As filed with the Securities and Exchange Commission on November 18, 2022
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
COYA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware |
|
|
2834 |
|
|
85-4017781 |
(State or other jurisdiction of incorporation or organization) |
|
|
(Primary Standard Industrial Classification Code Number) |
|
|
(I.R.S. Employer Identification Number) |
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
(800) 587-8170
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Howard Berman
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
(800) 587-8170
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)
Copies to:
Michael J. Lerner Steven M. Skolnick Lowenstein Sandler LLP 1251 Avenue of the Americas New York, New York 10020 (212) 262-6700
|
|
|
Stephen E. Older David S. Wolpa McGuireWoods LLP 1251 Avenue of the Americas, 20th Floor New York, New York 10020 212-548-2100
|
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, 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, 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. ☐
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 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. We may not sell these securities 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
PRELIMINARY PROSPECTUS, DATED NOVEMBER 18, 2022
Shares
Common Stock
$ per share
This is the initial public offering of shares of common stock of Coya Therapeutics, Inc.
We are offering shares of our common stock. It is currently estimated that the initial public offering price per share of common stock will be between $ and $ . Prior to this offering, there has been no public market for our common stock. We have applied to list our common stock on the Nasdaq Capital Market under the symbol “COYA.” No assurance can be given that our application will be approved. If our common stock is not approved for listing on the Nasdaq Capital Market, we will not consummate this offering.
We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, and will be subject to reduced public company reporting requirements. This prospectus complies with the requirements that apply to an issuer that is an emerging growth company. See “Summary—Implications of Being an Emerging Growth Company and Smaller Reporting Company.”
Investing in our common stock is highly speculative and involves a high degree of risk. See “Risk Factors” beginning on page 9.
Neither the Securities and Exchange Commission nor any other regulatory body 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.
|
|
Per Share |
|
|
Total |
|
||
Public offering price |
|
$ |
|
|
|
$ |
|
|
Underwriting discount and commissions(a) |
|
$ |
|
|
|
$ |
|
|
Proceeds, before expenses, to us |
|
$ |
|
|
|
$ |
|
|
(a) |
Underwriting discounts and commissions do not include the reimbursement of certain expenses of the underwriters we have agreed to pay and certain other compensation. See “Underwriting” for a complete description on the compensation payable to the underwriters. |
We have granted the underwriters the option for a period of 30 days to purchase up to an additional shares of common stock at the initial price to the public less the underwriting discount and commissions. If the underwriters exercise this option in full, the total underwriting discounts and commissions will be $ and the additional proceeds to us, before expenses, from the over-allotment option exercise will be $ .
The underwriters expect to deliver the shares against payment in New York, New York on , 2022 through the book-entry facilities of The Depository Trust Company.
Chardan |
Newbridge Securities Corporation |
Prospectus dated , 2022
|
Page |
ii |
|
1 |
|
5 |
|
7 |
|
9 |
|
48 |
|
49 |
|
50 |
|
51 |
|
53 |
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
55 |
68 |
|
102 |
|
107 |
|
113 |
|
115 |
|
118 |
|
119 |
|
126 |
|
128 |
|
129 |
|
132 |
|
132 |
|
133 |
|
F-1 |
Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any related free writing prospectuses. Neither we nor the underwriters take 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 of common stock offered by this prospectus, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date regardless of the time of delivery of this prospectus or any sale of shares of common stock. Our business, financial condition, results of operations and prospects may have changed since that date.
For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or the 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. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside the United States. See “Underwriting.”
i
Basis of Presentation
On December 22, 2020, we consummated the corporate reorganization as described in this prospectus under the section titled “Certain Relationships and Related Party Transactions—Corporate Reorganization with Nicoya Health, Inc.,” pursuant to which all of the issued and outstanding stock of Nicoya Health, Inc., a Delaware corporation formed in 2020, were exchanged for common stock or preferred stock, as applicable, of Coya Therapeutics, Inc., the issuer of the common stock being offered in this offering (the “Corporate Reorganization”).
The Corporate Reorganization is accounted for as a recapitalization for accounting purposes, with Nicoya Health, Inc. as the predecessor entity. For periods and at dates prior to the Corporate Reorganization, the financial statements included in this prospectus were prepared based on the historical financial statements of Nicoya Health, Inc., adjusted to give retroactive effect to the share exchange transaction for all periods presented.
Certain monetary amounts, percentages and other figures included in this prospectus have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables or charts may not be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.
Market, Industry, and Other Data
This prospectus includes statistics and other data relating to markets, market sizes and other industry data pertaining to our business that we have obtained from industry publications, surveys and other information available to us as well as our own estimates based on our management’s knowledge of, and experience in, the industry and markets in which we compete. Industry publications and surveys generally state that the information contained therein has been obtained from sources believed to be reliable. Although we have not independently verified the accuracy or completeness of the data contained in these industry publications and reports, based on our industry experience we believe that the publications are reliable, the conclusions contained in the publications and reports are reasonable and the third-party information included in this prospectus and in our estimates is accurate and complete. Nevertheless, market data and statistics are inherently predictive and speculative and are not necessarily reflective of actual market conditions. Such statistics are based on market research, which itself is based on sampling and subjective judgments by both the researchers and the respondents, including judgments about what types of products and transactions should be included in the relevant market. In addition, the value of comparisons of statistics for different markets is limited by many factors, including that (i) the markets are defined differently, (ii) the underlying information was gathered by different methods, and (iii) different assumptions were applied in compiling the data. Accordingly, the market statistics included in this prospectus should be viewed with caution. We believe that information from these industry publications included in this prospectus is reliable.
Trademarks, Service Marks, and Trade Names
This prospectus includes our trademarks, and trade names, including but not limited to Coya and Coya Therapeutics, which are protected under applicable intellectual property laws. This prospectus also may contain trademarks, service marks, trade names, and copyrights of other companies, which are the property of their respective owners. Solely for convenience, the trademarks, service marks, trade names, and copyrights referred to in this prospectus are listed without the TM, SM, ©, and ® symbols, but we will assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors, if any, to these trademarks, service marks, trade names, and copyrights.
ii
This summary highlights information contained elsewhere in this prospectus. This summary may not contain all of the information that you should consider before deciding to invest in shares of our common stock. You should read this entire prospectus carefully, including the “Risk Factors” section immediately following this summary, “Cautionary Statement Regarding Forward-Looking Statements,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and the financial statements and related notes thereto included elsewhere in this prospectus, before making an investment decision to purchase shares of our common stock. Unless the context otherwise requires, all references to “Coya,” “we,” “us,” “our,” the “Company” and similar designations refer to Coya Therapeutics, Inc., a Delaware company.
We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells (“Tregs”). Tregs consist of CD4+CD25high hFOXP3+ cells, which are a subpopulation of T-lymphocytes, a type of white blood cell that suppresses inflammatory responses. Tregs were first discovered in 1995 by Dr. Shimon Sakaguchi and since their discovery, multiple lines of research have contributed to elucidate Treg biology and its role in health and disease. Tregs and their transcription factors have been shown to be essential to maintaining cellular homeostasis by regulating autoimmune and inflammatory responses and maintaining self-tolerance in mammals. Self-tolerance is the ability of the immune system to recognize self-produced substances as a non-threat while appropriately mounting a response to foreign substances. Dysfunctional Tregs underlie numerous disease states, and this cellular dysfunction is driven by the chronic inflammatory environment and high levels of oxidative stress, an imbalance between free radicals and antioxidants in the body, commonly observed in certain diseases. Further, the degree of Treg dysfunction is correlated with the severity and progression of serious and life-threatening conditions. These and other recent advances in the understanding of Treg biology, have made this subset of T lymphocytes an important therapeutic target, which we believe may provide new treatments for serious diseases.
We have built a diversified product candidate pipeline that includes both ex vivo (outside the body) and in vivo (inside the body) therapeutic approaches intended to restore the suppressive and immunomodulatory functions of Tregs. Our product candidate pipeline is based on our three distinct therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes (tiny sac-like structures that are formed inside a cell and contain some of the cell’s proteins, lipids, and nucleic acids); and (3) autologous (obtained from the same individual) Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301 and COYA 302, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101.
We are initially focused on developing our Treg-based therapies for neurodegenerative, autoimmune and metabolic diseases where Treg dysfunction has been identified to be an important pathophysiological component of the disease and where new and effective therapies are urgently needed.
Since our inception in late 2020, we have generated preclinical and clinical data in multiple models and diseases. Our autologous Treg cell therapy program completed a Phase 1 study in 2017 and a Phase 2a study in 2021 in amyotrophic lateral sclerosis, or ALS. At the completion of the Phase 2a trial, we conducted a Pre-Investigational New Drug (“IND”) Application meeting with the U.S. Food and Drug Administration (the “FDA”) in Q4, 2021 in anticipation of a Phase 2b trial. In June 2021, we were granted an orphan drug designation (“ODD”) by the FDA for the active moiety (principal molecular structure) for our autologous Treg cell therapy in the treatment of ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline.
We are developing multiple product candidates, COYA 301, COYA 302, COYA 201, COYA 206, and COYA 101, each using one of our three therapeutic modalities: (i) biologics, (ii) Treg-derived exosomes, and (iii) autologous regulatory T-cells. COYA 301 is a biologic for subcutaneous administration, and we are currently conducting chemistry, manufacturing, and controls (“CMC”) activities and investigational new drug (“IND”) enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for the treatment of frontotemporal dementia (“FTD”). Our other biologic product candidate, COYA 302, is a combination of two large molecules for subcutaneous and/or intravenous administration. We are currently conducting CMC activities and IND enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for COYA 302 for the treatment of neurodegenerative and autoimmune diseases.
Our COYA 201 product candidate utilizes our Treg-derived exosome therapeutic modality. For COYA 201, we are currently completing animal model studies and will conduct pharmacology, toxicology and other IND-enabling studies to support the initiation of clinical trials in neurodegenerative, autoimmune and metabolic diseases. We will test a variety of doses in these models to assess safety, tolerability, and pharmacology. In an early pilot preclinical lupus nephritis mouse study conducted in the first half of 2022, COYA 201 (Treg exosomes) appeared to be well tolerated at the administered dose of 1x1010 exosomes (low dosage level). At the highest dose of 1x1011 administered twice weekly (or ten times the low dosage level), death in six animals (out of a total of 12 animals) was observed. Dose escalation studies are standard in the early development of new treatments and the identification of the “maximum
1
tolerated dose” and the “LD50”, the dose that produces lethality in 50% of animals, are common studies in early preclinical development. The primary endpoint of this study was proteinuria (amount of protein in urine) to assess renal function. The primary endpoint was not met. In a second study conducted in the third quarter of 2022, COYA 201 (Treg-derived exosomes) was studied in a humanized in vitro model of liver inflammation and fibrosis. The primary objectives of the study were to assess the biological activity of COYA 201 by evaluating inflammation, measured by the levels of released pro-inflammatory cytokines, and fibrosis, measured by the release of procollagen by the hepatic cells. We observed a significant decrease in the secretion of pro-inflammatory cytokines and a significant increase in the secretion of anti-inflammatory cytokines following administration of COYA 201, compared to the untreated controls. The study met its primary objectives by demonstrating that COYA 201 was biologically active in this model. To date, we have not observed any signs of toxicity in this cellular model.
In a third study of COYA 201, that is currently ongoing, we are evaluating Treg-derived exosomes in an initial preclinical model of scleroderma. The primary endpoint of this study is lung fibrosis, assessed by lung histopathology of exposed animals at the end of the study, compared to controls. We are currently conducting analyses of the tissue from this study. This study is ongoing and it is too early to establish any signals of toxicity in this model. In addition, we are in early stages of development of COYA 206 utilizing licensed proprietary technology from Carnegie Mellon University. We believe this technology has the potential to produce antigen-directed exosomes without performing genetic manipulation, which we believe may result in easier and more efficient manufacturing, compared to genetically modified products.
Lastly, COYA 101 is our autologous regulatory T-cell product candidate. COYA 101 completed a Phase 2a clinical trial in ALS in May 2021. The primary endpoint of the Phase 2a study was the change in Treg suppressive function at the end of the study compared to baseline values. COYA101 was well tolerated. No death occurred over the course of the study and no serious adverse event was considered to be related to the investigational product. We currently believe we are best served by utilizing our available cash to advance each of COYA 301, COYA 302, COYA 201 and COYA 206 before commencing a Phase 2b clinical trial of COYA 101. The costs associated with such a Phase 2b trial would significantly impede our ability to advance COYA 301, COYA 302, COYA 201 and COYA 206 before we can reasonably judge which product candidates and which therapeutic modalities may have the most potential. However, to manage these circumstances, we intend to apply for grant funding to advance COYA 101 into a Phase 2b trial. In the event we receive such grant funding, or we receive other non-dilutive financing from some other source, we would expect to begin the Phase 2b of COYA 101 but would incur Phase 2b clinical trial expenses for COYA 101 not otherwise covered by the non-dilutive financing. We believe that the expenses required to advance COYA 101, net of any grant amounts, would be limited and that we may continue to make appropriate progress in advancing COYA 301, COYA 302, COYA 201 and COYA 206.
We believe we have optimized our proprietary GMP manufacturing and cryopreservation technologies, the process of cooling and storing the product at very low or freezing temperatures to save them for future use and infusions, to support the development and potential future commercialization of our product candidates. We have developed a proprietary manufacturing process that isolates dysfunctional Tregs and converts and expands them into functional, restorative Tregs. We have also developed the technology that is designed to isolate and expand highly neuroprotective and immunomodulatory Treg-derived exosomes through our proprietary iscEXO™ platform. Additionally, we have developed proprietary preservation technology to cryopreserve the expanded and converted functional Treg cells via the CTreg™ platform. We believe this is the first cryopreservation platform in the Treg cell therapy field that is being clinically tested and validated, which is intended to allow for long-term monthly infusions while maintaining viability and suppressive function.
We licensed our initial technology from the Houston Methodist Hospital in October of 2020 and we continue to maintain a significant partnership with them through continued research and collaboration in the fields of Tregs and in ALS and other neurodegenerative diseases. We will seek additional collaborators and partnerships as we seek to advance the understanding of Treg biology and its applications in disease and medicine.
2
Our Pipeline
The core of our approach and strategy is leveraging our three Treg-modifying therapeutic modalities to advance the standard of care for neurodegenerative, metabolic and autoimmune diseases. Building on our learnings from the autologous Treg cell therapy, our goal is to offer patients therapies that improve outcomes of neurodegenerative, autoimmune, and metabolic diseases.
Risks Associated with our Business
Investing in our common stock involves substantial risks. Before you participate in this offering, you should carefully consider all of the information contained in this prospectus, including the information set forth under the heading “Risk Factors.” Some of the more significant risks include the following:
|
• |
We are a clinical-stage biopharmaceutical company with no product(s) approved for commercial sale. |
|
• |
We rely on our license agreements to provide certain intellectual property rights relating to autologous regulatory T cells (“Treg”) technology. If the license is terminated, we could lose the use of rights material to the development of our product candidates. |
|
• |
If we are unable to receive non-dilutive funding in the form of a government grant, or through a partnership with an established pharmaceutical company, then we may not be able to advance COYA 101 into a Phase 2b clinical trial. |
|
• |
We have incurred significant losses since inception. We expect to continue to incur losses for the foreseeable future, and we may not generate sufficient revenue to achieve or maintain profitability. |
|
• |
The audit report with respect to our financial statements contains a paragraph expressing substantial doubt about our ability to continue as a going concern. |
|
• |
We will need to raise significant additional capital following this offering, which may not be available to us on acceptable terms, or at all. If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened. |
|
• |
If we issue additional shares in the future, including issuances of shares upon exercise of our outstanding options and warrants, our existing stockholders will be diluted and our stock price may be negatively affected. |
|
• |
Our business may be materially adversely affected by the coronavirus (“COVID-19”) pandemic. While our operations have not been materially adversely affected to date, should the pandemic or its aftereffects continue for a prolonged period of time, our business operations could be delayed or interrupted. |
|
• |
We may encounter substantial delays in our planned clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all. |
|
• |
We do not currently own, lease or operate a principal laboratory, research and development or manufacturing facility of our own. We currently collaborate with various research institutions to perform these activities, including The Methodist Hospital in Houston, Texas. Establishing our own facilities would result in significant additional expense and may result in potential delays in testing and production. |
|
• |
Any clinical trials that are planned or are conducted on our product candidates may fail. Clinical trials are lengthy, complex and extremely expensive processes with uncertain outcomes and results and frequent failures. |
|
• |
Our dependence on third parties to manufacture our product candidates may increase the risk that preclinical development, clinical development and potential commercialization of our product candidates could be delayed, prevented or impaired. |
3
|
• |
Our business is subject to, and may be affected by, extensive and costly government regulation. |
|
• |
We may not obtain approval for our products and any product for which we obtain required regulatory marketing authorization could be subject to post-approval regulation, and we may be subject to penalties if we fail to comply with such post-approval requirements. |
|
• |
Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market. |
|
• |
We face competition from companies that have greater resources than we do, and we may not be able to effectively compete against these companies. |
|
• |
If others claim we are infringing on the intellectual property rights of third parties, we may be subject to costly and time-consuming litigation. |
|
• |
There is not now, and there may not ever be, an active market for our common stock. |
Corporate Information
We were incorporated under the laws of the state of Delaware on November 23, 2020 under the name Coya Therapeutics, Inc. On December 22, 2020, we consummated the Corporate Reorganization pursuant to which all of the issued and outstanding stock of Nicoya Health, Inc., a Delaware corporation formed in 2020, were exchanged for common stock of Coya Therapeutics, Inc. Our principal executive offices are located at 5850 San Felipe St, Suite 500, Houston, TX 77057. Our telephone number is (800) 587 – 8170. Our website address is http://www.coyatherapeutics.com. Information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus, and you should not consider information on our website to be part of this prospectus.
