections corresponding to the numbered and lettered sections contained in this Section 2, and the disclosures in any section of the Disclosure Schedule shall qualify other sections in this Section 2 only to the extent it is readily apparent from a reading of the disclosure that such disclosure is applicable to such other sections.

For purposes of these representations and warranties (other than those in Sections 2.2, 2.3, 2.4, 2.5, and 2.6), the term the “Company” shall include any subsidiaries of the Company, unless otherwise noted herein.

2.1            Organization, Good Standing, Corporate Power and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as presently conducted and as presently proposed to be conducted. The Company is duly qualified to transact business and is in good standing in each jurisdiction in which the failure to so qualify would have a Material Adverse Effect.

2.2            Capitalization.

(a)            Immediately prior to the Initial Closing, the authorized capital of the Company will consist of:

(i)          50,000,000 shares of common stock, $0.00001 par value per share (the “Common Stock”), 2,329,572 shares of which are issued and outstanding. All of the outstanding shares of Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws. The Company holds no Common Stock in its treasury.

(ii)        15,900,000 shares of preferred stock, $0.00001 par value per share (the “Preferred Stock”), 3,300,000 of which are designated Series A Convertible Preferred Stock, $0.00001 par value per share, 3,000,380 of which are issued and outstanding; 4,000,000 of which are designated Series B Convertible Preferred Stock, $0.00001 par value per share, 3,218,282 of which are issued and outstanding; 2,500,000 of which are designated Series B-2 Convertible Preferred Stock, $0.00001 par value per share, 2,095,874 of which are issued and outstanding, and 6,100,000 of which have been designated Series C Preferred Stock, none of which are issued and outstanding. The rights, privileges and preferences of the Preferred Stock are as stated in the Restated Certificate and as provided by the Delaware General Corporation Law. The Company holds no Preferred Stock in its treasury.

4 

(b)

(i)         The Company has reserved 3,850,000 shares of Common Stock for issuance to officers, directors, employees and consultants of the Company pursuant to its 2010 Stock Incentive Plan duly adopted by the Board and approved by the Company stockholders (the “2010 Plan”). Of such reserved shares of Common Stock, 3,287,230 shares are outstanding that have been issued pursuant to restricted stock purchase agreements, options to purchase 3,287,230 shares have been granted and are currently outstanding, and 0 shares of Common Stock remain available for issuance to officers, directors, employees and consultants pursuant to the 2010 Plan. The Company has furnished to the Purchasers complete and accurate copies of the 2010 Plan and forms of agreements used thereunder.

(ii)        The Company has reserved 1,000,000 shares of Common Stock for issuance to officers, directors, employees and consultants of the Company pursuant to its 2019 Equity Incentive Plan duly adopted by the Board and approved by the Company stockholders (the “2019 Plan,” and together with the 2010 Plan, the “Stock Plan”). Of such reserved shares of Common Stock, 481,500 shares are outstanding that have been issued pursuant to restricted stock purchase agreements, options to purchase 481,500 shares have been granted and are currently outstanding, and 518,500 shares of Common Stock remain available for issuance to officers, directors, employees and consultants pursuant to the 2019 Plan. The Company has furnished to the Purchasers complete and accurate copies of the 2019 Plan and forms of agreements used thereunder.

(c)            Section 2.2(c) of the Disclosure Schedule sets forth the capitalization of the Company immediately following the Initial Closing including the number of shares of the following: (i) issued and outstanding Common Stock, including, with respect to restricted Common Stock, vesting schedule and repurchase price; (ii)  outstanding stock options, including vesting schedule and exercise price; (iii) shares of Common Stock reserved for future award grants under the Stock Plan; (iv) each series of Preferred Stock; and (v) warrants or stock purchase rights, if any. Except for (A) the conversion privileges of the Shares to be issued under this Agreement, (B) the rights provided in Section 5 of the Side Letter, (C) the rights provided in the letter agreement dated June 22, 2018 between the Company and Cheshire, as amended on March 6, 2020, and (D) the securities and rights described in Section 2.2(a)(ii) and Section 2.2(b) of this Agreement and Section 2.2(c) of the Disclosure Schedule, there are no outstanding options, warrants, rights (including conversion or preemptive rights and rights of first refusal or similar rights) or agreements, orally or in writing, to purchase or acquire from the Company any shares of Common Stock or Series C Preferred Stock, or any securities convertible into or exchangeable for shares of Common Stock or Series C Preferred Stock. All outstanding shares of the Company’s Common Stock and all shares of the Company’s Common Stock underlying outstanding options are subject to (i) a right of first refusal in favor of the Company upon any proposed transfer (other than transfers for estate planning purposes); and (ii) a lock-up or market standoff agreement of not less than one hundred eighty (180) days following the Company’s initial public offering pursuant to a registration statement filed with the Securities and Exchange Commission under the Securities Act.

(d)            None of the Company’s stock purchase agreements or stock option documents contains a provision for acceleration of vesting (or lapse of a repurchase right) or other changes in the vesting provisions or other terms of such agreement or understanding upon the occurrence of any event or combination of events, including, without limitation, in the case where the Stock Plan is not assumed in an acquisition. The Company has never adjusted or amended the exercise price of any stock options previously awarded, whether through amendment, cancellation, replacement grant, repricing, or any other means. Except as set forth in the Restated Certificate, the Company has no obligation (contingent or otherwise) to purchase or redeem any of its capital stock.

5 

(e)            409A. The Company believes in good faith that any “nonqualified deferred compensation plan” (as such term is defined under Section 409A(d)(1) of the Code and the guidance thereunder) under which the Company makes, is obligated to make or promises to make, payments (each, a “409A Plan”) complies in all material respects, in both form and operation, with the requirements of Section 409A of the Code and the guidance thereunder. To the knowledge of the Company, no payment to be made under any 409A Plan is, or will be, subject to the penalties of Section 409A(a)(1) of the Code.

(f)             The Company has complied with or obtained valid waivers of any rights by other parties to purchase any of the Shares covered by this Agreement.

2.3            Subsidiaries. The Company does not currently own or control, directly or indirectly, any interest in any other corporation, partnership, trust, joint venture, limited liability company, association, or other business entity. The Company is not a participant in any joint venture, partnership or similar arrangement.

2.4            Authorization. All corporate action required to be taken by the Board and stockholders in order to authorize the Company to enter into the Transaction Agreements, and to issue the Shares at the Initial Closing and the Common Stock issuable upon conversion of the Shares, has been taken or will be taken prior to the Initial Closing. All action on the part of the officers of the Company necessary for the execution and delivery of the Transaction Agreements, the performance of all obligations of the Company under the Transaction Agreements to be performed as of the Initial Closing, and the issuance and delivery of the Shares has been taken or will be taken prior to the Initial Closing. The Transaction Agreements, when executed and delivered by the Company, shall constitute valid and legally binding obligations of the Company, enforceable against the Company in accordance with their respective terms except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, or other laws of general application relating to or affecting the enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies, or (iii) to the extent the indemnification provisions contained in the Investors’ Rights Agreement and the Indemnification Agreement may be limited by applicable federal or state securities laws.

2.5            Valid Issuance of Shares.

(a)            The Shares, when issued, sold and delivered in accordance with the terms and for the consideration set forth in this Agreement, will be validly issued, fully paid and nonassessable and free of restrictions on transfer other than restrictions on transfer under the Transaction Agreements, applicable state and federal securities laws and liens or encumbrances created by or imposed by a Purchaser. Assuming the accuracy of the representations of the Purchasers in Section 3 of this Agreement and subject to the filings described in Section 2.6(ii) below, the Shares will be issued in compliance with all applicable federal and state securities laws. The Common Stock issuable upon conversion of the Shares will be duly reserved for issuance, and upon issuance in accordance with the terms of the Restated Certificate, will be validly issued, fully paid and nonassessable and free of restrictions on transfer other than restrictions on transfer under the Transaction Agreements, applicable federal and state securities laws and liens or encumbrances created by or imposed by a Purchaser. Assuming the accuracy of the representations of the Purchasers in Section 3 of this Agreement, and subject to Sections 2.5(b) and 2.6 below, the Common Stock issuable upon conversion of the Shares will be issued in compliance with all applicable federal and state securities laws.

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(b)            No “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) of the Securities Act (a “Disqualification Event”) is applicable to the Company or, to the Company’s knowledge, any Company Covered Person, except for a Disqualification Event as to which Rule 506(d)(2)(ii-iv) or (d)(3), is applicable.

2.6            Governmental Consents and Filings. Assuming the accuracy of the representations made by the Purchasers in Section 3 of this Agreement, no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state or local governmental authority is required on the part of the Company in connection with the consummation of the transactions contemplated by this Agreement, except for (i) the filing of the Restated Certificate, which will have been filed as of the Initial Closing, and (ii) filings pursuant to applicable securities laws, which have been made or will be made in a timely manner.

2.7            Litigation. There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or to the Company’s knowledge, currently threatened in writing (i) against the Company or any officer, director or Key Employee of the Company arising out of their employment or board relationship with the Company; or (ii) to the Company’s knowledge, that questions the validity of the Transaction Agreements or the right of the Company to enter into them, or to consummate the transactions contemplated by the Transaction Agreements; or (iii) that would reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect. Neither the Company nor, to the Company’s knowledge, any of its officers, directors or Key Employees is a party or is named as subject to the provisions of any order, writ, injunction, judgment or decree of any court or government agency or instrumentality (in the case of officers, directors or Key Employees, such as would affect the Company). There is no action, suit, proceeding or investigation by the Company pending or which the Company intends to initiate. The foregoing includes, without limitation, actions, suits, proceedings or investigations pending or threatened in writing (or any basis therefor known to the Company) involving the prior employment of any of the Company’s employees, their services provided in connection with the Company’s business, any information or techniques allegedly proprietary to any of their former employers or their obligations under any agreements with prior employers.

2.8            Intellectual Property.

(a)            The Company owns or possesses sufficient legal rights to all Company Intellectual Property without any known conflict with, or infringement of, the rights of others, including prior employees or consultants, or academic or medical institutions with which any of them may be affiliated now or may have been affiliated in the past. The Company has not received any written communications alleging that the Company has violated, or by conducting its business, would violate any of the patents, trademarks, service marks, tradenames, copyrights, trade secrets, mask works or other proprietary rights or processes of any other Person.

(b)            To the Company’s knowledge, no product or service marketed or sold (or proposed to be marketed or sold) by the Company violates or will violate any license or infringes or will infringe any intellectual property rights of any other party.

(c)            Other than with respect to commercially available software products under standard end-user object code license agreements, there are no outstanding options, licenses, agreements, claims, encumbrances or shared ownership interests of any kind relating to the Company Intellectual Property, nor is the Company bound by or a party to any options, licenses or agreements of any kind with respect to the patents, trademarks, service marks, trade names, copyrights, trade secrets, licenses, information, proprietary rights and processes of any other Person.

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(d)            The Company has obtained and possesses valid licenses to use all of the software programs present on the computers and other software-enabled electronic devices that it owns or leases or that it has otherwise provided to its employees for their use in connection with the Company’s business.

(e)            Each employee and consultant has assigned to the Company all intellectual property rights that he or she owns that are related to the Company’s business as now conducted and as presently proposed to be conducted and all intellectual property rights that he, she or it solely or jointly conceived, reduced to practice, developed or made during the period of his, her or its employment or consulting relationship with the Company that (i) relate, at the time of conception, reduction to practice, development, or making of such intellectual property right, to the Company’s business as then conducted or as then proposed to be conducted, (ii) were developed on any amount of the Company’s time or with the use of any of the Company’s equipment, supplies, facilities or information or (iii) resulted from the performance of services for the Company. It will not be necessary to use any inventions of any of the Company’s employees or consultants (or Persons it currently intends to hire) made prior to their employment by the Company, including prior employees or consultants, or academic or medical institutions with which any of them may be affiliated now or may have been affiliated in the past.

(f)             Section 2.8(f) of the Disclosure Schedule lists all Company Intellectual Property owned by the Company other than trade secrets.

(g)            The Company has not embedded, used or distributed any open source, copyleft or community source code (including but not limited to any libraries or code, software, technologies or other materials that are licensed or distributed under any General Public License, Lesser General Public License or similar license arrangement or other distribution model described by the Open Source Initiative at www.opensource.org, collectively “Open Source Software”) in connection with any of its products or services that are generally available or in development in any manner that would materially restrict the ability of the Company to protect its proprietary interests in any such product or service or in any manner that requires, or purports to require (i) any Company Intellectual Property (other than the Open Source Software itself) be disclosed or distributed in source code form or be licensed for the purpose of making derivative works; (ii) any restriction on the consideration to be charged for the distribution of any Company Intellectual Property; (iii) the creation of any obligation for the Company with respect to Company Intellectual Property owned by the Company, or the grant to any third party of any rights or immunities under Company Intellectual Property owned by the Company; or (iv) any other limitation, restriction or condition on the right of the Company with respect to its use or distribution of any Company Intellectual Property.

(h)            No government funding, facilities of a university, college, other educational institution or research center, or funding from third parties was used in the development of any Company Intellectual Property. No Person who was involved in, or who contributed to, the creation or development of any Company Intellectual Property, has performed services for the government, university, college, or other educational institution or research center in a manner that would affect Company’s rights in the Company Intellectual Property.

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2.9            Compliance with Other Instruments. The Company is not in violation or default (i) of any provisions of its Restated Certificate or Bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) under any note, indenture or mortgage, (iv) under any lease, agreement, contract or purchase order to which it is a party or by which it is bound that is required to be listed on the Disclosure Schedule, or (v) of any provision of federal or state statute, rule or regulation applicable to the Company, in each case, the violation of which or default under would have a Material Adverse Effect. The execution, delivery and performance of the Transaction Agreements and the consummation of the transactions contemplated by the Transaction Agreements will not result in any such violation or be in conflict with or constitute, with or without the passage of time and giving of notice, either (i) a default under any such provision, instrument, judgment, order, writ, decree, contract or agreement; or (ii) an event which results in the creation of any lien, charge or encumbrance upon any assets of the Company or the suspension, revocation, forfeiture, or nonrenewal of any material permit or license applicable to the Company.

2.10          Agreements; Actions.

(a)            Except for the Transaction Agreements, there are no agreements, understandings, instruments, contracts or proposed transactions to which the Company is a party or by which it is bound that involve (i) obligations (contingent or otherwise) of, or payments to, the Company in excess of $250,000, (ii) the license of any patent, copyright, trademark, trade secret or other proprietary right to or from the Company (other than with respect to commercially available software products under standard end-user object code license agreements), (iii) the grant of rights to manufacture, produce, assemble, license, market, or sell its products to any other Person that limit the Company’s exclusive right to develop, manufacture, assemble, distribute, market or sell its products, or (iv) indemnification by the Company with respect to infringements of proprietary rights.

(b)            The Company has not (i) declared or paid any dividends, or authorized or made any distribution upon or with respect to any class or series of its capital stock, (ii) incurred any indebtedness for money borrowed or incurred any other liabilities individually in excess of $50,000 or in excess of $100,000 in the aggregate, (iii) made any loans or advances to any Person, other than ordinary advances for business expenses, or (iv) sold, exchanged or otherwise disposed of any of its assets or rights, other than in the ordinary course of business. For the purposes of (a) and (b) of this Section 2.10, all indebtedness, liabilities, agreements, understandings, instruments, contracts and proposed transactions involving the same Person (including Persons the Company has reason to believe are affiliated with each other) shall be aggregated for the purpose of meeting the individual minimum dollar amounts of such section.

(c)            The Company is not a guarantor or indemnitor of any indebtedness of any other Person.

2.11          Certain Transactions.

(a)            Other than (i) standard employee benefits generally made available to all employees, standard employee offer letters, consulting agreements or advisor letters, (ii) standard director and officer indemnification agreements approved by the Board, (iii) standard non-competition and non-solicitation agreements, (iv) standard invention and non-disclosure agreements, (v) the purchase of shares of the Company’s capital stock and the issuance of options to purchase shares of the Company’s Common Stock, in each instance, approved in the written minutes or consents of the Board (previously provided to the Purchasers or their respective counsel), and (vi) the Transaction Agreements, there are no agreements, understandings or proposed transactions between the Company and any of its officers, directors, consultants or Key Employees, or any Affiliate thereof.

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(b)            The Company is not indebted, directly or indirectly, to any of its directors, officers or employees or to their respective spouses or children or to any Affiliate of any of the foregoing, other than in connection with expenses or advances of expenses incurred in the ordinary course of business or employee relocation expenses and for other customary employee benefits made generally available to all employees. None of the Company’s directors, officers or employees, or any members of their immediate families, or any Affiliate of the foregoing are, directly or indirectly, indebted to the Company or, to the Company’s knowledge, have any (i) material commercial, industrial, banking, consulting, legal, accounting, charitable or familial relationship with any of the Company’s customers, suppliers, service providers, joint venture partners, licensees and competitors, (ii) direct or indirect ownership interest in any firm or corporation with which the Company is affiliated or with which the Company has a business relationship, or any firm or corporation which competes with the Company except that directors, officers, employees or stockholders of the Company may own stock in (but not exceeding two percent (2%) of the outstanding capital stock of) publicly traded companies that may compete with the Company; or (iii) financial interest in any material contract with the Company, other than those contracts described in Section 2.11(a) or set forth in Section 2.11(a) of the Disclosure Schedule.

2.12         Rights of Registration and Voting Rights. Except as provided in the Investors’ Rights Agreement, the Company is not under any obligation to register under the Securities Act any of its currently outstanding securities or any securities issuable upon exercise or conversion of its currently outstanding securities. To the Company’s knowledge, no stockholder of the Company has entered into any agreements with respect to the voting of shares of the Company’s capital stock.

2.13         Property. The property and assets that the Company owns are free and clear of all mortgages, deeds of trust, liens, loans and encumbrances, except for statutory liens for the payment of current taxes that are not yet delinquent and encumbrances and liens that arise in the ordinary course of business and do not materially impair the Company’s ownership or use of such property or assets. With respect to the property and assets it leases, the Company is in compliance with such leases and holds a valid leasehold interest free of any liens, claims or encumbrances other than those of the lessors of such property or assets. The Company does not own any real property.

2.14         Financial Statements. The Company has delivered to each Purchaser its audited financial statements as of December 31, 2020 and for the fiscal year ended December 31, 2019 and its unaudited financial statements (including balance sheet, income statement and statement of cash flows) as of March 31, 2021 (the “Balance Sheet Date”) and for the three-month period ended on the Balance Sheet Date (collectively, the “Financial Statements”). The Financial Statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods indicated, except that the unaudited Financial Statements may not contain all footnotes required by GAAP. The Financial Statements fairly present in all material respects the financial condition and operating results of the Company as of the dates, and for the periods, indicated therein, subject in the case of the unaudited Financial Statements to normal year-end audit adjustments. Except as set forth in the Financial Statements, the Company has no material liabilities or obligations, contingent or otherwise, other than (i) liabilities incurred in the ordinary course of business subsequent to the Balance Sheet Date; (ii) obligations under contracts and commitments incurred in the ordinary course of business; and (iii) liabilities and obligations of a type or nature not required under GAAP to be reflected in the Financial Statements, which, in all such cases, individually and in the aggregate would not have a Material Adverse Effect. The Company maintains and will continue to maintain a standard system of accounting established and administered in accordance with GAAP.

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2.15         Changes. Since the Balance Sheet Date there has not been:

(a)            any change in the assets, liabilities, financial condition or operating results of the Company from that reflected in the Financial Statements, except changes in the ordinary course of business that have not caused, in the aggregate, a Material Adverse Effect;

(b)            any damage, destruction or loss, whether or not covered by insurance, that would have a Material Adverse Effect;

(c)            any waiver or compromise by the Company of a valuable right or of a material debt owed to it;

(d)            any satisfaction or discharge of any lien, claim, or encumbrance or payment of any obligation by the Company, except in the ordinary course of business and the satisfaction or discharge of which would not have a Material Adverse Effect;

(e)            any material change to a material contract or agreement by which the Company or any of its assets is bound or subject;

(f)             any material change in any compensation arrangement or agreement with any employee, officer, director or stockholder;

(g)            any resignation or termination of employment of any officer or Key Employee of the Company;

(h)            any mortgage, pledge, transfer of a security interest in, or lien, created by the Company, with respect to any of its material properties or assets, except liens for taxes not yet due or payable and liens that arise in the ordinary course of business and do not materially impair the Company’s ownership or use of such property or assets;

(i)             any loans or guarantees made by the Company to or for the benefit of its employees, officers or directors, or any members of their immediate families, other than travel advances and other advances made in the ordinary course of its business;

(j)             any declaration, setting aside or payment or other distribution in respect of any of the Company’s capital stock, or any direct or indirect redemption, purchase, or other acquisition of any of such stock by the Company;

(k)            any sale, assignment or transfer of any Company Intellectual Property that could reasonably be expected to result in a Material Adverse Effect;

(l)             receipt of notice that there has been a loss of, or material order cancellation by, any major customer of the Company;

(m)           any other event or condition of any character, other than events affecting the economy or the Company’s industry generally, that could reasonably be expected to result in a Material Adverse Effect; or

(n)            any arrangement or commitment by the Company to do any of the things described in this Section 2.15.

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2.16         Employee Matters.

(a)            To the Company’s knowledge, none of its employees is obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would materially interfere with such employee’s ability to promote the interest of the Company or that would conflict with the Company’s business. Neither the execution or delivery of the Transaction Agreements, nor the carrying on of the Company’s business by the employees of the Company, nor the conduct of the Company’s business as now conducted and as presently proposed to be conducted, will, to the Company’s knowledge, conflict with or result in a breach of the terms, conditions, or provisions of, or constitute a default under, any contract, covenant or instrument under which any such employee is now obligated.

(b)            The Company is not delinquent in payments to any of its employees, consultants, or independent contractors for any wages, salaries, commissions, bonuses, or other direct compensation for any service performed for it to the date hereof or amounts required to be reimbursed to such employees, consultants or independent contractors. The Company has complied in all material respects with all applicable state and federal equal employment opportunity laws and with other laws related to employment, including those related to wages, hours, worker classification and collective bargaining. The Company has withheld and paid to the appropriate governmental entity or is holding for payment not yet due to such governmental entity all amounts required to be withheld from employees of the Company and is not liable for any arrears of wages, taxes, penalties or other sums for failure to comply with any of the foregoing.

(c)            To the Company’s knowledge, no Key Employee intends to terminate employment with the Company or is otherwise likely to become unavailable to continue as a Key Employee, nor does the Company have a present intention to terminate the employment of any of the foregoing. The employment of each employee of the Company is terminable at the will of the Company. Except as set forth in Section 2.16(c) of the Disclosure Schedule or as required by law, upon termination of the employment of any such employees, no severance or other payments will become due. Except as set forth in Section 2.16(c) of the Disclosure Schedule, the Company has no policy, practice, plan or program of paying severance pay or any form of severance compensation in connection with the termination of employment services.

(d)            The Company has not made any representations regarding equity incentives to any officer, employee, director or consultant that are inconsistent with the share amounts and terms set forth in the minutes of meetings of (or actions taken by unanimous written consent by) the Board.

(e)            Each former Key Employee whose employment was terminated by the Company has entered into an agreement with the Company providing for the full release of any claims against the Company or any related party arising out of such employment.

(f)             Section 2.16(f) of the Disclosure Schedule sets forth each employee benefit plan maintained, established or sponsored by the Company, or which the Company participates in or contributes to, which is subject to the Employee Retirement Income Security Act of 1974, as amended (“ERISA”). The Company has made all required contributions and has no liability to any such employee benefit plan, other than liability for health plan continuation coverage described in Part 6 of Title I(B) of ERISA, and has complied in all material respects with all applicable laws for any such employee benefit plan.

(g)            The Company is not bound by or subject to (and none of its assets or properties is bound by or subject to) any written or oral, express or implied, contract, commitment or arrangement with any labor union, and no labor union has requested or, to the knowledge of the Company, has sought to represent any of the employees, representatives or agents of the Company. There is no strike or other labor dispute involving the Company pending, or to the Company’s knowledge, threatened, which could have a Material Adverse Effect, nor is the Company aware of any labor organization activity involving its employees.

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(h)            To the Company’s knowledge, none of the Key Employees or directors of the Company has been (i) subject to voluntary or involuntary petition under the federal bankruptcy laws or any state insolvency law or the appointment of a receiver, fiscal agent or similar officer by a court for his or her business or property; (ii) convicted in a criminal proceeding or named as a subject of a pending criminal proceeding (excluding traffic violations and other minor offenses); (iii) subject to any order, judgment or decree (not subsequently reversed, suspended, or vacated) of any court of competent jurisdiction permanently or temporarily enjoining him or her from engaging, or otherwise imposing limits or conditions on his or her engagement in any securities, investment advisory, banking, insurance, or other type of business or acting as an officer or director of a public company; or (iv) found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated any federal or state securities, commodities, or unfair trade practices law, which such judgment or finding has not been subsequently reversed, suspended, or vacated.

2.17          Tax Returns and Payments. There are no federal, state, county, local or foreign taxes due and payable by the Company which have not been timely paid. There are no accrued and unpaid federal, state, county, local or foreign taxes of the Company which are due, whether or not assessed or disputed. There have been no examinations or audits of any tax returns or reports by any applicable federal, state, local or foreign governmental agency. The Company has duly and timely filed all federal, state, county, local and foreign tax returns required to have been filed by it and there are in effect no waivers of applicable statutes of limitations with respect to taxes for any year.

2.18          Insurance. The Company has in full force and effect insurance policies concerning such casualties as would be reasonable and customary for companies like the Company, with extended coverage, sufficient in amount (subject to reasonable deductions) to allow it to replace any of its properties that might be damaged or destroyed.

2.19          Employee Agreements. Each current and former employee, consultant and officer of the Company has executed an agreement with the Company regarding confidentiality and proprietary information substantially in the form or forms delivered to the Purchasers or their respective counsel (the “Confidential Information Agreements”). No current or former Key Employee has excluded works or inventions from his or her assignment of inventions pursuant to such Key Employee’s Confidential Information Agreement. Each current and former Key Employee has executed a non-competition and non-solicitation agreement substantially in the form or forms delivered to the Purchasers or their respective counsel. The Company is not aware that any of its Key Employees is in violation of any agreement described in this Section 2.19.

2.20          Permits. The Company has all franchises, permits, licenses and any similar authority necessary for the conduct of its business, the lack of which could reasonably be expected to have a Material Adverse Effect. The Company is not in default in any material respect under any of such franchises, permits, licenses or other similar authority.

2.21          Corporate Documents. The current Certificate of Incorporation and Bylaws of the Company as of the date of this Agreement are in the form provided to the Purchasers. The copy of the minute books of the Company provided to the Purchasers contains minutes of all meetings of directors and stockholders and all actions by written consent without a meeting by the directors and stockholders since the date of incorporation and accurately reflects in all material respects all actions by the directors (and any committee of directors) and stockholders with respect to all transactions referred to in such minutes.

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2.22          83(b) Elections. To the Company’s knowledge, all elections and notices under Section 83(b) of the Code have been or will be timely filed by all individuals who have acquired unvested shares of Common Stock.

2.23          Preclinical Development and Clinical Trials. The studies, tests, preclinical development and clinical trials, if any, conducted by or on behalf of the Company are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable laws and regulations, including the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. parts 50, 54, 56, 58, 312, and 812. The descriptions of, protocols for, and data and other results of, the studies, tests, development and trials conducted by or on behalf of the Company that have been furnished or made available to the Purchasers are accurate and complete. The Company is not aware of any studies, tests, development or trials the results of which reasonably call into question the results of the studies, tests, development and trials conducted by or on behalf of the Company, and the Company has not received any notices or correspondence from the U.S. Food and Drug Administration or any other governmental entity or any institutional review board or comparable authority requiring the termination, suspension or material modification of any studies, tests, preclinical development or clinical trials conducted by or on behalf of the Company.

2.24          Data Privacy. In connection with its collection, storage, use and/or disclosure of any information that constitutes “personal information,” “personal data” or “ personally identifiable information” as defined in applicable laws (collectively “Personal Information”) by or on behalf of the Company, the Company is and has been, to the Company’s knowledge, in compliance with (i) all applicable laws (including, without limitation, laws relating to privacy, data security, telephone and text message communications, and marketing by email or other channels) in all relevant jurisdictions, (ii) the Company’s privacy policies and (iii) the requirements of any contract or codes of conduct or industry standards by which the Company is bound (collectively, “Privacy Requirements”). The Company maintains reasonable physical, technical and administrative security measures and policies designed to protect all Personal Information owned, stored, used, maintained or controlled by or on behalf of the Company from and against unlawful, accidental or unauthorized access, destruction, loss, use, modification and/or disclosure. The Company is and has been, to the Company’s knowledge, in compliance in all material respects with all laws relating to data loss, theft and breach of security notification obligations. To the Company’s knowledge, there has been no occurrence of (x) unlawful, accidental or unauthorized destruction, loss, use, modification or disclosure of or access to Personal Information owned, stored, used, maintained or controlled by or on behalf of the Company such that Privacy Requirements require or required the Company to notify government authorities, affected individuals or other parties of such occurrence or (y) unauthorized access to or disclosure of the Company’s confidential information or trade secrets that reasonably would be expected to result in a Material Adverse Effect.

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3.              Representations and Warranties of the Purchasers. Each Purchaser hereby represents and warrants to the Company, severally and not jointly, that:

3.1            Authorization. The Purchaser has full power and authority to enter into the Transaction Agreements. The Transaction Agreements to which the Purchaser is a party, when executed and delivered by the Purchaser, will constitute valid and legally binding obligations of the Purchaser, enforceable against such Purchaser in accordance with their terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance and any other laws of general application affecting enforcement of creditors’ rights generally, and as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies, or (b) to the extent the indemnification provisions contained in the Investors’ Rights Agreement may be limited by applicable federal or state securities laws.

3.2            Purchase Entirely for Own Account. This Agreement is made with the Purchaser in reliance upon the Purchaser’s representation to the Company, which by the Purchaser’s execution of this Agreement, the Purchaser hereby confirms, that the Shares to be acquired by the Purchaser will be acquired for investment for the Purchaser’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Agreement, the Purchaser further represents that the Purchaser does not presently have any contract, undertaking, agreement or arrangement with any Person to sell, transfer or grant participations to such Person or to any third Person, with respect to any of the Shares. The Purchaser has not been formed for the specific purpose of acquiring the Shares.

3.3            Disclosure of Information. The Purchaser has had an opportunity to discuss the Company’s business, management, financial affairs and the terms and conditions of the offering of the Shares with the Company’s management and has had an opportunity to inspect the Company’s facilities. The foregoing, however, does not limit or modify the representations and warranties of the Company in Section 2 of this Agreement or the right of the Purchasers to rely thereon.

3.4            Restricted Securities. The Purchaser understands that the Shares have not been, and will not be, registered under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Purchaser’s representations as expressed herein. The Purchaser understands that the Shares are “restricted securities” under applicable U.S. federal and state securities laws and that, pursuant to these laws, the Purchaser must hold the Shares indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. The Purchaser acknowledges that the Company has no obligation to register or qualify the Shares, or the Common Stock into which it may be converted, for resale except as set forth in the Investors’ Rights Agreement. The Purchaser further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Shares, and on requirements relating to the Company which are outside of the Purchaser’s control, and which the Company is under no obligation and may not be able to satisfy.

3.5            No Public Market. The Purchaser understands that no public market now exists for the Shares, and that the Company has made no assurances that a public market will ever exist for the Shares.

3.6            Legends. The Purchaser understands that the Shares and any securities issued in respect of or exchange for the Shares, may be notated with one or all of the following legends:

“THE SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH TRANSFER MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.”

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(a)            Any legend set forth in, or required by, the other Transaction Agreements.

(b)            Any legend required by the securities laws of any state to the extent such laws are applicable to the Shares represented by the certificate, instrument, or book entry so legended.

3.7            Accredited Investor. The Purchaser is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

3.8            Foreign Investors. If the Purchaser is not a United States person (as defined by Section 7701(a)(30) of the Code), the Purchaser hereby represents that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Shares or any use of this Agreement, including (i) the legal requirements within its jurisdiction for the purchase of the Shares, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any governmental or other consents that may need to be obtained, and (iv) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Shares. The Purchaser’s subscription and payment for and continued beneficial ownership of the Shares will not violate any applicable securities or other laws of the Purchaser’s jurisdiction.

3.9            No General Solicitation. Neither the Purchaser, nor any of its officers, directors, employees, agents, stockholders or partners has either directly or indirectly, including, through a broker or finder (a) engaged in any general solicitation, or (b) published any advertisement in connection with the offer and sale of the Shares.