Implications of Being an Emerging Growth Company and Smaller Reporting Company
We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of certain reduced reporting and other requirements that are otherwise generally applicable to public companies. As a result:
|
• |
we are required to have only two years of audited financial statements and only two years of related selected financial data and Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure; |
|
• |
we are not required to engage an auditor to report on our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act; |
|
• |
we are permitted to take advantage of extended transition periods for complying with new or revised accounting standards which allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies; |
|
• |
we are not required to submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay,” “say-on-frequency,” and “say-on-golden parachutes;” and |
|
• |
we are not required to comply with certain disclosure requirements related to executive compensation, such as the requirement to disclose the correlation between executive compensation and performance and the requirement to present a comparison of our Chief Executive Officer’s compensation to our median employee compensation. |
We may take advantage of these reduced reporting and other requirements until the last day of our fiscal year following the fifth anniversary of the completion of this offering, or such earlier time that we are no longer an emerging growth company. If certain events occur prior to the end of such five-year period, including if we have more than $1.235 billion in annual gross revenue, have more than $700 million in market value of our common stock held by non-affiliates, or issue more than $1.0 billion of non-convertible debt over a three-year period, we will cease to be an emerging growth company prior to the end of such five-year period. We may choose to take advantage of some but not all of these reduced requirements. We have elected to adopt the reduced requirements with respect to our financial statements and the related selected financial data and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure. We have also elected to take advantage of the extended transition periods for complying with certain new or revised accounting standards. As a result, the information that we provide to stockholders may be different than the information you may receive from other public companies in which you hold equity.
We are also a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company after this offering if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 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.
4
Issuer |
Coya Therapeutics, Inc. |
|
|
Common stock offered by us |
shares |
|
|
Offering price |
$ per share |
|
|
Underwriters’ option to purchase additional shares |
We have granted the underwriters the option for a period of 30 days to purchase up to an additional shares of common stock to cover overallotments, if any. |
|
|
Common stock to be outstanding after this offering (1) |
shares (or shares if the underwriters exercise their option to purchase additional shares in full). |
|
|
Use of proceeds |
We estimate that the net proceeds from this offering will be approximately $ (or approximately $ if the underwriters exercise their option to purchase additional shares in full) at an assumed initial public offering price of $ per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses.
We intend to use the net proceeds that we receive in this offering to advance our programs in preclinical studies and into clinical trials, to advance our discovery and candidate selection stage programs and for general corporate purposes. See “Use of Proceeds.” |
|
|
Risk factors
|
Investing in our common stock involves substantial risks. You should read the section titled “Risk Factors” for a discussion of risks you should carefully consider before deciding to invest in our common stock. |
|
|
Lock-up agreements |
We, our successors, all of our directors, officers and all holders of our outstanding common stock have agreed with the underwriters, subject to certain exceptions, not to sell, transfer or dispose of, directly or indirectly, any of our shares of common stock or securities convertible into or exercisable or exchangeable for our common stock for a period of 180 days after the date of this prospectus. See “Underwriting” for more information. |
|
|
Underwriters warrants |
The registration statement of which this prospectus is a part also registers the offer and sale of shares of our common stock issuable upon exercise of warrants we will issue to the underwriters as a portion of the underwriting compensation payable to the underwriters in connection with this offering. The warrants will be exercisable for a three and one-half year period commencing 180 days following the effective date of the registration statement of which this prospectus is a part at an exercise price equal to 125% of the public offering price of the common stock. Please see “Underwriting — Underwriters’ Warrants” for a description of these warrants. |
|
|
Proposed Nasdaq listing |
We have applied to list our common stock on the Nasdaq Capital Market under the symbol “COYA.” |
5
The number of shares of our common stock to be outstanding after completion of this offering is based on shares of our common stock outstanding as of November , 2022, after giving effect to (i) the automatic conversion of all outstanding shares of our Series A Preferred Stock (the “Series A Preferred Stock”) into shares of our common stock, referred to herein as the “Preferred Conversion,” and (ii) the conversion of the outstanding aggregate principal and interest amount of our convertible promissory notes (the “Notes”) into an aggregate of shares of common stock upon the closing of this offering, referred to herein as the “Notes Conversion,” and excludes:
|
• |
525,049 shares of our common stock issuable upon the exercise of warrants issued to the placement agent in our Series A Preferred Stock offering (the “Series A Placement Agent Warrants”), at an exercise price of $1.606 per share; |
|
• |
shares of our common stock issuable upon the exercise of warrants issued to the placement agent in our Note offering, at an exercise price equal to 120% of the per share price paid by investors in this offering (the “Note Placement Agent Warrants”); |
|
• |
1,771,743 shares of common stock reserved for future issuance under our share option plans as of as described in “Executive Compensation—Incentive Arrangements”; |
|
• |
2,725,757 shares of common stock issuable upon the exercise of stock options outstanding at a weighted average exercise price of $0.32 per share; |
|
• |
shares of common stock issuable upon exercise of the underwriters’ warrants to be issued upon consummation of this offering, at an exercise price equal to 125% of the offering price paid by investors in this offering. |
Unless otherwise indicated or the context otherwise requires, all information in this prospectus assumes or gives effect to:
|
• |
a -for- stock split to be effected on , 2022; |
|
• |
the effectiveness of our restated certificate of incorporation and restated bylaws in connection with the completion of this offering; |
|
• |
an initial public offering price of $ per share of common stock, which is the midpoint of the price range set forth on the cover page of this prospectus; and |
|
• |
no exercise by the underwriters of the option to purchase up to additional shares of our common stock. |
6
|
The following tables summarize our financial and other data. The summary statements of operations data for the period from April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021 have been derived from our audited financial statements included elsewhere in this prospectus. For periods and at dates prior to the Corporate Reorganization, our financial statements were prepared based on the historical financial statements of Nicoya Health, Inc. The summary statements of operations data for the nine months ended September 30, 2021 and 2022 and the balance sheet data as of September 30, 2022 have been derived from our unaudited interim financial statements included elsewhere in this prospectus. These interim financial statements are unaudited and, in the opinion of management, reflect all normal recurring adjustments necessary to fairly present the financial position, results of operations, and cash flows for the periods presented.
Our historical results are not necessarily indicative of the results that may be expected in any future period. You should read the following summary financial data together with the information in the sections titled “Use of Proceeds,” “Capitalization,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited and unaudited financial statements and related notes included elsewhere in this prospectus.
|
|
Period From April 30, 2020 (Date of Inception) to December 31, |
|
|
Year Ended December 31, |
|
|
Nine Months Ended September 30, |
|
|||||||
|
|
2020 |
|
|
2021 |
|
|
2021 |
|
|
2022 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,969 |
|
|
$ |
2,542,135 |
|
|
$ |
1,686,328 |
|
|
$ |
3,704,466 |
|
In-process research and development |
|
|
225,000 |
|
|
|
- |
|
|
|
- |
|
|
|
135,000 |
|
General and administrative |
|
|
445,800 |
|
|
|
2,312,042 |
|
|
|
1,579,896 |
|
|
|
3,948,434 |
|
Depreciation |
|
|
- |
|
|
|
16,133 |
|
|
|
5,946 |
|
|
|
20,521 |
|
Total operating expenses |
|
|
694,769 |
|
|
|
4,870,310 |
|
|
|
3,272,170 |
|
|
|
7,808,421 |
|
Loss from operations |
|
|
(694,769 |
) |
|
|
(4,870,310 |
) |
|
|
(3,272,170 |
) |
|
|
(7,808,421 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(38,976 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Change in fair value of convertible promissory notes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,376,030 |
) |
Other income, net |
|
|
550 |
|
|
|
(21,482 |
) |
|
|
10,050 |
|
|
|
47,343 |
|
Net loss |
|
$ |
(733,195 |
) |
|
$ |
(4,891,792 |
) |
|
$ |
(3,262,120 |
) |
|
$ |
(9,137,108 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.62 |
) |
Weighted-average shares of common stock outstanding, basic and diluted (1) |
|
|
10,470,408 |
|
|
|
14,750,415 |
|
|
|
14,750,000 |
|
|
|
14,752,314 |
|
Pro forma net loss per share of common stock, basic and diluted (unaudited)(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per share of common stock, basic and diluted (unaudited)(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
See Note 2 of our audited financial statements included elsewhere in this prospectus for an explanation of the calculations of our basic and diluted net loss per share attributable to common stockholders and the weighted-average number of shares outstanding used in the computation of the per share amounts. |
7
Balance Sheet Data:
|
|
September 30, 2022 |
||||
|
|
Actual |
|
|
Pro forma (1) |
|
Cash and cash equivalents |
|
$ |
8,650,848 |
|
|
|
Working capital (2) |
|
|
6,129,295 |
|
|
|
Total assets |
|
|
9,064,497 |
|
|
|
Convertible promissory notes |
|
|
11,845,000 |
|
|
|
Total stockholders’ (deficit) equity |
|
|
(5,357,306 |
) |
|
|
(1) |
The pro forma balance sheet data give effect to (i) the Preferred Conversion and (ii) Notes Conversion upon the closing of this offering. |
(2) |
We define working capital as current assets less current liabilities. |
8
Investing in our securities involves a high degree of risk. You should consider carefully the risks described below, together with all of the other information included or incorporated by reference in this prospectus. The risks described below are material risks currently known, expected or reasonably foreseeable by us. However, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition. If any of these risks actually materialize, our business, prospects, financial condition and results of operations could be seriously harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment.
Risks Related to Our Business, Financial Condition and Capital Requirements
We are a clinical-stage biotechnology company with limited resources, have a limited operating history and have no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
We are a clinical-stage biotechnology company that commenced operations in December 2020. In addition, we have no products approved for commercial sale and therefore all sources of capital have been obtained solely through financing.
Pharmaceutical development is a highly uncertain undertaking and involves a substantial degree of risk. To date, we have completed a Phase 2a clinical trial for just one of our product candidates, and have not obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for a third party to do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization. Given the highly uncertain nature of drug development, we may never complete clinical trials beyond Phase 2 for any of our product candidates or initiate clinical trials for any of our product candidates, obtain marketing approval for any product candidates, manufacture a commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
Our limited operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage pharmaceutical companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business, operating results and financial condition will suffer.
We have incurred significant losses since our inception and we expect to incur significant losses for the foreseeable future, which raise substantial doubt regarding our ability to continue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient additional funding to finance our operations.
Since our inception in 2020, we have incurred significant operating losses. Our net losses were $4.9 million and $9.1 million for the year ended December 31, 2021 and the nine months ended September 30, 2022, respectively, and our accumulated deficit as of September 30, 2022 was $14.8 million. We expect to continue to incur increasing operating losses for the foreseeable future as we continue to develop our product candidates. In addition, we anticipate that our expenses will increase substantially if, and as, we:
|
• |
advance the development of COYA 301 and COYA 302; |
|
• |
advance additional product candidates to clinical trials, including COYA 201 and COYA 206 ; |
|
• |
continue clinical development of COYA 101; |
|
• |
seek to discover and develop additional product candidates; |
|
• |
establish and validate our own clinical- and commercial-scale current good manufacturing practices, or cGMP, facilities; |
|
• |
submit a biologics license application (“BLA”) or marketing authorization application (“MAA”) for COYA 301 or seek marketing approvals for any of our other product candidates that successfully complete clinical trials; |
|
• |
maintain, expand and protect our intellectual property portfolio; |
|
• |
acquire or in-license other product candidates and technologies; |
|
• |
incur additional costs associated with operating as a public company; and |
|
• |
increase our employee headcount and related expenses to support these activities. |
We may never succeed in any or all of these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve profitability. Our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. Our independent registered public accounting firm included an explanatory paragraph in its audit report on the financial statements for the period from April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021 , with respect to this uncertainty. Our ability to continue as a going concern depends on our ability to raise additional capital. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all. Further, if we cannot continue as a going concern, we may be forced to discontinue operations and liquidate our assets and may receive less than the value at which those assets are carried on our audited financial statements, which would cause our stockholders to lose all or a part of their investment.
9
We have never generated revenue from product sales and may never achieve or maintain profitability.
We continue to incur significant research and development and other expenses related to ongoing operations and the development of our product candidates, including COYA 301, COYA 302, COYA 201, COYA 206 and COYA 101. All of our product candidates will require substantial additional development time, capital and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. We do not anticipate generating revenues from product sales unless and until such time as our product candidates may be approved by the U.S. Food and Drug Administration (the “FDA”) or other applicable regulatory authorities, and we are able to successfully market and sell a product candidate. Our ability to generate revenues from product sales depends on our, or potential future collaborators, success in:
|
• |
completing clinical development of our product candidates; |
|
• |
seeking and obtaining regulatory approvals for product candidates for which we successfully complete clinical trials, if any; |
|
• |
launching and commercializing product candidates, by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner; |
|
• |
qualifying for adequate coverage and reimbursement by government and third-party payors for our product candidates; |
|
• |
establishing, maintaining and enhancing a sustainable, scalable, reproducible and transferable manufacturing process for our cell therapy product candidates; |
|
• |
establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate products and services, in both amount and quality, to support clinical development and the market demand for our product candidates, if approved; |
|
• |
obtaining market acceptance of our product candidates as a viable treatment option; |
|
• |
addressing any competing technological and market developments; |
|
• |
implementing additional internal systems and infrastructure, as needed; |
|
• |
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations in such collaborations; |
|
• |
maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets, know-how, and trademarks; |
|
• |
avoiding and defending against third-party interference or infringement claims; and |
|
• |
attracting, hiring and retaining qualified personnel. |
We anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond our current expectations if we are required by the FDA or other global regulatory authorities to perform clinical trials and other preclinical studies in addition to those that we currently anticipate.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable or be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could decrease the value of our Company and impair our ability to raise capital, thereby limiting our research and development programs and efforts to expand our business or continue our operations.
Even if this offering is successful, if we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened.
We believe that the net proceeds from this offering and our existing cash, together with interest thereon, will be sufficient to fund our operations into. We intend to use the net proceeds from this offering and our existing cash to, among other uses, advance our pipeline products through preclinical and clinical development. Developing pharmaceutical products and conducting preclinical studies and clinical trials is expensive. We will need raise significant additional capital following this offering. Market volatility resulting from Russia’s invasion of Ukraine, generally rising prices, increasing interest rates, effects of the COVID-19 pandemic or other factors could adversely impact our ability to access capital as and when needed. We have no commitments for any additional financing, and will likely be required to raise such financing through the sale of additional equity securities or debt, which, in the case of equity securities, may occur at prices lower than the offering price of our common stock in this offering. These financings could result in substantial dilution to the holders of our common stock or require contractual or other restrictions on our operations or on alternatives that may be available to us. If we issue debt, we may need to dedicate a substantial portion of our operating cash flow to paying principal and interest on such debt and we may need to comply with operating restrictions, such as limitations on incurring additional debt, which could impair our ability to acquire, sell or license intellectual property rights which could impede our ability to conduct our business. Furthermore, the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our common stock to decline. If we raise additional funds through licensing or collaboration 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.
10
Any such required financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing could have a material and adverse effect on our business, financial condition and results of operations, or threaten our ability to continue as a going concern.
Our present and future capital requirements will be significant and will depend on many factors, including:
|
• |
the progress and results of our development efforts for our product candidates; |
|
• |
the costs, timing and outcome of regulatory review of our product candidates; |
|
• |
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; |
|
• |
the effect of competing technological and market developments; |
|
• |
the degree and rate of market acceptance of our product candidates; |
|
• |
costs associated with prosecuting or defending any litigation that we are or may become involved in and any damages payable by us that result from such litigation; |
|
• |
the extent to which we acquire or in-license other products and technologies; |
|
• |
the cost associated with being a public company, including obligations to regulatory agencies, and increased investor relations and corporate communications expenses; and |
|
• |
legal, accounting, insurance and other professional and business-related costs. |
We may not be able to acquire additional funds on acceptable terms, or at all. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay, reduce the scope of or eliminate some or all of our development programs.
If we do not have, or are not able to obtain, sufficient funds, we may be required to delay development or commercialization of our product candidates. We also may have to reduce the resources devoted to our product candidates or cease operations. Any of these factors could harm our operating results.
We have identified material weaknesses in our internal control over financial reporting and may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we fail to remediate our material weaknesses, we may not be able to report our financial results accurately or to prevent fraud.
Our management is responsible for establishing and maintaining internal control over financial reporting, disclosure controls, and compliance with the other requirements of the Sarbanes-Oxley Act and the rules promulgated by the SEC thereunder. 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 applicable financial reporting standards. A material weakness is defined as a deficiency, or a 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 prevented or detected by the company’s internal controls on a timely basis.
Prior to this offering, we have operated as a private company that was not required to comply with the obligations of a public company with respect to internal control over financial reporting. We have historically operated with limited accounting personnel and other resources with which to address our internal control over financial reporting.
In connection with the audits of our financial statements in preparation for this offering, we and our independent registered public accounting firm identified material weaknesses primarily related to a (i) lack of sufficient accounting and supervisory personnel who have the appropriate level of technical accounting experience and training, (ii) lack of adequate procedures and controls, including those in information technology and oversight to ensure that accurate financial statements can be prepared and reviewed on a timely basis for financial reporting purposes, and (iii) lack of proper segregation of duties. These deficiencies constitute material weaknesses in our internal control over financial reporting in both design and operation. We have engaged outside advisors with expertise in these matters to assist us in the preparation of our financial statements and in our compliance with SEC reporting obligations related to this offering, and we expect to continue to do so while we remediate the material weaknesses.
In the third quarter of 2022, we initiated a remediation plan to address these material weaknesses aimed at streamlining our process in order to prepare and review financial information timely; however, our control environment needs improvements, and as a result we may be exposed to errors. We plan to take additional steps to remediate the material weaknesses and improve our accounting function, including hiring of additional senior level and staff accountants with US GAAP technical knowledge to support the timely completion of financial close procedures, implement robust processes, and provide additional needed technical expertise, and in the interim, continuing to engage third parties as required to assist with the preparation of our financial statements and our compliance with SEC reporting obligations. Additionally, we have begun to develop and implement consistent accounting policies, internal control procedures and provide additional training to our accounting and financial reporting personnel and have recently engaged a firm to begin assisting in the future development and adoption of a proper control environment.
11
Although we are working to remediate such material weaknesses as quickly and efficiently as possible, we cannot at this time estimate how long it will take, and our initiatives may not prove to be successful in remediating the material weaknesses. If we are unable to successfully remediate our identified material weaknesses, if we discover additional material weaknesses or if we otherwise are unable to report our financial statements accurately or in a timely manner, we would be required to continue disclosing such material weaknesses in future filings with the SEC, which could adversely affect our business, investor confidence in our company and the market price of our common shares and could subject us to litigation or regulatory enforcement actions. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the market value of our common shares.
Any acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities or subject us to other risks.
From time to time, we may evaluate various acquisitions and strategic collaborations, including licensing or acquiring complementary drugs, intellectual property rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including, but not limited to:
|
• |
increased operating expenses and cash requirements; |
|
• |
the assumption of indebtedness or contingent or unknown liabilities; |
|
• |
assimilation of operations, intellectual property and drugs of an acquired company, including difficulties associated with integrating new personnel; |
|
• |
the diversion of our management’s attention from our existing drug programs and initiatives in pursuing such a strategic partnership, merger or acquisition; |
|
• |
retention of key employees, the loss of key personnel, and uncertainties about our ability to maintain key business relationships; |
|
• |
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or product candidates and regulatory approvals; and |
|
• |
our inability to generate revenue from acquired drugs, intellectual property rights, technologies, and/or businesses sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. |
In addition, if we engage in acquisitions or strategic partnerships, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses or acquire intangible assets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities, and this inability could impair our growth or limit access to technology or drugs that may be important to the development of our business.
Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have never generated any revenue from product sales, we may never generate any revenue from product sales, and we may fail to generate further revenue from grants or contracts or to be profitable.
We have no products approved for commercial sale and have not generated any revenue from product sales. Our ability to successfully commercialize our existing product candidates depends on our ability to successfully obtain regulatory approvals, among other factors. Thus, we may not generate meaningful revenue until after we have successfully begun and completed clinical development and received regulatory approval for the commercial sale of a product candidate. We may never complete clinical development or receive regulatory approval for the commercial sale of a product candidate and thus may never generate revenue from product sales.
Our ability to generate revenue and achieve profitability depends significantly on many factors, including:
|
• |
successfully completing research and clinical development of our product candidates; |
|
• |
obtaining regulatory approvals and marketing authorizations for product candidates once we have successfully completed clinical development and clinical trials; |
|
• |
identifying, assessing, acquiring and/or developing new product candidates; |
|
• |
successfully competing for grant revenue from private foundations and state and federal agencies; |
|
• |
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; |
|
• |
launching and successfully commercializing product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure; |
|
• |
obtaining and maintaining an adequate price for our product candidates, both in the United States and in foreign countries where our products are commercialized; |
|
• |
obtaining adequate reimbursement for our product candidates from payors; |
|
• |
obtaining market acceptance of our product candidates as viable treatment options; |
|
• |
addressing any competing technological and market developments; |
12
|
|
• |
maintaining, protecting, expanding and enforcing our portfolio of intellectual property rights, including patents, trade secrets and know-how; and |
|
• |
attracting, hiring and retaining qualified personnel. |
Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of our expenses, or when, if ever, we will be able to generate any meaningful revenue or achieve or maintain profitability. In addition, our expenses could increase beyond our current expectations if we are required by the FDA or foreign regulatory agencies to perform studies in addition to those that we currently anticipate, or if there are any delays in any of our or our future collaborators’ clinical trials or the development of any of our product candidates. Even if one or more of our product candidates is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate and ongoing compliance efforts.
Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. Revenue from the sale of any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to get reimbursement at any price and whether we own the commercial rights for that territory. If the number of addressable patients is not as significant as we anticipate, the indication approved by regulatory authorities is narrower than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
Our failure to become and remain profitable would decrease the value of our Company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our pipeline of product candidates or continue our operations, and cause a decline in the value of our securities, all or any of which may adversely affect our viability.
Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we may prioritize development of certain product candidates. We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Due to the significant resources required for the development of our programs, we may focus our programs on specific diseases and disease pathways and decide which product candidates to prioritize and advance and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, our potential decisions to delay, terminate or collaborate with third parties in respect of certain programs may subsequently also prove to be suboptimal and could cause us to miss valuable opportunities. We may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization rights. If we make incorrect determinations regarding the viability or market potential of any or all of our programs or product candidates or misread trends in the pharmaceutical industry, in particular, for neurodegenerative diseases, our business, prospects, financial condition and results of operations could be materially adversely affected.
The recent and ongoing COVID-19 pandemic could materially affect our operations, as well as the business or operations of third parties with whom we conduct business. Our business could be adversely affected by the effects of other future health epidemics or pandemics in regions where we or third parties on which we rely have significant business operations.
Our business and its operations, including but not limited to clinical development, supply chain operations, research and development activities, and fundraising activities, could be adversely affected by health epidemics in regions where we have business operations, and such health epidemics could cause significant disruption in the operations of third parties upon whom we rely. In December 2019, a novel strain of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread to other countries and throughout the United States. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic, and the U.S. government-imposed restrictions on travel between the United States, Europe, and certain other countries. Further, the President of the United States declared the COVID-19 pandemic a national emergency. Since March 2020, numerous state and local jurisdictions have imposed, and others in the future may impose, quarantines, shelter-in-place orders, executive, and similar government orders for their residents to control the spread of COVID-19. As of the date of this prospectus, the COVID-19 pandemic has not had a material impact on our operations.
13
The effects of the executive orders, the shelter-in-place orders, and our work-from-home policies may negatively impact productivity, disrupt our business, and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition. We continue to monitor state and local quarantine, shelter-in-place, executive, and similar government orders.
Quarantines, shelter-in-place, executive, and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases, could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials we use or require to conduct our business, including product development, which would disrupt our supply chain. In particular, some of our suppliers of certain materials used in our laboratory operations and research and development activities are located in areas that are subject to executive orders and shelter-in-place orders. While many of these materials may be obtained from more than one supplier, port closures and other restrictions resulting from the COVID-19 pandemic or future pandemics may disrupt our supply chain or limit our ability to obtain sufficient materials to operate our business. To date, we are aware of certain suppliers for our research and development activities who have experienced operational delays directly related to the COVID-19 pandemic.
In addition, we expect our clinical trials may be affected by the COVID-19 pandemic. If COVID-19 continues to spread in the United States and elsewhere, we may experience additional disruptions that could severely impact our business, preclinical studies and clinical trials, including:
|
• |
delays or difficulties in enrolling patients in our clinical trials; |
|
• |
delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
|
• |
delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials; |
|
• |
changes in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether; |
|
• |
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
|
• |
interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data; |
|
• |
risk that participants enrolled in our clinical trials will contract COVID-19 while the clinical trial is ongoing, which could result in participants dropping out of the trial, missing scheduled doses or follow-up visits or failing to follow protocol or otherwise impact the results of the clinical trial, including by increasing the number of observed adverse events; |
|
• |
interruptions or delays in preclinical studies due to restricted or limited operations at our research and development laboratory facilities; |
|
• |
delays in necessary interactions with local regulators, ethics committees, and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; |
|
• |
limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; |
|
• |
refusal of the FDA to accept data from clinical trials in affected geographies; and |
|
• |
interruption or delays to our sourced discovery and clinical activities. |
The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by COVID-19, and the duration of such impact, may be difficult to assess or predict, the widespread pandemic has resulted in significant disruption of global financial markets, which could reduce our ability to access capital and negatively affect our future liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 and related government orders and restrictions could materially affect our business and the value of our Common Stock. The COVID-19 pandemic continues to evolve rapidly. The ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems, or the global economy as a whole.
Adverse global conditions, including economic uncertainty, may negatively impact our financial results.
Global conditions, dislocations in the financial markets, any negative financial impacts affecting United States corporations operating on a global basis as a result of tax reform or changes to existing trade agreements or tax conventions, or inflation, could adversely impact our business in a number of ways, including longer sales cycles, lower prices for our products, reduced licensing renewals, customer disruption or foreign currency fluctuations.
14
In addition, the global macroeconomic environment could be negatively affected by, among other things, the COVID-19 pandemic or other epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the withdrawal of the United Kingdom from the European Union, the Russian invasion of Ukraine and the resulting prolonged conflict and other political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.
Changes in U.S. tax law may materially adversely affect our financial condition, results of operations and cash flows.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was signed into law to address the COVID-19 crisis. The CARES Act is an approximately $2 trillion emergency economic stimulus package that includes numerous U.S. federal income tax provisions, including the modification of: (i) net operating loss rules, (ii) the alternative minimum tax refund and (iii) business interest deduction limitations under Section 163(j) of the Internal Revenue Code of 1986, as amended, or the Code.
On December 22, 2017, President Trump signed into law federal tax legislation commonly referred to as the “Tax Cuts and Jobs Act” (the “TCJA”), which also significantly changed the U.S. federal income taxation of U.S. corporations. TCJA remains unclear in many respects and has been, and may continue to be, subject to amendments and technical corrections, as well as interpretations and implementing regulations by the Treasury and Internal Revenue Service, or the IRS, any of which could lessen or increase certain adverse impacts of TCJA. In addition, it is unclear how these U.S. federal income tax changes will affect state and local taxation, which often uses federal taxable income as a starting point for computing state and local tax liabilities.
While some of these U.S. federal income tax changes may adversely affect us in one or more reporting periods and prospectively, other changes may be beneficial on a going-forward basis. We continue to work with our tax advisors and auditors to determine the full impact TCJA and the CARES Act will have on us. We urge our investors to consult with their legal and tax advisors with respect to both TCJA and the CARES Act and the potential tax consequences of investing in our common stock.
Our employment agreements with certain of our executive officers may require us to pay severance benefits to certain of those persons who are terminated, which could materially adversely affect our financial condition or results of operations.
Certain of our executive officers are parties to employment agreements that contain change in severance provisions providing for aggregate cash payments for severance and other benefits and/or acceleration of stock options vesting in the event of a termination of employment. The accelerated vesting of options could result in dilution to our existing stockholders and could materially adversely affect the market price of our common stock. The payment of these severance benefits could materially adversely affect our financial condition and results of operations. In addition, these potential severance payments may discourage or prevent third parties from seeking a business combination with us.
Our ability to use our net operating loss carryovers and certain other tax attributes may be limited.
We have incurred significant losses since our inception and we expect to continue to incur significant losses for the foreseeable future, which raise substantial doubt regarding our ability to continue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient additional funding to finance our operations. Under the Internal Revenue Code of 1986, or the Code, a corporation is generally allowed a deduction for net operating losses (“NOLs”), carried over from a prior taxable year. As of December 31, 2020, future tax losses and tax credits have no expiration date.
Net operating loss and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50% as defined under Sections 382 and 383 in the Internal Revenue Code, which could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the Company’s value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has not yet conducted a study to determine if any such limitation exists.
Risks Related to Development, Regulatory Approval and Commercialization
Our business depends upon the success of our therapeutic modalities and product candidates.
Our success depends on our ability to utilize our three Treg-modifying therapeutic modalities (the “Treg Modalities”) and to obtain regulatory approval for our product candidates, to generate other product candidates derived from our Treg Modalities, and to then commercialize our other product candidates for one or more indications. Our Treg Modalities and our product candidates have not been approved and may never become commercialized. All of our product candidates developed from our Treg Platforms will require significant additional clinical and non-clinical development, review and approval by the FDA or other applicable regulatory authorities
15
in one or more jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before they can be successfully commercialized. If any of our product candidates encounter safety or efficacy problems, developmental delays or regulatory issues or other problems, such problems could impact or halt the development plans for our other product candidates because all of our product candidates are based on the same core Treg engineering technology.
Utilizing Treg cells represents a novel approach to the treatment of neurodegenerative and auto immune diseases, and we must overcome significant challenges in order to develop, commercialize and manufacture our product candidates.
We have concentrated our research and development efforts on utilizing Treg cells as an immunotherapy. To date, the FDA has approved only a small number of cell-based therapies for commercialization. We are not aware of any Treg therapy approved by any regulatory authority for commercial use. The processes and requirements imposed by the FDA or other applicable regulatory authorities may cause delays and additional costs in obtaining approvals for marketing authorization for our product candidates. Because our Treg Modalities are novel, and cell-based therapies are relatively new, regulatory agencies may lack experience in evaluating product candidates like our Treg product candidates. This novelty may lengthen the regulatory review process, including the time it takes for the FDA to review our IND applications if and when submitted, increase our development costs and delay or prevent commercialization of our products. Additionally, advancing novel therapies for neurodegenerative and auto immune diseases creates significant challenges for us, including:
|
• |
educating medical personnel regarding the potential side-effect profile of our cells and, as the clinical program progresses, on observed side effects with the therapy; |
|
• |
training a sufficient number of medical personnel on how to properly administer the clinical trials; |
|
• |
enrolling sufficient numbers of patients in clinical trials; |
|
• |
developing a reliable, safe and effective means of genetically modifying our cells; |
|
• |
manufacturing our cells on a large scale and in a cost-effective manner; |
|
• |
sourcing starting material suitable for clinical and commercial manufacturing; and |
|
• |
establishing sales and marketing capabilities, as well as developing a manufacturing process and distribution network to support the commercialization of any approved products. |
We must be able to overcome these challenges in order for us to develop, commercialize and manufacture COYA 301, COYA 302, COYA 201, COYA 206 and COYA 101 and any of our other product candidates.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control.
Clinical trials are expensive, time consuming and subject to substantial uncertainty. Failure can occur at any time during the clinical trial process, due to scientific feasibility, safety, efficacy, changing standards of medical care and other variables. The results from preclinical testing or early clinical trials of a product candidate may not predict the results that will be obtained in later phase clinical trials of the product candidate. We, the FDA, or other applicable regulatory authorities may suspend or terminate clinical trials of a product candidate at any time for various reasons, including, but not limited to, a belief that subjects participating in such trials are being exposed to unacceptable health risks or adverse side effects, or other adverse initial experiences or findings. The FDA, or other applicable regulatory authorities may also require us to conduct additional testing, preclinical studies or clinical trials due to negative or inconclusive results or other reasons, fail to approve the raw materials, manufacturing processes or facilities of third-party manufacturers upon which we rely, find deficiencies in the manufacturing processes or facilities upon which we rely, and change their approval policies or regulations or their prior guidance to us during clinical development in a manner rendering our clinical data insufficient for approval. In addition, data collected from clinical trials may not be sufficient to support the submission of a Biologics License Application (“BLA”) or other applicable regulatory filing. We cannot guarantee that any clinical trials that we may plan or initiate will be conducted as planned or completed on schedule, if at all.
A failure of one or more of our clinical trials could occur at any stage. Events that may prevent successful initiation, timely completion, or positive outcomes of our clinical development include, but are not limited to:
|
• |
delays in obtaining regulatory approval to commence a clinical trial; |
|
• |
delays in reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different trial sites; |
|
• |
our ability to recruit sufficient patients for our clinical trials in a timely manner or at all; |
|
• |
delays in achieving a sufficient number of clinical trial sites or obtaining the required institutional review board, or IRB, approval at each clinical trial site; |
|
• |
imposition of a temporary or permanent clinical hold by us or by the FDA or other regulatory agencies based on emerging data; |
|
• |
clinical sites deviating from trial protocol or dropping out of a trial; |
16
|
|
• |
suspension or termination of a clinical trial by the IRBs of the institutions in which such trials are being conducted or by the Data Safety Monitoring Board, or DSMB (where applicable); |
|
• |
delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials; |
|
• |
delays in reaching a consensus with regulatory agencies on the design or implementation of our clinical trials; |
|
• |
changes in regulatory requirements or guidance that may require us to amend or submit new clinical protocols, or such requirements may not be as we anticipate; |
|
• |
changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; |
|
• |
insufficient or inadequate quality of our product candidates or other materials necessary to conduct preclinical studies or clinical trials of our product candidates; |
|
• |
clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; |
|
• |
failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, or additional administrative burdens associated with foreign regulatory schemes; or |
|
• |
failure of ourselves or any third-party manufacturers, contractors or suppliers to comply with regulatory requirements, maintain adequate quality controls, or be able to provide sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates. |
In addition, disruptions caused by the COVID-19 pandemic may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing preclinical studies and clinical trials, as applicable. If global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions. If we experience delays in the initiation, enrollment or completion of any preclinical study or clinical trial of our product candidates, or if any preclinical studies or clinical trials of our product candidates are canceled, the commercial prospects of our product candidates may be materially adversely affected, and our ability to generate product revenues from any of these product candidates will be delayed or not realized at all. In addition, any delays in completing our clinical trials may increase our costs and slow down our product candidate development and approval process.
If we are unable to receive non-dilutive funding in the form of a government grant, or through a partnership with an established pharmaceutical company, then we may not be able to advance COYA 101 into a Phase 2b clinical trial.
Our goal is to advance COYA 101 into a Phase 2b clinical trial utilizing non-dilutive funding in the form of a grant from a government organization, or by partnering with an established pharmaceutical company. If we are unable to receive such a grant or any other grant we may apply and qualify for in the future, or we are unable to find a suitable strategic partner with whom we can collaborate on terms that are favorable to us, or at all, we may delay or terminate the clinical development of COYA 101, which could materially adversely affect our business, financial condition, results of operations and growth prospects.
There is no assurance that we will develop our product candidates successfully or be able to obtain regulatory approval for them.
We cannot guarantee that any of our product candidates will be safe and effective, or will be approved for commercialization, on a timely basis or at all. Although certain of our employees have prior experience with clinical trials, regulatory approvals and cGMP manufacturing, we have not previously completed any clinical trials or 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 be successful in clinical trials or receive regulatory approval. The FDA, and other comparable global regulatory authorities can delay, limit or deny approval of a product candidate for many reasons. For further details about such reasons, see “—Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control.” Any delay in obtaining, or inability to obtain, applicable regulatory approval will delay or harm our ability to successfully commercialize any of our products and materially adversely affect our business, financial condition, results of operations and growth prospects.
Furthermore, because our product candidates are based on similar technology as COYA 301, if our clinical trials of COYA 301 encounter safety, efficacy or manufacturing problems, development delays, regulatory issues or other problems, our development plans for our other product candidates in our pipeline could be significantly impaired, which could materially adversely affect our business, financial condition, results of operations and growth prospects.
17
We currently collaborate with various research institutions to perform the research and development activities needed to develop our product candidates, and if we ever choose to or need to find alternative research institutions, we may not be able to do so at all or, if we are able to do so, it may be costly and may cause significant delays in the development and commercialization of our product candidates.
We do not currently own, lease or operate a principal laboratory, research and development or manufacturing facility of our own. Currently, we collaborate with various research institutions to perform research and development for our products, including The Methodist Hospital located in Houston, Texas. Establishing our own facilities would result in significant additional expense and may result in potential delays in testing and production. Building and operating our own production facilities would require substantial additional funds and other resources, of which there can be no assurance that we will be able to obtain. In addition, there can be no assurances that we would be able to enter into any arrangement with third parties to manufacture our product, if any, on acceptable terms or at all. The commercial success of products outside the United States will also be dependent on the successful completion of arrangements with future partners, licensees or distributors in each territory. There can be no assurance that we will be successful in continuing to contract with research institutions to perform research and development for our products, that we would be able to establish our own facilities should we choose to or find it necessary to do so, that we would be successful in establishing additional collaborative arrangements or that, if established, such future partners will be successful in commercializing our products.