3.10          Exculpation Among Purchasers. The Purchaser acknowledges that it is not relying upon any Person, other than the Company and its officers and directors, in making its investment or decision to invest in the Company. The Purchaser agrees that neither any Purchaser nor the respective controlling Persons, officers, directors, partners, agents, or employees of any Purchaser shall be liable to any other Purchaser for any action heretofore taken or omitted to be taken by any of them in connection with the purchase of the Shares.

3.11          Residence. If the Purchaser is an individual, then the Purchaser resides in the state or province identified in the address of the Purchaser set forth on Exhibit A; if the Purchaser is a partnership, corporation, limited liability company or other entity, then the office or offices of the Purchaser in which its principal place of business is identified in the address or addresses of the Purchaser set forth on Exhibit A.

3.12          Bad Actor Matters. Each Purchaser hereby represents that none of the “Bad Actor” disqualifying events described in Rule 506(d)(1)(i) to (viii) promulgated under the Securities Act (a “Disqualification Event”) is applicable to such Purchaser or any of its Rule 506(d) Related Parties, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. For purposes of this Agreement, “Rule 506(d) Related Party” shall mean a Person that is a beneficial owner of such Purchaser’s securities for purposes of Rule 506(d) of the Securities Act.

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4.              Conditions to the Purchasers’ Obligations at Closing. The obligations of each Purchaser to purchase Shares at the Initial Closing or any subsequent Closing are subject to the fulfillment, on or before such Closing, of each of the following conditions, unless otherwise waived:

4.1            Representations and Warranties. (i) The representations and warranties of the Company contained in Section 2.1, Section 2.2, Section 2.3, Section 2.4, Section 2.5, Section 2.8(a)-(b), and Section 2.15 shall be true and correct in all respects as of the Initial Closing, and (ii) all other representations and warranties of the Company contained in Section 2 shall be true and correct in all material respects as of the Initial Closing.

4.2            Performance. The Company shall have performed and complied with all covenants, agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by the Company on or before such Closing.

4.3            Compliance Certificate. The Chief Executive Officer of the Company shall deliver to the Purchasers at the Initial Closing a certificate certifying that the conditions specified in Sections 4.1 and 4.2 have been fulfilled. For any subsequent Closing, the Chief Executive Officer of the Company shall deliver to the Additional Purchasers a certificate certifying that the conditions specified in 4.2 have been fulfilled.

4.4            Qualifications. All authorizations, approvals or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Shares pursuant to this Agreement shall be obtained and effective as of such Closing.

4.5            Opinion of Company Counsel. The Purchasers purchasing Shares at the Initial Closing shall have received from Faegre Drinker Biddle & Reath LLP, counsel for the Company, an opinion, dated as of the Closing, in substantially the form of Exhibit E attached to this Agreement.

4.6            Board of Directors. As of the Initial Closing, the authorized size of the Board shall be six (6), and the Board shall be comprised of Jeff Ross, Paul Buckman, Ronald Eibensteiner, John Erb, Mahesh Krishnan and Mark Wagner.

4.7            Side Letter. The Company and Baxter shall have executed and delivered the Side Letter.

4.8            Restated Certificate. The Company shall have filed the Restated Certificate with the Secretary of State of Delaware on or prior to the Initial Closing, which shall continue to be in full force and effect as of such Closing.

4.9            Secretary’s Certificate. The Secretary of the Company shall have delivered to the Purchasers at such Closing a certificate certifying (i) the Restated Certificate and Bylaws of the Company as in effect at the Closing, (ii) resolutions of the Board approving the Transaction Agreements and the transactions contemplated under the Transaction Agreements, and (iii) actions of the stockholders of the Company approving the Restated Certificate.

4.10          Proceedings and Documents. All corporate and other proceedings in connection with the transactions contemplated at each Closing and all documents incident thereto shall be reasonably satisfactory in form and substance to each Purchaser, and each Purchaser (or its respective counsel) shall have received all such counterpart original and certified or other copies of such documents as reasonably requested. Such documents may include good standing certificates. The Company shall have fully satisfied (including with respect to rights of timely notification) or obtained enforceable waivers in respect of any preemptive or similar rights directly or indirectly affecting any of its securities.

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4.11          Preemptive Rights. The Company shall have fully satisfied (including with respect to rights of timely notification) or obtained enforceable waivers in respect of any preemptive or similar rights directly or indirectly affecting any of its securities.

4.12          Minimum Number of Shares at Initial Closing. The Initial Closing will be for the sale of Shares to Purchasers with an aggregate purchase price of at least $20,000,000.

5.              Conditions of the Company’s Obligations at Closing. The obligations of the Company to sell Shares to the Purchasers at the Initial Closing or any subsequent Closing are subject to the fulfillment, on or before the Closing, of each of the following conditions, unless otherwise waived:

5.1            Representations and Warranties. The representations and warranties of each Purchaser contained in Section 3 shall be true and correct in all material respects as of such Closing.

5.2            Performance. The Purchasers shall have performed and complied with all covenants, agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by them on or before such Closing.

5.3            Qualifications. All authorizations, approvals or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Shares pursuant to this Agreement shall be obtained and effective as of the Closing.

5.4            Stockholder Approval. The approval of the Restated Certificate by the stockholders of the Company shall be obtained and effective as of the Closing.

5.5            Preemptive Rights. The Company shall have fully satisfied (including with respect to rights of timely notification) or obtained enforceable waivers in respect of any preemptive or similar rights directly or indirectly affecting any of its securities, including without limitation the rights of Cheshire under Section 6 (a) of the Note and Warrant Purchase Agreement between the Company and Cheshire dated March 6, 2020.

5.6            Minimum Number of Shares at Initial Closing. The Initial Closing will be for the sale of Shares to Purchasers with an aggregate purchase price of at least $20,000,000.

6.              Miscellaneous.

6.1            Survival of Warranties. Unless otherwise set forth in this Agreement, the representations and warranties of the Company and the Purchasers contained in or made pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Closing and shall in no way be affected by any investigation or knowledge of the subject matter thereof made by or on behalf of the Purchasers or the Company.

6.2            Successors and Assigns. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

6.3            Governing Law. This Agreement and any controversy arising out of or relating to this Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware, without regard to conflict of law principles that would result in the application of any law other than the law of the State of Delaware.

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6.4            Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

6.5            Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

6.6            Notices; Electronic Notice.

(a)            General. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given upon the earlier of actual receipt, or (a) personal delivery to the party to be notified, (b) when sent, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) business day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their address as set forth on the signature page or Exhibit A, or to such e-mail address or address as subsequently modified by written notice given in accordance with this Section 6.6. If notice is given to the Company, a copy (which copy shall not constitute notice) shall also be sent to Faegre Drinker Biddle & Reath LLP Attn: Steven Kennedy, 2200 Wells Fargo Center, 90 South Seventh Street, Minneapolis, MN 55402 and if notice is given to the Purchasers, a copy (which copy shall not constitute notice) shall also be given to Latham & Watkins LLP, 330 N. Wabash Avenue, Suite 2800, Chicago, IL 60611, Attn: Mark Gerstein, Evan Smith.

(b)            Electronic Notice. Each Purchaser acknowledges that the Company may deliver any stockholder notice pursuant to the Delaware General Corporation Law (the “DGCL”), as amended or superseded from time to time, by electronic transmission pursuant to Section 232 of the DGCL (or any successor thereto) at the electronic mail address set forth below such Purchaser’s name on the Schedules hereto, as updated from time to time by notice to the Company, or as on the books of the Company, unless the Purchaser notifies the Company in writing or by electronic transmission of an objection to receiving notice by electronic mail. Each Purchaser agrees to promptly notify the Company of any change in such stockholder’s electronic mail address, and that failure to do so shall not affect the foregoing.

6.7            No Finder’s Fees. Each party represents that it neither is nor will be obligated for any finder’s fee or commission in connection with this transaction. Each Purchaser agrees to indemnify and to hold harmless the Company from any liability for any commission or compensation in the nature of a finder’s or broker’s fee arising out of this transaction (and the costs and expenses of defending against such liability or asserted liability) for which each Purchaser or any of its officers, employees or representatives is responsible. The Company agrees to indemnify and hold harmless each Purchaser from any liability for any commission or compensation in the nature of a finder’s or broker’s fee arising out of this transaction (and the costs and expenses of defending against such liability or asserted liability) for which the Company or any of its officers, employees or representatives is responsible.

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6.8            Fees and Expenses. At the Initial Closing, the Company shall pay the reasonable fees and expenses of Latham & Watkins LLP, the counsel for Baxter, in an amount not to exceed, in the aggregate, $100,000.

6.9            Amendments and Waivers. This Agreement may be amended, terminated or waived only with the written consent of the Company and the holders of at least a majority of the then-outstanding Shares. Any amendment or waiver effected in accordance with this Section 6.9 shall be binding upon the Purchasers and each transferee of the Shares (or the Common Stock issuable upon conversion thereof), each future holder of all such securities, and the Company.

6.10          Severability. The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision.

6.11          Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power or remedy of such non-breaching or non-defaulting party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

6.12          Entire Agreement. This Agreement (including the Exhibits hereto), the Restated Certificate and the other Transaction Agreements constitute the full and entire understanding and agreement between the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties are expressly canceled.

6.13          Dispute Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of Delaware and to the jurisdiction of the United States District Court for the District of Delaware for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the state courts of Delaware or the United States District Court for the District of Delaware, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.

Waiver of Jury Trial: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, THE OTHER TRANSACTION DOCUMENTS, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL.

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6.14          No Commitment for Additional Financing. The Company acknowledges and agrees that no Purchaser has made any representation, undertaking, commitment or agreement to provide or assist the Company in obtaining any financing, investment or other assistance, other than the purchase of the Shares as set forth herein and subject to the conditions set forth herein. In addition, the Company acknowledges and agrees that (i) no statements, whether written or oral, made by any Purchaser or its representatives on or after the date of this Agreement shall create an obligation, commitment or agreement to provide or assist the Company in obtaining any financing or investment, (ii) the Company shall not rely on any such statement by any Purchaser or its representatives, and (iii) an obligation, commitment or agreement to provide or assist the Company in obtaining any financing or investment may only be created by a written agreement, signed by such Purchaser and the Company, setting forth the terms and conditions of such financing or investment and stating that the parties intend for such writing to be a binding obligation or agreement. Each Purchaser shall have the right, in its sole and absolute discretion, to refuse or decline to participate in any other financing of or investment in the Company, and shall have no obligation to assist or cooperate with the Company in obtaining any financing, investment or other assistance.

[Signature Page Follows]

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IN WITNESS WHEREOF, the parties have executed this Series C Convertible Preferred Stock Purchase Agreement as of the date first written above.

MIROMATRIX MEDICAL INC.:
By:	/s/ Jeff Ross
Name:	Jeff Ross
Title:	Chief Executive Officer

Signature Page to Stock Purchase Agreement

IN WITNESS WHEREOF, the parties have executed this Series C Convertible Preferred Stock Purchase Agreement as of the date first written above.

PURCHASERS:
BAXTER HEALTHCARE CORPORATION
By:	/s/ Dennis Crowley
Name:	Dennis Crowley
Title:	SVP, Business Development & Licensing

Signature Page to Stock Purchase Agreement

IN WITNESS WHEREOF, the parties have executed this Series C Convertible Preferred Stock Purchase Agreement as of the date first written above.

PURCHASERS:
CAREDX, INC.
By:	/s/ Reginald Seeto
Name:	Reginald Seeto
Title:	CEO

Signature Page to Stock Purchase Agreement

EXHIBITS

Exhibit A - SCHEDULE OF PURCHASERS

EXHIBIT A

SCHEDULE OF PURCHASERS

Name and Address of Purchaser	Total Cash Consideration		Shares of Series C Preferred Stock		Purchase Price (Note Conversion Amount)
BAXTER HEALTHCARE CORPORATION One Baxter Parkway, Deerfield, Illinois, 60015 Attention: General Counsel Email: general.counsel@baxter.com	$	15,000,000		2,000,000	N/A
CareDx, Inc. 1 Tower Pl 9th floor, South San Francisco, CA 94080 Attention: Reginald Seeto	$	5,000,002.50		666,667	N/A
TOTAL	$	20,000,002.50		2,666,667	N/A

EX-10.25

Exhibit 10.25

Execution Version

MIROMATRIX MEDICAL INC.
10399 West 70th Street
Eden Prairie, MN 55344

May 21, 2021

Baxter Healthcare Corporation

One Baxter Parkway,

Deerfield, Illinois, 60015

Attn: General Counsel

Email: general.counsel@baxter.com

CareDx, Inc.

1 Tower Pl 9th floor,

South San Francisco, CA 94080

Attention: Reginald Seeto

RE: SERIES C CONVERTIBLE PREFERRED STOCK

Dear Investors:

Reference is made to that certain Series C Convertible Preferred Stock Purchase Agreement (as may be amended from time to time, the “Purchase Agreement”), dated as of May 3, 2021, by and among Miromatrix Medical Inc., a Delaware corporation (“Company”), Baxter Healthcare Corporation, a Delaware corporation (“Baxter”), CareDx, Inc., a Delaware corporation (“CareDx”) and the holders of Series C Preferred Stock of the Company listed on Exhibit A hereto (collectively with Baxter and CareDx, the “Investors,” and each an “Investor”). Capitalized terms used in this letter agreement (this “Agreement”), but not defined herein shall have the meaning assigned to them in that certain Investor Rights Agreement (as may be amended and/or amended and restated from time to time, the “Investor Rights Agreement”), dated October 16, 2017, by and among the Company and the Company’s stockholders party thereto.

1.             Registration Rights. The Company covenants and agrees as follows:

a.             Demand Registration.

i.              Form S-1 Demand. If at any time after the earlier of (i) three (3) years after the date of this Agreement or (ii) 180 days after the effective date of the registration statement for the IPO, the Company receives a request from the Investors holding of a majority of the Registrable Securities (the “Initiating Holders”) that the Company file a Form S-1 registration statement having an anticipated aggregate offering price, net of Selling Expenses, of at least $5 million (which such amount shall include the anticipated aggregate offering price of any request for registration under the Investor Rights Agreement, or any other outstanding agreement between the Company and its stockholders regarding registration rights, that is delivered on or about the same time as such request from the Initiating Holders), then the Company shall (x) within 10 days after the date such request is given, give notice thereof (the “Demand Notice”) to all Investors other than the Initiating Holders; and (y) as soon as practicable, and in any event within 60 days after the date such request is given by the Initiating Holders, file a Form S-1 registration statement under the Securities Act covering all Registrable Securities that the Initiating Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any other Investor, as specified by notice given by each such Holder to the Company within 20 days of the date the Demand Notice is given, and in each case, subject to the limitations of Sections 1(a)(iii) and 1(c).

ii.             Form S-3 Demand. If at any time when it is eligible to use a Form S-3 registration statement, the Company receives a request from the Initiating Holders that the Company file a Form S-3 registration statement with respect to outstanding Registrable Securities of the Initiating Holders having an anticipated aggregate offering price, net of Selling Expenses, of at least $2 million (which such amount shall include the anticipated aggregate offering price of any request for registration under the Investor Rights Agreement, or any other outstanding agreement between the Company and its stockholders regarding registration rights, that is delivered on or about the same time as such request from the Initiating Holders), then the Company shall (i) within 10 days after the date such request is given, give a Demand Notice to all Investors other than the Initiating Holders; and (ii) as soon as practicable, and in any event within 45 days after the date such request is given by the Initiating Holders, file a Form S-3 registration statement under the Securities Act covering all Registrable Securities requested to be included in such registration by any other Investor, as specified by notice given by each such Investor to the Company within 20 days of the date the Demand Notice is given, and in each case, subject to the limitations of Sections 1(a)(iii) and 1(c).

iii.            Notwithstanding the foregoing obligations, if the Company furnishes to the Initiating Holders a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Company’s Board of Directors (the “Board of Directors”) it would be materially detrimental to the Company and its stockholders for such registration statement to either become effective or remain effective for as long as such registration statement otherwise would be required to remain effective, then the Company shall have the right to defer taking action with respect to such filing, and any time periods with respect to filing or effectiveness thereof shall be tolled correspondingly, for a period of not more than 90 days after the request of the Initiating Holders is given; provided, however, that the Company may not invoke this right more than once in any twelve (12) month period; and provided further that the Company shall not register any securities for its own account or that of any other stockholder during such ninety (90) day period other than an Excluded Registration.

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iv.            The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Section 1(a)(i); (i) during the period that is 60 days before the Company’s good faith estimate of the date of filing of, and ending on a date that is 180 days after the effective date of, a Company-initiated registration, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become effective; (ii) after the Company has effected two (2) registrations pursuant to Section 1(a)(i); or (iii) if the Initiating Holders propose to dispose of shares of Registrable Securities that may be immediately registered on Form S-3 pursuant to a request made pursuant to Section 1(a)(ii). The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Section 1(a)(ii) (i) during the period that is 30 days before the Company’s good faith estimate of the date of filing of, and ending on a date that is 90 days after the effective date of, a Company-initiated registration, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become effective; or (ii) if the Company has effected two registrations pursuant to Section 1(a)(ii) within the 12 month period immediately preceding the date of such request. A registration shall not be counted as “effected” for purposes of this Section 1(a)(iv) until such time as the applicable registration statement has been declared effective by the SEC, unless the Initiating Holders withdraw their request for such registration, elect not to pay the registration expenses therefor, and forfeit their right to one demand registration statement pursuant to Section 1(f), in which case such withdrawn registration statement shall be counted as “effected” for purposes of this Section 1(a)(iv); provided, that if such withdrawal is during a period the Company has deferred taking action pursuant to Section 1(a)(iii), then the Initiating Holders may withdraw their request for registration and such registration will not be counted as “effected” for purposes of this Section 1(a)(iv).

b.             Company Registration. If the Company proposes to register (including for this purpose a registration effected by the Company for stockholders other than the Investors) any of its Common Stock under the Securities Act in connection with the public offering of such securities solely for cash (other than in an Excluded Registration or the IPO), the Company shall, at such time, promptly give each Investor notice of such registration. Upon the request of any Investor given within 20 days after such notice is given by the Company, the Company shall, subject to the provisions of Section 1(c), cause to be registered all of the Registrable Securities that such Investor has requested to be included in such registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 1(b) before the effective date of such registration, whether or not any Investor has elected to include Registrable Securities in such registration. The expenses (other than Selling Expenses) of such withdrawn registration shall be borne by the Company in accordance with Section 1(b). For avoidance of doubt, the parties hereby agree that the Investors will not have any rights to register Registrable Securities in connection with the IPO.

c.             Underwriting Requirements.

i.              If, pursuant to Section 1(c), the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to Section 1(a), and the Company shall include such information in the Demand Notice. The underwriter(s) will be selected by the Company and shall be reasonably acceptable to the Initiating Holders. In such event, the right of any Investor to include such Investor’s Registrable Securities in such registration shall be conditioned upon such Investor’s participation in such underwriting and the inclusion of such Investor’s Registrable Securities in the underwriting to the extent provided herein. Each Investor shall (together with the Company as provided in Section 1(d)(v)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting; provided, however, that no Investor (or any of its assignees) shall be required to make any representations, warranties or indemnities except as they relate to such Investor’s ownership of shares and authority to enter into the underwriting agreement and to such Investor’s intended method of distribution, and the liability of such Investor shall be several and not joint, and shall be limited to an amount equal to the net proceeds from the offering received by Investor. Notwithstanding any other provision of this Section 1(c), if the managing underwriter(s) advise(s) the Initiating Holders in writing that marketing factors require a limitation on the number of shares to be underwritten, then the Initiating Holders shall so advise all Investors of Registrable Securities that otherwise would be underwritten pursuant hereto, and the number of Registrable Securities that may be included in the underwriting shall be allocated among such Investors holding Registrable Securities, including the Initiating Holders, in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Investor or in such other proportion as shall mutually be agreed to by all such selling Investors; provided, however, that the number of Registrable Securities held by such Investor shall not be reduced unless all other securities are first entirely excluded from the underwriting. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Investor to the nearest one hundred (100) shares.

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ii.             In connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Section 1(b), the Company shall not be required to include any Investor’s Registrable Securities in such underwriting unless each Investor accepts the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company. If the total number of securities, including Registrable Securities, requested by stockholders to be included in such offering exceeds the number of securities to be sold (other than by the Company) that the underwriters in their reasonable discretion determine is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, which the underwriters and the Company in their sole discretion determine will not jeopardize the success of the offering. If the underwriters determine that less than all of the Registrable Securities requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering shall be allocated among each selling Investor in proportion (as nearly as practicable) to the number of Registrable Securities owned by such selling Investor or in such other proportions as shall mutually be agreed to by all such selling Investors. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Investor to the nearest 100 shares. Notwithstanding the foregoing, in no event shall (i) the number of Registrable Securities included in the offering be reduced unless all other securities (other than securities to be sold by the Company) are first entirely excluded from the offering, or (ii) the number of Registrable Securities included in the offering be reduced below 25% of the total number of securities included in such offering, unless such offering is the IPO, in which case each selling Investor may be excluded further if the underwriters make the determination described above and no other stockholder’s securities are included in such offering. For purposes of the provision in this Section 1(c)(ii) concerning apportionment, for any selling Investor that is a partnership, limited liability company, or corporation, the partners, members, retired partners, retired members, stockholders, and Affiliates of such Investor, or the estates and Immediate Family Members of any such partners, retired partners, members, and retired members and any trusts for the benefit of any of the foregoing Persons, shall be deemed to be a single “selling Investor,” and any pro rata reduction with respect to such “selling Investor” shall be based upon the aggregate number of Registrable Securities owned by all Persons included in such “selling Investor,” as defined in this sentence.

iii.            For purposes of Section 1(a), a registration shall not be counted as “effected” if, as a result of an exercise of the underwriter’s cutback provisions in Section 1(c)(i), fewer than 50% of the total number of Registrable Securities that each Investor requested to be included in such registration statement are actually included.

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d.            Obligations of the Company. Whenever required under this Section 1 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:

i.              prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its commercially reasonable efforts to cause such registration statement to become effective and, upon the request of the Investors holding a majority of the Registrable Securities registered thereunder, keep such registration statement effective for a period of up to 120 days or, if earlier, until the distribution contemplated in the registration statement has been completed; provided, however, that (i) such 120 day period shall be extended for a period of time equal to the period each Investor refrains, at the request of an underwriter of Common Stock (or other securities) of the Company, from selling any securities included in such registration, and (ii) in the case of any registration of Registrable Securities on Form S-3 that are intended to be offered on a continuous or delayed basis, subject to compliance with applicable SEC rules, such 120 day period shall be extended for up to 180 days, if necessary, to keep the registration statement effective until all such Registrable Securities are sold;

ii.             prepare and file with the SEC such amendments and supplements to such registration statement, and the prospectus used in connection with such registration statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities covered by such registration statement;

iii.            furnish to each Investor such numbers of copies of a prospectus, including a preliminary prospectus, as required by the Securities Act, and such other documents as each Investor may reasonably request in order to facilitate its disposition of its Registrable Securities;

iv.            use its commercially reasonable efforts to register and qualify the securities covered by such registration statement under such other securities or blue-sky laws of such jurisdictions as shall be reasonably requested by each Investor; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;

v.             in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering;

vi.            use its commercially reasonable efforts to cause all such Registrable Securities covered by such registration statement to be listed on a national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities issued by the Company are then listed;

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vii.           provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;

viii.          promptly make available for inspection by any Investor, any managing underwriter(s) participating in any disposition pursuant to such registration statement, and any attorney or accountant or other agent retained by any such underwriter or selected by any Investor, all financial and other records, pertinent corporate documents, and properties of the Company, and cause the Company’s officers, directors, employees, and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant, or agent, in each case, as necessary or advisable to verify the accuracy of the information in such registration statement and to conduct appropriate due diligence in connection therewith;

ix.             notify the each Investor, promptly after the Company receives notice thereof, of the time when such registration statement has been declared effective or a supplement to any prospectus forming a part of such registration statement has been filed; and

x.              after such registration statement becomes effective, notify each Investor of any request by the SEC that the Company amend or supplement such registration statement or prospectus.

In addition, the Company shall ensure that, at all times after any registration statement covering a public offering of securities of the Company under the Securities Act shall have become effective, its insider trading policy shall provide that the Company’s directors may implement a trading program under Rule 10b5-1 of the Exchange Act.

e.             Furnish Information. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 1 with respect to the Registrable Securities of each Investor that such Investor shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably required to effect the registration of such Investor’s Registrable Securities.

f.             Expenses of Registration. All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to Section 1, including all registration, filing, and qualification fees; printers’ and accounting fees; fees and disbursements of counsel for the Company; and the reasonable fees and disbursements, not to exceed $50,000, of counsel for the Investors, selected by the Investors holding a majority of the Registrable Securities to be registered (“Selling Holder Counsel”), shall be borne and paid by the Company; provided, however, that the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 1(a) if the registration request is subsequently withdrawn at the request of the Investors holding a majority of the Registrable Securities to be registered, unless such Investors agree to forfeit its right to one registration pursuant to Sections 1(a) or 1(b), as the case may be; provided further that if, at the time of such withdrawal, the Investors shall have learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Investors at the time of its request and have withdrawn the request with reasonable promptness after learning of such information then the Investors shall not be required to pay any of such expenses and shall not forfeit its right to one registration pursuant to Sections 1(a) or 1(b). All Selling Expenses relating to Registrable Securities registered pursuant to this Section 1 shall be borne and paid by the Investors pro rata on the basis of the number of Registrable Securities registered on its behalf vis a vis the number of Registrable Securities or other capital stock registered on behalf of any other stockholder of the Company pursuant to an agreement or arrangement providing such stockholder with registration rights.

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g.             Delay of Registration. No Investor shall have any right to obtain or seek an injunction restraining or otherwise delaying any registration pursuant to this Agreement as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 1.

h.             Indemnification. If any Registrable Securities are included in a registration statement under this Section 1:

i.              To the extent permitted by law, the Company will indemnify and hold harmless the Investors, and their partners, members, officers, directors, and stockholders of the Investors; legal counsel and accountants for the Investors; any underwriter (as defined in the Securities Act) for the Investors; and each Person, if any, who controls the Investors or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to the Investors, underwriter, controlling Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Section 1(h)(i) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably withheld, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of the Investors, underwriter, controlling Person, or other aforementioned Person expressly for use in connection with such registration except to the extent such information has been corrected in a subsequent writing prior to or concurrently with the sale of Registrable Securities to the Person asserting the claim.

ii.             To the extent permitted by law, each Investor, severally and not jointly, will indemnify and hold harmless the Company, and each of its directors, each of its officers who has signed the registration statement, each Person (if any), who controls the Company within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities Act), any other Investor selling securities in such registration statement, and any controlling Person of any such underwriter or other Investor, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of such selling Investor expressly for use in connection with such registration and has not been corrected in a subsequent writing prior to or concurrently with the sale of Registrable Securities to the Person asserting the claim; and each such selling Investor will pay to the Company and each other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Section 1(h)(ii) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Investor, which consent shall not be unreasonably withheld; and provided further that in no event shall the aggregate amounts payable by any Investor by way of indemnity or contribution under Sections 1(h)(ii) and 1(h)(iv) exceed the proceeds from the offering received by such Investor (net of any Selling Expenses paid by such Investor), except in the case of fraud or willful misconduct by such Investor.

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iii.            Promptly after receipt by an indemnified party under this Section 1(h) of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 1(h), give the indemnifying party notice of the commencement thereof. The indemnifying party shall have the right to participate in such action and, to the extent the indemnifying party so desires, participate jointly with any other indemnifying party to which notice has been given, and to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such action. The failure to give notice to the indemnifying party within a reasonable time of the commencement of any such action shall relieve such indemnifying party of any liability to the indemnified party under this Section 1(h), only to the extent that such failure materially prejudices the indemnifying party’s ability to defend such action. The failure to give notice to the indemnifying party will not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 1(h).

iv.            To provide for just and equitable contribution to joint liability under the Securities Act in any case in which either: (i) any party otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Section 1(h) but it is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding the fact that this Section 1(h) provides for indemnification in such case, or (ii) contribution under the Securities Act may be required on the part of any party hereto for which indemnification is provided under this Section 1(h), then, and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided, however, that, in any such case (x) no Investor will be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by such Holder pursuant to such registration statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation; and provided further that in no event shall a Investor’s liability pursuant to this Section 1(h)(iv), when combined with the amounts paid or payable by such Investor pursuant to Section 1(h)(ii), exceed the proceeds from the offering received by such Investor (net of any Selling Expenses paid by such Investor), except in the case of willful misconduct or fraud by such Investor.

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v.             Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control; provided, however, that any matter expressly provided for or addressed by the foregoing provisions that is not expressly provided for or addressed by the underwriting agreement shall be controlled by the foregoing provisions.

vi.            Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations of the Company and the Investors under this Section 1(h) shall survive the completion of any offering of Registrable Securities in a registration under this Section 1, and otherwise shall survive the termination of this Agreement or any provision(s) of this Agreement.

vii.           Reports Under Exchange Act. With a view to making available to the Investors the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit an Investor to sell securities of the Company to the public without registration or pursuant to a registration on Form S-3, the Company shall:

viii.          make and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144, at all times after the effective date of the registration statement filed by the Company for the IPO;

ix.             use commercially reasonable efforts to file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act (at any time after the Company has become subject to such reporting requirements); and

x.              furnish to any Investor, so long as such Investor own any Registrable Securities, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after 90 days after the effective date of the registration statement filed by the Company for the IPO), the Securities Act, and the Exchange Act (at any time after the Company has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3 (at any time after the Company so qualifies); (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company; and (iii) such other information as may be reasonably requested in availing any Investor of any rule or regulation of the SEC that permits the selling of any such securities without registration (at any time after the Company has become subject to the reporting requirements under the Exchange Act) or pursuant to Form S-3 (at any time after the Company so qualifies to use such form).

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i.              Limitations on Subsequent Registration Rights. From and after the date of this Agreement, the Company shall not, without the prior written consent of the Investors holding a majority of the then-outstanding Registrable Securities, enter into any agreement (including any amendment or amendment and restatement of the Investor Rights Agreement) with any holder or prospective holder of any securities of the Company that would (i) allow such holder or prospective holder to include such securities in any registration unless, under the terms of such agreement, such holder or prospective holder may include such securities in any such registration only to the extent that the inclusion of such securities will not reduce the number of the Registrable Securities of the Investors that are included, or (ii) allow such holder or prospective holder to initiate a demand for registration of any securities held by such holder or prospective holder (except as contemplated in the Investor Rights Agreement as of the date hereof); provided, that such limitation shall not apply to Registrable Securities acquired by any purchaser of Series C Preferred Stock pursuant to the Purchase Agreement.

j.              “Market Stand-off” Agreement. Each Investor hereby agree that they will not, without the prior written consent of the managing underwriter, during the period commencing on the date of the final prospectus relating to the registration by the Company of shares of its Common Stock or any other equity securities under the Securities Act on a registration statement on Form S-1 or Form S-3 (other than in the case of a registration on Form S-1 in connection with an IPO that is not consummated on an underwritten basis), and ending on the date specified by the Company and the managing underwriter (such period not to exceed 180 days in the case of the IPO, or such other period as may be requested by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research reports, and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in applicable FINRA rules, or any successor provisions or amendments thereto), (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable (directly or indirectly) for Common Stock held immediately before the effective date of the registration statement for such offering or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or other securities, in cash, or otherwise. The foregoing provisions of this Section 1(k) shall only apply to the IPO, shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement or to the establishment of a trading plan pursuant to Rule 10b5-1, provided such plan does not permit transfers during the restricted period, or the transfer of any shares to any trust for the direct or indirect benefit of the Investor or the immediate family of the Investor, provided that the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a disposition for value, and shall be applicable to the Investor only if all officers and directors are subject to the same restrictions and the Company uses commercially reasonable efforts to obtain a similar agreement from all stockholders individually owning more than two percent (2%) of the Company’s outstanding Common Stock (after giving effect to conversion into Common Stock of all outstanding Preferred Stock). The underwriters in connection with such registration are intended third-party beneficiaries of this Section 1(k) and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Investor further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Section 1(k) or that are necessary to give further effect thereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all Company stockholders that are subject to such agreements, based on the number of shares subject to such agreements.