Positive results from early studies of our product candidates are not necessarily predictive of the results of later studies and any future clinical trials of our product candidates. If we cannot show positive results or replicate any positive results from our earlier studies of our product candidates in our later studies and future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials. For example, preclinical models do not adequately represent the clinical setting, and thus cannot predict clinical activity nor all potential risks, and may not provide adequate guidance as to appropriate dose or administration regimen of a given therapy. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. Interim data from clinical trials that we may conduct are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously announced. Negative differences between preliminary or interim data and final data could materially adversely affect the prospects of any product candidate that is impacted by such data updates.
Any positive results from studies of our product candidates may not necessarily be predictive of the results from later studies and clinical trials. Similarly, even if we are able to complete our planned studies or any future clinical trials of our product candidates according to our current development timeline, the positive results from such studies and clinical trials of our product candidates may not be replicated in subsequent studies or clinical trial results.
Many companies in the pharmaceutical industry have suffered significant setbacks in mid and late-stage clinical trials after achieving positive results in early-stage development and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, findings made while clinical trials were underway, or safety or efficacy observations made in studies and clinical trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in studies and clinical trials nonetheless failed to obtain regulatory approval.
We may encounter substantial delays in our planned clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
Our planned clinical trials are expensive, time consuming, and subject to uncertainty. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. We cannot be sure that submission of an IND or, in the case of the European Medicines Agency (the “EMA”), a clinical trial application (a “CTA”), will result in the FDA or EMA allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical trials may not be successful. Events that may prevent successful or timely initiation or completion of clinical trials include:
|
• |
inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; |
|
• |
delays in confirming target engagement, patient selection or other relevant biomarkers to be utilized in preclinical and clinical product candidate development; |
|
• |
delays in reaching a consensus with regulatory agencies on study design; |
18
|
|
• |
delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; |
|
• |
delays in identifying, recruiting and training suitable clinical investigators; |
|
• |
delays in obtaining required IRB approval at each clinical trial site; |
|
• |
imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including, but not limited to, after review of an IND or amendment, CTA or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical trial operations or study sites; developments in trials conducted by competitors that raise FDA or EMA concerns about risk to patients broadly; or if the FDA or EMA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; |
|
• |
delays or difficulties resulting from the COVID-19 pandemic; |
|
• |
delays in identifying, recruiting and enrolling suitable patients to participate in our clinical trials, and delays caused by patients withdrawing from clinical trials or failing to return for post-treatment follow-up; |
|
• |
difficulty collaborating with patient groups and investigators; |
|
• |
failure by our CROs, other third parties, or us to adhere to clinical trial requirements; |
|
• |
failure to perform in accordance with the FDA’s or any other regulatory authority’s current good clinical practices, requirements, or applicable EMA or other regulatory guidelines in other countries; |
|
• |
occurrence of adverse events associated with a product candidate that are viewed to outweigh its potential benefits; |
|
• |
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |
|
• |
changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; |
|
• |
the cost of clinical trials of our product candidates being greater than we anticipate; |
|
• |
clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; and |
|
• |
delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing. |
Any inability to successfully initiate or complete future clinical trials could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
We could also encounter delays if a clinical trial is suspended or terminated by us, by the data safety monitoring board for such trial or by the FDA, EMA or any other regulatory authority, or if the IRBs of the institutions in which such trials are being conducted suspend or terminate the participation of their clinical investigators and sites subject to their review. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. If we are unable to design, conduct and complete our planned clinical trials successfully, our product candidates will not be able to receive regulatory approval.
In order to obtain FDA approval for any of our product candidates, we must submit to the FDA a new drug application with substantial evidence that demonstrates that the product candidate is both safe and effective in humans for its intended use. This demonstration will require significant research, preclinical studies and clinical trials.
Clinical trials are time-consuming, expensive and difficult to design and implement, in part because they are subject to rigorous requirements and the outcomes are inherently uncertain. Clinical testing may take many years to complete, and failure can occur at any time during the clinical trial process, even with active ingredients that have previously been approved by the FDA as safe and effective. If we receive authorization to conduct our planned clinical trials, we could encounter problems that could halt our planned clinical trials or require us to repeat such clinical trials. If patients participating in our planned clinical trials suffer drug-related adverse reactions during the course of such clinical trials, or if we or the FDA believe that patients are being exposed to unacceptable health risks, such clinical trials may have to be suspended or terminated. Suspension, termination or the need to repeat a clinical trial can occur at any stage.
19
The clinical trial success of each of our product candidates depends in part on reaching statistically significant changes in patients’ symptoms based on clinician-rated scales. There is a lack of consensus regarding standardized processes for assessing clinical outcomes based on clinician-rated scales. Accordingly, the scores from our clinical trials may not be reliable, useful or acceptable to the FDA or other regulatory agencies.
Changes in standards related to clinical trial design could have a material adverse effect on our ability to design and conduct clinical trials as planned. For example, we expect to conduct clinical trials comparing our product candidates to both placebo and other approved drugs, but regulatory authorities may not allow us to compare our product candidates to a placebo in a particular clinical indication where approved products are available. In that case, both the cost and the amount of time required to conduct such a planned clinical trial could increase. The FDA may disagree with our trial design and our interpretation of data from our planned clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our planned clinical trials. The FDA may also approve a product candidate for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials. In addition, the FDA may not approve the labeling claims or removal of certain warnings that we believe are necessary or desirable for the successful commercialization of our product candidates. Approval may be contingent on a Risk Evaluation and Mitigation Strategy, which could have a material adverse effect on the labeling, distribution or promotion of a drug product.
Any of these delays or additional requirements could cause our product candidates to not be approved, or if approved, significantly impact the timing and commercialization of our product candidates and significantly increase our overall costs of drug development.
Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
Identifying and qualifying patients to participate in our clinical trials is critical to our success. Clinical trials of a new product candidate require the enrollment of a sufficient number of patients, including patients who are suffering from the disease that the product candidate is intended to treat and who meet other eligibility criteria. The rates of patient enrollment, a significant component in the timing of clinical trials, are affected by many factors, including:
|
• |
our ability to open clinical trial sites; |
|
• |
the size and nature of the patient population; |
|
• |
the design and eligibility criteria of the clinical trial; |
|
• |
the proximity of subjects to clinical sites; |
|
• |
the patient referral practices of physicians; |
|
• |
changing medical practice patterns or guidelines related to the indications we are investigating; |
|
• |
competing clinical trials or approved therapies which present an attractive alternative to patients and their physicians; |
|
• |
perceived risks and benefits of the product candidate under study, including as a result of adverse effects observed in similar or competing therapies; |
|
• |
our ability to obtain and maintain patient consents due to various reasons, including but not limited to, patients unwillingness to participate due to the ongoing COVID-19 pandemic; |
|
• |
the risk that enrolled subjects will drop out or die before completion of the trial; |
|
• |
patients failing to complete a clinical trial or returning for post-treatment follow-up; and |
|
• |
our ability to manufacture the requisite materials for a patient and clinical trial. |
In addition, we need to compete with many ongoing clinical trials to recruit patients into our expected clinical trials. Our clinical trials may also compete with other clinical trials for product candidates that are in a similar cellular immunotherapy area as our product candidates, and this competition could reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial site. If we are unable to enroll a sufficient number of patients in our clinical trials in a timely manner, our completion clinical trials may be delayed or may not be achieved, which would prevent us from commercializing our product candidates.
Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
In order to obtain FDA or other regulatory authority approval to market a new biological product we must demonstrate proof of safety, purity and potency, and efficacy in humans. To meet these requirements we will have to conduct adequate and well-controlled clinical trials. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing and studies that support our planned INDs in the United States. We cannot be certain of the timely completion or outcome of our preclinical testing
20
and studies and cannot predict if the FDA will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
Conducting preclinical testing is a lengthy, time-consuming and expensive process. The length of time may vary substantially according to the type, complexity and novelty of the program, and often can be several years or more per program. Any delays in preclinical testing and studies conducted by us or potential future partners may cause us to incur additional operating expenses. The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including, for example:
|
• |
inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical trials; |
|
• |
delays in reaching a consensus with regulatory agencies on study design; and |
|
• |
the FDA not allowing us to rely on previous findings of safety and efficacy for other similar but approved products and published scientific literature. |
Moreover, because standards for pre-clinical assessment are evolving and may change rapidly, even if we reach an agreement with the FDA on a pre-IND proposal, the FDA may not accept the IND submission as presented, in which case patient enrollment would be placed on partial or complete hold and treatment of enrolled patients could be discontinued while the product candidate is re-evaluated. Even if clinical trials do begin for our preclinical programs, our clinical trials or development efforts may not be successful.
If any of our product candidates, or any competing product candidates, demonstrate serious adverse events, including the development of severe or fatal cytokine release syndrome, neurotoxicity or graft-versus-host disease, we may be required to halt or delay further clinical development.
Undesirable side effects that may be caused by any of our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label than anticipated or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
In a pilot initial study of COYA 201, our Treg exosome product candidate, in a preclinical lupus nephritis model in mice, COYA 201 was administered at different dose levels and appeared to be well tolerated at the administered dose of 1x1010 exosomes (the low dosage level). However, we observed fatalities as a result of toxicity when COYA 201 was administered in extremely high doses (1x1011 exosomes, or ten times the low dosage level), administered twice weekly. We do not know if these findings will translate into humans, for whom we expect to require significantly lower dosage levels. Though there were fatalities at the highest dosage administered (6 deaths out of a total of 12 animals), COYA 201 appeared to be well tolerated at the administered dose of 1x1010 exosomes. Dose escalation studies are standard in the early development of new treatments and the identification of the “maximum tolerated dose” and the “LD50”, the dose that produces lethality in 50% of animals, are common studies in early preclinical development. As such, there can be no guarantee that any toxicity, or other adverse events observed in this model, will not occur in human subjects during clinical trials. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects and/or unexpected characteristics. We continue to evaluate different potential indications to advance the development of COYA 201 into clinical studies. Following the completion of the preclinical studies in different animal models of disease, we will evaluate the data to potentially conduct further preclinical studies and to select a potential clinical indication for human studies.
There can be no assurance that patients will not experience cytokine release syndrome, or CRS, neurotoxicity, graft-versus-host disease, or GVHD or other serious adverse events. Severe adverse events associated with COYA 301 may also develop. Such adverse events may cause delays in completion of our clinical programs. If unacceptable side effects arise in the development of our product candidates such that there is no longer a positive benefit risk, we, the FDA, the IRBs at the institutions in which our trials are conducted or the DSMB could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff, and inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death.
We may seek special designations by the regulatory authorities to expedite regulatory approvals, but may not be successful in receiving such designations, and even if received, they may not benefit the development and regulatory approval process.
We may seek various designations by the regulatory authorities such as Regenerative Medicine Advanced Therapy Designation, or RMAT, Breakthrough Therapy Designation, Fast Track Designation, or PRIority Medicine, or PRIME, from regulatory authorities, for any product candidate that we develop. A product candidate may receive RMAT designation from the FDA if it is a regenerative medicine therapy that is intended to treat, modify, reverse or cure a serious or life-threatening condition, and preliminary clinical
21
evidence indicates that the product candidate has the potential to address an unmet medical need for such condition. A breakthrough therapy is defined by the FDA as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If a product is intended for the treatment of a serious or life-threatening condition and preclinical or clinical data demonstrate the potential to address an unmet medical need for this condition, the product sponsor may apply for Fast Track Designation by the FDA. PRIME is a voluntary scheme launched by the EMA to strengthen support for the development of medicines that target an unmet medical need through enhanced interaction and early dialogue with developers of promising medicines in order to optimize development plans and speed up evaluation to help such medicines reach patients earlier.
Seeking and obtaining these designations is dependent upon results of our clinical program, and we cannot guarantee whether and when we may have the data from our clinical programs to support an application to obtain any such designation. The FDA and the EMA, as applicable, have broad discretion whether or not to grant any of these designations, so even if we believe a particular product candidate is eligible for one or more of these designations, we cannot assure you that the applicable regulatory authority would decide to grant it. Even if we do receive the designations we may apply for, we may not experience a faster development process, review or approval compared to conventional FDA or EMA procedures, as applicable. The FDA or EMA, as applicable, may rescind any granted designations if it believes that the designation is no longer supported by data from any source.
We may seek Orphan Drug Designation for our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
We have received Orphan Drug Designation for our COYA 101 product candidate for the active moiety or the principal molecular structural features. Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the United States, Orphan Drug Designation may entitle a party to financial incentives such as grant funding towards clinical trial costs, tax advantages and user-fee waivers.
Similarly, in Europe, the European Commission grants Orphan Drug Designation after receiving the opinion of the EMA Committee for Orphan Medicinal Products on an Orphan Drug Designation application. Orphan Drug Designation is intended to promote the development of drugs that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in Europe and for which no satisfactory method of diagnosis, prevention, or treatment has been authorized (or the product would be a significant benefit to those affected). Additionally, designation is granted for drugs intended for the diagnosis, prevention, or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in Europe would be sufficient to justify the necessary investment in developing the drug. In Europe, Orphan Drug Designation may entitle a party to a number of incentives, such as protocol assistance and scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.
Generally, if a drug with an Orphan Drug Designation subsequently receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug and indication for that time period, except in limited circumstances. The applicable period is seven years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for Orphan Drug Designation or if the drug is sufficiently profitable such that market exclusivity is no longer justified.
Even if we obtain orphan drug exclusivity for our product candidates, that exclusivity may not effectively protect those product candidates from competition because different therapies can be approved for the same condition and the same therapies can be approved for different conditions but used off-label. Even after an orphan drug is approved, the FDA can subsequently approve another drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Moreover, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. While we may seek Orphan Drug Designation for applicable indications for our product candidates, we may never receive such designations. Even if we do receive such designations, there is no guarantee that we will enjoy the benefits of those designations.
22
We may not identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.
Our business depends upon our ability to identify, develop and commercialize product candidates. A key element of our strategy is to discover and develop additional product candidates based upon our Treg Modalities. We are seeking to do so through our internal research programs, and may also explore strategic collaborations for the discovery of new product candidates. Research programs to identify product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified. In addition, targets for different neurodegenerative and auto immune diseases may require changes to our cell manufacturing platform, which may slow down development or make it impossible to manufacture our product candidates. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including the following:
|
• |
the research methodology or technology modality used may not be successful in identifying potential product candidates; |
|
• |
competitors may develop alternatives that render our product candidates obsolete or less attractive; |
|
• |
we may choose to cease development if we determine that clinical results do not show promise; |
|
• |
product candidates we develop may nevertheless be covered by third-party patents or other exclusive rights; |
|
• |
a product candidate may be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; and |
|
• |
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors. |
Because we have limited resources, we must choose to pursue and fund the development of specific types of treatment, or treatment for a specific type of neurodegenerative or auto immune disease, and we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential. Our estimates regarding the potential market for our product candidates could be inaccurate, and if we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Alternatively, we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering arrangement.
If any of these events occur, we may be forced to abandon or delay our development efforts with respect to a particular product candidate or fail to develop a potentially successful product candidate.
If third parties that we rely on to conduct clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates.
We do not have the ability to independently conduct clinical trials. We rely on medical institutions, clinical investigators, contract laboratories, and other third parties, such as contract research organization, or CROs, to conduct or otherwise support clinical trials for our product candidates. We rely heavily on these parties for execution of clinical trials for our product candidates and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on CROs and other third parties will not relieve us of our regulatory responsibilities. For any violations of laws and regulations during the conduct of our clinical trials, we could be subject to untitled letters, warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.
We and the third parties on which we rely for clinical trials are required to comply with regulations and requirements, including Good Clinical Practice, or GCP, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial patients are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the competent authorities of the European Union member states, and comparable foreign regulatory authorities for any drugs in clinical development. The FDA enforces GCP requirements through periodic inspections of clinical trial sponsors, principal investigators and trial sites. If we or these third parties fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our future clinical trials will comply with GCP. In addition, our clinical trials must be conducted with product candidates produced under cGMP regulations. Our failure or the failure of these third parties to comply with these regulations may require us to repeat clinical trials, which would delay the marketing approval process and could also subject us to enforcement action. The COVID-19 pandemic and government measures taken in response have also had a significant impact on our CROs, and we expect that they will face further disruption, which may affect our ability to initiate and complete our preclinical studies and clinical trials. We also are required to register certain ongoing clinical trials and provide certain information, including information relating to the trial’s protocol, on a government-sponsored database, ClinicalTrials.gov, within specific timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
23
Although we intend to design the clinical trials for our product candidates, we plan to rely on third parties to conduct our clinical trials. As a result, many important aspects of our clinical development, including their conduct and timing, will be outside of our direct control. Our reliance on third parties to conduct future clinical trials will also result in less direct control over the management of data developed through clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:
|
• |
have staffing difficulties; |
|
• |
fail to comply with contractual obligations; |
|
• |
experience regulatory compliance issues; |
|
• |
undergo changes in priorities or become financially distressed; or |
|
• |
form relationships with other entities, some of which may be our competitors. |
If third parties do not perform our clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements, we would be unable to rely on clinical data collected by these third parties and may be required to repeat, extend the duration of, or increase the size of any clinical trials we conduct, which could significantly delay commercialization and require significantly greater expenditures.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. If third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any clinical trials such third parties are associated with may be extended, delayed or terminated, and we may not be able to obtain marketing approval for or successfully commercialize our product candidates. As a result, we believe that our financial results and the commercial prospects for our product candidates in the subject indication would be harmed, our costs could increase and our ability to generate revenue could be delayed.
If we fail to compete effectively with academic institutions and other biotechnology companies that are developing similar or alternatives to cellular immunotherapy product candidates, our business will be materially adversely affected.
The development and commercialization of new cellular immunotherapy products is highly competitive. We face competition from existing and future competitors with respect to each of our product candidates currently in development, and will face competition with respect to other product candidates that we may seek to develop or commercialize in the future. In addition, numerous academic institutions are conducting preclinical and clinical research in these areas, as well as with other white blood cell types including NK-T cells and gamma-delta T cells. It is also possible that new competitors, including those developing similar or alternatives to cellular immunotherapy product candidates, may emerge and acquire significant market share. Such competitors may have an advantage over us due to their greater size, resources or institutional experience, or may develop product candidates that are safer, more effective, more widely accepted, more cost-effective or enable higher patient quality of life than ours. More established biopharmaceutical companies may also develop and commercialize their product candidates at a faster rate, which could render our product candidates obsolete or non-competitive before they are fully developed or commercialized. If we are not able to compete effectively against our existing and potential competitors, our business, financial condition, results of operations and growth prospects may be materially adversely affected.
If any of our product candidates are approved for marketing and commercialization and we have not developed or secured third- party marketing, sales and distribution capabilities, we will be unable to successfully commercialize such products and may not be able to generate product revenue.
We currently have no sales, marketing or distribution organizational experience or capabilities. We will need to develop internal sales, marketing and distribution capabilities to commercialize any product candidate that gains FDA or other regulatory authority approval, which would be expensive and time-consuming, or enter into partnerships with third parties to perform these services. If we decide to market any approved products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration and compliance capabilities. If we rely on third parties to market products or decide to co-promote products with partners, we will need to establish and maintain marketing and distribution arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all. In entering into third-party marketing or distribution arrangements, any product revenue we receive will depend upon the efforts of the third parties and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for any approved product. If we are not successful in commercializing any product approved in the future, if any, either on our own or through third parties, our business, financial condition, results of operations and growth prospects could be materially adversely affected.
24
If we are not able to establish pharmaceutical or biotechnology collaborations on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
The advancement of our product candidates and development programs and the potential commercialization of our current and future product candidates will require substantial additional cash to fund expenses. For some of our programs, we may seek to collaborate with pharmaceutical and biotechnology companies to develop and commercialize such product candidates. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business.
We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Whether we reach a definitive agreement for other collaborations will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the progress of our clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate. Further, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for future product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy. Any delays in entering into new collaborations or strategic partnership agreements related to any product candidate we develop could delay the development and commercialization of our product candidates, which would harm our business prospects, financial condition, and results of operations.
If we enter into collaborations with third parties to develop or commercialize our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations.
If we enter into future collaboration with third parties, we could face the following risks:
|
• |
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
|
• |
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; |
|
• |
collaborators may not properly enforce, maintain or defend our intellectual property rights or may use our proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation, or other intellectual property proceedings; |
|
• |
disputes may arise between a collaborator and us that cause the delay or termination of the research, development or commercialization of the product candidate, or that result in costly litigation or arbitration that diverts management attention and resources; |
|
• |
if a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated; and |
|
• |
collaboration agreements may restrict our right to independently pursue new product candidates. |
If conflicts arise between our collaborators and us, our collaborators may act in a manner adverse to us and could limit our ability to implement our strategies. Future collaborators may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by the collaborators or to which the collaborators have rights, may result in the withdrawal of support for our product candidates. Our collaborators may preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely or fail to devote sufficient resources to the development and commercialization of products. Any of these developments could harm our product development efforts.
As a result, if we enter into additional collaboration agreements and strategic partnerships or license our intellectual property, products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction.
25
Our product candidates, including COYA 301, COYA 302, COYA 201, COYA 206 and COYA 101, could be subject to regulatory limitations following approval, if and when such approval is granted.
Following approval of a product candidate, if any, we must comply with comprehensive government regulations regarding the manufacture, labeling, marketing, distribution and promotion of biologic products. We must comply with the FDA’s regulations, which prohibit promoting off-label uses. We may not be able to obtain the labeling claims necessary or desirable to successfully commercialize our product candidates in development.
The FDA and foreign regulatory authorities could impose significant restrictions on the use of an approved product including potentially restricting its use to limited clinical centers as well as through the product label, and on advertising, promotional and distribution activities associated with such approved product. The FDA or a foreign regulatory authority could also condition their approval on the performance of post-approval clinical trials, patient monitoring or testing, which could be time-consuming and expensive. If the results of such post-marketing trials are not satisfactory, the FDA or such foreign regulatory authority could withdraw marketing authorization or may condition continued marketing on commitments from us or our partners that may be expensive and/or time-consuming to fulfill.
In addition, if we or others identify side-effects after any of our products are on the market, if manufacturing problems occur subsequent to regulatory approval, or if we, our manufacturers or our partners fail to comply with regulatory requirements, including those mentioned above, we or our partners could be subject to the following:
|
• |
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned clinical trials; |
|
• |
restrictions on such products manufacturing processes; |
|
• |
changes to the product label; |
|
• |
restrictions on the marketing of a product; |
|
• |
restrictions on product distribution; |
|
• |
requirements to conduct post-marketing clinical trials; |
|
• |
Untitled or Warning Letters from the FDA; |
|
• |
withdrawal of the product from the market; |
|
• |
refusal to approve pending applications or supplements to approved applications that we submit; |
|
• |
recall of products; |
|
• |
fines, restitution or disgorgement of profits or revenue; |
|
• |
suspension or withdrawal of regulatory approvals; |
|
• |
refusal to permit the import or export of our products; |
|
• |
product seizure; |
|
• |
injunctions; or |
|
• |
imposition of civil or criminal penalties. |
Any one or a combination of these penalties could prevent us from achieving or maintaining market acceptance of the affected product, or could substantially increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating any revenue or profit from the sale of such product and could materially adversely affect our business, financial condition, results of operations and growth prospects. In addition, third-party payors may impose limitations on centers and personnel that may administer our products, including but not limited to requiring third-party accreditation to be obtained before the use of our products is reimbursed in such a center, which could materially adversely affect our potential commercial success and lead to slower market acceptance.
The commercial success of any of our product candidates will depend upon such product candidate’s degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
Our product candidates may not be commercially successful. Even if requisite approvals are obtained from the FDA in the United States and other regulatory authorities internationally, the commercial success of our product candidates will depend, in part, on the acceptance by physicians, patients and healthcare payors of cell therapy products in general, and our product candidates in particular, as medically necessary, cost-effective and safe. Physicians, patients, healthcare payors and others in the medical community may not accept any product that we commercialize. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance of cell therapy products and, in particular, our product candidates, if approved for commercial sale, will depend on several factors, including:
|
• |
the efficacy and safety of such product candidates as demonstrated in clinical trials; |
|
• |
the potential and perceived advantages of product candidates over alternative treatments; |
|
• |
the cost of treatment relative to alternative treatments; |
26
|
|
• |
the clinical indications for which the product candidate is approved by the FDA; |
|
• |
the willingness of physicians to prescribe new therapies; |
|
• |
the willingness of the target patient population to try new therapies; |
|
• |
the prevalence and severity of any side effects; |
|
• |
product labeling or product insert requirements imposed by the FDA or other regulatory authorities, including any limitations or warnings contained in a product approved labeling; |
|
• |
relative convenience and ease of administration; |
|
• |
the timing of market introduction of competitive products; |
|
• |
adverse publicity concerning our product candidates or favorable publicity about competing products and treatments; |
|
• |
sufficient third-party payor coverage, any limitations in terms of center or personnel training requirement imposed by third parties and adequate reimbursement; |
|
• |
limitations or warnings contained in the FDA-approved labeling for our product candidates; |
|
• |
any FDA requirement to undertake a Risk Evaluation and Mitigation Strategy, or REMS; |
|
• |
the effectiveness of our sales, marketing and distribution efforts; and |
|
• |
potential product liability claims. |
Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be fully known until after such product is launched. Our product candidates may not achieve broad market acceptance.
Furthermore, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of a product. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. 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.
The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market such products and to generate product revenue.
We expect the cost of administration of our product candidates to be substantial, when and if they achieve regulatory approval. We expect that coverage and reimbursement by government and private payors will be essential for most patients to be able to afford these treatments. Accordingly, sales of our products, if approved, will depend substantially, both domestically and internationally, on the extent to which the costs of our product candidates will be reimbursed by government authorities, private health coverage insurers and other third-party payors. Coverage and reimbursement by a third-party payor could depend upon several factors, including the third-party payor’s determination that use of a product is (i) a covered benefit under its health plan, (ii) safe, effective and medically necessary, (iii) appropriate for the specific patient, (iv) cost-effective and (v) neither experimental nor investigational.
Obtaining coverage and reimbursement for a product from third-party payors is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. If coverage and reimbursement are not available, or are available only at limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be adequate to realize a sufficient return on our investment.
There is significant uncertainty related to third-party coverage and reimbursement of newly approved drug products. In the United States, third-party payors, including government payors such as Medicare and Medicaid, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. Medicare and Medicaid are increasingly used as models for the development of private payors’ and government payors’ coverage and reimbursement policies. Currently, few cell therapy products have been approved for coverage and reimbursement by the Centers for Medicare & Medicaid Services (the “CMS”), the agency responsible for administering Medicare. It is difficult to predict what CMS will decide with respect to coverage and reimbursement for fundamentally novel products such as ours, since there is a limited body of established protocols and precedents for these types of drug products. Moreover, reimbursement agencies in the European Union may be more conservative than CMS. For example, several immunotherapy drugs have been approved for reimbursement in the United States, whereas they have not been approved for reimbursement in certain European Union member states. It is difficult to predict what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.
Outside the United States, international operations vary significantly by country and are subject to extensive government price controls and other market regulations, and increasing emphasis on cost-containment initiatives in the European Union, Canada and other countries could place pricing pressure on us. In many countries, the prices of medical products are subject to varying price control
27
mechanisms as part of national health systems. It can also take a significant amount of time after approval of a product to secure pricing and reimbursement for such product in many counties outside the United States. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medical products, but monitor and control Company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable product revenues.
Moreover, increasing efforts by government and third-party payors in the United States and abroad to cap or reduce healthcare costs could limit coverage and the level of reimbursement for our product candidates. Payors are increasingly considering new metrics as the basis for reimbursement rates, such as average sales price, or ASP, average manufacturer price, or AMP, and Actual Acquisition Cost.
The existing data for reimbursement based on some of these metrics is relatively limited, although certain states have begun to survey acquisition cost data for the purpose of setting Medicaid reimbursement rates, and CMS has begun making pharmacy National Average Drug Acquisition Cost and National Average Retail Price data publicly available on at least a monthly basis. Therefore, it may be difficult to project the impact of these evolving reimbursement metrics on the willingness of payors to cover candidate products that we or our partners are able to commercialize. Furthermore, most third-party payors currently require additional accreditation for approved cell therapy drugs, which limits the centers that can administer the drugs, and similar limitations may also be imposed on the product candidates that we are developing. We expect to experience pricing pressures in connection with the sale of our product candidates, if any, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, and on prescription drugs and surgical procedures in particular, has become intense. As a result, increasingly high barriers to entry are developing for new drug products such as ours.
Healthcare reform initiatives and other administrative and legislative proposals may harm our business.
In the United States, the European Union 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 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.
Specifically, there have been proposals in the United States to control the cost of drug treatments, patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. We believe that coverage and reimbursement for new therapies will be increasingly restricted. Recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States, the European Union 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. Furthermore, future price controls or other changes in pricing regulation or negative publicity related to the pricing of pharmaceutical drugs could restrict the amount that we are able to charge for our drug products, which could render our product candidates, if approved, commercially unviable and materially adversely affect our ability to raise additional capital on acceptable terms.
We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.
We have never obtained marketing approval for a product candidate. It is possible that the FDA may refuse to accept for substantive review any BLAs that we submit for our product candidates or may conclude after review of our data that our application is insufficient to obtain marketing approval of our product candidates. If the FDA does not accept or approve our BLAs for our product candidates, it may require that we conduct additional clinical, preclinical, or manufacturing validation studies and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA-required studies, approval of any BLA that we submit may be delayed or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve our BLAs.
Any delay in obtaining, or an inability to obtain, marketing approvals would prevent us from commercializing our product candidates, generating revenues, and achieving and sustaining profitability. If any of these outcomes occur, we may be forced to abandon our development efforts for our product candidates, which could significantly harm our business.
28
Obtaining and maintaining marketing approval or commercialization of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions.
Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.
If we market approved products outside the United States, we expect that we will be subject to additional risks in commercialization, including:
|
• |
different regulatory requirements for approval of therapies in foreign countries; |
|
• |
reduced protection for intellectual property rights; |
|
• |
unexpected changes in tariffs, trade barriers and regulatory requirements; |
|
• |
economic weakness, including inflation, or political instability in particular foreign economies and markets; |
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
|
• |
foreign reimbursement, pricing and insurance regimes; |
|
• |
workforce uncertainty in countries where labor unrest is more common than in the United States; |
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
|
• |
business interruptions resulting from geopolitical actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, and other public health crises, illnesses, epidemics or pandemics, such as the potential impact of the COVID-19 outbreak. |
We have no prior experience in these areas. In addition, there are complex regulatory, tax, labor and other legal requirements imposed by many of the individual countries in which we may operate, with which we will need to comply. Any of the foregoing difficulties, if encountered, could materially adversely affect our business, financial condition, results of operations and growth prospects.
Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable fraud and abuse and other healthcare laws and regulations, which could expose us to penalties.
These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product candidates, if approved. Such laws include, the U.S. federal Anti- Kickback Statute, the U.S. federal civil and criminal false claims and civil monetary penalties laws, including the civil False Claims Act, the Health Insurance Portability and Accountability Act, or HIPAA, the Health Information Technology for Economic and Clinical Health Act, or HITECH, the U.S. Physician Payments Sunshine Act and its implementing regulations, U.S. state laws and regulations, including, state anti-kickback and false claims laws, 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, laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, laws requiring the registration of pharmaceutical sales representatives, laws governing the privacy and security of health information in certain circumstances, and similar healthcare laws and regulations in other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers.
It is not always possible to identify and deter 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 government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will also involve substantial costs. 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 non-compliance, disgorgement, individual 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. Any of the foregoing could significantly harm our business, financial condition, results of operations and growth prospects.
29
Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.
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 (collectively the “ACA”) was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include the following:
|
• |
an annual, non-deductible fee payable by any entity that manufactures or imports certain branded prescription drugs and biologic agents (other than those designated as orphan drugs), which is apportioned among these entities according to their market share in certain government healthcare programs; |
|
• |
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; |
|
• |
new requirements to report certain financial arrangements with physicians and teaching hospitals, including reporting “transfers of value” made or distributed to prescribers and other healthcare providers and reporting investment interests held by physicians and their immediate family members; |
|
• |
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
|
• |
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs and biologics that are inhaled, infused, instilled, implanted, or injected; |
|
• |
extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
|
• |
expansion of eligibility criteria for Medicaid programs thereby potentially increasing a manufacturer’s Medicaid rebate liability; |
|
• |
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; |
|
• |
establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; |
|
• |
expansion of the entities eligible for discounts under the Public Health Service program; and a licensure framework for follow on biologic products. |
Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA. The Supreme Court upheld the ACA in the main challenge to the constitutionality of the law in 2012. Specifically, the Supreme Court held that the individual mandate and corresponding penalty was constitutional because it would be considered a tax by the federal government. The Supreme Court also upheld federal subsidies for purchasers of insurance through federally facilitated exchanges in a decision released in June 2015. This includes enactment of the TCJA (as defined below), which, among other things, removes penalties for not complying with the ACA’s individual mandate to carry health insurance. It Is uncertain the extent to which any such changes may impact our business or financial condition.
Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our customers and accordingly, our financial operations.
In addition, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been Congressional inquiries and proposed federal and state legislation designed to bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.
Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-
30
party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates or put pressure on our product pricing.
In markets outside of the United States, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States 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.
Risks Related to Our Employees, Managing Our Growth and Our Operations
We will need to increase the size of our organization, and we may experience difficulties in managing growth.
As of November 1, 2022, we had six full-time employees. We will need to continue to expand our managerial, operational, quality, manufacturing, finance, sales and other resources in order to manage our operations and clinical trials, continue our development activities and eventually commercialize our product candidates. Our management and personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:
|
• |
discover new product candidates, develop the process and analytical methods for IND-enabling studies and FDA submissions, complete the required IND-enabling studies for each, and receive approval from the FDA and other regulatory authorities to initiate clinical trials for such product candidates; |
|
• |
manage our clinical trials effectively; |
|
• |
identify, recruit, retain, incentivize and integrate additional employees; |
|
• |
complete the technology transfer to and qualification of our cGMP manufacturing CDMO partner and process; and |
|
• |
continue to improve our operational, financial and management controls, reports systems and procedures. |
If we are unable to attract skilled employees, increase the size of our organization or manage our future growth effectively, it will impair our ability to execute our business strategy and our business, financial condition, results of operations and growth prospects will be materially adversely affected.
If we fail to attract and retain senior management and clinical and key scientific personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel. We are highly dependent upon our senior management, particularly our chief executive officer, as well as other members of our senior management team. We are currently under contract with or have a business relationships with certain members of our senior management and clinical and key scientific personnel, and the loss of services of any of these individuals, whether due to termination of contract, illness, death, or for any other reason, would likely have an adverse consequence on our business, including, but not limited to potentially delaying or preventing the successful development of our product pipeline, initiation or completion of our planned clinical trials or the commercialization of our future product candidates.
Competition for qualified personnel in the biotechnology and pharmaceuticals field is intense due to the limited number of individuals who possess the skills and experience required by our industry. We will need to hire additional personnel as we expand our clinical development and if we initiate commercial activities. We may not be able to attract and retain quality personnel on acceptable terms, or at all. If we are unable to hire and retain the qualified personnel we need to operate our business, our business, financial condition, results of operations and growth prospects would be materially adversely affected. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.
31
Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in clinical trials will face an even greater risk if we commercialize any product candidate that we may develop. If we cannot successfully defend ourselves against claims that any such product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
|
• |
decreased demand for any product candidate that we may develop; |
|
• |
loss of revenue; |
|
• |
substantial monetary awards to trial participants or patients; |
|
• |
significant time and costs to defend the related litigation; |
|
• |
withdrawal of clinical trial participants; |
|
• |
increased insurance costs; |
|
• |
the inability to commercialize any product candidate that we may develop; and |
|
• |
injury to our reputation and significant negative media attention. |
Any such outcomes could materially adversely affect our business, financial condition, results of operations and growth prospects.
Our insurance policies may be inadequate, may not cover all of our potential liabilities and may potentially expose us to unrecoverable risks.
We do not carry insurance for all categories of risk that our business may encounter. Although we maintain product liability insurance coverage that also covers our clinical trials, such insurance may not be adequate to cover all liabilities that we may incur, and we may be required to increase our product liability insurance coverage. We anticipate that we will need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any product candidate. Insurance availability, coverage terms and pricing continue to vary with market conditions. We endeavor to obtain appropriate insurance coverage for insurable risks that we identify. However, we may fail to correctly anticipate or quantify insurable risks, we may not be able to obtain appropriate insurance coverage and insurers may not respond as we intend to cover insurable events that may occur. Any significant uninsured liability may require us to pay substantial amounts, which would materially adversely affect our business, financial condition, results of operations and growth.
In addition, although we are dependent on certain key personnel, we do not have any key man life insurance policies on any such individuals. Therefore, if any of our chief executive officer or other executive officers die or become disabled, we will not receive any compensation to assist with such individual’s absence. The loss of such person could materially adversely affect our business, financial condition, results of operations and growth prospects.
Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
Our research and development activities and our third-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials owned by us. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our manufacturers’ facilities pending their use and disposal.
We cannot eliminate the risk of contamination, which could cause an interruption of our research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party manufacturers and suppliers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent over time. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage. Any contamination by such hazardous materials could therefore materially adversely affect our business, financial condition, results of operations and growth prospects.
32
Computer system interruptions, cyber-attacks or security breaches could significantly disrupt our product development programs and our ability to operate our business.
Our computer systems, as well as those of various third parties on which we rely, may sustain damage from computer viruses, unauthorized access, data breaches, phishing attacks, cybercriminals, natural disasters (including hurricanes and earthquakes), terrorism, war and telecommunication and electrical failures. We rely on our third-party providers to implement effective security measures and identify and correct for any such failures, deficiencies or breaches. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. While we have not experienced any significant system failure, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of nonclinical or clinical trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of any product candidate could be delayed.
Furthermore, federal, state and international laws and regulations, such as the European Union’s General Data Protection Regulation, or the GDPR, which took effect in May 2018, and the California Consumer Protection Act, which took effect on January 1, 2020, can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail or if our privacy practices do not meet the requirements of such laws. Other states are considering similar laws that could impact our use of research data with respect to individuals in those states. There are extensive documentation obligations and transparency requirements, which may impose significant costs on us. In addition, our software systems include cloud-based applications that are hosted by third-party service providers with security and information technology systems subject to similar risks. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed, any of which could materially adversely affect our business, financial condition, results of operations and growth prospects.
Risks Related to Manufacturing
Our manufacturing process is complex and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient supply of our product candidates for clinical trials or our products for patients, if approved.
Our manufacturing process will be susceptible to product loss or failure, or product variation that may negatively impact patient outcomes, due to logistical issues associated with the collection of starting material from the donor, shipping such material to the manufacturing site, shipping the final product back to the clinical trial recipient, preparing the product for administration, infusing the patient with the product, manufacturing issues or different product characteristics resulting from the differences in donor starting materials, variations between reagent lots, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth and variability in product characteristics.
Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If, for any reason in our clinical studies, we lose the starting material for a manufactured product for one of our clinical trial patients at any point in the process, the manufacturing process for that patient would need to be restarted, or could result in such patient no longer participating in our clinical trial. If microbial, viral or other contaminations are discovered in our product candidates or in any of the manufacturing facilities in which products or other materials are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We will be required to maintain a chain of identity with respect to materials as they move from the donor to the manufacturing facility, through the manufacturing process and back to the clinical trial recipient. Maintaining a chain of identity is difficult and complex, and failure to do so could result in adverse patient outcomes, loss of product or regulatory action, including withdrawal of our products from the market, if licensed. Any failure in the foregoing processes could render a batch of product unusable, could affect the regulatory approval of such product candidate, could cause us to incur fines or penalties or could harm our reputation and that of our product candidates.
We may make changes to our manufacturing process for various reasons, such as to control costs, achieve scale, decrease processing time, increase manufacturing success rate or for other reasons. Changes to our process made during the course of clinical development could require us to show the comparability of the product used in earlier clinical phases or at earlier portions of a trial to the product used in later clinical phases or later portions of the trial. Other changes to our manufacturing process made before or after commercialization could require us to show the comparability of the resulting product to the product candidate used in the clinical trials using earlier processes. Such showings could require us to collect additional nonclinical or clinical data from any modified process prior to obtaining marketing approval for the product candidate produced with such modified process. If such data are not ultimately comparable to that seen in the earlier trials or earlier in the same trial in terms of safety or efficacy, we may be required to make further
33
changes to our process and/or undertake additional clinical testing, either of which could significantly delay the clinical development or commercialization of the associated product candidate, which would materially adversely affect our business, financial condition, results of operations and growth prospects.
We rely on third parties to manufacture our product candidates, which increases the risk that we will not have sufficient quantities of such product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We do not own or operate cGMP facilities for the production of clinical or commercial supplies of the product candidates that we are developing or evaluating in our development programs. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. We outsource all manufacturing of our product candidates and products to third parties until we can complete a cGMP facility that will allow us to supply the product candidates needed for our early-stage clinical trials. We compete with other companies for access to cGMP facilities and cannot assure continued access.
In order to conduct clinical trials of product candidates, we will need to have them manufactured in potentially large quantities. Our third-party manufacturers may be unable to increase the manufacturing capacity for any of our product candidates in a timely or cost- effective manner, or at all. In addition, quality issues may arise during scale-up activities and at any other time. If these third-party manufacturers are unable to, or do not, scale up the manufacture of our product candidates in sufficient quality and quantity, the development, testing and clinical trials of that product candidate may be delayed or infeasible, and regulatory approval or commercial launch of that product candidate may be delayed or not obtained, which could significantly harm our business.
While we have entered into supply relationships with third-party manufacturers for supplies of certain of our product candidates for purpose of preclinical testing, we may be unable to enter into agreements with third-party manufacturers for commercial supplies of any product candidate that we develop, or may be unable to do so on acceptable terms. Even if we are able to establish and maintain arrangements with sufficient third-party manufacturers, reliance on third-party manufacturers entails risks, including:
|
• |
reliance on the third-party for regulatory compliance and quality assurance; |
|
• |
the possible breach of the manufacturing agreement by the third-party; |
|
• |
the possible misappropriation of our proprietary information, including our trade secrets and know-how; and |
|
• |
the possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us. |
Third-party manufacturers may not be able to comply with cGMP requirements or similar regulatory requirements outside the United States. The failure of our third-party manufacturers to comply with applicable requirements could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and/or criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates. If the third parties that we engage to supply any materials or to manufacture any products for our preclinical tests and clinical trials should cease to continue to do so for any reason, including due to the effects of the COVID-19 pandemic and the actions undertaken by governments and private enterprises to contain COVID-19, we likely would experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product candidates or the substances used to manufacture them, it will be more difficult for us to develop our product candidates and compete effectively.
For COYA 101 we rely on Terumo BCT to manufacture the Terumo Bioreactors, which house the Treg expansion process to generate the billions of Treg cells necessary for the end product. Most of the reagents used in this process can be sourced from multiple manufacturers. For COYA 201, we rely on Terumo BCT to manufacture the Terumo Bioreactors to generate the appropriate number of expanded Treg cells. Since the Treg exosomes are generated from these expanded Treg cells, the bioreactor is a required component of the process. As with COYA 101, most of the reagents used in the process can be sourced from multiple manufacturers. In addition, COYA 201 requires a tangential flow filtration technology sourced from Repligen. Furthermore, COYA 201 requires a Nanosight technology sourced from Malvern. With respect to COYA 206, we will rely on multiple manufacturers of materials and equipment that are utilized in the manufacturing of COYA 206. For example, to image the exosomes we will rely on Malvern, to measure the size of the exosomes we will rely on Izon, for western blotting we will rely on ThermoFisher, for mass spectrometry we will rely on Applied Biosystems, and for DNA tethering materials we will rely on multiple manufacturers. For COYA 301, we have licensed the biologic cytokine from ARScience Biotherapeutics, Inc. and will rely on its manufacturing of the subject cytokine. For COYA 302, which involves COYA 301 plus a fusion protein, we have entered into a binding term sheet with an India-based, multinational pharmaceutical company, and are currently negotiating for a definitive supply agreement for the supply of the fusion protein.
34
Identifying an appropriately qualified source of alternative supply for any one or more of the component substances for our product candidates could be time consuming, and we may not be able to do so without incurring material delays in the development and commercialization of our product candidates. Any alternative vendor would also need to be qualified through a New Drug Application (“NDA”) supplement and may need to undergo an FDA inspection before the supplement can be approved, which could result in further delay, including delays related to additional clinical trials.
These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, cause us to incur higher costs and prevent us from commercializing them successfully. Furthermore, if our suppliers fail to deliver the required commercial quantities of components and APIs on a timely basis and at commercially reasonable prices, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, commercialization of our product candidates, and clinical trials of future potential product candidates, may be delayed or we could lose potential revenue and our business, financial condition, results of operation and reputation could be adversely affected.
We are dependent on third parties to store our Treg cells and other products and any damage or loss would cause delays in replacement, and our business could suffer.
The Treg cells and other products are stored in freezers at third-party biorepositories and will also be stored in our freezers at our production facility. If these materials are damaged at these facilities, including by the loss or malfunction of these freezers or our back-up power systems, as well as by damage from fire, power loss or other natural disasters, we would need to establish replacement Treg cells and exosomes, viral vector, and master and working cell banks of the engineered K562 cells, which would impact clinical supply and delay our patients’ treatments. If we are unable to establish replacement materials, we could incur significant additional expenses and liability to patients whose treatment is delayed, and our business could suffer.
We have not yet developed a validated methodology for freezing and thawing large quantities of Treg cells, which we believe will be required for the storage and distribution of our Treg product candidates.
We have not yet demonstrated that Treg cells, which can be frozen and thawed in smaller quantities, can also be frozen and thawed in large quantities without damage, in a cost-efficient manner and without degradation over time. We may encounter difficulties not only in developing freezing and thawing methodologies for large scale use, but also in obtaining the necessary regulatory approvals for using such methodologies in treatment. If we cannot adequately demonstrate similarity of our frozen product to the unfrozen form to the satisfaction of the FDA, we could face substantial delays in our regulatory approvals. If we are unable to freeze Treg cells for shipping purposes, our ability to promote adoption and standardization of our products, as well as achieve economies of scale by centralizing our production facility, will be limited. Even if we are able to successfully freeze and thaw Treg cells in large quantities, we will still need to develop a cost-effective and reliable distribution and logistics network, which we may be unable to accomplish.
Furthermore, we have not yet demonstrated long-term stability of cryopreserved Treg cells and therefore do not know if we will be able to store the cryopreserved cells for extended periods of time. If we are unable to demonstrate long-term stability, we will need to reduce the manufacturing batch size to ensure that the material we produce will be used before it expires. In that case, the scaling of our production processes will not deliver the efficiencies we expect, and the cost per dose of our product candidates will be substantially higher.
For these and other reasons, we have not yet established the long-term stability of our cryopreserved Treg Cells and we may not be able to commercialize Treg cells on a large scale or in a cost-effective manner. If such product is found to be instable, we would be required to conduct more frequent manufacturing runs, which could cause us to incur significant additional expenses.
Risks Related to Our Intellectual Property
If our license agreement with The Methodist Hospital is terminated, we could lose our rights to key components enabling our Treg Modalities.
Key components of the technology utilized in our Treg Modalities have been in-licensed pursuant to an Amended and Restated Patent and Know How License Agreement, (the “Methodist License Agreement”), between us and The Methodist Hospital located in Houston, Texas (the “Methodist”). Pursuant to the Methodist License Agreement, Methodist granted to us an exclusive, worldwide, royalty-bearing, sublicensable license under specified patents and patent applications related to Treg technology in the field of therapeutics. Pursuant to the Methodist License Agreement, we are also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, royalties (subject to customary reductions) ranging from 1% to 10% of annual worldwide net sales of such licensed product. The applicable royalty percentage increases as Licensed Products are used to treat from only one to more than three indications and if a given licensed product utilizes only Treg cell therapy or is a combination of both Treg cell therapy and exosomes. Therefore, the lowest tier is paid when there is only a single indication being addressed with a single product. There is only one low double-digit tier with such tier bearing only on combination products where there are three or more indications being served. We are also required to pay a low single digit percentage for certain licensed services. We are required to pay mid-teens royalties on sublicense revenue.
35
The term of the Methodist License Agreement extends until expiration of the last of the patent rights licensed to us by the Licensor, which is currently expected to occur in approximately 2039. The Licensor may terminate the Methodist License Agreement or convert it into a non-exclusive license upon the occurrence or non-occurrence of certain events subject to the terms and conditions therein, such as (i) not “Actively Attempting to Develop or Commercialize” (as defined in the Methodist License Agreement) for a continuous period of 6 months anytime beginning October 2, 2025, (ii) breach of obligation to make timely payments or reports by us, (iii) an uncured material breach by us, (iv) the cessation of our business or our insolvency, liquidation or receivership. If the Licensor terminates or narrows the Methodist License Agreement, we could lose the use of intellectual property rights that may be material or necessary to the development or production of our product candidates, which could impede or prevent our successful commercialization of such product candidates and materially adversely affect our business, financial condition, results of operations and growth prospects.
Furthermore, our Methodist License Agreement with the Licensor is field-specific and has been granted to us in the field of therapeutics. This Methodist License Agreement permits Licensor to practice the licensed rights, and to allow non-profit academic third parties to practice the licensed rights for certain academic purposes. As such, certain patents in a patent family that is licensed to us by the Licensor have been licensed to at least one other third party. Although these patents should not be overlapping with our licensed patents, there is a risk that inadvertent overlap may occur, and thus resources may have to be expended to resolve any such overlap and to prevent other licensees from practicing under our licensed patents rights. If any of the foregoing were to occur, it could delay our development and commercialization of our product candidates, which in turn could materially adversely affect our business, financial condition, results of operations and growth prospects.
Our development and commercialization rights to our current and future product candidates and technology are subject, in part, to the terms and conditions of licenses granted to us by others.
Our patent portfolio consists of pending patent applications licensed from third parties, jointly owned with third parties and assigned solely to us based on our ongoing development activities. We are reliant upon certain of these rights and proprietary technology from third parties for the engineering and development of our current and future product candidates. However, these and other licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we choose to develop or commercialize our technology and products in the future. As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses.
We also engage in collaborations with scientists at academic and non-profit institutions to access technologies and materials that are not otherwise available to us. Although the agreements that govern these collaborations may include an option to negotiate an exclusive license to the institution’s rights in any inventions that are created in the course of these collaborations, we may not be able to come to a final agreement for an exclusive license with an institution.
Such licenses and other contracts may be the subject of disagreements with the grantors and/or various third parties regarding the interpretation of such licenses and contracts. The resolution of any such disagreements that may arise could affect the scope of our rights to the relevant technology, or affect financial or other obligations under the relevant agreement, either of which could inhibit our ability to utilize the underlying technology in a cost-effective manner to develop and commercialize our product candidates, which in turn could have materially adversely affect our business, financial condition, results of operations and growth prospects.
Under certain circumstances such as a material breach of terms, our licensors could terminate our license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our competitors) to receive licenses to a portion of the intellectual property that is subject to our existing licenses.
In addition, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications directed to the technology that we license from third parties. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with our best interests. If our licensors fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products that are the subject of such licensed rights could be impaired. Additionally, we may be required to reimburse our licensors for all of their expenses related to the prosecution, maintenance, enforcement and defense of patents and patent applications that we in-license from them.
Furthermore, our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third parties have ownership rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could harm our competitive position, and our business.
36
Duration of patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time, and the expiration of our patents may subject us to increased competition.
As of the date of this prospectus, our patent estate derived from our relationship with The Houston Methodist Hospital included two pending U.S. provisional patent applications, one U.S. non-provisional patent application, five foreign patent applications, and four pending Patent Cooperation Treaty (“PCT”) applications, each co-owned with or in-licensed from The Houston Methodist Hospital. These patent applications are directed to our Treg and exosome compositions and methods of use, methods of Treg and exosome manufacture, and methods of in vivo Treg expansion via combination therapies, among other things.
We have filed intellectual property claims on the contents of the exosomes, namely the micro RNAs that are reproducibly represented from batch to batch. Many of these micro RNAs confer anti-inflammatory functionality as a mechanism of action and may explain the exosomes immunomodulatory function. The exosome field is an emerging and new area at present and understanding the functional aspects of the exosomes is an important but evolving regulatory aspect. We have filed intellectual property claims for compositions of matter that teach the reproducible micro RNA contents. To date, no patents have been issued.
If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2040 and 2042, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. In addition, our patent estate derived from our relationship with ARScience Biotherapeutics, Inc. (described below) included one published patent application and one provision patent application. The patents are expected to expire in 2041 and 2043, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. All of our Houston Methodist Hospital patents have composition and method claims, with the exception of a biomarker patent, which has only method claims. The ARScience Biotherapeutics, Inc. patents have composition, method, and utility claims. Finally, our patent estate derived from our relationship with Carnegie Mellon included one pending patent application. The patents, if granted, would is expected to expire in 2043, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Carnegie Mellon patent has method claims.
We plan to file additional patent applications that could potentially allow for further increase of the exclusive market protection for use of COYA 101. However, we can provide no assurance that we will be able to file or receive additional patent protection for COYA 101 or other product candidates.
Patent expiration dates may be shortened or lengthened by a number of factors, including terminal disclaimers, patent term adjustments, supplemental protection certificates and patent term extensions. Patent term extensions and supplemental protection certificates, and the like, may be impacted by the regulatory process and may not significantly lengthen patent term. Our patent protection could also be reduced or eliminated for noncompliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies. In addition, if we fail to apply for applicable patent term extensions or adjustments, we will have a more limited time during which we can enforce our granted patent rights.
Given the amount of time required for the development, testing and regulatory review of product candidates, patents protecting such candidates might expire before or shortly after such product candidates are commercialized. We expect to seek extensions of patent terms in the United States and, if available, in other countries where we have or will obtain patent rights. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent; provided that the patent is not enforceable for more than 14 years from the date of drug approval, which is limited to the approved indication (or any additional indications approved during the period of extension). Furthermore, only one patent per approved product can be extended and only those claims directed to the approved product, a method for using it or a method for manufacturing it may be extended. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If we are responsible for patent prosecution and maintenance of patent rights in-licensed to us, we could be exposed to liability to the applicable patent owner. If we or our licensors fail to maintain the patents and patent applications covering our product candidates and technologies, we may not be able to prevent a competitor from marketing products that are the same as or similar to our product candidates. Further, others commercializing products similar or identical to ours, and our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case, which could increase competition for our product candidates and materially adversely affect our business, financial condition, results of operations and growth prospects.
If any patent protection we obtain is not sufficiently robust, our competitors could develop and commercialize products and technology similar or identical to ours.
The market for cell therapy is highly competitive and subject to rapid technological change. Our success depends, in large part, on our ability to maintain a competitive position in the development and protection of technologies and products for use in these fields
37
and to obtain and maintain patent protection in the United States and other countries with respect to our product candidates and our technology. We have sought, and intend to seek, to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates and our technology that are important to our business. If we are unable to protect our intellectual property, our competitive position could be materially adversely affected, as third parties may be able to make, use or sell products and technologies that are substantially the same as ours without incurring the sizeable development and licensing costs that we have incurred. This, in turn, would materially adversely affect our ability to compete in the market.