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k.             Restrictions on Transfer.

i.              The Preferred Stock and the Registrable Securities shall not be sold, pledged, or otherwise transferred, and the Company shall not recognize and shall issue stop-transfer instructions to its transfer agent with respect to any such sale, pledge, or transfer, except upon the conditions specified in this Agreement, which conditions are intended to ensure compliance with the provisions of the Securities Act. A transferring Investor will cause any proposed purchaser, pledgee, or transferee of the Preferred Stock and the Registrable Securities held by such Investor to agree to take and hold such securities subject to the provisions and upon the conditions specified in this Agreement. Notwithstanding the foregoing, the Company shall not require any transferee of shares pursuant to an effective registration statement or, following the IPO, SEC Rule 144, in each case, to be bound by the terms of this Agreement.

ii.             Each certificate, instrument, or book entry representing (i) the Preferred Stock, (ii) the Registrable Securities, and (iii) any other securities issued in respect of the securities referenced in clauses (i) and (ii), upon any stock split, stock dividend, recapitalization, merger, consolidation, or similar event, shall (unless otherwise permitted by the provisions of Section 1(m)(iii)) be notated with a legend substantially in the following form:

THE SECURITIES REPRESENTED HEREBY HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. SUCH SHARES MAY NOT BE SOLD, PLEDGED, OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR A VALID EXEMPTION FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID ACT.

THE SECURITIES REPRESENTED HEREBY MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY.

Each Investor consents to the Company making a notation in its records and giving instructions to any transfer agent of the Restricted Securities in order to implement the restrictions on transfer set forth in this Section 1(m).

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iii.            The holder of such Restricted Securities, by acceptance of ownership thereof, agrees to comply in all respects with the provisions of this Section 1. Before any proposed sale, pledge, or transfer of any Restricted Securities, unless there is in effect a registration statement under the Securities Act covering the proposed transaction or following the IPO, the transfer is made pursuant to SEC Rule 144, the holder thereof shall give notice to the Company of such holder’s intention to effect such sale, pledge, or transfer. Each such notice shall describe the manner and circumstances of the proposed sale, pledge, or transfer in sufficient detail and, if reasonably requested by the Company, shall be accompanied at such holder’s expense by either (i) a written opinion of legal counsel who shall, and whose legal opinion shall, be reasonably satisfactory to the Company, addressed to the Company, to the effect that the proposed transaction may be effected without registration under the Securities Act; (ii) a “no action” letter from the SEC to the effect that the proposed sale, pledge, or transfer of such Restricted Securities without registration will not result in a recommendation by the staff of the SEC that action be taken with respect thereto; or (iii) any other evidence reasonably satisfactory to counsel to the Company to the effect that the proposed sale, pledge, or transfer of the Restricted Securities may be effected without registration under the Securities Act, whereupon the holder of such Restricted Securities shall be entitled to sell, pledge, or transfer such Restricted Securities in accordance with the terms of the notice given by such holder to the Company. The Company will not require such a notice, legal opinion or “no action” letter (x) in any transaction in compliance with SEC Rule 144; or (y) in any transaction in which such holder distributes Restricted Securities to an Affiliate of such holder for no consideration; provided that with respect to transfers under the foregoing clause (y), each transferee agrees in writing to be subject to the terms of this Section 1. Each certificate, instrument, or book entry representing the Restricted Securities transferred as above provided shall be notated with, except if such transfer is made pursuant to SEC Rule 144, the appropriate restrictive legend set forth in Section 1(m)(ii), except that such certificate instrument, or book entry shall not be notated with such restrictive legend if, in the opinion of counsel for such holder and the Company, such legend is not required in order to establish compliance with any provisions of the Securities Act.

l.              Termination of Registration Rights. The right of any Investor to request registration or inclusion of Registrable Securities in any registration pursuant to Sections 1(a) or 1(b) shall terminate upon the earliest to occur of:

i.              the closing of a Liquidation, as such term is defined in the Company’s then effective Certificate of Incorporation (a “Deemed Liquidation Event”), in which the consideration received by the Investors in such Deemed Liquidation Event is in the form of cash and/or publicly traded securities, or if the Investors receive registration rights from the acquiring company or other successor to the Company reasonably comparable to those set forth in this Section 1;

ii.             such time after the consummation of the IPO as SEC Rule 144 or another similar exemption under the Securities Act is available for the sale of all of the Investors’ shares without limitation during a three-month period without registration; and

iii.            the fifth anniversary of the IPO (or such later date that is 180 days following the expiration of all deferrals of the Company’s obligations pursuant to Section 1 that remain in effect as of the fifth anniversary of the consummation of the IPO).

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2.             Information and Inspection Rights.

a.            Annual and Quarterly Financial Statements. The Company shall deliver to each Investor (i) as soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, an income statement for such fiscal year, a balance sheet of the Company as of the end of such year and a statement of stockholders’ equity as of the end of such year, all such financial statements audited and certified by independent public accountants of regionally recognized standing selected by the Company, and (ii) as soon as practicable, but in any event within forty-five (45) days after the end of each of the first three fiscal quarters of the Company, an income statement for such fiscal quarter, a balance sheet of the Company as of the end of such quarter and a statement of stockholders’ equity as of the end of such fiscal quarter, all such financial reports to be in reasonable detail, prepared in accordance with generally accepted accounting principles in the United States as in effect from time to time.

b.            Other Information Rights. The Company will deliver to each Investor (i) within 45 days following the end of each calendar quarter, a current and detailed capitalization table of the Company, in sufficient detail as to permit each Investor to calculate its percentage equity ownership in the Company, (ii) such study reports of clinical trials of products under development by the Company and other technical reports that the Company provides to its advisory board as each Investor may from time to time reasonably request, and (iii) such other information relating to the products, financial condition, business, prospects, or corporate affairs of the Company as each Investor may from time to time reasonably request.

c.            Inspection Rights. The Company shall permit each Investor, at each Investor’s expense and upon reasonable advance notice from such Investor, to visit and inspect the Company’s properties; examine its books of account and records; and discuss the Company’s affairs, finances, and accounts with its officers, during normal business hours of the Company as may be reasonably requested by each Investor; provided, however, that the Company shall not be obligated pursuant to this Section 2(c) to provide access to any information that it reasonably and in good faith considers to be a trade secret or confidential information (unless covered by an enforceable confidentiality agreement, in form acceptable to the Company) or the disclosure of which would adversely affect the attorney-client privilege between the Company and its counsel.

d.            The obligations of the Company with respect to this Section 2 shall terminate and be of no further force and effect immediately upon the consummation of the IPO.

e.            The information delivered by the Company to each Investor in connection with its obligations under this Section 2 shall be subject to the confidentiality provision contained in Section 4 of this Agreement.

3.             Board Seat.

a.            The Company will take all necessary actions to nominate and elect one (1) representative as directed in writing by Baxter to the Company’s Board of Directors (the “Baxter Director”). Such actions will include, but not be limited to, expanding the size of the Company’s Board of Directors and electing the Baxter Director to the resulting vacancy, nominating the Baxter Director as a candidate in connection with any and all elections of the Board of Directors at annual meetings of the Company’s stockholders, recommending to all of the Company’s stockholders that they vote or provide written consent to elect the Baxter Director as a member of the Board of the Directors and ensuring that any future agreements that the Company may enter into governing the composition of the Company’s Board of Directors, including any voting agreement entered into in connection with future equity financing rounds, provide for a seat on the Company’s Board of Directors for the Baxter Director. The Baxter Director will initially be James DeStephens.

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b.            The Company will provide coverage to the Baxter Director under the Company’s Director’s and Officer’s Insurance Policy consistent with the coverage provided to the other directors, and will enter into a customary indemnification agreement with the Baxter Director.

c.            The obligations of the Company with respect to this Section 3 will terminate upon the earlier of (i) the consummation of an IPO and (ii) Baxter’s failure to exercise its right under Section 6 to purchase New Securities issued by the Company, provided that the Company has complied with its obligations under Section 6 with respect to such New Securities. Notwithstanding the foregoing, the obligations of the Company with respect to this Section 3 will not terminate as a result of Baxter’s failure to exercise its right to purchase New Securities following a waiver by Baxter of its right to purchase New Securities issued by the Company following a request for such waiver by the Company or the other Investors.

d.            The information delivered by the Company to the Baxter Director in connection with its obligations under this Section 3 shall be subject to the confidentiality provisions contained in Section 5 hereof.

4.             Board Observer Rights.

a.            As long as the Baxter Director is not a member of the Board of Directors as provided in Section 3, the Company shall invite a representative of Baxter (the “Observer”) to attend all meetings of the Board of Directors and its committees in their entirety in a nonvoting observer capacity and, in this respect, shall give such representative copies of all notices, minutes, consents, and other materials that it provides to its directors at the same time and in the same manner as provided to such directors.

b.            In no event shall the Observer (i) be deemed to be a member of the Board of Directors; (ii) have the right to propose or offer any motions or resolutions to the Board of Directors; or (iii) be required for purposes of establishing a quorum. Upon request, the Company shall allow the Observer to attend Board of Directors and committee meetings by telephone or electronic communication.

c.            The Company reserves the right to withhold any information and to exclude the Observer from any meeting or portion thereof (i) if access to such information or attendance at such meeting could, in the opinion of the Company’s external counsel, adversely affect the attorney-client privilege between the Company and its counsel; or (ii) if such access or attendance could, in the opinion of the Company’s external counsel and Baxter’s counsel create an actual conflict of interest with respect to (A) a pending or threatened suit, action, arbitration, cause of action, or claim, or (B) a transaction, in each case, in which the Company, on the one hand, and Baxter or its affiliates, on the other hand, have a direct interest.

d.            The obligations of the Company with respect to this Section 4 shall terminate and be of no further force and effect on the fifth anniversary of the consummation of an IPO; provided that such obligations will terminate immediately and be of no further force and effect if (i) at any time before the second anniversary of the consummation of an IPO, Baxter no longer holds at least fifty percent (50%) of the shares of the Series C Preferred Stock it purchased under the Purchase Agreement (or an equivalent amount of Common Stock issued upon conversion thereof) or (ii) at any time on or after the second anniversary of the consummation of an IPO, Baxter no longer holds at least 5% of the outstanding capital stock of the Company. For the avoidance of doubt, the obligations of the Company with respect to this Section 4 shall survive the IPO and the completion of any offering of Registrable Securities in a registration under Section 1, and otherwise shall survive the termination of any other provision of this Agreement.

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e.            The information delivered by the Company to the Observer in connection with its obligations under this Section 4 shall be subject to the confidentiality provisions contained in Section 5 hereof.

5.             Confidential Information.

a.            “Confidential Information” means, with respect to an Investor, all information or data concerning the Company or its Affiliates, whether in verbal, visual, written, electronic or other form, which is disclosed to such Investor pursuant to this Agreement, by the Company or any director, officer, employee or advisor (each, a “Representative”) of the Company, together with all analyses, compilations, or reports created by or on behalf of any Investor or any of its Affiliates, or any of their respective Representatives to the extent such analyses, compilations, or reports contain Confidential Information; provided, however, that “Confidential Information” shall not include information that:

i.               is or becomes generally available to the public other than as a result of disclosure of such information by such Investor, any of its Affiliates, or any of their Representatives;

ii.              is independently developed by such Investor, any of its Affiliates, or any of their Representatives without use of Confidential Information provided by the Company or its Representatives as can be demonstrated by documentary evidence;

iii.             becomes available to such Investor, any of its Affiliates, or any of their Representatives at any time on a non-confidential basis from a third party that is not, to the recipient’s knowledge, prohibited from disclosing such information by any contractual, legal or fiduciary obligation to the Company; or

iv.            was known by such Investor, any of its Affiliates, or any of their Representatives prior to receipt from the Company or from any director, officer, employee or agent thereof, as can be demonstrated by documentary evidence.

b.            Each Investor shall (i) keep confidential and not divulge, directly or indirectly, any Confidential Information in any manner and (ii) not use or cause, or suffer to be used any of the Confidential Information; provided, however, that an Investor may disclose Confidential Information (y) to its attorneys, accountants, consultants, and other professionals to the extent necessary to obtain their services in connection with monitoring its investment in the Company; and (z) to any Affiliate or Representative of such Investor in the ordinary course of business; provided that such Affiliates and Representatives are informed of the confidential nature of the information and are subject to confidentiality obligations to such Investor that are not less restrictive than those in this Agreement. The foregoing shall not apply to the extent such Investor, its Affiliates, any of its or their Representatives is required to disclose Confidential Information by judicial or administrative process, pursuant to the advice of its counsel, or by requirements of law; provided, that, if legally permissible, prior written notice of such disclosure shall be given to the Company so that the Company may take action, at its expense, to prevent such disclosure and any such disclosure is limited only to that portion of the Confidential Information which such person is required to disclose. The restrictions on disclosure and use of the Confidential Information contained in this Agreement will continue to be binding on such Investor for a period of two years from the date of an IPO.

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c.            None of the Investors, any of their Affiliates, their Representatives or the Observer shall, by virtue of the Company’s disclosure of, or such person’s use of any Confidential Information, acquire any rights with respect thereto, all of which rights (including intellectual property rights) shall remain exclusively with the Company. Each Investor shall be responsible for any breach of this Section 5 by any of its Affiliates, or its or their Representatives.

d.            Each Investor agrees that in the event that it no longer owns equity securities of the Company, upon the request of the Company, it will (and will cause its Affiliates and its and their Representatives to) promptly (a) return or destroy, at such Investor’s option, all physical materials containing or consisting of Confidential Information and all hard copies thereof in their possession or control; and (b) destroy all electronically stored Confidential Information in their possession or control; provided, however, that each of such Investor, its Affiliates, and its and their Representatives may retain any electronic or written copies of Confidential Information as may be (i) stored on its electronic records or storage system resulting from automated back-up systems; (ii) required by law, other regulatory requirements, or internal document retention policies; or (iii) contained in board presentations or minutes of board meetings of such Investor or its Affiliates; provided, further, that any such retained Confidential Information shall remain subject to this Section 5 for a period of two years after the date of such request.

e.            Money damages may not be a sufficient remedy for any breach of this Agreement by an Investor and that the Company shall be entitled to seek specific performance and injunctive or other equitable relief as a remedy for any such breach or threatened breach. Such remedy shall not be deemed to be the exclusive remedy for breach of this Agreement by an Investor or the Observer, but shall be in addition to all other remedies available at law or equity to the Company.

f.             Notwithstanding the foregoing, the Company and each Investor agree that this Section 5 shall not apply to information provided by the Company or its Representatives to an Investor or an Affiliate of such Investor, pursuant to a separate commercial agreement between the Company and such Investor or an Affiliate of such Investor.

6.            Preemptive Rights.

a.            Subject to the terms and conditions of this Section 6 and applicable securities, laws, if the Company proposes to offer or sell any equity securities of the Company, whether or not currently authorized, as well as rights, options, or warrants to purchase such equity securities, or securities of any type whatsoever that are, or may become, convertible or exchangeable into or exercisable for such equity securities (collectively, “New Securities”), each Investor shall have the right to purchase up to the number of New Securities which equals the proportion that the Common Stock held by such Investor as of the time of measurement (including all shares of Common Stock then issuable (directly or indirectly) upon conversion and/or exercise, as applicable, of the Preferred Stock and any other Derivative Securities then held by such Investor) bears to the total Common Stock of the Company then outstanding (including the shares of Preferred Stock on an as-if converted-to-Common-Stock basis, but excluding shares that are issuable upon exercise of options and warrants or conversion of convertible securities). Each Investor shall be entitled to apportion the right of first offer hereby granted to it in such proportions as it deems appropriate, among (i) itself and (ii) its Affiliates.

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b.            The Company shall give notice to each Investor each time that it proposes to offer or sell New Securities, stating (i) its bona fide intention to offer such New Securities, (ii) the number of such New Securities to be offered, and (iii) the price and terms, if any, upon which it proposes to offer such New Securities. Each Investor will have thirty (30) days after it receives such notice to inform the Company of its election regarding the purchase of such New Securities.

c.            For purposes of this Agreement, the term “New Securities” does not include: (i) the Series C Preferred Stock (as defined below) issued pursuant to the Purchase Agreement and securities issued upon the conversion thereof; (ii) securities issued pursuant to the acquisition of another business entity or business segment of any such entity by the Company by merger, purchase of all or substantially all the assets or other reorganization; (iii) securities issued to banks, equipment lessors or other financial institutions, or to real property lessors, pursuant to a debt financing, equipment leasing or real property leasing, in each case approved by the Board of Directors; (iv) Common Stock or options or other equity rights to acquire Common Stock issued to employees, consultants, officers or directors of the Company and Common Stock issued upon exercise thereof issued pursuant to an equity incentive plan approved by the Board of Directors; (v) securities issued to vendors or customers or to other persons in similar commercial situations with the Company, or securities issued to any entity or person in connection with the purchase by the Company of strategic assets, whether tangible or intangible, in each case approved by the Board of Directors; (vi) securities issued in connection with any stock split, stock dividend, recapitalization or other reorganization of the Company; (vii) any securities issued in connection with the IPO and (viii) securities issued upon exercise or conversion of any Derivative Security outstanding as of the date hereof, or permitted under Sections (d)(i-vii) above.

d.            In the event that any rights of any Investor to purchase New Securities pursuant to this Agreement (the “Participation Rights”) are waived with respect to an offer of New Securities and any Investor who waived such Participation Rights (each, a “Waiving Investor”) purchases all or a portion of such New Securities (any such Waiving Investor who purchases New Securities, the “Participating Waiving Investors”), then the Company shall provide each other Investor the opportunity prior to the closing of such offering of New Securities to elect to purchase (on terms and conditions no less favorable) a proportionate amount of such New Securities as purchased by each Participating Waiving Investor (based on the relative number of New Securities each would have been able to purchase absent such waiver) up to the number of New Securities that each other Investor would have been entitled to purchase had any rights under this Agreement not been waived with respect to such offer of New Securities.

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e.            The obligations of the Company with respect to this Section 6 shall terminate and be of no further force and effect immediately upon the consummation of the IPO.

7.            No Publicity. The Company will not use the name or trademarks of the Investors or any of their ultimate parent entities, in any form of advertising, publicity or release without such Investor’s prior written approval in such Investor’s sole discretion. The Company will not disclose, publish or make known to third parties that any Investor or any of their ultimate parent entities are indirect investors in the Company without such Investor’s prior written consent. Each Investor and the Company will coordinate in good faith a statement disclosing such Investor’s involvement with the Company that can be disclosed to potential large investors of the Company with each Investor’s prior written consent.

8.            Series C Protective Provisions.

a.            At any time when any shares of Series C Preferred Stock are outstanding, the Company shall not, either directly or indirectly by amendment, merger, consolidation, recapitalization, reclassification, or otherwise, do any of the following without the written consent or affirmative vote of Investors holding a majority of the outstanding shares of Series C Preferred Stock given in writing or by vote at a meeting, consenting or voting (as the case may be), and any such act or transaction entered into without such consent or vote shall be null and void ab initio, and of no force or effect:

i.              change the composition of the Board of Directors, except to the extent a member of the Board of Directors resigns, retires or is incapable to perform due to death or disability;

ii.             create, incur, assume guarantee or become liable with respect to any Indebtedness or allow or suffer to exist any mortgage, lien, pledge, charge, security interest or other encumbrance upon or in any property or assets owned by the Company. “Indebtedness” shall include any (i) indebtedness for borrowed money, (ii) indebtedness evidenced by a note, bond, debenture or similar instrument or commercial paper (including purchase money obligations), (iii) obligations to reimburse or repay in respect of letters of credit, surety bonds or similar instruments, (iv) obligations under financing leases, and (v) capital leases for equipment entered into after the date of this Agreement to the extent that the aggregate value of all of such new capital leases exceed $300,000;

iii.            incorporate, form or otherwise create any new direct or indirect subsidiaries, or permit any subsidiary of the Company to become a party to any joint venture, partnership or similar arrangement;

iv.            acquire, in any one transaction or series of related transactions, by purchase of securities or assets or otherwise, for cash or debt, any business or other enterprise;

v.             authorize or make any loans, advances or guarantees to, or for the benefit of, any person or entity;

vi.            modify in any material respect, the Company’s budget as delivered to and approved by the Board of Directors;

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vii.           sell or divest in any one transaction or series of related transactions, any division or other business enterprise, or any assets, of the Company or any subsidiary, other than immaterial amounts sold or divested in the ordinary course of business;

viii.          engage in any business which is not being conducted by the Company on the date hereof, other than reasonably-related extensions of the business conducted by the Company on such date;

ix.             settle any outstanding claim, litigation, audit or other dispute for an amount in excess of $20,000 (net of insurance coverage), individually or in the aggregate;

x.              issue, sell or authorize the issuance or sale of any shares of Series C Preferred Stock other than pursuant to the Purchase Agreement; or

xi.             approve, adopt, authorize, commit or agree to commit to any of the foregoing actions.

b.            The obligations of the Company with respect to this Section 6 shall terminate and be of no further force and effect immediately upon the consummation of the IPO.

9.             Definitions. For purposes of this Agreement:

a.            “Damages” means any loss, damage, claim or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability (or any action in respect thereof) arises out of or is based upon: (i) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents or Affiliates) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities Act, the Exchange Act, or any state securities law.

b.            “Derivative Securities” means any outstanding securities or rights convertible into, or exercisable or exchangeable for (in each case, directly or indirectly), Common Stock, including options and warrants.

c.            “Excluded Registration” means (i) a registration relating to the sale or grant of securities to employees of the Company or a subsidiary pursuant to a stock option, stock purchase, equity incentive or similar plan; (ii) a registration relating to an SEC Rule 145 transaction; (iii) a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered.

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d.            “Form S-1” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.

e.            “Form S-3” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities Act subsequently adopted by the SEC that permits forward incorporation of substantial information by reference to other documents filed by the Company with the SEC.

f.             “Immediate Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, life partner or similar statutorily-recognized domestic partner, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships of a natural person referred to herein.

g.            “Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

h.            “Preferred Stock” means, collectively, shares of the Company’s Preferred Stock, par value $0.00001 per share.

i.             “Registrable Securities” means (i) the Common Stock issuable or issued upon conversion of the Preferred Stock; (ii) any Common Stock, or any Common Stock issued or issuable (directly or indirectly) upon conversion and/or exercise of any other securities of the Company, acquired by the Investors after the date hereof; and (iii) any Common Stock issued as (or issuable upon the conversion or exercise of any Derivative Security that is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, the shares referenced in clauses (i) and (ii) above; excluding for purposes of Section 1 any shares for which registration rights have terminated pursuant to this Agreement.

j.             “Registrable Securities then outstanding” means the number of shares determined by adding the number of shares of outstanding Common Stock that are Registrable Securities and the number of shares of Common Stock issuable (directly or indirectly) pursuant to then exercisable and/or convertible securities that are Registrable Securities.

k.            “Restricted Securities” means the securities of the Company required to be notated with the legend set forth in Section 1(m)(ii) hereof.

l.             “SEC” means the Securities and Exchange Commission.

m.           “SEC Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.

n.            “SEC Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.

o.            “Selling Expenses” means all underwriting discounts, selling commissions, and stock transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for the Investors, except for the fees and disbursements of the Selling Holder Counsel borne and paid by the Company as provided in Section 1(f).

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p.            “Series C Preferred Stock” means the Series C Convertible Preferred Stock of the Company, $0.00001 par value per share.

10.           Miscellaneous.

a.            Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and of at least the holders of a majority of Series C Preferred Stock; provided that any provision hereof may be waived by any waiving party on such party’s own behalf, without the consent of any other party. Notwithstanding the foregoing, (i) this Agreement may not be amended, modified or terminated and the observance of any term hereof may not be waived with respect to any Investor without the written consent of such Investor, unless such amendment, modification, termination, or waiver applies to all Investors in the same fashion (it being agreed that a waiver of the provisions of Section 6 with respect to a particular transaction shall be deemed to apply to all Investors in the same fashion if such waiver does so by its terms, notwithstanding the fact that certain Investors may nonetheless, by agreement with the Company, purchase securities in such transaction) and (ii) Sections 2(a) – (c) and Section 6 and any other section of this Agreement applicable to all of the Investors (including this Section 10(a)(ii)) may be amended, modified, terminated or waived with only the written consent of the Company and the holders of at least a majority of the Series C Preferred Stock then outstanding and held by the Investors; provided that (A) Sections 2, 5 and 10(a) may not be amended or modified without the written consent of CareDx, and (B) Sections 2, 3, 4, 5 and 10(a) may not be amended or modified without the written consent of Baxter. The Company shall give prompt notice of any amendment, modification or termination hereof or waiver hereunder to any party hereto that did not consent in writing to such amendment, modification, termination, or waiver. Any amendment, modification, termination, or waiver effected in accordance with this Section 10(a) shall be binding on all parties hereto, regardless of whether any such party has consented thereto. No waivers of or exceptions to any term, condition, or provision of this Agreement, in any one (1) or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.

b.            Additional Investors. Notwithstanding anything to the contrary contained herein, if the Company issues additional shares of the Company’s Series C Preferred Stock pursuant to the Purchase Agreement after the date hereof, any purchaser of such shares of Series C Preferred Stock may become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement, and thereafter shall be deemed an “Investor” for all purposes hereunder. No action or consent by the Investors shall be required for such joinder to this Agreement by such additional Investor or the addition of such Investor to Exhibit A hereof, so long as such additional Investor has agreed in writing to be bound by all of the obligations as an “Investor” hereunder.

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c.            Sections 6.2, 6.3, 6.4, 6.5, 6.6, 6.10 and 6.13 of the Purchase Agreement shall apply to this Agreement, mutatis mutandis.

[Signature Page Follows.]

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If the foregoing is acceptable to you, please indicate by signing and returning this Agreement.

Very truly yours,
Miromatrix Medical Inc.
By:
Name:	Jeff Ross
Title:	Chief Executive Officer

[Signature Page to Series C Letter Agreement]

ACCEPTED AND AGREED TO:
Baxter Healthcare Corporation
By:
Name:	Dennis Crowley
Title:	SVP, Business Development & Licensing

[Signature Page to Series C Letter Agreement]

ACCEPTED AND AGREED TO:
CareDx, Inc.
By:
Name:	Reginald Seeto
Title:	CEO

[Signature Page to Series C Letter Agreement]

Exhibit A
Investors

Investor	Series C Preferred Stock
Baxter Healthcare Corporation		2,000,000
CareDx, Inc.		666,667

EX-10.26

Exhibit 10.26

MIROMATRIX MEDICAL INC.

2010 STOCK INCENTIVE PLAN

1.            Purpose. The purpose of the 2010 Stock Incentive Plan (the “Plan”) of Miromatrix Medical Inc., a Delaware corporation (the “Company”), is to increase stockholder value and to advance the interests of the Company by furnishing a variety of economic incentives (the “Incentives”) designed to attract, retain and motivate employees, directors, officers and consultants. Incentives may consist of opportunities to purchase or receive shares of the Company’s Common Stock, $0.00001 par value, or other equity securities of the Company (collectively referred to herein as the “Company Stock”), monetary payments, or other incentive awards, on terms determined under this Plan.

2.            Administration.

2.1            The Plan shall be administered by a committee of the Company’s Board of Directors (the “Board”) or by the Board itself. The Board shall have complete authority to determine all provisions of all Incentives awarded under the Plan (as consistent with the terms of the Plan), to interpret the Plan, and to make any other determination which it believes necessary and advisable for the proper administration of the Plan. The Board’s decisions and matters relating to the Plan shall be final and conclusive on the Company and its participants. No member of the Board will be liable for any action or determination made in good faith with respect to the Plan or any Incentives granted under the Plan. The Board will also have the authority under the Plan to amend or modify the terms of any outstanding Incentives in any manner; provided, however, that the amended or modified terms are permitted by the Plan as then in effect. No amendment or modification to an Incentive, however, whether pursuant to this Section 2 or any other provisions of the Plan, will be deemed to be a re-grant of such Incentive for purposes of this Plan.

2.2            In the event of (i) any reorganization, merger, consolidation, recapitalization, liquidation, reclassification, stock dividend, stock split, combination of stock, rights offering, extraordinary dividend or divestiture (including a spin-off) or any other similar change in organizational structure; (ii) any purchase, acquisition, sale or disposition of a significant amount of assets or a significant business; (iii) any change in accounting principles or practices; or (iv) any other similar change, in each case with respect to the Company or any other entity whose performance is relevant to the grant or vesting of an Incentive, the Board (or, if the Company is not the surviving entity in any such transaction, the board of directors or similar governing body of the surviving entity) may, without the consent of any affected participant, amend or modify the vesting criteria of any outstanding Incentive that is based in whole or in part on the financial performance of the Company (or any subsidiary or division thereof) or such other entity so as equitably to reflect such event, with the desired result that the criteria for evaluating such financial performance of the Company or such other entity will be substantially the same (in the sole discretion of the Board or the board of directors or other governing body of the surviving entity) following such event as prior to such event; provided, however, that the amended or modified terms are permitted by the Plan as then in effect.

3.            Eligible Participants. Employees of the Company or its subsidiaries (including officers and employees of the Company or its subsidiaries), directors and consultants, advisors or other independent contractors who provide services to the Company or its subsidiaries (including stockholders of the Company) shall be eligible to receive Incentives under the Plan when designated by the Board. Participants may be designated individually or by groups or categories (for example, by pay grade) as the Board deems appropriate. Participation by officers of the Company or its subsidiaries and any performance objectives relating to such officers must be approved by the Board. Participation by others and any performance objectives relating to others may be approved by groups or categories (for example, by pay grade) and authority to designate participants who are not officers and to set or modify such targets may be delegated to Company officers.

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4.            Types of Incentives. Incentives under the Plan may be granted in any one or a combination of the following forms: (a) incentive stock options and non-statutory stock options; (b) stock-appreciation rights (“Appreciation Rights”); (c) stock awards; (d) restricted stock; and (e) performance shares.

5.            Shares Subject to the Plan.

5.1.           Number of Shares. Subject to adjustment as provided in Section 11.6, the aggregate number of shares of Company Stock, of any class, which may be issued under the Plan shall not exceed Three Hundred Seventy-Five Thousand (375,000). Shares of Company Stock that are issued under the Plan or that are subject to outstanding Incentives will be applied to reduce the maximum number of shares of Company Stock remaining available for issuance under the Plan.

5.2.           Cancellation. To the extent that cash in lieu of shares of Company Stock is delivered upon the exercise of an Appreciation Right pursuant to Section 7.4, the Company shall be deemed, for purposes of applying the limitation on the number of shares of Company Stock, to have issued the greater of the number of shares of Company Stock which it was entitled to issue upon such exercise or on the exercise of any related option. In the event that an option or Appreciation Right granted hereunder expires or is terminated or canceled unexercised or unvested as to any shares of Company Stock, such shares of Company Stock may again be issuable under the Plan. In the event that shares of Company Stock are issued as restricted shares or pursuant to an award and thereafter are forfeited or reacquired by the Company pursuant to rights reserved upon issuance thereof, such forfeited and reacquired shares of Company Stock may again be issued under the Plan. The Board may also determine to cancel, and agree to the cancellation of, Incentives in order to make a participant eligible for the grant of an incentive at a lower price than the Incentive to be canceled; provided, however, that the substituted Incentive must satisfy or be exempt from the requirements of Code Section 409A of the Internal Revenue Code of 1986, as amended, including the rules and regulations thereunder (together, “Code Section 409A”).

5.3            Type of Company Stock. Company Stock issued under the Plan in connection with Incentives may be authorized and unissued shares or treasury stock, as designated by the Board.

6.            Options. An option is a right to purchase shares of Company Stock from the Company. Each option granted under this Plan shall be subject to the following terms and conditions:

6.1.           Price. The option price per share shall be determined by the Board, subject to adjustment under Section 11.6. Notwithstanding the foregoing sentence, except as permitted under Section 11.16, the option price per share shall not be less than the Fair Market Value (as defined in Section 11.2) of the Company Stock on the grant date, unless the stock option satisfies the provisions of Code Section 409A

6.2.           Number. The number of shares of Company Stock subject to the option shall be determined by the Board, subject to adjustment as provided in Section 11.6. The number of shares of Company Stock issuable upon exercise of an option shall be reduced in the same proportion that the holder thereof exercises an Appreciation Right if any Appreciation Right is granted in conjunction with or related to the option.

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6.3.           Duration and Time for Exercise. Subject to earlier termination as provided in Section 11.4, the term of each option shall be determined by the Board. Each option shall become exercisable at such time or times during its term as shall be determined by the Board at the time of grant. The Board may accelerate the exercisability of any option. Subject to the foregoing and with the approval of the Board, all or any part of the shares of Company Stock with respect to which the right to purchase has accrued may be purchased by the Company at the time of such accrual or at any time or times thereafter during the term of the option.

6.4.           Manner of Exercise. Subject to the conditions contained in this Plan and in the agreement with the recipient evidencing such option, an option may be exercised, in whole or in part, by giving written notice to the Company, specifying the number of shares of Company Stock to be purchased and accompanied by the full purchase price for such shares. The exercise price shall be payable (a) in United States dollars upon exercise of the option and may be paid by cash, uncertified or certified check or bank draft; (b) at the discretion of the Board, by delivery of shares of Company Stock that are already owned by the participant in payment of all or any part of the exercise price, which shares shall be valued for this purpose at the Fair Market Value on the date such option is exercised; or (c) at the discretion of the Board, by instructing the Company to withhold, from the shares of Company Stock issuable upon exercise of the option, shares in payment of all or any part of the exercise price and/or any related withholding tax obligations, which shares shall be valued for this purpose at the Fair Market Value or in such other manner as may be authorized from time to time by the Board. The shares of Company Stock delivered by the participant pursuant to Section 6.4 must have been held by the participant for a period of not less than six months prior to the exercise of the option, unless otherwise determined by the Board. Prior to the issuance of shares of Company Stock upon the exercise of an option, a participant shall have no rights as a stockholder of the Company. Except as otherwise provided in the Plan, no adjustment will be made for distributions with respect to such options as to which there is a record date preceding the date the participant becomes the holder of record of such shares of Company Stock, except as the Board may determine in its discretion.

6.5            Incentive Stock Options. Notwithstanding anything in the Plan to the contrary, the following additional provisions shall apply to the grant of stock options which are intended to qualify as Incentive Stock Options (as such term is defined in Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”)):

(a)            The aggregate Fair Market Value (determined as of the time the option is granted) of the shares of Company Stock with respect to which Incentive Stock Options are exercisable for the first time by any participant during any calendar year (under all of the Company’s plans) shall not exceed $100,000. The determination will be made by taking Incentive Stock Options into account in the order in which they were granted. If such excess only applies to a portion of an Incentive Stock Option, the Board, in its discretion, will designate which shares will be treated as shares to be acquired upon exercise of an Incentive Stock Option.

(b)           Any option agreement for an Incentive Stock Option under the Plan shall contain such other provisions as the Board shall deem advisable, but shall in all events be consistent with and contain all provisions required in order to qualify the options as Incentive Stock Options.

(c)            All Incentive Stock Options must be granted within ten years from the earlier of the date on which this Plan was adopted by the Board or the date this Plan was approved by the stockholders.

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(d)           Unless sooner exercised, all Incentive Stock Options shall expire no later than ten years after the grant date.

(e)            The option price for Incentive Stock Options shall be not less than the Fair Market Value of the Company Stock subject to the option on the grant date.

(f)            If Incentive Stock Options are granted to any participant who, at the time such option is granted, would own (within the meaning of Code Section 422) stock possessing more than 10% of the total combined voting power of all classes of stock of the employer corporation or of its parent or subsidiary corporation, (i) the option price for such Incentive Stock Options shall be not less than 110% of the Fair Market Value of the Company Stock subject to the option on the grant date and (ii) such Incentive Stock Options shall expire no later than five years after the grant date.

7.            Stock-Appreciation Rights. An Appreciation Right is a right to receive, without payment to the Company, a number of shares of Company Stock, cash or any combination thereof, the amount of which is determined pursuant to the formula set forth in Section 7.4. An Appreciation Right may be granted (a) with respect to any option granted under this Plan, either concurrently with the grant of such option or at such later time as determined by the Board (as to all or any portion of the shares of Company Stock issuable upon exercise of the option), or (b) alone, without reference to any related option. Each Appreciation Right granted by the Board under this Plan shall be subject to the following terms and conditions:

7.1.           Number; Exercise Price. Each Appreciation Right granted to any participant shall relate to such number of shares of Company Stock as shall be determined by the Board, subject to adjustment as provided in Section 11.6. In the case of an Appreciation Right granted with respect to an option, the number of shares of Company Stock to which the Appreciation Right pertains shall be reduced in the same proportion that the holder of the option exercises the related option. The exercise price of an Appreciation Right will be determined by the Board, in its discretion, at the date of grant but may not be less than 100% of the Fair Market Value of one share of Company Stock on the date of grant unless the Appreciation Right satisfies the provisions of Code Section 409A.

7.2.           Duration. Subject to earlier termination as provided in Section 11.4, the term of each Appreciation Right shall be determined by the Board. Unless otherwise provided by the Board, each Appreciation Right shall become exercisable at such time or times, to such extent and upon such conditions as the option, if any, to which it relates is exercisable. The Board may in its discretion accelerate the exercisability of any Appreciation Right. Subject to the first sentence of this paragraph, the Board may extend the term of any Appreciation Right to the extent provided in Section 11.4.

7.3.           Exercise. An Appreciation Right may be exercised, in whole or in part, by giving written notice to the Company, specifying the number of Appreciation Rights which the holder wishes to exercise. Upon receipt of such written notice, the Company shall, within 90 days thereafter, deliver to the exercising holder certificates for the shares of Company Stock, or cash, or both, as determined by the Board, to which the holder is entitled pursuant to Section 7.4.

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7.4.           Payment. Subject to the right of the Board to deliver cash in lieu of shares of Company Stock, the number of shares of Company Stock which shall be issuable upon the exercise of an Appreciation Right shall be determined by dividing:

(a)            the number of shares of Company Stock as to which the Appreciation Right is exercised multiplied by the amount of the appreciation in such shares (for this purpose, the “appreciation” shall be the amount by which the Fair Market Value of the shares of Company Stock subject to the Appreciation Right on the exercise date exceeds (i) in the case of an Appreciation Right related to an option, the exercise price of the shares of Company Stock under the option or (ii) in the case of an Appreciation Right granted alone, without reference to a related option, an amount which shall be determined by the Board at the time of grant, subject to adjustment under Section 11.6); by

(b)            the Fair Market Value of a share of Company Stock (of the applicable class or series) on the exercise date.

In lieu of issuing shares of Company Stock upon the exercise of an Appreciation Right, the Board may elect to pay the holder of the Appreciation Right cash equal to the Fair Market Value on the exercise date of any or all of the shares of Company Stock which would otherwise be issuable. No fractional shares of Company Stock shall be issued upon the exercise of an Appreciation Right; instead, the holder of the Appreciation Right shall be entitled to receive a cash adjustment equal to the same fraction of the Fair Market Value of a share of Company Stock on the exercise date or to purchase the portion necessary to make a whole share at its Fair Market Value on the date of exercise.

8.            Stock Awards and Restricted Stock. A stock award consists of the Company’s issuance/transfer of shares of Company Stock to a participant, without other payment therefor, as additional compensation for services rendered to the Company. A share of restricted stock consists of a share of Company Stock which is sold or transferred by the Company to a participant at a price determined by the Board and subject to restrictions on resale or other transfer by the participant, which contractual restrictions and conditions may be determined by the Board as long as such restrictions and conditions are not inconsistent with the terms of the Plan. The transfer of shares of Company Stock pursuant to stock awards and the transfer and sale of restricted stock shall be subject to the following terms and conditions:

8.1.           Number of Shares. The number of shares to be transferred or sold by the Company to a participant pursuant to a stock award or as restricted stock shall be determined by the Board.

8.2.           Sale Price. The Board shall determine the price, if any, at which shares of restricted stock shall be sold or granted to a participant, which may vary from time to time and among participants and which may be below the Fair Market Value of such shares of Company Stock at the date of sale.

8.3.           Restrictions. All shares of restricted stock transferred or sold hereunder shall be subject to such restrictions as the Board may determine, including without limitation any or all of the following:

(a)            a prohibition against the sale, transfer, pledge or other encumbrance of the shares of restricted stock, such prohibition to lapse at such time or times as the Board shall determine (whether in annual or more frequent installments, at the time of the death, disability or retirement of the holder of such shares, or otherwise);

(b)           a requirement that the holder of shares of restricted stock forfeit, or (in the case of shares sold to a participant) resell back to the Company at his or her cost, all or a part of such shares in the event of termination of his or her employment or consulting engagement during any period in which such shares are subject to restrictions; or

(c)           such other conditions or restrictions as the Board may deem advisable.

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8.4.           Escrow. In order to enforce the restrictions imposed by the Board pursuant to Section 8.3, the participant receiving shares of restricted stock shall enter into an agreement with the Company setting forth the conditions of the grant. Shares of restricted stock shall be registered in the name of the participant and deposited, together with an assignment separate from certificate endorsed in blank, with the Company. Each such certificate shall bear a legend in substantially the following form:

THE TRANSFERABILITY OF THE SHARES REPRESENTED BY THIS CERTIFICATE IS SUBJECT TO THE TERMS AND CONDITIONS (INCLUDING CONDITIONS OF FORFEITURE) CONTAINED IN THE 2010 STOCK INCENTIVE PLAN OF MIROMATRIX MEDICAL INC. (THE “COMPANY”), AND AN AGREEMENT ENTERED INTO BETWEEN THE REGISTERED OWNER HEREOF AND THE COMPANY. A COPY OF THE 2010 STOCK INCENTIVE PLAN AND THE AGREEMENT IS ON FILE IN THE OFFICE OF THE SECRETARY OF THE COMPANY.

8.5.           End of Restrictions. Subject to Section 11.5, at the end of any time period during which the shares of restricted stock are subject to forfeiture and restrictions on transfer, such shares will be delivered free of all restrictions to the participant or to the participant’s legal representative, beneficiary or heir.

8.6.           Rights as Holders of Restricted Stock. Subject to the terms and conditions of the Plan, each participant receiving restricted stock shall have all the rights of a stockholder with respect to shares of restricted stock during any period in which such shares are subject to forfeiture and restrictions on transfer, including without limitation the right to vote such shares. Dividends paid in cash or property (other than dividends payable in stock, in the nature of a stock dividend or split) with respect to restricted stock shall be paid to the participant currently, unless the Board determines otherwise in its sole discretion. Unless the Board specifically determines otherwise in its sole discretion, any dividends (including regular quarterly cash dividends) paid with respect to restricted stock will be subject to the same restrictions as the shares of restricted stock to which such dividends relate. In the event the Board determines not to pay dividends currently, the Board will determine in its sole discretion whether any interest will be paid on such dividends. In addition, the Board in its sole discretion may require such dividends to be reinvested (and in such case the participant consents to such reinvestment) in shares of restricted stock that will be subject to the same restrictions as the shares to which such dividends relate.

9.            Performance Shares. A performance share consists of an award which shall be paid in shares of Company Stock, as described below. The grant of a performance share shall be subject to such terms and conditions as the Board deems appropriate, including the following:

9.1.           Performance Objectives. Each performance share will be subject to performance objectives for the Company or one of its operating divisions to be achieved by the participant before the end of a specified period. The number of performance shares granted shall be determined by the Board and may be subject to such terms and conditions as the Board shall determine. If the performance objectives are achieved, each participant will be paid in shares of Company Stock, or cash, or both, as determined by the Board. If such objectives are not met, each grant of performance shares may provide for lesser payments in accordance with formulae established in the award.

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9.2.           Not a Stockholder. The grant of performance shares to a participant shall not create any rights in such participant as a stockholder of the Company, until the payment of shares of Company Stock with respect to an award.

9.3.           No Adjustments. No adjustment shall be made in performance shares granted on account of cash dividends which may be paid or other rights which may be issued to the holders of shares of Company Stock prior to the end of any period for which performance objectives were established.

9.4.           Expiration of Performance Share. If any participant’s employment or consulting engagement with the Company is terminated for any reason other than normal retirement, death or disability prior to the achievement of the participant’s stated performance objectives, all the participant’s rights with respect to the performance shares shall expire and terminate unless otherwise determined by the Board. In the event of termination of employment or consulting by reason of death, disability, or normal retirement, then the Board, in its own discretion may determine what portions, if any, of the performance shares should be paid to the participant.

10.           Change of Control.

10.1          Change in Control. For purposes of this Section 10, a “Change in Control” of the Company will mean the following:

(a)            the sale, lease, exchange or other transfer, directly or indirectly, of substantially all of the assets of the Company (in one transaction or in a series of related transactions) to a person or entity that is not controlled by the Company;

(b)           the approval by the stockholders of the Company of any plan or proposal for the liquidation or dissolution of the Company;

(c)            any person becomes after the effective date of the Plan the “beneficial owner” (as defined in Rule 13d-3 under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), directly or indirectly, of (i) 20% or more, but not 50% or more, of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders, unless the transaction resulting in such ownership has been approved in advance by the Continuing Directors (as defined below), or (ii) 50% or more of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders (regardless of any approval by the Continuing Directors); or

(d)           a merger or consolidation to which the Company is a party if the Company’s stockholders immediately prior to effective date of such merger or consolidation have “beneficial ownership” (as defined in Rule 13d-3 of the Exchange Act), immediately following the effective date of such merger or consolidation, of securities of the surviving entity representing (i) 50% or more, but less than 80%, of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity, unless such merger or consolidation has been approved in advance by the Continuing Directors, or (ii) less than 50% of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity (regardless of any approval by the Continuing Directors).

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(e)            notwithstanding the foregoing, any transaction that is fundamentally a financing transaction, as determined in good faith by the Board, shall not be deemed a change of control for the purposes of the Plan.

10.2          Continuing Directors. For purposes of this Section 10, “Continuing Directors” of the Company will mean any individuals who are members of the Board on the effective date of the Plan and any individual who subsequently becomes a member of the Board whose (i) election or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the Continuing Directors, or (ii) appointment is permitted under the Company’s Certificate of Incorporation and Bylaws.

10.3          Acceleration of Incentives. Without limiting the authority of the Board under the Plan, if a Change in Control of the Company occurs whereby the acquiring entity or successor to the Company does not assume the Incentives or replace them with substantially equivalent incentive awards; then, unless otherwise determined by the Board in its reasonable discretion or provided by the Board in its sole discretion in the agreement evidencing an Incentive at the time of grant, as of the date of the Change of Control: (a) all outstanding options and Appreciation Rights will vest and will become immediately exercisable in full and will remain exercisable for the remainder of their terms, regardless of whether the participant to whom such options or Appreciation Rights have been granted remains in the employ or service of the Company or any subsidiary of the Company or any acquiring entity or successor to the Company; (b) the restrictions on all shares of restricted stock under the Plan shall lapse immediately; and (c) all performance objectives relating to performance shares shall be deemed to be met and payment made immediately.

10.4          Cash Payment for Options. If a Change in Control of the Company occurs, then the Board, if approved by the Board in its sole discretion either in an agreement evidencing an option at the time of grant or at any time after the grant of an option, and without the consent of any participant affected thereby, may determine that:

(a)            some or all participants holding outstanding options will receive, with respect to some or all of the shares of Company Stock subject to such options, as of the effective date of any such Change in Control of the Company, cash in an amount equal to the excess of the Fair Market Value of such shares immediately prior to the effective date of such Change in Control of the Company over the exercise price per share of such options; and

(b)           any options as to which, as of the effective date of any such Change in Control, the Fair Market Value of the shares of Company Stock subject to such options is less than or equal to the exercise price per share of such options, shall terminate as of the effective date of any such Change in Control.

If the Board makes a determination as set forth in subparagraph (a) of this Section 10.4, then as of the effective date of any such Change in Control of the Company such options will terminate as to such shares of Company Stock and the participants formerly holding such options will only have the right to receive such cash payment(s). If the Board makes a determination as set forth in subparagraph (b) of this Section 10.4, then as of the effective date of any such Change in Control of the Company such options will terminate, become void and expire as to all unexercised shares of Company Stock subject to such options on such date, and the participants formerly holding such options will have no further rights with respect to such options.

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11.          General Provisions.

11.1.         Effective Date. The Plan will become effective upon approval by the Company’s Board.

11.2.         Duration. The Plan shall remain in effect until all Incentives granted under the Plan have either been satisfied by the issuance of shares of Company Stock or the payment of cash or been terminated under the terms of the Plan and all restrictions imposed on shares of Company Stock in connection with their issuance under the Plan have lapsed.

11.3.         Non-transferability of Incentives. Except in the event of the holder’s death, by will or the laws of descent and distribution to the limited extent provided in the Plan or the Incentive, no option, Appreciation Right, share of restricted stock or performance share may be transferred, pledged or assigned by the holder thereof, either voluntarily or involuntarily, directly or indirectly, by operation of law or otherwise, and the Company shall not be required to recognize any attempted assignment of such rights by any participant, unless the Board determines otherwise. During a participant’s lifetime, an Incentive may be exercised only by him or her or by his or her guardian or legal representative.

11.4.         Effect of Termination or Death. In the event that a participant ceases to be an employee, director, officer of or consultant to the Company (or a subsidiary of the Company), or the participant’s other service with the Company is terminated for any reason, including death, any Incentives may be exercised or shall expire at such times as may be determined by the Board in its sole discretion in the agreement evidencing an Incentive. Notwithstanding the other provisions of this Section 11.4, upon a participant’s termination of employment or other service with the Company and all subsidiaries, the Board may, in its sole discretion (which may be exercised at any time on or after the date of grant, including following such termination), cause options and Appreciation Rights (or any part thereof) then held by such participant to become or continue to become exercisable and/or remain exercisable following such termination of employment or service and awards of restricted stock, performance shares and stock awards then held by such participant to vest and/or continue to vest or become free of transfer restrictions, as the case may be, following such termination of employment or service, in each case in the manner determined by the Board; provided, however, that no Incentive may remain exercisable or continue to vest beyond its expiration date, unless the Incentive satisfies (or is amended to satisfy) the requirements of Code Section 409A.

11.5.         Additional Conditions. Notwithstanding anything in this Plan to the contrary: (a) the Company may, if it shall determine it necessary or desirable for any reason, at the time of award of any Incentive or the issuance of any shares of Company Stock pursuant to any Incentive, require the recipient of the Incentive, as a condition to the receipt thereof or to the receipt of shares of Company Stock issued pursuant thereto, to deliver to the Company a written representation of present intention to acquire the Incentive or the shares of Company Stock issued pursuant thereto for his or her own account for investment and not for distribution; and (b) if at any time the Company further determines, in its sole discretion, that the listing, registration or qualification (or any updating of any such document) of any Incentive or the shares of Company Stock issuable pursuant thereto is necessary on any securities exchange or under any federal or state securities or blue sky law, or that the consent or approval of any governmental regulatory body is necessary or desirable as a condition of, or in connection with the award of any Incentive, the issuance of shares of Company Stock pursuant thereto, or the removal of any restrictions imposed on such shares, such Incentive shall not be awarded or such shares of Company Stock shall not be issued or such restrictions shall not be removed, as the case may be, in whole or in part, unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Company. Notwithstanding any other provision of the Plan or any agreements entered into pursuant to the Plan, the Company will not be required to issue any shares of Company Stock under this Plan, and a participant may not sell, assign, transfer or otherwise dispose of shares of Company Stock issued pursuant to any Incentives granted under the Plan, unless (a) there is in effect with respect to such shares a registration statement under the Securities Act of 1933 (the “Securities Act”), and any applicable state or foreign securities laws or an exemption from such registration under the Securities Act and applicable state or foreign securities laws, and (b) there has been obtained any other consent, approval or permit from any other regulatory body which the Board, in its sole discretion, deems necessary or advisable. The Company may condition such issuance, sale or transfer upon the receipt of any representations or agreements from the parties involved, and the placement of any legends on any certificates representing shares, as may be deemed necessary or advisable by the Company in order to comply with such securities law or other restrictions.

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11.6.         Adjustment. In the event of any merger, consolidation or reorganization of the Company with any other entity, there shall be substituted for each of the shares of Company Stock then subject to the Plan, including shares subject to restrictions, options, or achievement of performance objectives, the number and kind of other securities to which the holders of the shares will be entitled pursuant to the transaction. In the event of any recapitalization, reclassification, stock split, combination of stock or other similar change in the organizational or capital structure of the Company, the exercise price of an outstanding Incentive and the number of shares of Company Stock then subject to the Plan, including shares subject to restrictions, options or achievements of performance shares, shall be adjusted in proportion to the change in outstanding shares in order to prevent dilution or enlargement of the rights of the participants. In the event of any such adjustments, the purchase price of any option, the performance objectives of any Incentive, and the shares issuable pursuant to any Incentive shall be adjusted as and to the extent appropriate, in the discretion of the Board, to provide participants with the same relative rights before and after such adjustment.

11.7.         Incentive Plans and Agreements. Except in the case of stock awards or cash awards, the terms of each Incentive shall be stated in a plan or agreement approved by the Board. The Board may also determine to enter into agreements with holders of options to reclassify or convert certain outstanding options, within the terms of the Plan, and for any other purpose not manifestly inconsistent with the intent of the Plan.

11.8.         Withholding.

(a)            The Company shall have the right to (i) withhold and deduct from any payments made under the Plan or from future wages or guaranteed payments of the participant (or from other amounts that may be due and owing to the participant from the Company or a subsidiary of the Company), or make other arrangements for the collection of, all legally required amounts necessary to satisfy any and all foreign, federal, state and local withholding and employment-related tax requirements attributable to an Incentive, or (ii) require the participant promptly to remit the amount of such withholding to the Company before taking any action, including issuing any shares of Company Stock, with respect to an Incentive. At any time when a participant is required to pay to the Company an amount required to be withheld under applicable income tax laws in connection with a distribution of shares or upon exercise of an option or Appreciation Right, the participant may satisfy this obligation in whole or in part by electing (the “Election”) to have the Company withhold from the distribution shares of Company Stock having a value up to the amount required to be withheld. The value of the shares of Company Stock to be withheld shall be based on the Fair Market Value of the shares on the date that the amount of tax to be withheld shall be determined (the “Tax Date”).

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(b)            Each Election must be made prior to the Tax Date. The Board may disapprove of any Election, may suspend or terminate the right to make Elections, or may provide with respect to any Incentive that the right to make Elections shall not apply to such Incentive. An Election is irrevocable.

11.9.         No Continued Employment, Engagement or Right to Company Assets. No participant under the Plan shall have any right, because of his or her participation, to continue in the employ of the Company for any period of time or to any right to continue his or her present or any other rate of compensation. Nothing contained in the Plan shall be construed as giving an employee, a consultant, a director, an officer, or any such persons’ beneficiaries or any other person any equity or interests of any kind in the assets of the Company or creating a trust of any kind or a fiduciary relationship of any kind between the Company and any such person.

11.10.       Deferral Permitted. Payment of cash or distribution of any shares of Company Stock to which a participant is entitled under any Incentive shall be made as provided in the Incentive. Payment may be deferred at the option of the participant if provided in the Incentive. Except as permitted under Section 11.16, payments and distributions may not be deferred under any incentive unless the deferral complies with the requirements of Code Section 409A.

11.11.       Amendment of the Plan. The Board may amend, suspend or discontinue the Plan at any time. The Board may restrict the rights of participants or the applicability of this Section 11.11 to the extent necessary to comply with Section 16(b) of the Exchange Act, the Code or any other applicable law or regulation. The grant of an Incentive award pursuant to the Plan shall not limit in any way the right or power of the Company to make adjustments, reclassifications, reorganizations or changes of its capital or business structure or to merge, exchange or consolidate or to dissolve, liquidate, sell or transfer all or any part of its business or assets.

11.12.       Definition of Fair Market Value. For purposes of this Plan, the “Fair Market Value” of an applicable share of Company Stock at a specified date shall, unless otherwise expressly provided in this Plan, be the amount which the Board determines in good faith in the exercise of its reasonable discretion to be 100% of the fair market value of such share as of the date in question.

11.13        Breach of Non-Disclosure, Confidential Information, Non-Competition, Non-Solicitation or Invention Assignment Agreements. Notwithstanding anything in the Plan to the contrary, in the event that a participant materially breaches the terms of any non-disclosure, confidential information, non-competition, non-solicitation or invention assignment covenant or agreement entered into with the Company or any subsidiary of the Company (regardless of how such covenant or agreement is styled or titled), whether such breach occurs before or after termination of such participant’s employment or other service with the Company or any subsidiary, the Board in its sole discretion may immediately terminate all rights of the participant under the Plan and any agreements evidencing an Incentive then held by the participant without notice of any kind.

11.14        Governing Law. The validity, construction, interpretation, administration and effect of the Plan and any rules, regulations and actions relating to the Plan will be governed by and construed exclusively in accordance with the laws of the State of Minnesota, notwithstanding the conflict-of-laws principles of any jurisdictions.

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11.15        Successors and Assigns. The Plan will be binding upon and inure to the benefit of the successors and permitted assigns of the Company and the participants in the Plan.

11.16        Compliance with Code Section 409A. This Agreement will be interpreted and administered in a manner intended to comply with Code Section 409A.

Date of Adoption: February 26, 2010

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EX-10.27

Exhibit 10.27

Executive version

MIROMATRIX MEDICAL INC.

2019 EQUITY INCENTIVE PLAN

1.       Purpose. The purpose of the Miromatrix Medical Inc. 2019 Equity Incentive Plan (the “Plan”) is to attract and retain the best available personnel for positions of responsibility with the Company, to provide additional incentives to them and align their interests with those of the Company’s stockholders, and to thereby promote the Company’s long-term business success.

2.       Definitions. In this Plan, the following definitions will apply.

(a)       “Affiliate” means any corporation that is a Subsidiary or Parent of the Company.

(b)       “Agreement” means the written or electronic agreement, notice or other document containing the terms and conditions applicable to each Award granted under the Plan. An Agreement is subject to the terms and conditions of the Plan.

(c)       “Award” means a grant made under the Plan in the form of Options, Stock Appreciation Rights, Restricted Stock, Stock Units or an Other Stock-Based Award.

(d)       “Board” means the Board of Directors of the Company.

(e)       “Cause” means, unless otherwise defined in a then-effective written agreement (including an Agreement) between a Participant and the Company or any Affiliate, a Participant’s (i) failure or refusal to perform satisfactorily the duties reasonably required of the Participant by the Company (other than by reason of Disability) in any material respect; (ii) material violation of any law, rule, regulation, court order or Company code of conduct; (iii) material breach of any fiduciary duty to the Company or any Affiliate; (iv) material breach of any nondisclosure, non-solicitation, non-competition or similar obligation owed to the Company or any of its Affiliates; or (v) engaging in dishonorable or disruptive behavior, practices or acts which would be reasonably expected to harm or bring disrepute to Company or any of its Affiliates, their business or any of their customers, employees or vendors.

(f)       “Change in Control” means, unless otherwise defined in a then-effective written agreement (including an Agreement) between a Participant and the Company or any Affiliate hereunder:

(1)     any person becomes after the effective date of the Plan the “beneficial owner” (as defined in Rule 13d-3 under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), directly or indirectly, of:

(A)     20% or more, but not 50% or more, of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders, unless the transaction resulting in such ownership has been approved in advance by the Continuing Directors; or

(B)     50% or more of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders (regardless of any approval by the Continuing Directors); or

(2)     a merger or consolidation to which the Company is a party if the Company’s stockholders immediately prior to effective date of such merger or consolidation have “beneficial ownership” (as defined in Rule 13d-3 of the Exchange Act), immediately following the effective date of such merger or consolidation, of securities of the surviving entity representing:

(A)     50% or more, but less than 80%, of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity, unless such merger or consolidation has been approved in advance by the Continuing Directors; or

(B)     less than 50% of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity (regardless of any approval by the Continuing Directors); or

(3)     the sale, lease, exchange or other transfer, directly or indirectly, of substantially all of the assets of the Company (in one transaction or in a series of related transactions) to a person or entity that is not controlled by the Company; or

(4)     the consummation of a complete liquidation or dissolution of the Company.

Notwithstanding the foregoing, any transaction that is fundamentally a financing transaction, as determined in good faith by the Board, shall not be deemed a change of control for the purposes of the Plan. In addition, if any repurchase or other acquisition by the Company of its outstanding equity securities causes any person to become the beneficial owner of the combined voting power of the Company’s outstanding equity securities over the threshold amounts referenced in clauses 1(A) and 1(B) above, then no change of control will be deemed to have occurred for the purposes of the Plan.

Notwithstanding the foregoing, to the extent that any Award constitutes a deferral of compensation subject to Code Section 409A, and if that Award provides for a change in the time or form of payment upon a Change in Control, then no Change in Control shall be deemed to have occurred upon an event described in this Section 2(f) unless the event would also constitute a change in ownership or effective control of, or a change in the ownership of a substantial portion of the assets of, the Company under Code Section 409A.

(g)       “Code” means the Internal Revenue Code of 1986, as amended and in effect from time to time. For purposes of the Plan, references to sections of the Code shall be deemed to include any applicable regulations thereunder and any successor or similar statutory provisions.

(h)       “Committee” means the Board or a committee of the Board comprised of two or more Non-Employee Directors designated by the Board to administer the Plan.

(i)         “Company” means Miromatrix Medical Inc., a Delaware corporation, and any successor thereto.

(j)       “Continuing Director” means any individual who is a member of the Board on the effective date of the Plan and any individual who subsequently becomes a member of the Board whose (i) election or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the Continuing Directors, or (ii) appointment is permitted under the Company’s Certificate of Incorporation and Bylaws.

(k)      “Disability” means (A) any permanent and total disability under any long-term disability plan or policy of the Company or its Affiliates that covers the Participant, or (B) if there is no such long-term disability plan or policy, “total and permanent disability” within the meaning Code Section 22(e)(3).

(l)       “Employee” means an employee of the Company or an Affiliate.

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(m)       “Exchange Program” means a program under which (i) outstanding Options or SARs are surrendered or cancelled in exchange for Options or SARs of the same type (which may have lower or higher exercise prices and different terms), Awards of a different type and/or cash, or (ii) the exercise price of an outstanding Option or SAR is reduced. The terms and conditions of any Exchange Program shall be determined by the Committee in its sole discretion.

(n)       “Fair Market Value” means the fair market value of a Share determined as follows:

(1)       If the Shares are readily tradable on an established securities market (as determined under Code Section 409A), then Fair Market Value will be the closing or last sales price for a Share on the principal securities market on which it trades on the date for which it is being determined, or if no sale of Shares occurred on that date, on the next preceding date on which a sale of Shares occurred, as reported in The Wall Street Journal or such other source as the Committee deems reliable; or

(2)       If the Shares are not then readily tradable on an established securities market (as determined under Code Section 409A), then Fair Market Value will be determined by the Committee as the result of a reasonable application of a reasonable valuation method that satisfies the requirements of Code Section 409A.

(o)       “Grant Date” means the date on which the Committee approves the grant of an Award under the Plan, or such later date as may be specified by the Committee on the date the Committee approves the Award.

(p)       “Group” means two or more persons who act, or agree to act together, as a partnership, limited partnership, syndicate or other group for the purpose of acquiring, holding, voting or disposing of securities of the Company.

(q)       “Non-Employee Director” means a member of the Board who is not an Employee.

(r)       “Option” means a right granted under the Plan to purchase a specified number of Shares at a specified price. An “Incentive Stock Option” or “ISO” means any Option designated as such and granted in accordance with the requirements of Code Section 422. A “Non-Qualified Stock Option” means an Option other than an Incentive Stock Option.

(s)       “Other Stock-Based Award” means an Award described in Section 11 of this Plan.

(t)       “Parent” means a “parent corporation,” as defined in Code Section 424(e).

(u)       “Participant” means a Service Provider to whom a then-outstanding Award has been granted under the Plan.

(v)       “Plan” means this Miromatrix Medical Inc. 2019 Equity Incentive Plan, as amended and in effect from time to time.

(w)      “Restricted Stock” means Shares issued to a Participant that are subject to such restrictions on transfer, vesting conditions and other restrictions or limitations as may be set forth in this Plan and the applicable Agreement.

(x)       “Service” means the provision of services by a Participant to the Company or any Affiliate in any Service Provider capacity. A Service Provider’s Service shall be deemed to have terminated either upon an actual cessation of providing services or upon the entity for which the Service Provider provides services ceasing to be an Affiliate. Except as otherwise provided in this Plan or any Agreement, Service shall not be deemed terminated in the case of (i) any approved leave of absence; (ii) transfers among the Company and any Affiliates in any Service Provider capacity; or (iii) any change in status so long as the individual remains in the service of the Company or any Affiliate in any Service Provider capacity.

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(y)       “Service Provider” means an Employee, a Non-Employee Director, or any consultant or advisor who is a natural person and who provides services (other than in connection with (i) a capital-raising transaction or (ii) promoting or maintaining a market in Company securities) to the Company or any Affiliate.

(z)       “Share” means a share of Stock.