The patent position of biotechnology and pharmaceutical companies generally is uncertain, involves complex legal and factual questions and has, in recent years, been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued that protect our technology or product candidates or effectively prevent others from commercializing competitive technologies and product candidates.
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. We may also fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
Claim scope in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if the patent applications we license or own do issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us or otherwise provide us with any competitive advantage. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative products in a non-infringing manner.
Even after issuance, our owned and in-licensed patents may be subject to challenge, which if successful could require us to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to cease the use of the underlying technology, which could materially adversely affect our business.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents, even after issuance, may be challenged in the courts or patent offices in the United States and abroad. Third-party challenges may result in a loss of exclusivity or in our patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to prevent others from using or commercializing similar or identical technology and products, or could limit the duration of the patent protection of our technology and product candidates.
Even if our patents are determined to be valid and enforceable, they may not be interpreted sufficiently broadly to prevent others from marketing products similar to ours or designing around our patents.
We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which could materially adversely affect our ability to develop, manufacture and market our product candidates.
There are many patents issued or applied for in the biotechnology industry, and we may not be aware of patents or patent applications held by others that relate to our business. We cannot guarantee that any of our or our licensors’ patent searches or analyses, including but not limited to the identification of relevant patents, analysis of the scope of relevant patent claims or determination of the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and elsewhere that is relevant to or necessary for the development and commercialization of our product candidates in any jurisdiction.
For example, patent applications in the United States and many international jurisdictions are typically not published until 18 months after the filing of certain priority documents (or, in some cases, are not published until they issue as patents) and publications in the scientific literature often lag behind actual discoveries. Thus, we cannot be certain that others have not filed patent applications or made public disclosures relating to our technology or our contemplated technology. A third party may have filed, and may in the future file, patent applications directed to our products or technology similar to ours. Any such patent application may have priority over our patent applications or patents, which could further require us to obtain rights to patents directed to such technologies. If third parties have filed such patent applications, an interference proceeding in the United States can be initiated by such third party, or by the USPTO itself, to determine who was the first to invent any of the subject matter recited by the patent claims of our applications.
Furthermore, after issuance, the scope of patent claims remains subject to construction as determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, and we may incorrectly determine that our product candidates are not covered by a third party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or elsewhere that we consider relevant may also be incorrect, which. If we fail to correctly identify or interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able
38
to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay monetary damages, we may be temporarily or permanently prohibited from commercializing our product candidates. We may also be forced to attempt to redesign our product candidates in a manner that no longer infringes third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to the development and commercialization of our product candidates.
Claims brought against us for infringing, misappropriating or otherwise violating intellectual property rights of third parties or engaging in unfair competition, would be costly and time-consuming and could prevent or delay us from successfully developing or commercializing our product candidates.
Our success depends in part on our ability to develop, manufacture and market our technology and use our technology without infringing the proprietary rights of third parties. As the relevant product industries expand and more patents are issued, the risk increases that there may be patents issued to third parties that relate to our products and technology of which we are not aware or that we may need to challenge to continue our operations as currently contemplated. As a result, our technology and any future products that we commercialize could be alleged to infringe patent rights and other proprietary rights of third parties, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and/or limit our ability to commercialize our product candidates.
We may face allegations that we have infringed the trademarks, copyrights, patents and other intellectual property rights of third parties. We employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Accordingly, we may be subject to claims that these employees, or we, have used or disclosed trade secrets or other proprietary information of their former employers. Litigation may make it necessary to defend ourselves by determining the scope, enforceability and validity of third-party proprietary rights, or to establish our proprietary rights. Regardless of whether any such claims that we are infringing patents or other intellectual property rights have merit, such claims can be time consuming, divert management attention and financial resources and are costly to evaluate and defend.
Results of any such litigation are difficult to predict and may require us to stop treating certain conditions, obtain licenses or modify our product candidates while we develop non-infringing substitutes, or may result in significant settlement costs. Litigation can involve substantial damages for infringement (and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees), and the court could prohibit us from selling or require us to take a license from a third party, which the third party is not required to do at a commercially reasonable price or at all. If a license is available from a third party, we may have to pay substantial royalties, upfront fees, milestone fees, or grant cross-licenses to intellectual property rights for our products. We may also have to redesign our products so they do not infringe third-party intellectual property rights, which may not be possible or may require substantial monetary expenditures and time, during which our products may not be available for manufacture, use, or sale.
We may not be able to effectively monitor unauthorized use of our intellectual property and enforce our intellectual property rights against infringement, and may incur substantial costs as a result of bringing litigation or other proceedings relating to our intellectual property rights.
Monitoring unauthorized use of our intellectual property is difficult and costly. From time to time, we review our competitors’ products for potential infringement of our rights. We may not be able to detect unauthorized use of, or take appropriate steps to enforce, our intellectual property rights. Any inability to meaningfully monitor unauthorized use of our intellectual property could result in competitors offering products that incorporate our product or service features, which could in turn reduce demand for our products.
We may also, from time to time, seek to enforce our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of the intellectual property.
If we choose to enforce our patent rights against a party, that party could counterclaim that our patent is invalid and/or unenforceable. The defendant may challenge our patents through proceedings before the Patent Trial and Appeal Board, or PTAB, including inter partes and post-grant review. Proceedings to challenge patents are also available internationally, including, for example, opposition proceedings and nullity actions. In patent litigation in the United States, counterclaims alleging invalidity and/or unenforceability and PTAB challenges are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before the PTAB, even outside the context of litigation. The outcome 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 and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we may lose at least part, and perhaps all, of the patent protection on our product candidates.
39
In addition, such lawsuits and proceedings are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we were successful in stopping the infringement of such patents. Litigation is inherently unpredictable, and there is a risk that the court will decide that such patents are not valid and that we do not have the right to stop the other party from using the inventions. Furthermore, some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. There is also the risk that, even if the validity of such patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our intellectual property rights.
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 materially adversely affect the price of our common stock. Finally, any uncertainties resulting from the initiation and continuation of any litigation could materially adversely affect our ability to raise the funds necessary to continue our operations.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
We have a number of international patents and patent applications, and expect to continue to pursue patent protection in many of the significant markets in which we intend to do business. However, filing, prosecuting and defending patents relating to our product candidates, including all of our in-licensed patent rights, in all countries throughout the world would be prohibitively expensive. We must ultimately seek patent protection on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.
Furthermore, the protection offered by intellectual property rights in certain countries outside of the United States may be less extensive than those in the United States. Consequently, we may not be able to prevent third parties from utilizing proprietary technology in all countries outside of the United States, even if we pursue and obtain issued patents in particular foreign jurisdictions, or from selling or importing products made using our proprietary technology in and into the United States or other jurisdictions. Such products may compete with our products, and our patent rights or other intellectual property rights may not be effective or sufficient to prevent them from competing. If such competing products arise in jurisdictions where we are unable to exercise intellectual property rights to combat them, our business, financial condition, results of operations and growth prospects could be materially adversely affected.
Changes in U.S. patent law or the patent law of other jurisdictions could decrease the certainty of our ability to obtain patents and diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
The U.S. Supreme Court and the Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. For example, in recent years the U.S. Supreme Court modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of a challenge of any patents we obtain or license. Similarly, international courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. Those changes may materially adversely affect our patent rights and our ability to obtain issued patents.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Under the Leahy-Smith America Invents Act, or the America Invents Act, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
The America Invents Act also includes a number of significant changes that affect the way patent applications are prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. 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, all of which could materially adversely affect our business, financial condition, results of operations and growth prospects.
In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. 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 value of patents, once obtained. Depending on 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 patents that we own, have licensed or might obtain in the future. Similarly, changes in patent law and regulations in other countries or
40
jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we own or have licensed or that we may obtain in the future, which in turn could materially adversely affect our business, financial condition, results of operations and growth prospects.
We may fail to obtain or enforce assignments of intellectual property rights from our employees and contractors.
While it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing an enforceable agreement with each party who in fact conceives or develops intellectual property that we regard as our own. Furthermore, our assignment agreements may not be self-executing or may be breached, and we may be forced to bring or defend claims to determine the ownership of what we regard as our intellectual property, and we may not be successful in such claims. If we fail in bringing or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Such an outcome could materially adversely affect our business, financial condition, results of operations and growth prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and distraction to management and other employees.
If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be materially diminished.
Trade secrets are difficult to protect. We rely on trade secrets to protect our proprietary information and technologies, especially where we do not believe patent protection is appropriate or obtainable, or where such patents would be difficult to enforce. We rely in part on confidentiality agreements with our employees, consultants, contractors, outside scientific collaborators and other advisors to protect our trade secrets and other proprietary information. We cannot guarantee that we have entered into such agreements with each party that may have had access to our proprietary information or technologies, or that such agreements, even if in place, will not be circumvented. These agreements may not effectively prevent disclosure of proprietary information or technology and may not provide an adequate remedy in the event of unauthorized disclosure of such information or technology. In addition, others may independently discover our trade secrets and proprietary information, in which case we may have no right to prevent them from using such trade secrets or proprietary information to compete with us. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could materially adversely affect our business, financial condition, results of operations and growth prospects.
Risks Related to Our Securities and the Offering
If we sell securities in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
We may from time to time issue additional shares of common stock at a discount from the current market price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase of any of our securities sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock. If we issue common stock or securities convertible into common stock, our common stockholders could experience additional dilution and, as a result, our stock price may decline.
We will have broad discretion in how we use the net proceeds of this offering. We may not use these proceeds effectively, which could affect our results of operations and cause our stock price to decline.
We will have broad discretion in the application of the net proceeds of this offering, including for any of the purposes described in the section entitled “Use of Proceeds.” We intend to use the net proceeds from this offering to advance our product candidate programs in preclinical studies and into clinical trials, to advance our discovery and candidate selection stage programs and for general corporate purposes. As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the balance of the net proceeds of this offering. We may use the net proceeds for purposes that do not yield a significant return or any return at all for our stockholders. In addition, pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
After this offering, certain of our current stockholders will continue to own % of our Company for the foreseeable future, including the outcome of matters requiring stockholder approval.
Following the consummation of this offering, our directors, executive officers, and 5% stockholders will beneficially own approximately% of the voting power of our outstanding common stock. As a result, such entities and individuals will have the ability, acting together, to significantly influence the election of our directors and the outcome of corporate actions requiring stockholder approval, such as: (i) a merger or a sale of our Company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our Certificate of Incorporation and Bylaws. This concentration of voting power and control could have a significant effect in delaying,
41
deferring or preventing an action that might otherwise be beneficial to our other stockholders and be disadvantageous to our stockholders (including investors in this offering) with interests different from those entities and individuals. Certain of these individuals also have significant control over our business, policies and affairs as officers or directors of our Company. Therefore, you should not invest in reliance on your ability to have any control over our Company.
No active trading market for our common stock currently exists. An active trading market may not develop and you may not be able to resell your shares of our common stock at or above the initial offering price, or at all.
Prior to this offering, there has not been an active trading market for our common stock. If an active trading market for our common stock does not develop following this offering, you may not be able to sell your shares quickly or at the market price. Our ability to raise capital to continue to fund operations by selling shares of our common stock and our ability to acquire other companies or technologies by using shares of our common stock as consideration may also be impaired. The initial public offering price of our common stock will be determined by negotiations between us and the underwriters and may not be indicative of the market prices of our common stock that will prevail in the trading market. Although, we have applied to list our shares of common stock on the Nasdaq Capital Market under the symbol “COYA,” there can be no assurances that this results in an active public market for our shared being sustained after this offering.
The market price for our common stock may be volatile, and your investment in our securities could decline in value.
The stock market in general has experienced extreme price and volume fluctuations. The market prices of the securities of biotechnology and specialty pharmaceutical companies, particularly companies like ours without product revenues and earnings, have been highly volatile and may continue to be highly volatile in the future. This volatility has often been unrelated to the operating performance of particular companies. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock:
|
• |
announcements of technological innovations or new products by us or our competitors; |
|
• |
announcement of FDA approval or disapproval of our product candidates or other product-related actions; |
|
• |
developments involving our discovery efforts and clinical trials; |
|
• |
developments or disputes concerning patents or proprietary rights, including announcements of infringement, interference or other litigation against us or our potential licensees; |
|
• |
developments involving our efforts to commercialize our products, including developments impacting the timing of commercialization; |
|
• |
announcements concerning our competitors, or the biotechnology, pharmaceutical or drug delivery industry in general; |
|
• |
public concerns as to the safety or efficacy of our product candidates or our competitors’ products; |
|
• |
changes in government regulation of the pharmaceutical or medical industry; |
|
• |
changes in the reimbursement policies of third party insurance companies or government agencies; |
|
• |
actual or anticipated fluctuations in our operating results; |
|
• |
changes in financial estimates or recommendations by securities analysts; |
|
• |
developments involving corporate collaborators, if any; |
|
• |
changes in accounting principles; and |
|
• |
the loss of any of our key scientific or management personnel. |
In the past, securities class action litigation has often been brought against companies that experience volatility in the market price of their securities. Whether or not meritorious, litigation brought against us could result in substantial costs and a diversion of management’s attention and resources, which could adversely affect our business, operating results and financial condition.
If you purchase shares of our common stock in this offering, you will suffer immediate dilution of your investment.
The initial public offering price of our common stock is substantially higher than the net tangible book value (deficit) per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on the assumed initial public offering price of $ per share, the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $ per share, representing the difference between our pro forma as adjusted net tangible book value per share after this offering and the assumed initial public offering price.
In addition, as of September 30, 2022, we had (i) outstanding stock options to purchase an aggregate of 2,725,757 shares of common stock at a weighted average exercise price of $0.32 per share, (ii) Series A Placement Agent Warrants exercisable for an aggregate of 525,049 shares of our common stock at a weighted average exercise price of $1.606 per share, (iii) Convertible Notes in the aggregate principal amount of approximately $10.5 million, convertible into an aggregate of shares of our common stock, (iv)shares of our common stock issuable upon the exercise of the Note Placement Agent Warrants, and (v) 7,500,713 shares of our Series A Preferred Stock convertible into an aggregate of shares of our common stock. The Series A Preferred Stock and the Convertible Notes will automatically convert into shares of capital stock upon the consummation of this offering. To the extent outstanding options and warrants are exercised, and the convertible notes and shares of Series A Preferred Stock are converted, there will be further dilution to investors in this offering.
42
We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
As a public company, and particularly after we no longer qualify as an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur previously. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose various requirements on U.S. reporting public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our board of directors. In addition, these rules and regulations are often subject to varying interpretations, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
While we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualify as an emerging growth company, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors.
We qualify as an “emerging growth company,” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to public companies that are not emerging growth companies. These provisions include, but are not limited to: being permitted to have 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 disclosure; an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act; not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; reduced disclosure obligations regarding executive compensation arrangements in our periodic reports, registration statements and proxy statements; and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We intend to take advantage of the exemptions discussed above. As a result, the information we provide will be different than the information that is available with respect to other public companies. In this prospectus, we have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. 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 the market price of our common stock may be more volatile.
We will remain an emerging growth company until the earliest of (i) the end of the fiscal year following the fifth anniversary of the completion of this offering, (ii) the first fiscal year after our annual gross revenue exceeds $1.24 billion, (iii) the date on which we have, during the immediately preceding three-year period, issued more than $1.0 billion in non-convertible debt securities, or (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeds $700.0 million as of the end of the second quarter of that fiscal year.
43
We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment.
We have never declared or paid cash dividends on our common stock and do not expect to do so in the foreseeable future. The declaration of dividends is subject to the discretion of our board of directors and limitations under applicable law, and will depend on various factors, including our operating results, financial condition, future prospects and any other factors deemed relevant by our board of directors. You should not rely on an investment in our company if you require dividend income from your investment in our company. The success of your investment will likely depend entirely upon any future appreciation of the market price of our common stock, which is uncertain and unpredictable. There is no guarantee that our common stock will appreciate in value.
Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline. Based on shares of common stock outstanding as of , 2022, upon the closing of this offering we will have outstanding a total of shares of common stock. Of these shares, only the shares of common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters’ option to purchase additional shares, will be freely tradable without restriction in the public market immediately following this offering.
Our directors, executive officers and the holders of a majority of our outstanding equity securities have entered into lock-up agreements pertaining to this offering that will expire 180 days from the date of this prospectus, subject to earlier release of all or a portion of the shares subject to such agreements by the underwriters in their sole discretion. After the lock-up agreements expire, these shares of common stock will be eligible for sale in the public market, unless held by directors, executive officers and other affiliates, in which case such shares will be subject to certain limitations of Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our existing equity compensation plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. Unless our board of directors elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution.
After this offering, the holders of shares of our common stock as of , 2022 will be entitled to rights with respect to the registration of the resale of their shares under the Securities Act, subject to the 180-day lock-up agreements described above. See “Description of Capital Stock—Registration Rights.” Registration of the resale of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
The administrator of our amended and restated 2021 Equity Incentive Plan (the “Amended and Restated Equity Plan”) is authorized to exercise its discretion to effect the repricing of stock options and stock appreciation rights and there may be adverse consequences to our business if the administrator of the Amended and Restated Equity Plan exercises such discretion.
Pursuant to our Amended and Restated Equity Plan, we are authorized to grant equity awards, including stock options and stock appreciation rights, to our employees, directors and consultants. The administrator of the Amended and Restated Equity Plan (which is our compensation committee) is authorized to exercise its discretion to reduce the exercise price of stock options or stock appreciation rights or effect the repricing of such awards. Although we do not anticipate needing to exercise this discretion in the near term, or at all, if the administrator of the Amended and Restated Equity Plan were to exercise such discretion without seeking prior stockholder approval, certain proxy advisory firms or institutional investors may be unsupportive of such actions and publicly criticize our compensation practices, and proxy advisory firms may recommend an “against” or “withhold” vote for members of our compensation committee. In addition, if we are required to hold an advisory vote on named executive officer compensation (known as the “say-on-pay” vote) at the time of, or subsequent to, any such repricing, it is likely that proxy advisory firms would issue an “against” recommendation on our say on pay vote and institutional investors may not be supportive of our say-on-pay vote. If proxy advisory firms or institutional investors are successful in aligning their views with our broader stockholder base and we are required to make changes to the composition of our board and its committees, or if we need to make material changes to our compensation and corporate governance practices, our business might be disrupted and our stock price might be negatively impacted. Even if we are able to successfully rationalize the exercise of such discretionary power, defending against any “against” or “withhold” recommendation for members of our compensation committee, any “against” recommendation on our say on pay vote or public criticism could be distracting to management, and responding to such positions from such firms or investors, even if remedied, can be costly and time-consuming.