(aa)     “Stock” means the common stock, par value $0.00001 per share, of the Company.

(bb)     “Stock Appreciation Right” or “SAR” means the right to receive, in cash and/or Shares as determined by the Committee, an amount equal to the appreciation in value of a specified number of Shares between the Grant Date of the SAR and its exercise date.

(cc)     “Stock Unit” means a right to receive, in cash and/or Shares as determined by the Committee, the Fair Market Value of a Share, subject to such restrictions on transfer, vesting conditions and other restrictions or limitations as may be set forth in this Plan and the applicable Agreement.

(dd)     “Subsidiary” means a “subsidiary corporation,” as defined in Code Section 424(f), of the Company.

3.       Administration of the Plan.

(a)       Administration. The authority to control and manage the operations and administration of the Plan shall be vested in the Committee in accordance with this Section 3.

(b)       Scope of Authority. Subject to the terms of the Plan, the Committee shall have the authority, in its discretion, to take such actions as it deems necessary or advisable to administer the Plan, including:

(1)       determining the Service Providers to whom Awards will be granted, the timing of each such Award, the types of Awards and the number of Shares covered by each Award, the terms, conditions, performance criteria, restrictions and other provisions of Awards, and the manner in which Awards are paid or settled;

(2)       cancelling or suspending an Award, accelerating the vesting or extending the exercise period of an Award, or otherwise amending the terms and conditions of any outstanding Award, subject to the requirements of Section 15(d);

(3)       adopting sub plans or special provisions applicable to Awards, establishing, amending or rescinding rules to administer the Plan, interpreting the Plan and any Award or Agreement made under the Plan, reconciling any inconsistency, correcting any defect or supplying an omission in the Plan or any Agreement, and making all other determinations necessary or desirable for the administration of the Plan;

(4)       instituting an Exchange Program, the terms and conditions of which shall be determined by the Committee in its sole discretion; and

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(5)       requiring or permitting the deferral of the settlement of an Award, and establishing the terms and conditions of any such deferral.

(c)       Acts of the Committee; Delegation. A majority of the members of the Committee shall constitute a quorum for any meeting of the Committee, and any act of a majority of the members present at any meeting at which a quorum is present or any act unanimously approved in writing by all members of the Committee shall be the act of the Committee. To the extent not inconsistent with applicable law or stock exchange rules, the Committee may delegate all or any portion of its authority under the Plan to any one or more of its members or, as to Awards that are made to Participants who are neither Non-Employee Directors nor executive officers of the Company, to one or more directors or executive officers of the Company. The Committee may also delegate non-discretionary administrative responsibilities in connection with the Plan to such other persons as it deems advisable.

(d)       Finality of Decisions. The Committee’s interpretation of the Plan and of any Award or Agreement made under the Plan and all related decisions or resolutions of the Board or Committee shall be final and binding on all parties with an interest therein.

(e)       Indemnification. Each person who is or has been a member of the Committee or of the Board, and any other person to whom the Committee delegates authority under the Plan, shall be indemnified by the Company, to the maximum extent permitted by law, against liabilities and expenses imposed upon or reasonably incurred by such person in connection with or resulting from any claims against such person by reason of the performance of the individual's duties under the Plan. This right to indemnification is conditioned upon such person providing the Company an opportunity, at the Company’s expense, to handle and defend the claims before such person undertakes to handle and defend them on such person’s own behalf. The Company will not be required to indemnify any person for any amount paid in settlement of a claim unless the Company has first consented in writing to the settlement. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such person or persons may be entitled under the Company’s Certificate of Incorporation or Bylaws, as a matter of law, or otherwise.

4.       Shares Available Under the Plan.

(a)       Maximum Shares Available. Subject to Section 4(b) and to adjustment as provided in Section 12(a), a total of 1,000,000 Shares may be the subject of Awards and issued under the Plan. The maximum number of Shares that may be issued upon the exercise of Incentive Stock Options shall equal the aggregate number of Shares stated in the previous sentence. Shares issued under the Plan may come from authorized and unissued shares or treasury shares. In determining the number of Shares to be counted against this Share reserve in connection with any Award, the following rules shall apply:

(1)       Where the number of Shares subject to an Award is variable on the Grant Date, the number of Shares to be counted against the share reserve shall be the maximum number of Shares that could be received under that particular Award, until such time as it can be determined that only a lesser number of shares could be received.

(2)       Where two or more types of Awards are granted to a Participant in tandem with each other, such that the exercise of one type of Award with respect to a number of Shares cancels at least an equal number of Shares of the other, the number of Shares to be counted against the share reserve shall be the largest number of Shares that would be counted against the share reserve under either of the Awards.

(3)       Awards that may be settled solely in cash shall not be counted against the share reserve.

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(b)       Effect of Forfeitures and Other Actions. Any Shares subject to an Award that is forfeited, expires, is settled for cash, is surrendered pursuant to an Exchange Program, or otherwise does not result in the issuance of all or a portion of the Shares subject to such Award shall, to the extent of such forfeiture, expiration, cash settlement, surrender or non-issuance, again become available for Awards under this Plan, and the Share reserve under Section 4(a) shall be correspondingly increased. In the event that (i) any Award is exercised through the tendering of Shares (either actually or by attestation) or by the withholding of Shares by the Company in payment of the applicable exercise price, or (ii) any tax withholding obligations arising from such Award are satisfied by the tendering of Shares (either actually or by attestation) or by the withholding of Shares by the Company, then the Shares so tendered or withheld shall again become available for Awards under this Plan, and the Share reserve under Section 4(a) shall be correspondingly increased.

(c)       No Fractional Shares. Unless otherwise determined by the Committee, the number of Shares subject to an Award shall always be a whole number. No fractional Shares may be issued under the Plan, but the Committee may, in its discretion, adopt any rounding convention it deems suitable or pay cash in lieu of any fractional Share in settlement of an Award.

5.       Eligibility. Participation in the Plan is limited to Service Providers. Incentive Stock Options may only be granted to Employees.

6.       General Terms of Awards.

(a)       Award Agreement. Each Award shall be evidenced by an Agreement setting forth the amount of the Award together with such other terms and conditions applicable to the Award (and not inconsistent with the Plan) as determined by the Committee. An Award to a Participant may be made singly or in combination with any form of Award.

(b)       Vesting and Term. Each Agreement shall set forth the period until the applicable Award is scheduled to vest and, if applicable, expire (which shall not be more than ten years from the Grant Date), the applicable vesting conditions and any applicable performance period. The Committee may provide in an Agreement for such vesting conditions and timing as it may determine.

(c)       Transferability. Except as provided in this Section 6(c), (i) during the lifetime of a Participant, only the Participant or the Participant’s guardian or legal representative may exercise an Option or SAR, or receive payment with respect to any other Award; and (ii) no Award may be sold, assigned, transferred, exchanged or encumbered, voluntarily or involuntarily, other than by will or the laws of descent and distribution. Any attempted transfer in violation of this Section 6(c) shall be of no effect. The Committee may, however, provide in an Agreement or otherwise that an Award (other than an Incentive Stock Option) may be transferred pursuant to a domestic relations order or may be transferable by gift to any “family member” (as defined in Rule 701 under the Securities Act of 1933) of the Participant. Any Award held by a transferee shall continue to be subject to the same terms and conditions that were applicable to that Award immediately before the transfer thereof. For purposes of any provision of the Plan relating to notice to a Participant or to acceleration or termination of an Award upon the death or termination of Service of a Participant, the references to “Participant” shall mean the original grantee of an Award and not any transferee.

(d)       Designation of Beneficiary. To the extent permitted by the Committee, a Participant may designate a beneficiary or beneficiaries to exercise any Award or receive a payment under any Award that is exercisable or payable on or after the Participant’s death. Any such designation shall be on a form approved by the Committee and shall be effective upon its receipt by the Company.

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(e)       Termination of Service. Unless otherwise provided in an Agreement or another then effective written agreement between a Participant and the Company, and subject to Section 12 of this Plan, if a Participant’s Service with the Company and all of its Affiliates terminates, the following provisions shall apply (in all cases subject to the scheduled expiration of an Option or SAR Award, as applicable):

(1)       Upon termination of Service for Cause, all unexercised Option and SAR Awards and all unvested portions of any other outstanding Awards shall be immediately forfeited without consideration.

(2)       Upon termination of Service for any other reason, all unvested and unexercisable portions of any outstanding Awards shall be immediately forfeited without consideration.

(3)       Upon termination of Service for any reason other than Cause, death or Disability, the currently vested and exercisable portions of Option and SAR Awards may be exercised for a period of three months after the date of such termination. However, if a Participant thereafter dies during such three-month period, the vested and exercisable portions of the Option and SAR Awards may be exercised for a period of one year after the date of such termination.

(4)       Upon termination of Service due to death or Disability, the currently vested and exercisable portions of Option and SAR Awards may be exercised within one year of the date of such termination.

(f)       Rights as Stockholder. No Participant shall have any rights as a stockholder with respect to any Shares covered by an Award unless and until the date the Participant becomes the holder of record of the Shares, if any, to which the Award relates.

(g)       Performance-Based Awards. Any Award may be granted as a performance-based Award if the Committee establishes one or more measures of corporate, business unit or individual performance which must be attained, and the performance period over which the specified performance is to be attained, as a condition to the grant, vesting, exercisability, lapse of restrictions and/or settlement in cash or Shares of such Award. In connection with any such Award, the Committee shall determine the extent to which performance measures have been attained and other applicable terms and conditions have been satisfied, and the degree to which the grant, vesting, exercisability, lapse of restrictions and/or settlement of such Award has been earned. The Committee shall also have the authority to provide, in an Agreement or otherwise, for the modification of a performance period and/or an adjustment or waiver of the achievement of performance measures under specified circumstances such as (i) the occurrence of events that are unusual in nature or infrequently occurring, such as a Change in Control, an equity restructuring (as described in Section 12(a)), acquisitions, divestitures, restructuring activities, recapitalizations, or asset write-downs, (ii) a change in applicable tax laws or accounting principles, or (iii) the Participant’s death or Disability.

7.       Stock Option Awards.

(a)       Type and Exercise Price. The Agreement pursuant to which an Option Award is granted shall specify whether the Option is an Incentive Stock Option or a Non-Qualified Stock Option. The exercise price at which each Share subject to an Option may be purchased shall be determined by the Committee and set forth in the Agreement, and shall not be less than the Fair Market Value of a Share on the Grant Date.

(b)       Payment of Exercise Price. The purchase price of the Shares with respect to which an Option Award is exercised shall be payable in full at the time of exercise. The purchase price may be paid in cash or in such other manner as the Committee may permit, including by withholding Shares otherwise issuable to the Participant upon exercise of the Option, by delivery to the Company of Shares (by actual delivery or attestation) already owned by the Participant (in each case, such Shares having a Fair Market Value as of the date the Option is exercised equal to the purchase price of the Shares being purchased), by delivery of a promissory note, or a combination thereof. Any promissory note to be accepted in payment of the exercise price of an Option Award shall contain such terms and conditions as may be specified by the Committee, and be secured by the Option Shares and such other collateral as the Committee may deem acceptable.

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(c)       Exercisability and Expiration. Each Option Award shall be exercisable in whole or in part on the terms provided in the Agreement. An Agreement may provide that a Participant, while still a Service Provider, may elect to exercise an Option Award in whole or in part at any time prior to the full vesting of the Option Award. Any unvested Shares so purchased shall be subject to a repurchase right in favor of the Company or to any other restriction the Committee deems appropriate. No Option Award shall be exercisable at any time after its scheduled expiration. When an Option Award is no longer exercisable, it shall be deemed to have terminated.

(d)       Incentive Stock Options.

(1)       Incentive Stock Option Awards may be granted pursuant to the Plan only if the Company’s stockholders approve the Plan within 12 months of its adoption by the Board. If the stockholders fail to approve the Plan within 12 months of its adoption by the Board, any Incentive Stock Option Award already made under the Plan shall cease to be treated as an Incentive Stock Option and shall be treated for tax purposes as a Non-Qualified Stock Option.

(2)       An Option Award will constitute an Incentive Stock Option Award only if the Participant receiving the Option Award is an Employee, and only to the extent that (i) it is so designated in the applicable Agreement and (ii) the aggregate Fair Market Value (determined as of the Option Grant Date) of the Shares with respect to which Incentive Stock Option Awards held by the Participant first become exercisable in any calendar year (under the Plan and all other plans of the Company and its Affiliates) does not exceed $100,000. To the extent an Option Award granted to a Participant exceeds this limit, the Option Award shall be treated as a Non-Qualified Stock Option Award.

(3)       No Participant may receive an Incentive Stock Option Award under the Plan if, immediately after the grant of such Award, the Participant would own (after application of the rules contained in Code Section 424(d)) Shares possessing more than 10% of the total combined Voting Power of all classes of stock of the Company or an Affiliate, unless (i) the per Share exercise price for such Award is at least 110% of the Fair Market Value of a Share on the Grant Date and (ii) such Award will expire no later than five years after its Grant Date.

(4)       For purposes of continued Service by a Participant who has been granted an Incentive Stock Option Award, no approved leave of absence may exceed three months unless reemployment upon expiration of such leave is provided by statute or contract. If reemployment is not so provided, then on the date six months following the first day of such leave, any Incentive Stock Option held by the Participant shall cease to be treated as an Incentive Stock Option and shall be treated for tax purposes as a Non-Qualified Stock Option.

(5)       If an Incentive Stock Option Award is exercised after the expiration of the exercise periods that apply for purposes of Code Section 422, such Option shall thereafter be treated as a Non-Qualified Stock Option Award.

(6)       The Agreement covering an Incentive Stock Option Award shall contain such other terms and provisions that the Committee determines necessary to qualify the Option Award as an Incentive Stock Option.

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8.       Stock Appreciation Right Awards.

(a)       Nature of Award. An Award of Stock Appreciation Rights shall be subject to such terms and conditions as are determined by the Committee, and shall provide a Participant the right to receive upon exercise of the SAR Award all or a portion of the excess of (i) the Fair Market Value as of the date of exercise of the SAR Award of the number of Shares as to which the SAR Award is being exercised, over (ii) the aggregate exercise price for such number of Shares. The per Share exercise price for any SAR Award shall be determined by the Committee and set forth in the applicable Agreement, and shall not be less than the Fair Market Value of a Share on the Grant Date.

(b)       Exercise of SAR. Each SAR Award may be exercisable in whole or in part at the times, on the terms and in the manner provided in the Agreement. No SAR Award shall be exercisable at any time after its scheduled expiration. When a SAR Award is no longer exercisable, it shall be deemed to have terminated. Upon exercise of a SAR Award, payment to the Participant shall be made at such time or times as shall be provided in the Agreement in the form of cash, Shares or a combination of cash and Shares as determined by the Committee. The Agreement may provide for a limitation upon the amount or percentage of the total appreciation on which payment (whether in cash and/or Shares) may be made in the event of the exercise of a SAR Award.

9.       Restricted Stock Awards.

(a)       Vesting and Consideration. Shares subject to a Restricted Stock Award shall be subject to vesting and the lapse of applicable restrictions based on such conditions or factors and occurring over such period of time as the Committee may determine in its discretion. The Committee may provide whether any consideration other than Services must be received by the Company or any Affiliate as a condition precedent to the grant of a Restricted Stock Award, and may correspondingly provide for Company reacquisition or repurchase rights if such additional consideration has been required and some or all of a Restricted Stock Award does not vest.

(b)       Shares Subject to Restricted Stock Awards. Unvested Shares subject to a Restricted Stock Award shall be evidenced by a book-entry in the name of the Participant with the Company or its transfer agent or by one or more Stock certificates issued in the name of the Participant. Any such Stock certificate shall be deposited with the Company or its designee, together with an assignment separate from the certificate, in blank, signed by the Participant, and bear an appropriate legend referring to the restricted nature of the Restricted Stock evidenced thereby. Any book-entry shall be subject to comparable restrictions and corresponding stop transfer instructions. Upon the vesting of Shares of Restricted Stock, and the Company’s determination that any necessary conditions precedent to the release of vested Shares (such as satisfaction of tax withholding obligations and compliance with applicable legal requirements) have been satisfied, such vested Shares shall be made available to the Participant in such manner as may be prescribed or permitted by the Committee. Such vested Shares may, however, remain subject to additional restrictions as provided in Sections 16 and 17(c).

(c)       Stockholder Rights. Except as otherwise provided in this Plan or the applicable Agreement, a Participant with a Restricted Stock Award shall have all the rights of a stockholder, including the right to vote the Shares of Restricted Stock. Unless otherwise expressly provided in an applicable Agreement, any dividends or distributions, including regular cash dividends and distributions of Shares, securities or property as a result of adjustments pursuant to Section 12(a), payable with respect to Shares that are subject to the unvested portion of a Restricted Stock Award will be subject to the same restrictions and risk of forfeiture as the Shares to which such dividends or distributions relate.

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10.       Stock Unit Awards.

(a)       Vesting and Consideration. A Stock Unit Award shall be subject to vesting and the lapse of applicable restrictions based on such conditions or factors and occurring over such period of time as the Committee may determine in its discretion. If vesting of a Stock Unit Award is conditioned on the achievement of specified performance goals, the extent to which they are achieved over the specified performance period shall determine the number of Stock Units that will be earned and eligible to vest, which may be greater or less than the target number of Stock Units stated in the Agreement. The Committee may provide whether any consideration other than Services must be received by the Company or any Affiliate as a condition precedent to the settlement of a Stock Unit Award.

(b)       Settlement of Award. Following the vesting of a Stock Unit Award, and the Company’s determination that any necessary conditions precedent to the settlement of the Award (such as satisfaction of tax withholding obligations and compliance with applicable legal requirements) have been satisfied, settlement of the Award and payment to the Participant shall be made at such time or times in the form of cash, Shares (which may themselves be considered Restricted Stock under the Plan) or a combination of cash and Shares as determined by the Committee.

(c)       Dividend Equivalents. In its discretion, the Committee may provide in an Agreement for a Stock Unit Award that the Participant will be entitled to receive dividend equivalents, based on dividends actually declared and paid on outstanding Shares, on the units subject to the Stock Unit Award, and such dividend equivalents will be subject to the same restrictions and risk of forfeiture as the underlying units to which such dividend equivalents relate unless otherwise provided in the applicable Agreement. The additional terms of any such dividend equivalents will be as set forth in the applicable Agreement, including the time and form of payment and whether such dividend equivalents will be credited with interest or deemed to be reinvested in additional units. Any Shares issued or issuable during the term of this Plan as the result of the deemed reinvestment of dividend equivalents in connection with an Award shall be counted against, and replenish upon any subsequent forfeiture, the Plan’s share reserve as provided in Section 4.

11.       Other Stock-Based Awards. The Committee may from time to time grant Shares and other forms of Awards that are valued by reference to and/or payable in whole or in part in Shares under the Plan. The Committee shall determine the terms and conditions of such Awards, which shall be consistent with the terms and purposes of the Plan. The Committee may direct the Company to issue Shares subject to restrictive legends and/or stop transfer instructions that are consistent with the terms and conditions of the Award to which the Shares relate.

12.       Changes in Capitalization, Change in Control.

(a)       Adjustments for Changes in Capitalization. In the event of any equity restructuring (within the meaning of FASB ASC Topic 718) that causes the per share value of Shares to change, such as a stock dividend, stock split, spinoff, rights offering or recapitalization through an extraordinary dividend, the Committee shall make such adjustments as it deems equitable and appropriate to (i) the aggregate number and kind of Shares or other securities issued or reserved for issuance under the Plan, (ii) the number and kind of Shares or other securities subject to outstanding Awards, (iii) the exercise price of outstanding Options and SARs, and (iv) any maximum limitations prescribed by the Plan with respect to certain types of Awards. In the event of any other change in corporate capitalization, including a merger, consolidation, reorganization, or partial or complete liquidation of the Company, such equitable adjustments described in the foregoing sentence may be made as determined to be appropriate and equitable by the Committee to prevent dilution or enlargement of rights of Participants.  In either case, any such adjustment shall be conclusive and binding for all purposes of the Plan.  No adjustment shall be made pursuant to this Section 12(a) in connection with the conversion of any convertible securities of the Company, or in a manner that would cause Incentive Stock Options to violate Section 422(b) of the Code or cause an Award to be subject to adverse tax consequences under Section 409A of the Code.

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(b)       Change in Control. Unless otherwise provided in an applicable Agreement or another then effective written agreement between the Participant and the Company, the following provisions shall apply to outstanding Awards in the event of a Change in Control.

(1)       Continuation, Assumption or Replacement of Awards. In the event of a Change in Control, then the surviving or successor entity (or its Parent) may continue, assume or replace Awards outstanding as of the date of the Change in Control (with such adjustments as may be required or permitted by Section 12(a)), and such Awards or replacements therefor shall remain outstanding and be governed by their respective terms, subject to Section 12(b)(4) below. A surviving or successor entity may elect to continue, assume or replace only some Awards or portions of Awards. For purposes of this Section 12(b)(1), an Award shall be considered assumed or replaced if, in connection with the Change in Control and in a manner consistent with Code Section 409A (and Code Section 424 if the Award is an ISO), either (i) the contractual obligations represented by the Award are expressly assumed by the surviving or successor entity (or its Parent) with appropriate adjustments to the number and type of securities subject to the Award and the exercise price thereof that preserves the intrinsic value of the Award existing at the time of the Change in Control, or (ii) the Participant has received a comparable equity-based award that preserves the intrinsic value of the Award existing at the time of the Change in Control and contains terms and conditions that are substantially similar to those of the Award.

(2)       Acceleration. If and to the extent that outstanding Awards under the Plan are not continued, assumed or replaced in connection with a Change in Control, then the Committee may provide that (i) all outstanding Option and SAR Awards shall become fully exercisable for such period of time prior to the effective time of the Change in Control as is deemed fair and equitable by the Committee, and shall terminate at the effective time of the Change in Control, and (ii) all outstanding Restricted Stock and Stock Unit Awards shall fully vest immediately prior to the effective time of the Change in Control. The Committee shall provide written notice of the period of accelerated exercisability of Option and SAR Awards to all affected Participants. The exercise of any Option or SAR Award whose exercisability is accelerated as provided in this Section 12(b)(2) shall be conditioned upon the consummation of the Change in Control and shall be effective only immediately before such consummation.

(3)       Payment for Awards. If and to the extent that outstanding Awards under the Plan are not continued, assumed or replaced in connection with a Change in Control, then the Committee may provide that holders of some or all of such outstanding Awards shall be canceled at or immediately prior to the effective time of the Change in Control in exchange for payments to the holders as provided in this Section 12(b)(3). The Committee will not be required to treat all Awards similarly for purposes of this Section 12(b)(3). The payment for any Award surrendered shall be in an amount equal to the difference, if any, between (i) the fair market value (as determined in good faith by the Committee) of the consideration that would otherwise be received in the Change in Control for the number of Shares subject to the Award, and (ii) the aggregate exercise price (if any) for the Shares subject to such Award. If the amount determined pursuant to the preceding sentence is not a positive number with respect to any Award, such Award may be canceled pursuant to this Section 12(b)(3) without payment of any kind to the affected Participant. Payment of any amount under this Section 12(b)(3) shall be made in such form, on such terms and subject to such conditions as the Committee determines in its discretion, which may or may not be the same as the form, terms and conditions applicable to payments to the Company’s stockholders in connection with the Change in Control, and may, in the Committee’s discretion, include subjecting such payments to vesting conditions comparable to those of the Award surrendered, subjecting such payments to escrow or holdback terms comparable to those imposed upon the Company’s stockholders under the Change in Control, or calculating and paying the present value of payments that would otherwise be subject to escrow or holdback terms.

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(4)       Termination After a Change in Control. If and to the extent that Awards are continued, assumed or replaced under the circumstances described in Section 12(b)(1), and if within one year after the Change in Control a Participant experiences an involuntary termination of Service for reasons other than Cause, then (i) outstanding Option and SAR Awards issued to the Participant that are not yet fully exercisable shall immediately become exercisable in full and shall remain exercisable for one year following the Participant’s termination of Service, and (ii) any Restricted Stock or Stock Unit Awards that are not yet fully vested shall immediately vest in full.

13.       Plan Participation and Service Provider Status. Status as a Service Provider shall not be construed as a commitment that any Award will be made under the Plan to that Service Provider or to eligible Service Providers generally. Nothing in the Plan or in any Agreement or related documents shall confer upon any Service Provider or Participant any right to continued Service with the Company or any Affiliate, nor shall it interfere with or limit in any way any right of the Company or any Affiliate to terminate the person’s Service at any time with or without Cause or change such person’s compensation, other benefits, job responsibilities or title.

14.       Tax Withholding. The Company or any Affiliate, as applicable, shall have the right to (i) withhold from any cash payment under the Plan or any other compensation owed to a Participant an amount sufficient to cover any required withholding taxes related to the grant, vesting, exercise or settlement of an Award, and (ii) require a Participant or other person receiving Shares under the Plan to pay a cash amount sufficient to cover any required withholding taxes before actual receipt of those Shares. In lieu of all or any part of a cash payment from a person receiving Shares under the Plan, the Committee may permit the Participant to satisfy all or any part of the required tax withholding obligations (but not to exceed the maximum individual statutory tax rate in each applicable jurisdiction) by authorizing the Company to withhold a number of the Shares that would otherwise be delivered to the Participant pursuant to the Award, or by transferring to the Company Shares already owned by the Participant, with the Shares so withheld or delivered having a Fair Market Value on the date the taxes are required to be withheld equal to the amount of taxes to be withheld.

15.       Effective Date, Duration, Amendment and Termination of the Plan.

(a)       Effective Date. The Plan shall become effective on the date it is approved by the requisite vote of the Company’s Board.

(b)       Duration of the Plan. The Plan shall remain in effect until all Shares subject to it shall be distributed, all Awards have expired or terminated, the Plan is terminated pursuant to Section 15(c), or the tenth anniversary of the effective date of the Plan, whichever occurs first (the “Termination Date”). Awards made before the Termination Date shall continue to be outstanding in accordance with their terms and the terms of the Plan unless otherwise provided in the applicable Agreements.

(c)       Amendment and Termination of the Plan. The Board may at any time terminate, suspend or amend the Plan. The Company shall submit any amendment of the Plan to its stockholders for approval only to the extent required by applicable laws or regulations or the rules of any securities exchange on which the Shares may then be listed. No termination, suspension, or amendment of the Plan may materially impair the rights of any Participant under a previously granted Award without the Participant’s consent, unless such action is necessary to comply with applicable law or stock exchange rules.

(d)       Amendment of Awards. The Committee may unilaterally amend the terms of any Agreement previously granted, except that no such amendment may materially impair the rights of any Participant under the applicable Award without the Participant's consent, unless such amendment is necessary to comply with applicable law or stock exchange rules.

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16.       Restrictions on Shares. At the discretion of the Committee, the Company may reserve to itself and its successors and assignees in an Agreement or otherwise (i) a right of first refusal to purchase all Shares that a Participant (or a subsequent transferee) may propose to transfer to a third party, (ii) a right to repurchase a portion of or all Shares held by a Participant upon the Participant’s termination of Service with the Company and its Affiliates for any reason within a specified time (but not to exceed 90 days of the later of termination or exercise of the Award, if required by applicable laws), (iii) the right to require the Participant from time to time to execute and deliver stockholder, voting or similar agreements to which holders of a majority of the Stock are parties,  (iv) the right of the Company to require the Participant from time to time to execute and deliver underwriter lock-up agreements, and (v) the right to repurchase upon a Participant's termination of Service any or all unvested Shares acquired in accordance with Section 7(c) as the result of the exercise of an unvested Option. The price to be paid upon any purchase or repurchase of Shares pursuant to clause (i) or (ii) above shall be determined by the Committee, and the per Share price to be paid upon repurchase of Shares pursuant to clause (v) shall be the lesser of (A) the exercise price per Share paid by the Participant or (B) the Fair Market Value per Share at the time of the Participant's termination of Service. Any reservation of rights pursuant to clauses (i) through (iii) above shall be effective only during any period prior to registration of the Stock pursuant to Section 12 of the Securities Exchange Act of 1934.

17.       Other Provisions.

(a)       Unfunded Plan. The Plan shall be unfunded and the Company shall not be required to segregate any assets that may at any time be represented by Awards under the Plan. Neither the Company, its Affiliates, the Committee, nor the Board shall be deemed to be a trustee of any amounts to be paid under the Plan nor shall anything contained in the Plan or any action taken pursuant to its provisions create or be construed to create a fiduciary relationship between the Company and/or its Affiliates, and a Participant. To the extent any person has or acquires a right to receive a payment in connection with an Award under the Plan, this right shall be no greater than the right of an unsecured general creditor of the Company.

(b)       Limits of Liability. Except as may be required by law, neither the Company nor any member of the Board or of the Committee, nor any other person participating (including participation pursuant to a delegation of authority under Section 3(c) of the Plan) in any determination of any question under the Plan, or in the interpretation, administration or application of the Plan, shall have any liability to any party for any action taken, or not taken, in good faith under the Plan.

(c)       Compliance with Applicable Legal Requirements. No Shares distributable pursuant to the Plan shall be issued and delivered unless the issuance of the Shares complies with all applicable legal requirements, including compliance with the provisions of applicable state and federal securities laws, and the requirements of any exchanges on which the Company’s Shares may, at the time, be listed. During any period in which the offering and issuance of Shares under the Plan is not registered under federal or state securities laws, Participants shall acknowledge that they are acquiring Shares under the Plan for investment purposes and not for resale, and that Shares may not be transferred except pursuant to an effective registration statement under, or an exemption from the registration requirements of, such securities laws.  Any stock certificate or book-entry evidencing Shares issued under the Plan that are subject to securities law restrictions shall bear or be accompanied by an appropriate restrictive legend or stop transfer instruction.

(d)       Other Benefit and Compensation Programs. Payments and other benefits received by a Participant under an Award made pursuant to the Plan shall not be deemed a part of a Participant’s regular, recurring compensation for purposes of the termination, indemnity or severance pay laws of any country and shall not be included in, nor have any effect on, the determination of benefits under any other employee benefit plan, contract or similar arrangement provided by the Company or an Affiliate unless expressly so provided by such other plan, contract or arrangement, or unless the Committee expressly determines that an Award or portion of an Award should be included to accurately reflect competitive compensation practices or to recognize that an Award has been made in lieu of a portion of competitive cash compensation.

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(e)       Governing Law. To the extent that federal laws do not otherwise control, the Plan and all determinations made and actions taken pursuant to the Plan shall be governed by the laws of the State of Minnesota without regard to its conflicts-of-law principles and shall be construed accordingly.

(f)       Severability. If any provision of the Plan shall be held illegal or invalid for any reason, the illegality or invalidity shall not affect the remaining parts of the Plan, and the Plan shall be construed and enforced as if the illegal or invalid provision had not been included.

(g)       Code Section 409A.

(1)It is intended that (i) all Awards of Options, SARs and Restricted Stock under the Plan will not provide for the deferral of compensation within the meaning of Code Section 409A and thereby be exempt from Code Section 409A, and (ii) all other Awards under the Plan will either not provide for the deferral of compensation within the meaning of Code Section 409A, or will comply with the requirements of Code Section 409A, and Awards shall be structured and the Plan administered and interpreted in accordance with this intent. The Plan and any Agreement may be unilaterally amended by the Company in any manner deemed necessary or advisable by the Committee or Board in order to maintain such exemption from or compliance with Code Section 409A, and any such amendment shall conclusively be presumed to be necessary to comply with applicable law. Notwithstanding anything to the contrary in the Plan or any Agreement, with respect to any Award that constitutes a deferral of compensation subject to Code Section 409A, if any amount is payable under such Award upon a termination of Service, a termination of Service will be deemed to have occurred only at such time as the Participant has experienced a “separation from service” as such term is defined for purposes of Code Section 409A.

(2)None of the Company, the Board, the Committee nor any other person involved with the administration of this Plan shall (i) in any way be responsible for ensuring the exemption of any Award from, or compliance by any Award with, the requirements of Code Section 409A, (ii) have any obligation to design or administer the Plan or Awards granted thereunder in a manner that minimizes a Participant’s tax liabilities, including the avoidance of any additional tax liabilities under Code Section 409A, and (iii) shall have any liability to any Participant for any such tax liabilities.

(h)       Forfeiture and Compensation Recovery. The Committee may specify in an Agreement that the Participant’s rights, payments, and benefits with respect to an Award will be subject to reduction, cancellation, forfeiture or recovery by the Company upon the occurrence of certain specified events, in addition to any otherwise applicable vesting or performance conditions of an Award. Such events may include termination of Service for Cause; violation of any material Company or Affiliate policy; breach of noncompetition, non-solicitation or confidentiality provisions that apply to the Participant; a determination that the payment of the Award was based on an incorrect determination that financial or other criteria were met or other conduct by the Participant that is detrimental to the business or reputation of the Company or its Affiliates.

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EX-10.29

Exhibit 10.29

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into as of March 3, 2017 (the “Effective Date”), by and between Miromatrix Medical Inc., a Delaware corporation (the “Company”) located in Minneapolis, Minnesota and Jeff Ross, a Minnesota resident (the “Executive”).

BACKGROUND

A.Executive has been employed by the Company and serving as its Executive Vice President Product Development pursuant to an unwritten employment arrangement.

B.The Company desires to appoint Executive to serve as Interim Chief Executive Officer and employ Executive in accordance with the terms and conditions of this Agreement, and wishes to obtain reasonable protection against unfair use of its confidential business and technical information.

C.Executive wishes to continue in the employ of the Company, to serve as Interim Chief Executive Officer and to provide services to the Company in exchange for the compensation and on the other terms conditions set forth in the Agreement and is willing to re-affirm the benefits of various covenants contained herein and in the Confidentiality Agreement (as defined below in Section 9).

AGREEMENT

NOW, THEREFORE, in consideration of the above-referenced facts and circumstances, the mutual covenants contained herein, and for other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

1.Employment. Commencing on the Effective Date, the Company shall employ Executive as Interim Chief Executive Officer of the Company and Executive accepts such employment and agrees to serve the Company to the best of his ability and to promote the Company’s interests and business. Executive will serve the Company faithfully and to the best of Executive’s ability and will devote Executive’s full working time, attention, and efforts to the business of the Company. While employed by the Company, Executive shall be subject to, and comply with, the rules, practices and policies of the Company applicable to employees of the Company whether reflected in an employee handbook, code of conduct, compliance policy or otherwise, as the same may exist and be amended from time to time, and will not engage in other employment or other material business activity, except for activities set forth on Exhibit A or as approved in writing by the Board of Directors of the Company (the “Board”). Notwithstanding the foregoing, the Board in its discretion may appoint a successor Chief Executive Officer, in which case Executive’s employment will continue to governed by this Agreement but his title may revert to Executive Vice President Product Development.

2.Duties and Powers. Executive shall report to the Board. Executive shall perform such duties, have such power, and exercise such supervision and control with regard to the business of the Company as are commonly associated with his title including (with respect to serving as Interim Chief Executive Officer), but not limited to, the day-to-day general management, supervision and control of all of the Company’s business and operations and those of any of the Company’s subsidiaries that may exist from time to time. As Interim Chief Executive Officer, all other senior executives of the Company shall report to Executive or as Executive may direct. In addition, Executive shall perform such other duties in the nature of a senior executive as the Board shall reasonably determine from time to time.

Contemporaneously herewith, Executive is also being appointed to serve as a director on the Board. Executive acknowledges that his service on the Board shall be at the discretion of the Company’s shareholders, who shall have the right to remove Executive from the Board or not re-appoint Executive, in accordance with the Company’s governing documents. Executive shall not be entitled to any additional compensation for serving as a director on the Board. If Executive is no longer serving as Chief Executive Officer (on an interim or permanent basis), then at the Board’s request he agrees not to stand for re-election to the Board. If requested to do so by the Board, Executive agrees to tender his resignation as a director on the Board upon termination of his employment with the Company for any reason.

3.Term. This Agreement, and the terms and conditions of Executive’s employment with the Company hereunder, shall commence on the Effective Date and continue for a period of four (4) years thereafter (the “Term”), unless earlier terminated as provided in Section 10.

4.Base Salary. The Company shall pay to Executive a base salary of $275,000 (gross) per year, which shall be paid in installments in accordance with the Company’s regular payroll practices. The Board may review Executive’s performance and from time to time increase Executive’s base salary, but may not decrease the base salary during the Term so long as Executive continues to serve as Interim Chief Executive Officer. Such review shall occur no less frequently than once per year.

5.Bonuses. Employee shall be eligible to receive bonuses from time to time to the extent awarded in the sole discretion of the Company’s Board of Directors.

6.Employee Benefits. Executive will be entitled to participate in all employee benefit plans and programs generally made available to executive employees of the Company to the extent that Executive meets the eligibility requirements for each individual plan or program. Executive’s participation in any plan or program will be subject to the provisions, rules, and regulations of, or applicable to, the plan or program. Except as expressly provided in this Section 6, the Company provides no assurance as to the adoption or continuation of any particular employee benefit plan or program.

7.Stock Option Grant. Contemporaneously with the execution and delivery of this Agreement, the Company and Executive shall enter into an Incentive Stock Option Agreement in the Company’s standard form pursuant to which the Company will grant Executive an option (the “Option”) to purchase up to 100,000 shares of the Company’s common stock (the “Common Stock”) under the Company’s 2010 Stock Incentive Plan. The Option has an exercise price that is no less than the fair market value of the Common Stock on the grant date (as determined by the Board) and will have a term of ten (10) years (subject to earlier termination as provided in the Incentive Stock Option Agreement if Executive ceases to be employed by the Company) and vest in four (4) equal annual installments commencing on the one (1) year anniversary of the grant date.

8.Reimbursement of Business Expenses. Upon presentation of appropriate receipts and/or vouchers, the Company shall reimburse Executive for reasonable and necessary expenses he incurs in connection with the performance of his duties including, but not limited to, cell phone service.

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9.Confidentiality Agreement. Executive and the Company are parties to and bound by that certain Confidentiality, Non-Competition and Assignment of Inventions Agreement (the “Confidentiality Agreement”) dated March 25, 2010. Executive reaffirms his obligations under the Confidentiality Agreement and further acknowledges and agrees that (a) the Confidentiality Agreement remains in full force and effect and is enforceable against the undersigned in accordance with its terms, and (b) the execution, delivery and performance of this Agreement by Executive shall in no way impair, limit or otherwise adversely affect the rights of the Company under the Confidentiality Agreement.

10.Termination. Notwithstanding the term set forth in Section 3 hereof, this Agreement may be earlier terminated as set forth below:

(a)by the Company without Cause or by Executive for any reason, upon thirty (30) days advanced written notice to the other party;

(b)immediately by the Company upon written notice to Executive for the following events, each of which would constitute “Cause”: (i) Executive is convicted of a felony; (ii) Executive has committed any gross misconduct, theft, fraudulent or dishonest act that is injurious in any material respect to the financial condition, business or reputation of the Company; (iii) Executive has materially breached this Agreement, any written agreement made between Executive and the Company, or any fiduciary duty owed to the Company; (iv) Executive has committed a material violation of Company policy that has had or is likely to have an adverse impact on the performance of Executive’s duties as required by this Agreement, which violation has not been cured by Executive after thirty (30) days advanced written notice thereof to Executive by the Company;

(c)by Executive upon thirty (30) days advanced written notice to the Company, provided that the Company has failed to cure such event during said thirty (30) day period, for the following events which constitute “Good Reason”: (i) the relocation of Executive’s principal office for Company business to a location more than thirty (30) miles from such location as of the Effective Date; (ii) the Company’s failure to pay Executive his base salary or earned bonus as set forth herein or to provide Employee Benefits as set forth herein; (iii) a reduction in Executive’s annualized base salary below $275,000 while he is serving as Interim Chief Executive Officer or, if Executive is no longer serving as Chief Executive Officer (on an interim or permanent basis), then a reduction in Executive’s annualized base salary below $220,000; or (iv) a material breach by the Company of this Agreement or any written agreement made between Executive and the Company; provided, however, that following events shall not constitute Good Reason: (y) the Company’s removal from Executive of the Interim Chief Executive Officer title and/or demotion of Executive through the transfer to another person of some or all of the responsibility for management of the Company’s day-to-day operations, or (z) Executive’s removal from or failure to be re-appointed to the Board; provided, further, that no act shall constitute Good Reason unless the Executive has provided advance written notice of such Good Reason to the Company within three (3) months following the initial existence of the condition that constitutes Good Reason; or

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(d) upon the death or disability of the Executive. For the purposes of this Agreement, disability shall occur if Executive shall become incapacitated by accident or illness and, in the reasonable determination of the Board, shall be unable to fully perform the duties of the positions he then occupies with reasonable accommodation for a period of time of not less than ninety (90) consecutive days, and the Company provides thirty (30) days advanced written notice to the Executive at any time after such period of disability.

In the event of any termination occurring by virtue of paragraphs (a) through (d) above, Executive’s last day of employment shall be the “Termination Date” and Executive shall be entitled to compensation and benefits accrued through the Termination Date in accordance with the terms hereof or any applicable employee benefit plan, including any bonuses earned by Executive through the Termination Date. For purposes of Section 11 of this Agreement only, with respect to the timing of any severance payments thereunder, the Termination Date means the date on which a “separation from service” has occurred for purposes of Section 409A of the Internal Revenue Code and the regulations and guidance thereunder (the “Code”).

11.Termination Payments.

(a)If Executive’s employment with the Company is terminated prior to the expiration of the Term (x) by the Company for any reason other than for Cause or disability, or (y) by Executive for Good Reason, then the Company will, subject to Executive satisfying the conditions in Section 11(c), provide the following severance benefits:

(i)pay to Executive severance pay in the aggregate amount equal to the greater of (A) his current annual Base Salary and (B) his total actual compensation (including any bonus paid) for the prior year, payable in substantially equal installments on the Company’s regular payroll schedule over a twelve (12) month period following the Termination Date, beginning on the Company’s first regular payroll date after the expiration of all rescission periods applicable to the release described in Section 11(c);

(ii)promptly pay to Executive in cash any portion of that year’s annual potential Bonus that was earned but unpaid as of the Termination Date; and

(iii)if Executive is eligible for and elects continuation of group medical and/or dental insurance coverage with the Company following the Termination Date (for himself and/or his family, as applicable) in accordance with applicable laws and plans, reimburse Executive for the premium costs of such continuation coverage, at the same level of coverage that was in effect as of the Termination Date, for up to twelve (12) consecutive months following the Termination Date or, if earlier, until such continuation coverage is no longer available to Executive under applicable laws and plans.

(b)If Executive’s employment with the Company is terminated due to Executive’s death or disability, Executive’s resignation other than for Good Reason, termination by the Company for Cause, or expiration of the Term, Executive shall be entitled to compensation and benefits accrued through the Termination Date in accordance with the terms hereof or any applicable employee benefit plan, including any portion of that year’s annual potential Bonus that was earned but unpaid as of the Termination Date, but shall not be entitled to any other pay or benefits from the Company, unless otherwise agreed to in writing by Executive and the Company.

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(c)Notwithstanding the foregoing provisions of this Section 11, the Company will not be obligated to make any payments to Executive under Section I 1(a)(i) or (iii) hereof unless: Executive has signed a release of claims in favor of the Company and its affiliates and related entities, and their directors, officers, insurers, employees and agents, in a commercially reasonable form of mutual release prescribed by the Board; all applicable rescission periods provided by law for releases of claims shall have expired and Executive shall have signed and not rescinded the release of claims; and Executive has not materially breached the terms of this Agreement, the Confidentiality Agreement, and any other agreements with the Company as of the dates of such payments.

12.Post-Termination Obligations.

(a)Immediately upon termination of Executive’s employment with the Company for any reason, whether such termination is before or after the Term, Executive will resign all positions then held as a director or officer of the Company and of any subsidiary, parent or affiliated entity of the Company.

(b)Upon termination of Executive’s employment with the Company, whether such termination is before or after the Term, Executive shall promptly deliver to the Company any and all Company records and any and all Company property in Executive’s possession or under Executive’s control, including without limitation manuals, books, blank forms, documents, letters, memoranda, notes, notebooks, reports, printouts, computer disks, computer tapes, source codes, data, tables or calculations and all copies thereof, documents that in whole or in part contain any trade secrets or confidential, proprietary or other secret information of the Company and all copies thereof, and keys, access cards, access codes, passwords, credit cards, personal computers, telephones and other electronic equipment belonging to the Company.

(c)Following termination of Executive’s employment with the Company for any reason, whether such termination is before or after the Term, Executive will, upon reasonable request of the Company or its designee, and in return for commercially reasonable compensation to be agreed up by Executive and the Company, cooperate with the Company in connection with the transition of Executive’s duties and responsibilities for the Company; consult with the Company regarding business matters that he was directly and substantially involved with while employed by the Company; and be reasonably available, with or without subpoena, to be interviewed, review documents or things, give depositions, testify, or engage in other reasonable activities in connection with any litigation or investigation, with respect to matters that Executive then has or may have knowledge of by virtue of Executive’s employment by or service to the Company or any related entity.

13.Conflicts of Interest. Executive agrees that he will not, directly or indirectly, transact business with the Company for his own benefit, or as agent, owner, partner or shareholder of any other entity; except that any such transaction may be entered into if approved by all of the disinterested members of the Board after full disclosure.

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14.Additional Documents. Each party shall, without further consideration, execute such additional documents as may reasonably be required in order to carry out the purpose and intent of this Agreement.

15.General Provisions.

(a)The Company may withhold from any amounts payable under this Agreement such federal, state and local income and employment taxes as the Company shall determine are required to be withheld pursuant to any applicable law or regulation, as well as any legally permitted deductions that Executive voluntarily authorizes in writing.

(b)This Agreement and all payments hereunder are intended to satisfy, or be exempt from, the requirements of Section 409A(a)(2), (3) and (4) of the Code of 1986, including current and future guidance and regulations interpreting such provisions. In particular, and without limiting the preceding sentence, if Executive is a “specified employee” under Section 409A(a)(2)(B)(i) of the Code and any then-applicable policy of the Company with respect to designation of specified employees, then any payment under this Agreement that is treated as deferred compensation under Section 409A of the Code shall be delayed until the date which is six months after the date of “separation from service” as determined under Section 409A (without interest or earnings).

(c)This Agreement shall be interpreted and enforced in accordance with the laws of the State of Minnesota.

(d)If any provision of this Agreement shall be held by any court of competent jurisdiction to be illegal, invalid or unenforceable, such provision shall be construed and enforced as if it had been more narrowly drawn so as not to be illegal, invalid or unenforceable, and such illegality, invalidity or unenforceability shall have no effect upon and shall not impair the enforceability of any other provision of this Agreement.

(e)This Agreement contains the entire understanding of the parties with regard to all matters contained herein and incorporates the Confidentiality Agreement and restricted stock agreement by reference. There are no other agreements, conditions or representations, oral or written, expressed or implied, between the parties with regard to the matters contained in this Agreement other than those referenced in this paragraph. This Agreement supersedes all prior agreements relating to the matters contained herein.

(¹)                 This Agreement is and shall be binding upon the heirs, personal representatives, legal representatives, successors and assigns of the parties hereto; provided, however, Executive may not assign this Agreement. The Company may assign or delegate its rights and obligations under this Agreement to any successor to all or a portion of the Company stock or assets.

(f)This Agreement may be amended only in writing, signed by both parties. Any wavier by either party of compliance with any provision of this Agreement by the other party shall not operate or be construed as a waiver of any other provision of this Agreement, or of any subsequent breach by such party of a provision of this Agreement.

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(g) Executive and the Company consent to jurisdiction of the courts of the State of Minnesota and/or the United States District Court, District of Minnesota, for the purpose of resolving all issues of law, equity, or fact arising out of or in connection with this Agreement. Any action involving claims of a breach of this Agreement must be brought in such courts. Each party consents to personal jurisdiction over such party in the state and/or federal courts of Minnesota and hereby waives any defense of lack of personal jurisdiction or inconvenient forum. Venue, for the purpose of all such suits in state court, will be in Hennepin County, State of Minnesota.

(h)To the extent permitted by law, Executive and the Company waive any and all rights to a jury trial with respect to any dispute arising out of or relating to this Agreement.

If any action at law or in equity is necessary to enforce or interpret the terms of this Agreement, the prevailing party shall be entitled to reasonable attorneys’ fees, costs and necessary disbursements in addition to any other relief to which he or it may be entitled.

(i)Nothing herein expressed or implied is intended or shall be construed as conferring upon or giving to any person, firm or corporation other than the parties hereto any rights or benefits under or by reason of this Agreement.

Any notice to be given under this Agreement by either Executive or the Company shall be in writing and shall be effective upon personal delivery or delivery by mail, registered or certified, postage prepaid with return receipt requested. Mailed notices shall be addressed to the party as follows:

If to the Company:

Miromatrix Medical Inc.
10399 West 70th Street
Eden Prairie, MN 55344
Attention: Board of Directors

With a copy to:

Maslon LLP

3300 Wells Fargo Center

90 South Sixth Street

Minneapolis, MN 55402

Attention: Joseph Alexander

If to Executive:

Jeff Ross

470 Liberty Heights Drive

Chaska, MN 55318

Either party may change its or his address by written notice in accordance with this paragraph. Notice delivered personally shall be deemed given as of actual receipt and mailed notices shall be deemed given as of three business days after mailing.

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(j) This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same agreement.

IN WITNESS WHEREOF, the parties have executed this Agreement to be effective as of the Effective Date.

EXECUTIVE: COMPANY:

By:	/s/ Jeff Ross	By:	/s/ Walter Sembrowich
	Jeff Ross		Name: Walter Sembrowich
			Title: Chairman

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Exhibit A

Permitted Activities

Executive shall be permitted to engage in the following activities so long such activities do not violate the terms of the Confidentiality Agreement (as defined in the Employment Agreement) or interfere with Executive’s duties to the Company or the performance of his obligations under the Employment Agreement:

1.Serving as an member of the Eastern Carver County School Board (District 112) or its committees; and

2.Reviewing scientific grants and making podium presentations related to the Company’s field of study, it being acknowledged that Executive is entitled to retain honorariums provided for making such presentations.

EX-10.30

Exhibit 10.30

Appendix D

MIROMATRIX MEDICAL INC.

2021 EQUITY INCENTIVE PLAN

1.            Purpose. The purpose of the Plan is to assist the Company in attracting, retaining, motivating and rewarding certain key employees, officers, directors, and consultants of the Company and its Affiliates, promoting the creation of long-term value for stockholders of the Company by closely aligning the interests of such individuals with those of such stockholders. The Plan authorizes the award of stock based incentives to selected Service Providers to encourage such persons to expend the maximum effort in the creation of stockholder value.

2.            Definitions. In this Plan, the following definitions will apply.

(a)            “Affiliate” means any entity that is a Subsidiary of the Company, or any other entity in which the Company owns, directly or indirectly, at least 20% of combined voting power of the entity’s Voting Securities and which is designated by the Committee as covered by the Plan.

(b)            “Award” means a grant made under the Plan in the form of Options, Stock Appreciation Rights, Restricted Stock, Stock Units, or an Other Stock-Based Award.

(c)            “Award Agreement” means the written or electronic agreement, notice or other document containing the terms and conditions applicable to each Award granted under the Plan, including all amendments thereto. An Award Agreement is subject to the terms and conditions of the Plan.

(d)            “Board” means the Board of Directors of the Company.

(e)            “Cause” means, unless otherwise defined in a then-effective written agreement (including an Award Agreement) between a Participant and the Company or any Affiliate, (i) the Participant’s failure or refusal to perform satisfactorily the duties reasonably required of the Participant by the Company (other than by reason of Disability) in any material respect; (ii) the Participant’s material violation of any law, rule, regulation, or court order, including any commission of or indictment for any crime (whether or not involving the Company or any of its Affiliates); (iii) conduct of the Participant, in connection with their employment or service, that has resulted, or could reasonably be expected to result, in material injury to the business or reputation of the Company or any of its Affiliates; (iv) a material violation of the policies of the Company or any of its Affiliates applicable to the Participant, including but not limited to, those relating to sexual harassment, the disclosure or misuse of confidential information, or those set forth in the manuals or policy statements of the Company or any of its Affiliates or any breach of any fiduciary duty or non-solicitation, non-competition or similar obligation owed to the Company or any of its Affiliates; (v) the Participant’s act(s) of gross negligence or willful misconduct in the course of their employment or service with the Company and its Affiliates; (vi) misappropriation by the Participant of any assets or business opportunities of the Company or any of its Affiliates; (vii) embezzlement or fraud committed by the Participant, at the Participant’s direction or with the Participant’s prior actual knowledge; or (viii) willful neglect in the performance of the Participant’s duties for the Company or any of its Affiliates or willful or repeated failure to perform such duties. If, subsequent to the Participant’s termination of Services for any reason other than Cause it is discovered that the Participant’s Services could have been terminated for Cause, such Participant’s Services shall, at the discretion of the Committee, be deemed to have been terminated for Cause for all purposes under this Plan, and the Participant shall be required to repay to the Company all amounts they received in connection with Awards following such termination of Services that would have been forfeited under the Plan had such termination of Services been by the Company or its Affiliates for Cause. In the event that there is an Award Agreement or other then-effective written agreement between the Company or an Affiliate and a Participant otherwise defining Cause, “Cause” shall have the meaning provided in such agreement, and a termination of Services for Cause hereunder shall not be deemed to have occurred unless all applicable notice and cure periods in such other agreement are complied with.

(f)            “Change in Control” means:

(i)            any person becomes after the Effective Date of the Plan the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of:

(A)        20% or more, but not 50% or more, of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders, unless the transaction resulting in such ownership has been approved in advance by the Continuing Directors; or

(B)        50% or more of the combined voting power of the Company’s outstanding equity securities ordinarily having the right to vote in matters submitted to a vote of the Company’s stockholders (regardless of any approval by the Continuing Directors); or

(ii)            a merger or consolidation to which the Company is a party if the Company’s stockholders immediately prior to the effective date of such merger or consolidation have “beneficial ownership” (as defined in Rule 13d-3 of the Exchange Act), immediately following the effective date of such merger or consolidation, of securities of the surviving entity representing:

(A)     50% or more, but less than 80%, of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity, unless such merger or consolidation has been approved in advance by the Continuing Directors; or

(B)         less than 50% of the combined voting power of the surviving entity’s then-outstanding securities ordinarily having the right to vote in matters submitted to a vote of the owners of such entity (regardless of any approval by the Continuing Directors); or

(iii)         the sale, lease, exchange or other transfer, directly or indirectly, of substantially all of the assets of the Company (in one transaction or in a series of related transactions) to a person or entity that is not controlled by the Company; or

(iv)          the consummation of a complete liquidation or dissolution of the Company.

Notwithstanding the foregoing, any transaction that is fundamentally a financing transaction, as determined in good faith by the Board, shall not be deemed a change of control for the purposes of the Plan. In addition, if any repurchase or other acquisition by the Company of its outstanding equity securities causes any person to become the beneficial owner of the combined voting power of the Company’s outstanding equity securities over the threshold amounts referenced in clauses i(A) and i(B) above, then no change of control will be deemed to have occurred for the purposes of the Plan.

Notwithstanding the foregoing, to the extent that any Award constitutes a deferral of compensation subject to Code Section 409A, and if that Award provides for a change in the time or form of payment upon a Change in Control, then no Change in Control shall be deemed to have occurred upon an event described in this Section 2(f) unless the event would also constitute a change in ownership or effective control of, or a change in the ownership of a substantial portion of the assets of, the Company under Code Section 409A.

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(g)          “Code” means the Internal Revenue Code of 1986, as amended and in effect from time to time. For purposes of the Plan, references to sections of the Code shall be deemed to include any applicable regulations thereunder and any successor or similar statutory provisions.

(h)           “Committee” means two or more Non-Employee Directors designated by the Board to administer the Plan under Section 3, each member of which shall be (i) an independent director within the meaning of applicable stock exchange rules and regulations and (ii) a non-employee director within the meaning of Exchange Act Rule 16b-3.

(i)            “Company” means Miromatrix Medical Inc., a Delaware corporation, and any successor thereto.

(j)            “Continuing Director” means an individual (i) who is, as of the Effective Date of the Plan, a director of the Company, or (ii) who becomes a director of the Company after the Effective Date hereof and whose initial election, or nomination for election by the Company’s stockholders, was approved by at least a majority of the then Continuing Directors.

(k)          “Corporate Transaction” means (i) a sale or other disposition of all or substantially all of the assets of the Company, or (ii) a merger, consolidation, share exchange or similar transaction involving the Company, regardless of whether the Company is the surviving entity.

(l)             “Disability” means (A) any permanent and total disability under any long-term disability plan or policy of the Company or its Affiliates that covers the Participant, or (B) if there is no such long-term disability plan or policy, “total and permanent disability” within the meaning of Code Section 22(e)(3).

(m)            “Employee” means an employee of the Company or an Affiliate.

(n)             “Exchange Act” means the Securities Exchange Act of 1934, as amended and in effect from time to time.

(o)             “Fair Market Value” means the fair market value of a Share determined as follows:

  (i)            If the Shares are readily tradable on an established securities market (as determined under Code Section 409A), then Fair Market Value will be the closing sales price for a Share on the principal securities market on which it trades on the date for which it is being determined, or if no sale of Shares occurred on that date, on the next preceding date on which a sale of Shares occurred, as reported in The Wall Street Journal or such other source as the Committee deems reliable; or

  (ii)            If the Shares are not then readily tradable on an established securities market (as determined under Code Section 409A), then Fair Market Value will be determined by the Committee as the result of a reasonable application of a reasonable valuation method that satisfies the requirements of Code Section 409A.

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(p)            “Grant Date” means the date on which the Committee approves the grant of an Award under the Plan, or such later date as may be specified by the Committee on the date the Committee approves the Award.

(q)           “Group” means two or more persons who act, or agree to act together, as a partnership, limited partnership, syndicate or other group for the purpose of acquiring, holding, voting or disposing of securities of the Company.

(r)             “Non-Employee Director” means a member of the Board who is not an Employee.

(s)            “Option” means a right granted under the Plan to purchase a specified number of Shares at a specified price. An “Incentive Stock Option” or “ISO” means any Option designated as such and granted in accordance with the requirements of Code Section 422. A “Non-Qualified Stock Option” or “NQSO” means an Option other than an Incentive Stock Option.

(t)            “Other Stock-Based Award” means an Award described in Section 11 of this Plan.

(u)            “Participant” means a Service Provider to whom a then-outstanding Award has been granted under the Plan.

(v)            “Plan” means this Miromatrix Medical Inc. 2021 Equity Incentive Plan, as amended and in effect from time to time.

(w)           “Prior Plan” means the Miromatrix Medical Inc. 2019 Equity Incentive Plan.

(x)         “Restricted Stock” means Shares issued to a Participant that are subject to such restrictions on transfer, vesting conditions and other restrictions or limitations as may be set forth in this Plan and the applicable Award Agreement.

(y)          “Service” means the provision of services by a Participant to the Company or any Affiliate in any Service Provider capacity. A Service Provider’s Service shall be deemed to have terminated either upon an actual cessation of providing services to the Company or any Affiliate or upon the entity to which the Service Provider provides services ceasing to be an Affiliate. Unless otherwise determined by the Committee, in the event that a Subsidiary to whom the Participant provides Services ceases for any reason to be an Affiliate of the Company, the Participant shall be deemed to have had a termination of Services for purposes of the Plan effective as of the date of such cessation. Except as otherwise provided in this Plan or any Award Agreement, Service shall not be deemed terminated in the case of (i) any approved leave of absence; (ii) transfers among the Company and any Affiliates in any Service Provider capacity; or (iii) any change in status so long as the individual remains in the service of the Company or any Affiliate in any Service Provider capacity.

(z)            “Service Provider” means an Employee, a Non-Employee Director, or any natural person who is a consultant or advisor, or is employed by a consultant or advisor retained by the Company or any Affiliate, and who provides services to the Company or any Affiliate.

(aa)          “Share” means a share of Stock.

(bb)         “Stock” means the common stock, $.00001 par value per Share, of the Company.

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(cc)         “Stock Appreciation Right” or “SAR” means the right to receive, in cash and/or Shares as determined by the Committee, an amount equal to the appreciation in value of a specified number of Shares between the Grant Date of the SAR and its exercise date.

(dd)        “Stock Unit” means a right to receive, in cash and/or Shares as determined by the Committee, the Fair Market Value of a Share, subject to such restrictions on transfer, vesting conditions and other restrictions or limitations as may be set forth in this Plan and the applicable Award Agreement.

(ee)         “Subsidiary” means a “subsidiary corporation,” as defined in Code Section 424(f), of the Company.

(ff)          “Substitute Award” means an Award granted upon the assumption of, or in substitution or exchange for, outstanding awards granted by a company or other entity acquired by the Company or any Affiliate or with which the Company or any Affiliate combines. The terms and conditions of a Substitute Award may vary from the terms and conditions set forth in the Plan to the extent that the Committee at the time of the grant may deem appropriate to conform, in whole or in part, to the provisions of the award in substitution for which it has been granted.

3.            Administration of the Plan.

(a)            Administration. The authority to control and manage the operations and administration of the Plan shall be vested in the Committee in accordance with this Section 3.

(b)            Scope of Authority. Subject to the terms of the Plan, the Committee shall have the authority, in its discretion, to take such actions as it deems necessary or advisable to administer the Plan, including:

(1)           determining the Service Providers to whom Awards will be granted, the timing of each such Award, the type of and the number of Shares covered by each Award, the terms, conditions, performance criteria, restrictions and other provisions of Awards, and the manner in which Awards are paid or settled;

(2)           cancelling or suspending an Award, accelerating the vesting or extending the exercise period of an Award, or otherwise amending the terms and conditions of any outstanding Award, subject to the requirements of Sections 15(d) and 15(e);

(3)           adopting sub-plans or special provisions applicable to Awards, establishing, amending or rescinding rules to administer the Plan, interpreting the Plan and any Award or Award Agreement, reconciling any inconsistency, correcting any defect or supplying an omission in the Plan or any Award Agreement, and making all other determinations necessary or desirable for the administration of the Plan;

(4)            granting Substitute Awards under the Plan;

(5)            taking such actions as are provided in Section 3(c) with respect to Awards to foreign Service Providers; and

(6)            requiring or permitting the deferral of the settlement of an Award, and establishing the terms and conditions of any such deferral.

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(c)           Awards to Foreign Service Providers. The Committee may grant Awards to Service Providers who are located outside of the United States, who are not United States citizens, who are not compensated from a payroll maintained in the United States, or who are otherwise subject to (or could cause the Company to be subject to) legal or regulatory requirements of countries outside of the United States, on such terms and conditions different from those specified in the Plan as may, in the judgment of the Committee, be necessary or desirable to comply with applicable foreign laws and regulatory requirements and to promote achievement of the purposes of the Plan. In connection therewith, the Committee may establish such subplans and modify exercise procedures and other Plan rules and procedures to the extent such actions are deemed necessary or desirable, and may take any other action that it deems advisable to obtain local regulatory approvals or to comply with any necessary local governmental regulatory exemptions.

(d)          Acts of the Committee; Delegation. A majority of the members of the Committee shall constitute a quorum for any meeting of the Committee, and any act of a majority of the members present at any meeting at which a quorum is present or any act unanimously approved in writing by all members of the Committee shall be the act of the Committee. Any such action of the Committee shall be valid and effective even if one or more members of the Committee at the time of such action are later determined not to have satisfied all of the criteria for membership in clauses (i) and (ii) of Section 2(h). To the extent not inconsistent with applicable law or stock exchange rules, the Committee may delegate all or any portion of its authority under the Plan to any one or more of its members or, as to Awards to Participants who are not subject to Section 16 of the Exchange Act, to one or more directors or executive officers of the Company or to a committee of the Board comprised of one or more directors of the Company. The Committee may also delegate non-discretionary administrative responsibilities in connection with the Plan to such other persons as it deems advisable.

(e)           Finality of Decisions. The Committee’s interpretation of the Plan and of any Award or Award Agreement made under the Plan and all related decisions or resolutions of the Board or Committee shall be final and binding on all parties with an interest therein.

(f)            Indemnification. Each person who is or has been a member of the Committee or of the Board, and any other person to whom the Committee delegates authority under the Plan, shall be indemnified by the Company, to the maximum extent permitted by law, against liabilities and expenses imposed upon or reasonably incurred by such person in connection with or resulting from any claims against such person by reason of the performance of the individual's duties under the Plan. This right to indemnification is conditioned upon such person providing the Company an opportunity, at the Company’s expense, to handle and defend the claims before such person undertakes to handle and defend them on such person’s own behalf. The Company will not be required to indemnify any person for any amount paid in settlement of a claim unless the Company has first consented in writing to the settlement. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such person or persons may be entitled under the Company’s Certificate of Incorporation or Bylaws, as a matter of law, or otherwise.

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4.            Shares Available Under the Plan.

(a)            Maximum Shares Available. Subject to Sections 4(b), 4(c) and 4(d) and to adjustment as provided in Section 12(a), the number of Shares that may be the subject of Awards and issued under the Plan shall be 1,000,000, plus any Shares of Stock remaining available for future grants under the Prior Plan on the Effective Date of this Plan. No further awards may be made under the Prior Plan after the Effective Date of this Plan. Shares issued under the Plan may come from authorized and unissued shares or treasury shares. In determining the number of Shares to be counted against this share reserve in connection with any Award, the following rules shall apply:

(1)           Where the number of Shares subject to an Award is variable on the Grant Date, the number of Shares to be counted against the share reserve shall be the maximum number of Shares that could be received under that particular Award, until such time as it can be determined that only a lesser number of shares could be received.

(2)            Shares subject to Substitute Awards shall not be counted against the share reserve, nor shall they reduce the Shares authorized for grant to a Participant in any calendar year.

(3)            Awards that may be settled solely in cash shall not be counted against the share reserve, nor shall they reduce the Shares authorized for grant to a Participant in any calendar year.

(b)            Effect of Forfeitures and Other Actions. Any Shares subject to an Award, or to an award granted under the Prior Plan that is outstanding on the Effective Date of this Plan (a “Prior Plan Award”), that expires, is cancelled or forfeited, is settled for cash or otherwise does not result in the issuance of all of the Shares subject to such Award (including as a result of the settlement in Shares of the exercise of a Stock Appreciation Right) shall, to the extent of such cancellation, forfeiture, expiration, cash settlement or non-issuance, again become available for Awards under this Plan, and the share reserve under Section 4(a) shall be correspondingly replenished as provided in Section 4(c) below. In addition, if (i) payment of the exercise price of any Award or Prior Plan Award is made through the tendering (either actually or by attestation) of Shares by the Participant or by the withholding of Shares by the Company, (ii) satisfaction of any tax withholding obligations arising from any Award or Prior Plan Award occurs through the tendering (either actually or by attestation) of Shares by the Participant or by the withholding of Shares by the Company, or (iii) any Shares are repurchased by the Company with proceeds received from the exercise of a stock option issued under this Plan or the Prior Plan, then the Shares so tendered, withheld or repurchased shall become available for Awards under this Plan and the share reserve under Section 4(a) shall be correspondingly replenished as provided in Section 4(c) below.

(c)            Counting Shares Again Available. Each Share that again becomes available for Awards as provided in Section 4(b) shall correspondingly increase the share reserve under Section 4(a).

(d)            Automatic Share Reserve Increase. The share reserve specified in Section 4(a) will be increased on January 1 of each year, for a period of not more than ten years from the date the Plan is approved by the holders of the voting stock of the Company, commencing on January 1, 2022 and ending on (and including) January 1, 2031 in an amount equal to the least of: (i) 4.5% of the total number of Shares outstanding as of December 31 of the immediately preceding calendar year; (ii) 600,000 Shares; or (iii) such number of Shares determined by the Board.

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(e)            Effect of Plans Operated by Acquired Companies. If a company acquired by the Company or any Subsidiary or with which the Company or any Subsidiary combines has shares available under a pre-existing plan approved by stockholders and not adopted in contemplation of such acquisition or combination, the shares available for grant pursuant to the terms of such pre-existing plan (as adjusted, to the extent appropriate, using the exchange ratio or other adjustment or valuation ratio or formula used in such acquisition or combination to determine the consideration payable to the holders of common stock of the entities party to such acquisition or combination) may be used for Awards under the Plan and shall supplement the Share reserve under Section 4(a). Awards using such available shares shall not be made after the date awards or grants could have been made under the terms of the pre-existing plan absent the acquisition or combination, and shall only be made to individuals who were not Employees or Non-Employee Directors prior to such acquisition or combination.

(f)            No Fractional Shares. Unless otherwise determined by the Committee, the number of Shares subject to an Award shall always be a whole number. No fractional Shares may be issued under the Plan, but the Committee may, in its discretion, adopt any rounding convention it deems suitable or pay cash in lieu of any fractional Share in settlement of an Award.

(g)            Limits on Awards to Non-Employee Directors. (i) The aggregate value of Awards granted under the Plan to any Participant who is a Non-Employee Director in any calendar year, solely with respect to his or her service as a Non-Employee Director on the Board, may not exceed $500,000, determined based on the aggregate Fair Market Value of such Awards as of the Grant Date; and

(ii)  the aggregate value of Awards granted under the Plan to any Non-Employee Director in connection with their initial appointment as a Non-Employee Director on the Board may not exceed $500,000, determined based on the aggregate Fair Market Value of such Awards as of the Grant Date, which, for the avoidance of doubt, may be in addition to any Awards granted to such Participant under Sections 4(g)(i).

5.            Eligibility. Participation in the Plan is limited to Service Providers. Incentive Stock Options may only be granted to Employees.

6.            General Terms of Awards.

(a)            Award Agreement. Each Award shall be evidenced by an Award Agreement setting forth the amount of the Award together with such other terms and conditions applicable to the Award (and not inconsistent with the Plan) as determined by the Committee. If an Award Agreement calls for acceptance by the Participant, the Award evidenced by the Award Agreement will not become effective unless acceptance of the Award Agreement in a manner permitted by the Committee is received by the Company within thirty (30) days of the date the Award Agreement is delivered to the Participant. An Award to a Participant may be made singly or in combination with any form of Award. Two types of Awards may be made in tandem with each other such that the exercise of one type of Award with respect to a number of Shares reduces the number of Shares subject to the related Award by at least an equal amount.

(b)            Vesting and Term. Each Award Agreement shall set forth the period until the applicable Award is scheduled to vest and, if applicable, expire (which shall not be more than ten years from the Grant Date), and, consistent with the requirements of this Section 6(b), the applicable vesting conditions and any applicable performance period. The Committee may provide in an Award Agreement for such vesting conditions and timing as it may determine.

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(c)            Transferability. Except as provided in this Section 6(c), (i) during the lifetime of a Participant, only the Participant or the Participant’s guardian or legal representative may exercise an Option or SAR, or receive payment with respect to any other Award; and (ii) no Award may be sold, assigned, transferred, exchanged or encumbered, voluntarily or involuntarily, other than by will or the laws of descent and distribution. Any attempted transfer in violation of this Section 6(c) shall be of no effect. The Committee may, however, provide in an Award Agreement or otherwise that an Award (other than an Incentive Stock Option) may be transferred pursuant to a domestic relations order or may be transferable by gift to any “family member” (as defined in General Instruction A.1(a)(5) to Form S-8 under the Securities Act of 1933) of the Participant. Any Award held by a transferee shall continue to be subject to the same terms and conditions that were applicable to that Award immediately before the transfer thereof. For purposes of any provision of the Plan relating to notice to a Participant or to acceleration or termination of an Award upon the death or termination of Service of a Participant, the references to “Participant” shall mean the original grantee of an Award and not any transferee.

(d)            Designation of Beneficiary. To the extent permitted by the Committee, a Participant may designate a beneficiary or beneficiaries to exercise any Award or receive a payment under any Award that is exercisable or payable on or after the Participant’s death. Any such designation shall be on a form approved by the Company and shall be effective upon its receipt by the Company.

(e)            Termination of Service. Unless otherwise provided in an applicable Award Agreement or another then-effective written agreement between a Participant and the Company, and subject to Section 12 of this Plan, if a Participant’s Service with the Company and all of its Affiliates terminates, the following provisions shall apply (in all cases subject to the scheduled expiration of an Option or SAR Award, as applicable):

(1)            Upon termination of Service for Cause, or upon conduct during a post-termination exercise period that would constitute Cause, all unexercised Option and SAR Awards and all unvested portions of any other outstanding Awards shall be immediately forfeited without consideration.

(2)           Upon termination of Service for any other reason, all unvested and unexercisable portions of any outstanding Awards shall be immediately forfeited without consideration.

(3)            Upon termination of Service for any reason other than Cause, death or Disability, the currently vested and exercisable portions of Option and SAR Awards may be exercised for a period of three months after the date of such termination. However, if a Participant thereafter dies during such three-month period, the vested and exercisable portions of the Option and SAR Awards may be exercised for a period of one year after the date of such termination.

(4)            Upon termination of Service due to death or Disability, the currently vested and exercisable portions of Option and SAR Awards may be exercised for a period of one year after the date of such termination.

(f)            Rights as Stockholder. No Participant shall have any rights as a stockholder with respect to any Shares covered by an Award unless and until the date the Participant becomes the holder of record of the Shares, if any, to which the Award relates.

(g)            Performance-Based Awards. Any Award may be granted as a performance-based Award if the Committee establishes one or more measures of corporate, business unit or individual performance which must be attained, and the performance period over which the specified performance is to be attained, as a condition to the grant, vesting, exercisability, lapse of restrictions and/or settlement in cash or Shares of such Award. In connection with any such Award, the Committee shall determine the extent to which performance measures have been attained and other applicable terms and conditions have been satisfied, and the degree to which the grant, vesting, exercisability, lapse of restrictions and/or settlement of such Award has been earned. The Committee shall also have the authority to provide, in an Award Agreement or otherwise, for the modification of a performance period and/or adjustments to or waivers of the achievement of performance goals under specified circumstances such as (i) the occurrence of events that are unusual in nature or infrequently occurring, such as a Change in Control, an equity restructuring (as described in Section 12(a)), acquisitions, divestitures, restructuring activities, recapitalizations, or asset write-downs, (ii) a change in applicable tax laws or accounting principles, or (iii) the Participant’s death or Disability.

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(h)            Dividends and Dividend Equivalents. Any dividends or distributions payable with respect to Shares that are subject to the unvested portion of a Restricted Stock Award will be subject to the same restrictions and risk of forfeiture as the Shares to which such dividends or distributions relate. In its discretion, the Committee may provide in an Award Agreement for a Stock Unit Award or an Other Stock-Based Award that the Participant will be entitled to receive dividend equivalents, based on dividends actually declared and paid on outstanding Shares, on the units or other Share equivalents subject to the Stock Unit Award or Other Stock-Based Award, and such dividend equivalents will be subject to the same restrictions and risk of forfeiture as the units or other Share equivalents to which such dividend equivalents relate. The additional terms of any such dividend equivalents will be as set forth in the applicable Award Agreement, including the time and form of payment and whether such dividend equivalents will be credited with interest or deemed to be reinvested in additional units or Share equivalents. Any Shares issued or issuable during the term of this Plan as the result of the reinvestment of dividends or the deemed reinvestment of dividend equivalents in connection with an Award or a Prior Plan Award shall be counted against, and replenish upon any subsequent forfeiture, the Plan’s share reserve as provided in Section 4.

(i)            Deferrals of Full Value Awards. The Committee may, in its discretion, permit or require the deferral by a Participant of the issuance of Shares or payment of cash in settlement of any Award, subject to such terms, conditions, rules and procedures as it may establish or prescribe for such purpose and with the intention of complying with the applicable requirements of Code Section 409A. The terms, conditions, rules and procedures for any such deferral shall be set forth in writing in the relevant Award Agreement or in such other agreement, plan or document as the Committee may determine. The terms, conditions, rules and procedures for any such deferral shall address, to the extent relevant, matters such as: (i) the amount of compensation that may or must be deferred (or the method for calculating the amount); (ii) the permissible time(s) and form(s) of payment of deferred amounts; (iii) the terms and conditions of any deferral elections by a Participant or of any deferral required by the Company; and (iv) the crediting of interest or dividend equivalents on deferred amounts. Unless otherwise determined by the Committee, to the extent that any such deferral is effected in accordance with a nonqualified deferred compensation plan, the Share equivalents credited to any such plan account of a Participant shall be deemed Stock Units for purposes of this Plan, and, if settled in Shares, such Shares shall be drawn from and charged against this Plan’s share reserve.

7.            Stock Option Awards.

(a)            Type and Exercise Price. The Award Agreement pursuant to which an Option Award is granted shall specify whether the Option is an Incentive Stock Option or a Non-Qualified Stock Option. The exercise price at which each Share subject to an Option Award may be purchased shall be determined by the Committee and set forth in the Award Agreement, and shall not be less than the Fair Market Value of a Share on the Grant Date, except in the case of Substitute Awards (to the extent consistent with Code Section 409A and, in the case of Incentive Stock Options, Code Section 424).

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(b)            Payment of Exercise Price. The purchase price of the Shares with respect to which an Option Award is exercised shall be payable in full at the time of exercise. The purchase price may be paid in cash or in such other manner as the Committee may permit, including by payment under a broker-assisted sale and remittance program, by withholding Shares otherwise issuable to the Participant upon exercise of the Option or by delivery to the Company of Shares (by actual delivery or attestation) already owned by the Participant (in either case, such Shares having a Fair Market Value as of the date the Option is exercised equal to the purchase price of the Shares being purchased).

(c)            Exercisability and Expiration. Each Option Award shall be exercisable in whole or in part on the terms provided in the Award Agreement. No Option Award shall be exercisable at any time after its scheduled expiration. When an Option Award is no longer exercisable, it shall be deemed to have terminated.

(d)            Incentive Stock Options.

(1)            An Option Award will constitute an Incentive Stock Option Award only if the Participant receiving the Option Award is an Employee, and only to the extent that (i) it is so designated in the applicable Award Agreement and (ii) the aggregate Fair Market Value (determined as of the Option Award’s Grant Date) of the Shares with respect to which Incentive Stock Option Awards held by the Participant first become exercisable in any calendar year (under the Plan and all other plans of the Company and its Affiliates) does not exceed $100,000 or such other amount specified by the Code. To the extent an Option Award granted to a Participant exceeds this limit, the Option Award shall be treated as a Non-Qualified Stock Option Award. The maximum number of Shares that may be issued upon the exercise of Incentive Stock Option Awards under the Plan shall be 1,000,000, subject to adjustment as provided in Section 12(a).

(2)            No Participant may receive an Incentive Stock Option Award under the Plan if, immediately after the grant of such Award, the Participant would own (after application of the rules contained in Code Section 424(d)) Shares possessing more than 10% of the total combined Voting Power of all classes of stock of the Company or an Affiliate, unless (i) the per Share exercise price for such Award is at least 110% of the Fair Market Value of a Share on the Grant Date and (ii) such Award will expire no later than five years after its Grant Date.

(3)            For purposes of continued Service by a Participant who has been granted an Incentive Stock Option Award, no approved leave of absence may exceed three months unless reemployment upon expiration of such leave is provided by statute or contract. If reemployment is not so provided, then on the date six months following the first day of such leave, any Incentive Stock Option held by the Participant shall cease to be treated as an Incentive Stock Option and shall be treated for tax purposes as a Non-Qualified Stock Option.

(4)           If an Incentive Stock Option Award is exercised after the expiration of the exercise periods that apply for purposes of Code Section 422, such Option shall thereafter be treated as a Non-Qualified Stock Option.

(5)            The Award Agreement covering an Incentive Stock Option Award shall contain such other terms and provisions that the Committee determines necessary to qualify the Option Award as an Incentive Stock Option Award.

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8.            Stock Appreciation Right Awards.

(a)            Nature of Award. An Award of Stock Appreciation Rights shall be subject to such terms and conditions as are determined by the Committee, and shall provide a Participant the right to receive upon exercise of the SAR Award all or a portion of the excess of (i) the Fair Market Value as of the date of exercise of the SAR Award of the number of Shares as to which the SAR Award is being exercised, over (ii) the aggregate exercise price for such number of Shares. The per Share exercise price for any SAR Award shall be determined by the Committee and set forth in the applicable Award Agreement, and shall not be less than the Fair Market Value of a Share on the Grant Date, except in the case of Substitute Awards (to the extent consistent with Code Section 409A).

(b)           Exercise of SAR. Each SAR Award may be exercisable in whole or in part at the times, on the terms and in the manner provided in the Award Agreement. No SAR Award shall be exercisable at any time after its scheduled expiration. When a SAR Award is no longer exercisable, it shall be deemed to have terminated. Upon exercise of a SAR Award, payment to the Participant shall be made at such time or times as shall be provided in the Award Agreement in the form of cash, Shares or a combination of cash and Shares as determined by the Committee. The Award Agreement may provide for a limitation upon the amount or percentage of the total appreciation on which payment (whether in cash and/or Shares) may be made in the event of the exercise of a SAR Award.

9.            Restricted Stock Awards.

(a)            Vesting and Consideration. Shares subject to a Restricted Stock Award shall be subject to vesting and the lapse of applicable restrictions based on such conditions or factors and occurring over such period of time as the Committee may determine in its discretion. The Committee may provide whether any consideration other than Services must be received by the Company or any Affiliate as a condition precedent to the grant of a Restricted Stock Award, and may correspondingly provide for Company reacquisition or repurchase rights if such additional consideration has been required and some or all of a Restricted Stock Award does not vest.

(b)            Shares Subject to Restricted Stock Awards. Unvested Shares subject to a Restricted Stock Award shall be evidenced by a book-entry in the name of the Participant with the Company’s transfer agent or by one or more Stock certificates issued in the name of the Participant. Any such Stock certificate shall be deposited with the Company or its designee, together with an assignment separate from the certificate, in blank, signed by the Participant, and bear an appropriate legend referring to the restricted nature of the Restricted Stock evidenced thereby. Any book-entry shall be subject to comparable restrictions and corresponding stop transfer instructions. Upon the vesting of Shares of Restricted Stock, and the Company’s determination that any necessary conditions precedent to the release of vested Shares (such as satisfaction of tax withholding obligations and compliance with applicable legal requirements) have been satisfied, such vested Shares shall be made available to the Participant in such manner as may be prescribed or permitted by the Committee. Except as otherwise provided in the Plan or an applicable Award Agreement, a Participant with a Restricted Stock Award shall have all the rights of a shareholder, including the right to vote the Shares of Restricted Stock.

10.            Stock Unit Awards.

(a)            Vesting and Consideration. A Stock Unit Award shall be subject to vesting and the lapse of applicable restrictions based on such conditions or factors and occurring over such period of time as the Committee may determine in its discretion. If vesting of a Stock Unit Award is conditioned on the achievement of specified performance goals, the extent to which they are achieved over the specified performance period shall determine the number of Stock Units that will be earned and eligible to vest, which may be greater or less than the target number of Stock Units stated in the Award Agreement. The Committee may provide whether any consideration other than Services must be received by the Company or any Affiliate as a condition precedent to the settlement of a Stock Unit Award.

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(b)           Settlement of Award. Following the vesting of a Stock Unit Award, and the Company’s determination that any necessary conditions precedent to the settlement of the Award (such as satisfaction of tax withholding obligations and compliance with applicable legal requirements) have been satisfied, settlement of the Award and payment to the Participant shall be made at such time or times in the form of cash, Shares (which may themselves be considered Restricted Stock under the Plan) or a combination of cash and Shares as determined by the Committee.

11.            Other Stock-Based Awards. The Committee may from time to time grant Shares and other Awards that are valued by reference to and/or payable in whole or in part in Shares under the Plan. The Committee shall determine the terms and conditions of such Awards, which shall be consistent with the terms and purposes of the Plan. The Committee may direct the Company to issue Shares subject to restrictive legends and/or stop transfer instructions that are consistent with the terms and conditions of the Award to which the Shares relate.

12.            Changes in Capitalization, Corporate Transactions, Change in Control.

(a)            Adjustments for Changes in Capitalization. In the event of any equity restructuring (within the meaning of FASB ASC Topic 718) that causes the per share value of Shares to change, such as a stock dividend, stock split, spinoff, rights offering or recapitalization through an extraordinary dividend, the Committee shall make such adjustments as it deems equitable and appropriate to (i) the aggregate number and kind of Shares or other securities issued or reserved for issuance under the Plan, (ii) the number and kind of Shares or other securities subject to outstanding Awards, (iii) the exercise price of outstanding Options and SARs, and (iv) any maximum limitations prescribed by the Plan with respect to certain types of Awards or the grants to individuals of certain types of Awards. In the event of any other change in corporate capitalization, including a merger, consolidation, reorganization, or partial or complete liquidation of the Company, such equitable adjustments described in the foregoing sentence may be made as determined to be appropriate and equitable by the Committee to prevent dilution or enlargement of rights of Participants.  In either case, any such adjustment shall be conclusive and binding for all purposes of the Plan.  No adjustment shall be made pursuant to this Section 12(a) in connection with the conversion of any convertible securities of the Company, or in a manner that would cause Incentive Stock Options to violate Section 422(b) of the Code or cause an Award to be subject to adverse tax consequences under Section 409A of the Code.

(b)            Corporate Transactions. Unless otherwise provided in an applicable Award Agreement or another written agreement between a Participant and the Company, the following provisions shall apply to outstanding Awards in the event of a Change in Control that involves a Corporate Transaction.

(1)            Continuation, Assumption or Replacement of Awards. In the event of a Corporate Transaction, then the surviving or successor entity (or its Parent) may continue, assume or replace Awards outstanding as of the date of the Corporate Transaction (with such adjustments as may be required or permitted by Section 12(a)), and such Awards or replacements therefor shall remain outstanding and be governed by their respective terms, subject to Section 12(b)(4) below. A surviving or successor entity may elect to continue, assume or replace only some Awards or portions of Awards. For purposes of this Section 12(b)(1), an Award shall be considered assumed or replaced if, in connection with the Corporate Transaction and in a manner consistent with Code Section 409A (and Code Section 424 if the Award is an ISO), either (i) the contractual obligations represented by the Award are expressly assumed by the surviving or successor entity (or its Parent) with appropriate adjustments to the number and type of securities subject to the Award and the exercise price thereof that preserves the intrinsic value of the Award existing at the time of the Corporate Transaction, or (ii) the Participant has received a comparable award that preserves the intrinsic value of the Award existing at the time of the Corporate Transaction and contains terms and conditions that are substantially similar to those of the Award.

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(2)            Acceleration. If and to the extent that outstanding Awards under the Plan are not continued, assumed or replaced in connection with a Corporate Transaction, then (i) all outstanding Option and SAR Awards shall become fully vested and exercisable for such period of time prior to the effective time of the Corporate Transaction as is deemed fair and equitable by the Committee, and shall terminate at the effective time of the Corporate Transaction, and (ii) all outstanding Awards (other than Options and SAR Awards) shall fully vest immediately prior to the effective time of the Corporate Transaction, and (iii) to the extent vesting of any Award is subject to satisfaction of specified performance goals, such Award shall be deemed “fully vested” for purposes of this Section 12(b)(2) if the performance goals are deemed to have been satisfied at the target level of performance and the vested portion of the Award at that level of performance is proportionate to the portion of the performance period that has elapsed as of the effective time of the Corporate Transaction. The Committee shall provide written notice of the period of accelerated exercisability of Option and SAR Awards to all affected Participants. The exercise of any Option or SAR Award whose exercisability is accelerated as provided in this Section 12(b)(2) shall be conditioned upon the consummation of the Corporate Transaction and shall be effective only immediately before such consummation.

(3)            Payment for Awards. If and to the extent that outstanding Awards under the Plan are not continued, assumed or replaced in connection with a Corporate Transaction, then the Committee may provide that some or all of such outstanding Awards shall be canceled at or immediately prior to the effective time of the Corporate Transaction in exchange for payments to the holders as provided in this Section 12(b)(3). The Committee will not be required to treat all Awards similarly for purposes of this Section 12(b)(3). The payment for any Award canceled shall be in an amount equal to the difference, if any, between (i) the fair market value (as determined in good faith by the Committee) of the consideration that would otherwise be received in the Corporate Transaction for the number of Shares subject to the Award, and (ii) the aggregate exercise price (if any) for the Shares subject to such Award. If the amount determined pursuant to the preceding sentence is not a positive number with respect to any Award, such Award may be canceled pursuant to this Section 12(b)(3) without payment of any kind to the affected Participant. With respect to an Award whose vesting is subject to the satisfaction of specified performance goals, the number of Shares subject to such an Award for purposes of this Section 12(b)(3) shall be the number of Shares as to which the Award would have been deemed “fully vested” for purposes of Section 12(b)(2). Payment of any amount under this Section 12(b)(3) shall be made in such form, on such terms and subject to such conditions as the Committee determines in its discretion, which may or may not be the same as the form, terms and conditions applicable to payments to the Company’s stockholders in connection with the Corporate Transaction, and may, in the Committee’s discretion, include subjecting such payments to vesting conditions comparable to those of the Award canceled, subjecting such payments to escrow or holdback terms comparable to those imposed upon the Company’s stockholders under the Corporate Transaction, or calculating and paying the present value of payments that would otherwise be subject to escrow or holdback terms.

(4)            Termination after a Corporate Transaction. If and to the extent that Awards are continued, assumed or replaced under the circumstances described in Section 12(b)(1), and if within twenty-four months after the Corporate Transaction a Participant experiences an involuntary termination of Service for reasons other than Cause, then (i) outstanding Option and SAR Awards issued to the Participant that are not yet fully exercisable shall immediately become exercisable in full and shall remain exercisable for one year following the Participant’s termination of employment, and (ii) any equity-based awards other than Options and SAR Awards that are not yet fully vested shall immediately vest in full (with vesting in full for a performance-based award determined as provided in Section 12(b)(2), except that the proportionate vesting amount will be determined with respect to the portion of the performance period during which the Participant was a Service Provider).

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(c)            Other Change in Control. In the event of a Change in Control that does not involve a Corporate Transaction, the Committee may, in its discretion, take such action as it deems appropriate with respect to outstanding Awards, which may include: (i)  providing for the cancellation of any Award in exchange for payments in a manner similar to that provided in Section 12(b)(3) or (ii) making such adjustments to the Awards then outstanding as the Committee deems appropriate to reflect such Change in Control, which may include the acceleration of vesting in full or in part. The Committee will not be required to treat all Awards similarly in such circumstances, and may include such further provisions and limitations in any Award Agreement as it may deem equitable and in the best interests of the Company.

(d)            Dissolution or Liquidation. Unless otherwise provided in an applicable Award Agreement, in the event of a proposed dissolution or liquidation of the Company, an Award will terminate immediately prior to the consummation of such proposed action.

(e)             Parachute Payment Limitation.

(1)            Notwithstanding any other provision of this Plan or any other plan, arrangement or agreement to the contrary, if any of the payments or benefits provided or to be provided by the Company or its Affiliates to a Participant or for the Participant’s benefit pursuant to the terms of this Plan or otherwise ("Covered Payments") constitute parachute payments ("Parachute Payments") within the meaning of Section 280G of the Code, and would, but for this Section 12(e) be subject to the excise tax imposed under Section 4999 of the Code (or any successor provision thereto) or any similar tax imposed by state or local law and any interest or penalties with respect to such taxes (collectively, the "Excise Tax"), then the Covered Payments shall be payable either (i) in full or (ii) reduced to the minimum extent necessary to ensure that no portion of the Covered Payments is subject to the Excise Tax, whichever of the foregoing clauses (i) or (ii) results in the Participant’s receipt on an after-tax basis of the greatest amount of payments and benefits after taking into account the applicable federal, state, local and foreign income, employment and excise taxes (including the Excise Tax).

(2)            Any such reduction shall be made in accordance with Section 409A of the Code and the following: (i) the Covered Payments which do not constitute deferred compensation subject to Section 409A of the Code shall be reduced first, and (ii) Covered Payments that are cash payments shall be reduced before non-cash payments, and Covered Payments to be made on a later payment date shall be reduced before payments to be made on an earlier payment date.

(3)            If, notwithstanding the initial application of this Section 12(e), the Internal Revenue Service determines that any Covered Payment constitutes an “excess parachute payment” (as defined by Section 280G(b) of the Code), this Section 12(e) will be reapplied based on the Internal Revenue Service's determination, and the Participant will be required to promptly repay the portion of the Covered Payments required to avoid imposition of the Excise Tax together with interest at the applicable federal rate (as defined in Section 7872(f)(2)(A) of the Code) from the date of the Participant’s receipt of the excess payments until the date of repayment).

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(4)            Any determination required under this Section 12(e) shall be made in writing in good faith by the accounting firm which was the Company's independent auditor immediately before the Change in Control (the "Accountants"), which shall provide detailed supporting calculations to the Company and the Participant as requested by the Company or the Participant. The Company and the Participant shall provide the Accountants with such information and documents as the Accountants may reasonably request in order to make a determination under this Section 12(e). The Company shall be responsible for all fees and expenses of the Accountants.

13.            Plan Participation and Service Provider Status. Status as a Service Provider shall not be construed as a commitment that any Award will be made under the Plan to that Service Provider or to eligible Service Providers generally. Nothing in the Plan or in any Award Agreement or related documents shall confer upon any Service Provider or Participant any right to continued Service with the Company or any Affiliate, nor shall it interfere with or limit in any way any right of the Company or any Affiliate to terminate the person’s Service at any time with or without Cause or change such person’s compensation, other benefits, job responsibilities or title.

14.            Tax Withholding. The Company or any Affiliate, as applicable, shall have the right to (i) withhold from any cash payment under the Plan or any other compensation owed to a Participant an amount sufficient to cover any required withholding taxes related to the grant, vesting, exercise or settlement of an Award, and (ii) require a Participant or other person receiving Shares under the Plan to pay a cash amount sufficient to cover any required withholding taxes before actual receipt of those Shares. In lieu of all or any part of a cash payment from a person receiving Shares under the Plan, the Committee may permit the Participant to satisfy all or any part of the required tax withholding obligations (but not to exceed the maximum individual statutory tax rate in each applicable jurisdiction) by authorizing the Company to withhold a number of the Shares that would otherwise be delivered to the Participant pursuant to the Award, or by transferring to the Company Shares already owned by the Participant, with the Shares so withheld or delivered having a Fair Market Value on the date the taxes are required to be withheld equal to the amount of taxes to be withheld.

15.            Effective Date, Duration, Amendment and Termination of the Plan.

(a)            Effective Date. The Plan was adopted by the Board on April 28, 2021 and approved by the Company’s stockholders on May [•], 2021 (the “Effective Date”).

(b)            Duration of the Plan. The Plan shall remain in effect until all Shares subject to it are distributed, all Awards have expired or terminated, the Plan is terminated pursuant to Section 15(c), or the tenth anniversary of the Effective Date of the Plan, whichever occurs first (the “Termination Date”). Awards made before the Termination Date shall continue to be outstanding in accordance with their terms and the terms of the Plan unless otherwise provided in the applicable Award Agreements.

(c)            Amendment and Termination of the Plan. The Board may at any time terminate, suspend or amend the Plan. The Company shall submit any amendment of the Plan to its stockholders for approval only to the extent required by applicable laws or regulations or the rules of any securities exchange on which the Shares may then be listed. No termination, suspension, or amendment of the Plan may materially impair the rights of any Participant under a previously granted Award without the Participant's consent, unless such action is necessary to comply with applicable law or stock exchange rules.

(d)            Amendment of Awards. Subject to Section 15(e), the Committee may unilaterally amend the terms of any Award Agreement evidencing an Award previously granted, except that no such amendment may materially impair the rights of any Participant under the applicable Award without the Participant's consent, unless such amendment is necessary to comply with applicable law or stock exchange rules or any compensation recovery policy as provided in Section 16(i).

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(e)            No Option or SAR Repricing. Except as provided in Section 12(a), no Option or Stock Appreciation Right Award granted under the Plan may be (i) amended to decrease the exercise price thereof, (ii) cancelled in conjunction with the grant of any new Option or Stock Appreciation Right Award with a lower exercise price, (iii) cancelled in exchange for cash, other property or the grant of any Full Value Award at a time when the per share exercise price of the Option or Stock Appreciation Right Award is greater than the current Fair Market Value of a Share, or (iv) otherwise subject to any action that would be treated under accounting rules as a “repricing” of such Option or Stock Appreciation Right Award, unless such action is first approved by the Company’s stockholders.

16.            Other Provisions.

(a)            Unfunded Plan. The Plan shall be unfunded and the Company shall not be required to segregate any assets that may at any time be represented by Awards under the Plan. Neither the Company, its Affiliates, the Committee, nor the Board shall be deemed to be a trustee of any amounts to be paid under the Plan nor shall anything contained in the Plan or any action taken pursuant to its provisions create or be construed to create a fiduciary relationship between the Company and/or its Affiliates, and a Participant. To the extent any person has or acquires a right to receive a payment in connection with an Award under the Plan, this right shall be no greater than the right of an unsecured general creditor of the Company.

(b)            Limits of Liability. Except as may be required by law, neither the Company nor any member of the Board or of the Committee, nor any other person participating (including participation pursuant to a delegation of authority under Section 3(c) of the Plan) in any determination of any question under the Plan, or in the interpretation, administration or application of the Plan, shall have any liability to any party for any action taken, or not taken, in good faith under the Plan.

(c)            Compliance with Applicable Legal Requirements and Company Policies. No Shares distributable pursuant to the Plan shall be issued and delivered unless and until the issuance of the Shares complies with all applicable legal requirements, including compliance with the provisions of applicable state and federal securities laws, and the requirements of any securities exchanges on which the Company’s Shares may, at the time, be listed. During any period in which the offering and issuance of Shares under the Plan is not registered under federal or state securities laws, Participants shall acknowledge that they are acquiring Shares under the Plan for investment purposes and not for resale, and that Shares may not be transferred except pursuant to an effective registration statement under, or an exemption from the registration requirements of, such securities laws.  Any stock certificate or book-entry evidencing Shares issued under the Plan that are subject to securities law restrictions shall bear or be accompanied by an appropriate restrictive legend or stop transfer instruction. Notwithstanding any other provision of this Plan, the acquisition, holding or disposition of Shares acquired pursuant to the Plan shall in all events be subject to compliance with applicable Company policies, including those relating to insider trading, pledging or hedging transactions, minimum post-vesting holding periods and stock ownership guidelines, and to forfeiture or recovery of compensation as provided in Section 16(i).

(d)            Other Benefit and Compensation Programs. Payments and other benefits received by a Participant under an Award made pursuant to the Plan shall not be deemed a part of a Participant’s regular, recurring compensation for purposes of the termination, indemnity or severance pay laws of any country and shall not be included in, nor have any effect on, the determination of benefits under any other employee benefit plan, contract or similar arrangement provided by the Company or an Affiliate unless expressly so provided by such other plan, contract or arrangement, or unless the Committee expressly determines that an Award or portion of an Award should be included to accurately reflect competitive compensation practices or to recognize that an Award has been made in lieu of a portion of competitive cash compensation.

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(e)            Governing Law. To the extent that federal laws do not otherwise control, the Plan and all determinations made and actions taken pursuant to the Plan shall be governed by the laws of the State of Delaware without regard to its conflicts-of-law principles and shall be construed accordingly.

(f)            Severability. If any provision of the Plan shall be held illegal or invalid for any reason, the illegality or invalidity shall not affect the remaining parts of the Plan, and the Plan shall be construed and enforced as if the illegal or invalid provision had not been included.

(g)            Code Section 409A. It is intended that (i) all Awards of Options, SARs and Restricted Stock under the Plan will not provide for the deferral of compensation within the meaning of Code Section 409A and thereby be exempt from Code Section 409A, and (ii) all other Awards under the Plan will either not provide for the deferral of compensation within the meaning of Code Section 409A, or will comply with the requirements of Code Section 409A, and Awards shall be structured and the Plan administered and interpreted in accordance with this intent. The Plan and any Award Agreement may be unilaterally amended by the Company in any manner deemed necessary or advisable by the Committee or Board in order to maintain such exemption from or compliance with Code Section 409A, and any such amendment shall conclusively be presumed to be necessary to comply with applicable law. Notwithstanding anything to the contrary in the Plan or any Award agreement, with respect to any Award that constitutes a deferral of compensation subject to Code Section 409A:

(1)           If any amount is payable under such Award upon a termination of Service, a termination of Service will be deemed to have occurred only at such time as the Participant has experienced a “separation from service” as such term is defined for purposes of Code Section 409A;

(2)            If any amount shall be payable with respect to any such Award as a result of a Participant’s “separation from service” at such time as the Participant is a “specified employee” within the meaning of Code Section 409A, then no payment shall be made, except as permitted under Code Section 409A, prior to the first business day after the earlier of (i) the date that is six months after the Participant’s separation from service or (ii) the Participant’s death. Unless the Committee has adopted a specified employee identification policy as contemplated by Code Section 409A, specified employees will be identified in accordance with the default provisions specified under Code Section 409A.

None of the Company, the Board, the Committee nor any other person involved with the administration of this Plan shall (i) in any way be responsible for ensuring the exemption of any Award from, or compliance by any Award with, the requirements of Code Section 409A, (ii) have any obligation to design or administer the Plan or Awards granted thereunder in a manner that minimizes a Participant’s tax liabilities, including the avoidance of any additional tax liabilities under Code Section 409A, and (iii) shall have any liability to any Participant for any such tax liabilities.

(h)            Rule 16b-3. It is intended that the Plan and all Awards granted pursuant to it shall be administered by the Committee so as to permit the Plan and Awards to comply with Exchange Act Rule 16b-3. If any provision of the Plan or of any Award would otherwise frustrate or conflict with the intent expressed in this Section 16(h), that provision to the extent possible shall be interpreted and deemed amended in the manner determined by the Committee so as to avoid the conflict. To the extent of any remaining irreconcilable conflict with this intent, the provision shall be deemed void as applied to Participants subject to Section 16 of the Exchange Act to the extent permitted by law and in the manner deemed advisable by the Committee.

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(i)            Forfeiture and Compensation Recovery. Notwithstanding anything to the contrary contained herein, unless otherwise determined by the Committee or provided in an Award Agreement, all Awards granted under the Plan shall be and remain subject to any incentive compensation or clawback or recoupment policy currently in effect, as may be adopted by the Board or as may be required by applicable law, and, in each case, as may be amended from time to time. No such policy, adoption or amendment shall in any event required the prior consent of any Participant, and any Award Agreement may be unilaterally amended by the Committee to comply with any such compensation, clawback or recoupment policy. No recovery of compensation under such a clawback policy will be an event giving rise to a right to resign for “good reason” or “constructive termination” (or similar term) under any agreement with the Company or any of its Subsidiaries.

(j)            Data Privacy. As a condition of receipt of any Award, each Participant explicitly and unambiguously consents to the collection, use, and transfer, in electronic or other form, of personal data as described in this subsection by and among, as applicable, the Company and its Affiliates for the exclusive purpose of implementing, administering, and managing the Plan and Awards and the Participant’s participation in the Plan. In furtherance of such implementation, administration, and management, the Company and its Affiliates may hold certain personal information about a Participant, including, but not limited to, the Participant’s name, home address, telephone number, date of birth, social security or insurance number or other identification number, salary, nationality, job title(s), information regarding any securities of the Company and its Subsidiaries held by such Participant, and details of all Awards (the “Data”). In addition to transferring the Data amongst themselves as necessary for the purpose of implementation, administration, and management of a Participant’s participation in the Plan, the Company and each of its Affiliates may transfer the Data to any third parties assisting the Company in the implementation, administration, and management of the Plan and Awards and the Participant’s participation in the Plan. Recipients of the Data may be located in the Participant’s country or elsewhere, and the Participant’s country and any given recipient’s country may have different data privacy laws and protections. By accepting an Award, each Participant authorizes such recipients to receive, possess, use, retain, and transfer the Data, in electronic or other form, for the purposes of assisting the Company in the implementation, administration, and management of the Plan and Awards and such Participant’s participation in the Plan, including any requisite transfer of such Data as may be required to a broker or other third party with whom the Company or the Participant may elect to deposit any shares of Stock. The Data related to a Participant will be held only as long as is necessary to implement, administer, and manage the Plan and Awards and the Participant’s participation in the Plan. A Participant may, at any time, view the Data held by the Company with respect to such Participant, request additional information about the storage and processing of the Data with respect to such Participant, recommend any necessary corrections to the Data with respect to the Participant, or refuse or withdraw the consents herein in writing, in any case without cost, by contacting his or her local human resources representative. The Company may cancel the Participant’s eligibility to participate in the Plan, and, in the Committee’s discretion, the Participant may forfeit any outstanding Awards if the Participant refuses or withdraws the consents described herein. For more information on the consequences of refusal to consent or withdrawal of consent, Participants may contact their local human resources representative.

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EX-10.31

Exhibit 10.31

Appendix D

MIROMATRIX MEDICAL INC.

EMPLOYEE STOCK PURCHASE PLAN

1.              Purpose of the Plan. The purpose of this Miromatrix Medical Inc. Employee Stock Purchase Plan (the “Plan”) is to provide the employees of Miromatrix Medical Inc. (the “Company”) and its participating subsidiaries with a convenient means of purchasing shares of the Company’s common stock from time to time at a discount to market prices through the use of payroll deductions. The Company intends that the Plan shall qualify as an “employee stock purchase plan” under Section 423 of the Code.

2.              Definitions. The terms defined in this section are used (and capitalized) elsewhere in this Plan.

2.1.           “Affiliate” means each domestic or foreign entity that is a “parent corporation” or “subsidiary corporation” of the Company, as defined in Code Sections 424(e) and 424(f) or any successor provisions.

2.2 “Board” means the Board of Directors of the Company.

2.3            “Code” means the Internal Revenue Code of 1986, as amended and in effect from time to time. For purposes of the Plan, references to sections of the Code shall be deemed to include any applicable regulations thereunder and any successor or similar statutory provisions.

2.4            “Committee” means the Compensation Committee of the Board or such other committee of non-employee directors appointed by the Board to administer the Plan as provided in Section 13.

2.5            “Common Stock” means the common stock, par value $0.00001 per share, of the Company.

2.6 “Company” means Miromatrix Medical Inc., a Delaware corporation.

2.7            “Corporate Transaction” means (i) a merger, consolidation or other reorganization of the Company with or into another corporation, or (ii) the sale of all or substantially all of the assets of the Company.

2.8            “Designated Affiliate” means any Affiliate which has been expressly designated by the Board or Committee as a corporation whose Eligible Employees may participate in the Plan.

2.9            “Eligible Compensation” means the total cash compensation (including wages, salary, commission, bonus, and overtime earnings) paid by the Company or any Affiliate to a Participant in accordance with the Participant’s terms of employment, but shall not include any employer contributions to a 401(k) or other retirement plan, any expense reimbursements or allowances, or any income (whether paid in Shares or cash) realized by the Participant as a result of participation in any equity-based compensation plan of the Company or any Affiliate.

2.10          “Eligible Employee” means any employee of the Company or a Designated Affiliate, except for any employee who, immediately after a right to purchase is granted under the Plan, would be deemed, for purposes of Code Section 423(b)(3), to own stock possessing 5% or more of the total combined voting power or value of all classes of stock of the Company or any Affiliate. Notwithstanding the foregoing, with respect to any Offering, the Committee may provide for the exclusion of certain employees within the limitations described in Treasury Regulations §1.423-2(e)(1), (2) and (3).

2.11          “Exchange Act” means the Securities Exchange Act of 1934, as amended from time to time, and the regulations promulgated thereunder.

2.12          “Fair Market Value” of a Share of Common Stock as of any date means (i) if the Company’s Common Stock is then listed on a national securities exchange, the closing sale price for a Share on such exchange on said date, or, if no sale has been made on such exchange on said date, on the last preceding day on which any sale shall have been made; (ii) if the Company’s Common Stock is not then listed on a national securities exchange, such value as the Committee in its discretion may in good faith determine. The determination of Fair Market Value shall be subject to adjustment as provided in Section 14.1.

2.13          “Offering” means the right provided to Participants to purchase Shares under the Plan with respect to a Purchase Period.

2.14          “Offering Date” means the first Trading Day of a Purchase Period.

2.15          “Participant” means an Eligible Employee who has elected to participate in the Plan in the manner set forth in Section 4 and whose participation has not ended pursuant to Section 8.1 or Section 9.

2.16          “Plan” means this Miromatrix Medical Inc. Employee Stock Purchase Plan, as it may be amended from time to time.

2.17          “Purchase Date” means the last Trading Day of a Purchase Period.

2.18          “Purchase Period” means a period of time (but not to exceed 27 months or such longer period as may be permitted under Code Section 423) commencing on such date as may be established by the Committee under the Plan.

2.19          “Recordkeeping Account” means the account maintained in the books and records of the Company recording the amount contributed to the Plan by each Participant through payroll deductions.

2.20          “Shares” means shares of Common Stock.

2.21          “Trading Day” means a day on which the national stock exchanges in the United States are open for trading.

3.              Shares Available. Subject to adjustment as provided in Section 14.1, the maximum number of Shares that may be sold by the Company to Eligible Employees under the Plan shall be 300,000 Shares, plus an automatic annual increase in such amount on January 1 of each year beginning on January 1, 2022 and ending on (and including) January 1, 2031 equal to the lesser of: (i) 1% of the total number of Shares outstanding as of December 31 of the immediately preceding calendar year, or (ii) 200,000 Shares, provided, however, that the Board may determine that any annual increase shall be for a number of Shares that is less than the number of Shares determined by the application of clauses (i) and (ii). If the purchases by all Participants in an Offering would otherwise cause the aggregate number of Shares to be sold under the Plan to exceed the number specified in this Section 3, each Participant in that Offering shall be allocated a ratable portion of the remaining number of Shares which may be sold under the Plan.

4.              Eligibility and Participation. To be eligible to participate in the Plan for a given Purchase Period, an employee must be an Eligible Employee on the first day of such Purchase Period. An Eligible Employee may elect to participate in the Plan by filing an election form with the Company before the Offering Date for a Purchase Period that authorizes regular payroll deductions from Eligible Compensation beginning with the first payday in such Purchase Period and continuing until the Plan is terminated or the Eligible Employee withdraws from the Plan, modifies his or her authorization, or ceases to be an Eligible Employee, as hereinafter provided.

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5.              Amount of Common Stock Each Eligible Employee May Purchase.

5.1.           Purchase Amounts and Limitations. Subject to the provisions of this Plan, each Participant shall be offered the right to purchase on the Purchase Date the maximum number of whole Shares that can be purchased with the balance in the Participant’s Recordkeeping Account at the per Share price specified in Section 5.2. Notwithstanding the foregoing, no Participant shall be entitled to:

(a)              the right to purchase Shares under this Plan and all other employee stock purchase plans (within the meaning of Code Section 423(b)), if any, of the Company and its Affiliates that accrues at a rate which in the aggregate exceeds $25,000 of Fair Market Value (determined on the Offering Date of a Purchase Period when the right is granted) for each calendar year in which such right is outstanding at any time; or

(b)              purchase more than 10,000 Shares in any Offering under this Plan, such limit subject to adjustment from time to time as provided in Section 14.1.

5.2.           Purchase Price. Unless a greater purchase price is established by the Committee for an Offering prior to the commencement of the applicable Purchase Period, the purchase price of each Share sold pursuant to this Plan will be the lesser of (i) 85% of the Fair Market Value of such Share on the Offering Date of the applicable Purchase Period, or (ii) 85% of the Fair Market Value of such Share on the Purchase Date.

6.              Method of Participation.

6.1.           Notice and Date of Grant. The Company shall give notice to each Eligible Employee of the opportunity to purchase Shares pursuant to this Plan and the terms and conditions of such Offering. The Company contemplates that for tax purposes the Offering Date for a Purchase Period will be considered the date of the grant of the right to purchase such Shares.

6.2.           Contribution Elections. Each Eligible Employee who desires to participate in the Plan for a Purchase Period shall signify his or her election to do so by signing and filing with the Company an election form approved by the Committee. An Eligible Employee may elect to have any whole percent of Eligible Compensation (that is, 1%, 2%, 3%, etc.) withheld as a payroll deduction, but not exceeding 15% per pay period (or such other maximum percentage as the Committee may establish from time to time prior to the commencement of an Offering). An election to participate in the Plan and to authorize payroll deductions as described herein must be made before the Offering Date of a Purchase Period, and shall be effective beginning with the first payday in the Purchase Period immediately following the filing of such election form. Any election form submitted shall remain in effect until the Plan is terminated or such Participant withdraws from the Plan, modifies his or her authorization, or ceases to be an Eligible Employee, as hereinafter provided.

6.3            Additional Contributions. If specifically provided by the Committee in connection with an Offering (including for purposes of complying with applicable local law), in addition to or instead of making contributions by payroll deductions, a Participant may make additional contributions to his or her Recordkeeping Account through the payment by cash or check prior to a Purchase Date. A Participant may make such additional contributions into his or her Recordkeeping Account only if the Participant has not already had the maximum permitted amount withheld during the Offering through payroll deductions, subject to the limitations set forth in Section 5.1.

6.4.           Offering Terms and Conditions. Each Offering shall consist of a single Purchase Period and shall be in such form and shall contain such terms and conditions as the Committee shall deem appropriate, consistent with the terms of the Plan. The Committee may provide for separate Offerings for different Designated Affiliates, and the terms and conditions of the separate Offerings, including the applicable Purchase Period, need not be consistent. Any Offering shall comply with the requirement of Code Section 423 that all Participants shall have the same rights and privileges for such Offering. The terms and conditions of any Offering shall be incorporated by reference into the Plan and treated as part of the Plan.

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7.              Recordkeeping Accounts.

7.1.           Crediting Payroll Deduction Contributions. The Company shall maintain a Recordkeeping Account for each Participant. Payroll deductions pursuant to Section 6 will be credited to such Recordkeeping Accounts on each payday.

7.2.           No Interest Payable. No interest will be credited to a Participant’s Recordkeeping Account (unless required under local law).

7.3.           No Segregation of Accounts. The Recordkeeping Account is established solely for accounting purposes, and all amounts credited to the Recordkeeping Account will remain part of the general assets of the Company and need not be segregated from other corporate funds (unless required under local law).

7.4.           Additional Contributions. A Participant may not make any separate cash payment into a Recordkeeping Account, except as may be permitted in accordance with Section 6.3, and any such additional contributions will be credited to the Recordkeeping Accounts when received by the Company.

8.              Right to Adjust Participation; Withdrawals from Recordkeeping Account.

8.1.           Withdrawal from Plan. A Participant may at any time withdraw from the Plan. If a Participant withdraws from the Plan, the Company will pay to the Participant in cash the entire balance in such Participant’s Recordkeeping Account and no further deductions will be made from the Participant’s Eligible Compensation during such Purchase Period. A Participant who withdraws from the Plan will not be eligible to reenter the Plan until the next succeeding Purchase Period, and any such reentry shall be through the enrollment process described in Section 6.2.

8.2.           Adjusting Level of Participation. A Participant may adjust his or her rate of payroll deduction contributions to the Plan as follows:

(a)              A Participant may, by written notice, direct the Company to increase or decrease his or her rate of payroll deduction contributions, with such change to be effective as of the first day of the next Purchase Period.

(b)              A Participant may, by written notice, direct the Company to decrease his or her rate of payroll deduction contributions for a Purchase Period (including a decrease to 0%) one time during the applicable Purchase Period, with such change to become effective as soon as reasonably practicable. Any Participant who has decreased his or her rate of payroll deductions to 0% and does not increase such rate of payroll deductions from 0% to at least 1% in accordance with Section 8.2(a) prior to the start of the next Purchase Period will be withdrawn from the Plan effective as of the first day of that next Purchase Period.

8.3.           Submission of Notices. Notification of a Participant’s election to withdraw from the Plan as provided in Section 8.1 or to change his or her rate of payroll deductions as provided in Section 8.2 shall be made by signing and submitting to the Company an appropriate form for that purpose approved by the Committee. The Committee may promulgate rules regarding the time and manner for submitting any such written notice, which may include a requirement that the notice be on file with the Company’s designated office for a reasonable period before it will be effective.

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8.4            Adjustments by Company. To the extent necessary to comply with Section 423(b)(8) of the Code or Section 5.1 of the Plan, a Participant’s payroll deduction contributions to the Plan may be decreased by the Company to 0% at any time during a Purchase Period.

9.              Termination of Employment. If the employment of a Participant is terminated for any reason, including death, disability, or retirement, the entire balance in the Participant’s Recordkeeping Account will be refunded in cash to the Participant within 30 days after the date of termination of employment. For purposes of the Plan, a Participant will not be deemed to have terminated employment while the Participant is on sick leave, military leave or other leave of absence approved by the Company. Where the period of leave exceeds 90 days and the Participant’s right to reemployment is not guaranteed either by statute or by contract, the employment relationship shall be deemed to have terminated on the ninety-first day of such leave.

10.            Purchase of Shares.

10.1.         Number of Shares Purchased. As of each Purchase Date, the balance in each Participant’s Recordkeeping Account will be used to purchase the maximum number of whole Shares (subject to the limitations of Section 5.1) at the purchase price determined in accordance with Section 5.2, unless the Participant has filed an appropriate form with the Company in advance of that date to withdraw from the Plan in accordance with Section 8.1. Any amount remaining in a Participant’s Recordkeeping Account that represents the purchase price for any fractional share will be carried over in the Participant’s Recordkeeping Account to the next Purchase Period. Any amount remaining in a Participant’s Recordkeeping Account that represents the purchase price for any whole Shares that could not be purchased by reason of the limitations of Section 5.1 or under the circumstances described in Section 3 will be refunded to the Participant.

10.2.         Conversion of Foreign Currency. In circumstances where payroll deductions have been taken from a Participant’s Eligible Compensation in a currency other than United States dollars, Shares shall be purchased by converting the balance in the Participant’s Recordkeeping Account to United States dollars at the exchange rate in effect at the end of the fifth Trading Day preceding the Purchase Date, as published by Bloomberg.com if available or otherwise as determined with respect to a particular jurisdiction by the Committee or its delegate for this purpose, and such dollar amount shall be used to purchase Shares as of the Purchase Date.

10.3.         Crediting of Shares. Promptly after the end of each Purchase Period, the number of Shares purchased by all Participants as of the applicable Purchase Date shall be issued and delivered to an agent selected by the Company. Delivery of the shares to the agent shall be effected by an appropriate book-entry in the stock register maintained by the Company’s transfer agent or delivery of a certificate. The agent will hold the Shares for the benefit of all Participants who have purchased Shares and will maintain a Share subaccount for each Participant reflecting the number of Shares credited to each Participant. Each Participant will be entitled to direct the voting by the agent of all Shares credited to such Participant’s Share subaccount, and the agent may reinvest any dividends paid on Shares credited to a Participant’s Share subaccount in additional Shares in accordance with such rules as the Committee may prescribe. Each Participant may also direct the agent to sell any or all of the Shares credited to the Participant’s Share subaccount and distribute the net proceeds of such sale to the Participant.

10.4          Withdrawal of Shares from Share Subaccount. Except for sales through the agent as provided in Section 10.3, a Participant may not withdraw Shares from the Participant’s Share subaccount until after the Participant has satisfied the minimum holding period requirements established by Code Section 423(a)(1). Once these holding period requirements have been satisfied with respect to Shares credited to a Participant’s Share subaccount, the Participant may request that the agent transfer any or all of those Shares directly to the Participant or to a brokerage account maintained by the Participant. The agent shall deliver the requested number of whole Shares by the issuance of a stock certificate, the electronic delivery of the Shares to a brokerage account designated by the Participant, or an appropriate book-entry in the stock register maintained by the Company’s transfer agent with a notice of issuance provided to the Participant, and will pay the Participant a cash amount representing the Fair Market Value of any applicable fractional Share withdrawn.

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11.            Rights as a Shareholder. A Participant shall not be entitled to any of the rights or privileges of a shareholder of the Company with respect to Shares, including the right to vote or direct the voting or to receive any dividends that may be declared by the Company, until (i) the Participant actually has paid the purchase price for such Shares and (ii) certificates for such Shares have been issued either to the agent or to the Participant, as provided in Section 10.3.

12.            Rights Not Transferable. A Participant’s rights under this Plan are exercisable only by the Participant during his or her lifetime, and may not be sold, pledged, assigned, transferred or disposed of in any manner other than by will or the laws of descent and distribution. Any attempt to sell, pledge, assign, transfer or dispose of the same shall be void and without effect. The amounts credited to a Recordkeeping Account may not be sold, pledged, assigned, transferred or disposed of in any way, and any attempted sale, pledge, assignment, transfer or other disposition of such amounts will be void and without effect.

13.            Administration of the Plan.

13.1.         Authority of the Committee. This Plan shall be administered by the Committee. Subject to the express provisions of the Plan and applicable law, and in addition to other express powers and authorizations conferred on the Committee by the Plan, the Committee shall have full power and authority to:

(a)              Determine when each Purchase Period under this Plan shall occur, and the terms and conditions of each related Offering (which need not be identical);

(b)              Designate from time to time which Affiliates of the Company shall be eligible to participate in the Plan;

(c)              Construe and interpret the Plan and establish, amend and revoke rules, regulations and procedures for the administration of the Plan. The Committee may, in the exercise of this power, correct any defect, omission or inconsistency in the Plan, in such manner and to the extent it may deem necessary, desirable or appropriate to make the Plan fully effective;

(d)              Exercise such powers and perform such acts as the Committee may deem necessary, desirable or appropriate to promote the best interests of the Company and its Designated Affiliates and to carry out the intent that the Offerings made under the Plan are treated as qualifying under Code Section 423(b);

(e)              As more fully described in Section 18, to adopt such rules, procedures and sub-plans as may be necessary, desirable or appropriate to permit participation in the Plan by employees who are foreign nationals or employed outside the United States by a non-U.S. Designated Affiliate, and to achieve tax, securities law and other compliance objectives in particular locations outside the United States; and

(f)              Adopt and amend as the Committee deems appropriate a Plan rule specifying that Shares purchased by a Participant during a Purchase Period may not be sold by the Participant for a specified period of time after the Purchase Date on which the Shares were purchased by the Participant, and establish such procedures as the Committee may deem necessary to implement such rule.

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13.2.         Interpretations and Decisions by the Committee. Unless otherwise expressly provided in the Plan, all designations, determinations, interpretations, and other decisions under or with respect to the Plan shall be within the sole discretion of the Committee, may be made at any time and shall be final, conclusive, and binding upon all persons, including the Company, any Affiliate, any Participant and any Eligible Employee.

13.3.         Delegation by the Committee. Subject to the terms of the Plan and applicable law, the Committee may delegate ministerial duties associated with the administration of the Plan to such of the Company’s officers, employees or agents as the Committee may determine.

13.4.         Indemnification. No member of the Board or Committee shall be liable for any action taken or determination made in good faith with respect to the Plan. In addition to such other rights of indemnification as they may have as members of the Board or officers or employees of the Company or a Designated Affiliate, members of the Board and Committee and any officers or employees of the Company or Designated Affiliate to whom authority to act for the Committee is delegated shall be indemnified by the Company from and against any and all liabilities, costs and expenses incurred by such persons as a result of any act or omission to act in connection with the performance of such person’s duties, responsibilities and obligations under the Plan if such person has acted in good faith and in a manner that he or she reasonably believes to be in, or not opposed to, the best interests of the Company.

14.            Changes in Capitalization and Corporate Transactions.

14.1.         Adjustments. In the event of any change in the Common Stock of the Company by reason of a stock dividend, stock split, reverse stock split, corporate separation, recapitalization, merger, consolidation, combination, exchange of shares and the like, the Committee shall make such equitable adjustments as it deems appropriate in the aggregate number and class of Shares or other securities available under this Plan, the Share limitation expressed in Section 5.1(b) of the Plan, and the number, class and purchase price of Shares or other securities subject to purchase under any pending Offering.

14.2.         Corporate Transactions. In the event of a Corporate Transaction, each right to acquire Shares on any Purchase Date that is scheduled to occur after the date of the consummation of the Corporate Transaction may be continued or assumed or an equivalent right may be substituted by the surviving or successor corporation or a parent or subsidiary of such corporation. If such surviving or successor corporation or parent or subsidiary thereof refuses to continue, assume or substitute for such outstanding rights, then the Board may, in its discretion, either terminate the Plan or shorten the Purchase Period then in progress by setting a new Purchase Date for a specified date before the date of the consummation of the Corporate Transaction. Each Participant shall be notified in writing, prior to any new Purchase Date, that the Purchase Date for the existing Offering has been changed to the new Purchase Date and that the Participant’s right to acquire Shares will be exercised automatically on the new Purchase Date unless prior to such date the Participant’s employment has been terminated or the Participant has withdrawn from the Plan. In the event of a dissolution or liquidation of the Company, any Offering and Purchase Period then in progress will terminate immediately prior to the consummation of such action, unless otherwise provided by the Board.

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15.            Amendment or Suspension of Plan. The Board may at any time suspend this Plan or amend it in any respect, but no such amendment may, without shareholder approval, increase the number of shares reserved under this Plan, increase the rate of automatic annual increase in the number of shares reserved as provided in Section 3, or effect any other change in the Plan that would require shareholder approval under applicable law or regulations or the rules of any securities exchange on which the Shares may then be listed, or to maintain compliance with Code Section 423. No such amendment or suspension shall adversely affect the rights of Participants pursuant to Shares previously acquired under the Plan. During any suspension of the Plan, no new Offering or Purchase Period shall begin and no Eligible Employee shall be offered any new right to purchase Shares under the Plan or any opportunity to elect to participate in the Plan, and any existing payroll deduction authorizations shall be suspended, but any such right to purchase Shares previously granted for a Purchase Period that began prior to the Plan suspension shall remain subject to the other provisions of this Plan and the discretion of the Board and the Committee with respect thereto.

16.            Effective Date and Term of Plan. The Plan was adopted by the Board of Directors of the Company on April 28, 2021, and approved by the shareholders of the Company on May [•], 2021. The Plan will become effective on the effective date of the Company’s registration statement on Form S-1 for the initial public offering of the Common Stock. The Plan and all rights of Participants hereunder shall terminate (i) at any time, at the discretion of the Board of Directors, or (ii) upon the completion of any Offering under which the limitation on the total number of shares to be issued during the entire term of the Plan, as determined in accordance with Section 3 and including the annual increased provided thereby, has been reached. Except as otherwise determined by the Board, upon termination of this Plan, the Company shall pay to each Participant cash in an amount equal to the entire remaining balance in such Participant’s Recordkeeping Account.

17.            Governmental Regulations and Listing. All rights granted or to be granted to Eligible Employees under this Plan are expressly subject to all applicable laws and regulations and to the approval of all governmental authorities required in connection with the authorization, issuance, sale or transfer of the Shares reserved for this Plan, including, without limitation, there being a current registration statement of the Company under the Securities Act of 1933, as amended, covering the Shares purchasable on the Purchase Date applicable to such Shares, and if such a registration statement shall not then be effective, the term of such Purchase Period shall be extended until the first Trading Day after the effective date of such a registration statement, or post-effective amendment thereto. If applicable, all such rights hereunder are also similarly subject to effectiveness of an appropriate listing application to a national securities exchange covering the Shares issuable under the Plan upon official notice of issuance.

18.            Rules for Foreign Jurisdictions. The Committee may adopt rules, procedures or subplans relating to the operation and administration of the Plan to accommodate the specific requirements of local laws and procedures. Without limiting the generality of the foregoing, the Committee is specifically authorized to adopt rules and procedures regarding handling of payroll deductions, payment of interest, conversion of local currency, payroll tax, the definition of Eligible Compensation, withholding procedures and handling of stock certificates that vary with local requirements.

19.            Miscellaneous.

19.1.         Effect on Employment Status. This Plan shall not be deemed to constitute a contract of employment between the Company and any Participant, nor shall it interfere with the right of the Company to terminate the employment of any Participant and treat him or her without regard to the effect that such treatment might have upon him or her under this Plan.

19.2.         Governing Law. This Plan, and all agreements hereunder, shall be construed in accordance with and governed by the laws of the State of Delaware.

19.3.         Electronic Documentation and Signatures. Any reference in the Plan to election or enrollment forms, notices, authorizations or any other document to be provided in writing shall include the provision of any such form, notice, authorization or document by electronic means, including through the Company’s intranet, and any reference in the Plan to the signing of any document shall include the authentication of any such document provided in electronic form, in each case in accordance with procedures established by the Committee.

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19.4.         Book-Entry and Electronic Transfer of Shares. Any reference in this Plan to the issuance or transfer of a stock certificate evidencing Shares shall be deemed to include, in the Committee’s discretion, the issuance or transfer of such Shares in book-entry or electronic form. Uncertificated Shares shall be deemed delivered for all purposes of this Plan when the Company or its agent shall have provided to the recipient of the Shares a notice of issuance or transfer by electronic mail (with proof of receipt) or by United States mail, and have recorded the issuance or transfer in its records.

19.5.         Registration of Share Accounts and Certificates. Any Share account contemplated by Section 10.3 and certificate to be issued to a Participant shall be registered in the name of the Participant, or jointly in the name of the Participant and another person, as the Participant may direct on an appropriate form filed with the Company or the agent.

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EX-23.1

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the use in this Registration Statement on Form S-1 of Miromatrix Medical Inc. of our report dated March 26, 2021, relating to the financial statements as of December 31, 2020 and 2019 and for the years then ended, and to the reference to our Firm under the caption "Experts".

/s/ BAKER TILLY US, LLP

Minneapolis, Minnesota

May 27, 2021