44
In addition, if the administrator of the Amended and Restated Equity Plan does determine to reprice stock options or stock appreciation rights, even absent negative reactions from proxy advisory firms and institutional investors, management attention may be diverted and we could incur significant costs, including accounting and administrative costs and attorneys’ fees. We may also be required to recognize incremental compensation expense as such result of a repricing. These actions could cause our stock price to decrease and experience periods of increased volatility.
The rights of the holders of our securities may be impaired by the potential issuance of preferred stock.
Our amended and restated certificate of incorporation (the “Amended Charter”) will contain provisions that gives our board of directors the ability to designate and issue preferred stock in one or more series. As a result, the board of directors may, without stockholder approval, issue preferred stock with voting, dividend, conversion, liquidation or other rights which could adversely affect the relative voting power and equity interest of the holders of common stock. Preferred stock, which could be issued with the right to more than one vote per share, could have the effect of discouraging, delaying or preventing a change of control of us. The possible impact on takeover attempts could adversely affect the price of our securities. Although we have no present intention to designate any series, or issue any shares, of preferred stock, other than pursuant to this offering, we may do so in the future.
If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. We currently do not have research coverage by securities industry and financial analysts. As a newly public company, we may not receive any research coverage by equity research analysts. Equity research analysts may elect not to initiate or to continue to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market price of our common stock. Even if we obtain research coverage by such securities or industry analysts after this offering, if one or more of the analysts who cover us downgrade our stock, our stock price may decline significantly. If one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Anti-takeover provisions in our organizational documents and Delaware law might discourage or delay attempts to acquire us that you might consider favorable.
Our Amended Charter, Amended Bylaws and Delaware law contain or will contain provisions that could have the effect of rendering more difficult, delaying or preventing an acquisition deemed undesirable by our board of directors. Our corporate governance documents include or will include provisions:
|
• |
classifying our board into three classes; |
|
• |
authorizing “blank check” preferred stock, which would be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend, and other rights superior to our common stock; |
|
• |
limiting the liability of, and providing indemnification to, our directors and officers; |
|
• |
limiting the ability of our stockholders to call and bring business before special meetings; |
|
• |
requiring advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates for election to our board of directors; |
|
• |
controlling the procedures for the conduct and scheduling of board of directors and stockholder meetings; and |
|
• |
providing our board of directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled special meetings. |
These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.
As a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations without approval of the holders of substantially all of our outstanding common stock.
Any provision of our amended and restated certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.
See “Description of Capital Stock – Anti-Takeover Effects of Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws and Certain Provisions of Delaware Law.”
45
Our Amended Charter will provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders and federal district courts will be the sole and exclusive forum for Securities Act claims, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Our Amended Charter, which will become effective prior to the completion of this offering, will provide that, unless we consent to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by any of our current or former directors, officers, or other employees to us or to our stockholders; (iii) any action asserting a claim arising pursuant to the Delaware General Corporation Law (the “DGCL”), the Amended Charter or the Amended Bylaws or as to which the DGCL confers exclusive jurisdiction on the Court of Chancery of the State of Delaware; or (iv) any action asserting a claim governed by the internal affairs doctrine of the law of the State of Delaware, provided that the exclusive forum provisions will not apply to suits brought to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended, or the Exchange Act or to any claim for which the federal courts have exclusive jurisdiction. Our Amended Charter will further provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts are the sole and exclusive forum for the resolution of any complaint asserting a right under the Securities Act, subject to a final adjudication in the State of Delaware of the enforceability of such exclusive forum provision. We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. The choice of forum provisions 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. Further, the choice of forum provisions may result in increased costs for a stockholder to bring a claim. Alternatively, if a court were to find the choice of forum provisions contained in our Amended Charter to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
Provisions in our organizational documents regarding exculpation and indemnification of our directors and officers may result in substantial expenditures by us and may discourage lawsuits against our directors and officers.
Our Amended Charter and Amended Bylaws will, to the maximum extent permissible under Delaware law, eliminate the personal liability of our directors and officers to us and our stockholders for damages for breach of fiduciary duty. These provisions may discourage us, or our stockholders through derivative litigation, from bringing a lawsuit against any of our current or former directors or officers for any breaches of their fiduciary duties, even if such legal actions, if successful, might benefit us or our stockholders. In addition, our Amended Charter and Amended Bylaws will provide that we will, to the fullest extent permitted by Delaware law, indemnify our directors and officers for costs or damages incurred by them in connection with any threatened, pending, or completed action, suit, or proceeding brought against them by reason of their positions as directors and officers. We also intend to enter into indemnification agreements with each of our directors and executive officers. See “Certain Relationships and Related Party Transactions – Agreements with Directors and Officers – Indemnification Agreements.” Although we expect to purchase directors’ and officers’ insurance, these indemnification obligations could result in our incurring substantial expenditures to cover the cost of settlement or damage awards against our directors or officers.
We ratified certain actions pursuant to Section 204 of the Delaware General Corporation Law and filed Certificates of Validation with the Secretary of State of the State of Delaware.
As of February 1 and 2, 2022 respectively, our Board and our stockholders, ratified certain actions (the “2020 Ratifications”) pursuant to Section 204 (“§204”) of the Delaware General Corporation Law (the “DGCL”), which allows a Delaware corporation to ratify a defective corporate act retroactive to the date the corporate act was originally taken. The Ratification was adopted in order to correct certain failures of authorization with respect to the (i) merger of Nicoya Health, Inc. with and into the Company as of December 22, 2020 (the “Merger”), and (ii) amendment and restatement of the Corporation’s certificate of incorporation filed with the Secretary of State of the State of Delaware (the “Secretary of State”) on December 22, 2020 (the “A&R Charter”) (collectively, the “2020 Corporate Acts”) and thereby remove any uncertainty and confirm the valid issuance of (a) 10,750,000 shares of putative Common Stock of the Company to the former stockholders of Nicoya Health, Inc. pursuant to the Merger effective December 22, 2020, and (b) 7,500,713 shares of putative Series A Preferred Stock to the investors participating in that certain Series A Financing effective on December 22, 2020 (collectively, the “2020 Issuances”).
Consequently, in accordance with §204, our Board ratified the 2020 Corporate Acts and the 2020 Issuances, and approved the submission to (i) the stockholders of the Company for ratification and approval of each of the 2020 Corporate Acts and the 2020 Issuances; and (ii) upon receiving stockholder ratification and approval, the Secretary of State of the State of Delaware of a Certificate of Validation regarding the Merger, and a separate Certificate of Validation regarding the A&R Charter. Our stockholders ratified the 2020 Corporate Acts and the 2020 Issuances on February 2, 2022.
Similarly, on February 16, 2022, our Board ratified certain actions (the “2021 Ratifications”) pursuant to §204 in order to correct certain failures of authorization with respect to the (i) appointment and removal of certain members of our Board that occurred
46
between March 30, 2021 and June 6, 2021 (the “Director Designations”); (ii) approval of our 2021 Equity Incentive Plan on February 5, 2021 (the “Equity Plan Adoption”); and (iii) certain option grants under the 2021 Equity Incentive Plan on April 10, 2021, May 17, 2021 and June 7, 2021 that resulted in the issuance of options exercisable for up to an aggregate of 260,000 putative shares of Common Stock at an exercise price of $0.19 per share (the “Option Grants”), and thereby remove any uncertainty regarding the composition of our Board as well as confirm the valid issuance of the Option Grants.
Consequently, in accordance with §204, our Board ratified the Director Designations, the Equity Plan Adoption and the Option Grants, and approved the submission to the stockholders of the Company for ratification and approval of each of the Director Designations and the Equity Plan Adoption, which our stockholders ratified on February 24, 2022.
Although we believe we have fully complied with the procedures and requirements of §204, there can be no assurance that (i) claims that the 2020 Corporate Acts, the 2020 Issuances, the Director Designations, the Equity Plan Adoption, and/or the Option Grants or putative stock ratified in connection with the 2020 Issuances and/or the Option Grants are void or voidable due to the identified failure of authorization, or (ii) claims that the Delaware Court of Chancery should declare in its discretion that the ratification pursuant to §204 not be effective or be effective only on certain conditions or other claims related thereto, will not be asserted, and, if asserted, that any such claims will not be successful. Under §204, these claims must be brought within 120 days from (A) the filing of the applicable Certificate of Validation in the case of 2020 Corporate Acts and 2020 Issuances; (B) the date the stockholders ratify the Director Designations and Equity Plan Adoption in the case of the Director Designations and Equity Plan Adoption; and (C) the date the Board approved the 2021 Ratifications in the case of the Option Grants. If any of the ratifications pursuant to §204 were not effective, then the 2020 Corporate Acts, the 2020 Issuances, the Director Designations, the Equity Plan Adoption, and the Option Grants, as applicable, would be invalid and, as applicable, we could have liability to holders of the Common Stock and/or the Series A Preferred Stock corresponding to the 2020 Issuances and the grantees under the Option Grants, as applicable, including being subject to monetary damages and rescission rights.
47
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements made under the headings “Summary,” “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this prospectus contain forward-looking statements that reflect our plans, beliefs, expectations and current views with respect to, among other things, future events and financial performance.
Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and are often characterized by the use of words such as “believe,” “can,” “could,” “potential,” “plan,” “predict,” “goals,” “seek,” “should,” “may,” “may have,” “would,” “estimate,” “continue,” “anticipate,” “intend,” “expect” or by discussions of strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other important factors that could cause our actual results, performance or achievements, or industry results, to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by such forward-looking statements. These include, but are not limited to, statements about:
|
• |
our ability to develop, obtain regulatory approval for and commercialize our product candidates; |
|
• |
the timing of future IND submissions, initiation of preclinical studies and clinical trials, and timing of expected clinical results for our product candidates; |
|
• |
our success in early preclinical studies, which may not be indicative of results obtained in later studies or clinical trials; |
|
• |
the outbreak of the novel strain of coronavirus disease, COVID-19, which could adversely impact our business, including our preclinical studies and any future clinical trials; |
|
• |
the potential benefits of our product candidates; |
|
• |
our ability to obtain regulatory approval to commercialize our existing or any future product candidates; |
|
• |
our ability to identify patients with the diseases treated by our product candidates, and to enroll patients in clinical trials; |
|
• |
the success of our efforts to expand our pipeline of product candidates and develop marketable products through the use of our therapeutic modalities; |
|
• |
our expectations regarding collaborations and other agreements with third parties and their potential benefits; |
|
• |
our ability to obtain, maintain and protect our intellectual property; |
|
• |
our reliance upon intellectual property licensed from third parties; |
|
• |
our ability to identify, recruit and retain key personnel; |
|
• |
our expected use of net proceeds from this offering and the sufficiency of such net proceeds, together with our cash and cash equivalents, to fund our operations; |
|
• |
our financial performance; |
|
• |
developments or projections relating to our competitors or our industry; |
|
• |
the impact of laws and regulations; |
|
• |
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and |
|
• |
other factors and assumptions described in this prospectus under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Our Business”, and elsewhere in this prospectus. |
These statements are based on our historical performance and on our current plans, estimates and projections in light of information currently available to us, and therefore you should not place undue reliance on them. The inclusion of this forward-looking information should not be regarded as a representation by us, the underwriters or any other person that the future plans, estimates or expectations contemplated by us will be achieved. Forward-looking statements made in this prospectus speak only as of the date of this prospectus, and we undertake no obligation to update them in light of new information or future events, except as required by law.
You should carefully consider the above factors, as well as the factors discussed elsewhere in this prospectus, including under “Risk Factors,” before deciding to invest in our common stock. The factors identified above should not be construed as an exhaustive list of factors that could affect our future results and should be read in conjunction with the other cautionary statements that are included in this prospectus. Furthermore, new risks and uncertainties arise from time to time, and it is impossible for us to predict those events or how they may affect us. If any of these trends, risks or uncertainties actually occurs or continues, our business, revenue and financial results could be harmed, the trading prices of our securities could decline and you could lose all or part of your investment. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.
48
We estimate that we will receive net proceeds of approximately $ million from the sale of shares of common stock in this offering at the assumed initial public offering price of $ per share, the midpoint of the range set forth on the cover page of this prospectus, after deducting underwriting commissions and discounts of $ million and estimated offering expenses of $ million. If the underwriters exercise in full their option to purchase additional shares of common stock, then we estimate that our net proceeds from this offering will be approximately $ million.
We believe the proceeds from this offering, combined with existing cash as of the closing of this offering, will be sufficient to allow us to continue pursuing our business strategy into . We currently intend to use the net proceeds we receive from this offering, as follows, to advance the indicated product candidates through the described milestones (see “Business— Key Milestones” for a further description of these intended milestones) as well for advancing our research and development efforts and for general corporate purposes. We currently intend to use the net proceeds we receive from this offering, as follows:
|
• |
approximately between $ to $ million to advance COYA 301 and COYA 302 through IND-enabling CMC and toxicology studies, and the initiation of a Phase 1 studies; |
|
• |
approximately between $ to $ million to advance COYA 201 and COYA 206 through or into, respectively, preclinical studies including target validation and animal studies; |
|
• |
approximately between $ to $ million to advance COYA 101 towards a Phase 2b trial in the event we are successful in receiving non-dilutive funding from government grants or from a strategic partner (we currently anticipate that grant funding, or other non-dilutive funding, in the amount of approximately $3 million would be sufficient to begin advancing COYA 101 into a Phase 2b trial; this amount is an estimate and may be subject to change); |
|
• |
approximately between $ to $ million to fund expenses to advance research and development activities that relate to all our other preclinical activities, including process development activities related to the advancement of our product candidates and the cost of research and development personnel; and |
|
• |
the remainder for planned general and administrative expenses, the costs of operating as a public company, working capital and general corporate purposes. |
This expected use of net proceeds from this offering and our existing cash and cash equivalents represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, as well as any collaborations that we may enter into with third parties for our drug candidates, and any unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of those net proceeds. The timing and amount of our actual expenditures will be based on many factors, including the focus, pace and timing of our development efforts and the existence of unforeseen opportunities or obstacles. As a result, we may find it necessary or advisable to use portions of the proceeds from this offering for other purposes. Pending these uses, we plan to invest these net proceeds in short-term, interest bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States.
Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $ , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares we are offering. An increase (decrease) of 1,000,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $ , assuming the initial public offering price stays the same. We do not expect that a change in the offering price or the number of shares offered by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.
49
We have never declared or paid any cash dividends on our capital stock. 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 declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our board of directors, subject to applicable laws, and will depend on a number of factors, including our business prospects, results of operations, financial condition, cash requirements and availability, debt repayment obligations, capital expenditure needs, contractual restrictions, covenants in the agreements governing our current and future indebtedness, industry trends, the provisions of Delaware law affecting the payment of dividends and distributions to stockholders and any other factors or considerations our board of directors may regard as relevant.
Our ability to pay dividends may also be restricted by the terms of any credit agreement or any future debt or preferred equity securities agreement that we or our subsidiaries enter into. Accordingly, you may need to sell your shares of our common stock to realize a return on your investment, and you may not be able to sell your shares at or above the price you paid for them. See “Risk Factors—Risks Related to Our Securities and the Offering—We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment.”
50
The following table sets forth our cash, cash equivalents and capitalization as of September 30, 2022:
|
• |
on an actual basis; and |
|
• |
on a pro forma basis to give effect to the following events, as if each event had occurred on September 30, 2022: (i) the Preferred Conversion; (ii) the Notes Conversion; and (iii) the -for- stock split and the filing and effectiveness of our Amended Charter and the adoption of our Amended Bylaws; and |
|
• |
on a pro forma as adjusted basis giving further effect to the issuance and sale of shares of common stock in this offering and the application of the proceeds from this offering as described in “Use of Proceeds,” based on an assumed initial public offering price of $ per share, the midpoint of the range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses. |
You should read this table, together with the information contained in this prospectus, including “Use of Proceeds,” “Unaudited Pro Forma Financial Information,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the historical financial statements and related notes included elsewhere in this prospectus.
|
|
As of September 30, 2022 |
||||||
|
|
|
|
|
|
|
|
Pro Forma |
|
|
Actual |
|
|
Pro Forma |
|
As Adjusted |
|
Cash and cash equivalents |
|
$ |
8,650,848 |
|
|
|
|
|
Convertible promissory notes |
|
|
11,845,000 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.0001 par value: 7,500,713 authorized, issued and outstanding as of September 30, 2022, actual, shares authorized, issued and outstanding as of September 30, 2022, pro forma and pro forma as adjusted |
|
|
8,793,637 |
|
|
|
|
|
Common stock, $0.0001 par value: 30,000,000 authorized, 14,752,500 shares issued and outstanding as of September 30, 2022, actual, shares authorized, issued and outstanding as of September 30, 2022, pro forma and pro forma as adjusted |
|
|
1,475 |
|
|
|
|
|
Additional paid‑in capital |
|
|
609,677 |
|
|
|
|
|
Accumulated deficit |
|
|
(14,762,095 |
) |
|
|
|
|
Total stockholders’ (deficit) equity |
|
$ |
(5,357,306 |
) |
|
|
|
|
Total capitalization |
|
$ |
6,487,694 |
|
|
|
|
|
Less deferred offering costs within other assets |
|
|
(258,248) |
|
|
|
|
|
Net tangible book value (deficit) |
|
$ |
(5,615,554 |
) |
|
|
|
|
Common shares outstanding |
|
|
14,752,500 |
|
|
|
|
|
Net tangible value (deficit) per share |
|
$ |
(0.38 |
) |
|
|
|
|
The above table gives effect to the pro forma transactions described above and excludes:
|
• |
525,049 shares of our common stock issuable upon the exercise of the Series A Placement Agent Warrants outstanding as of September 30, 2022; |
|
• |
shares of our common issuable upon the exercise of the Note Placement Agent Warrants outstanding as of September 30, 2022; |
|
• |
1,771,743 shares of our common stock reserved for future issuance under our share option plans as of September 30, 2022 as described in “Executive Compensation—Incentive Arrangements”; |
|
• |
2,725,757 shares of our common stock issuable upon the exercise of stock options outstanding as of September 30, 2022, at a weighted average exercise price of $0.32 per share; and |
|
• |
shares of our common stock issuable upon exercise of the underwriters’ warrants to be issued upon consummation of this offering at an exercise price equal to 125% of the offering price per share paid by investors in this offering. |
51
Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the amount of cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $ , assuming the number of shares, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of one million shares offered by us would increase (decrease) cash, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $ , assuming the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.
52
Investors purchasing our common stock in this offering will experience immediate and substantial dilution in the pro forma net tangible book value of their shares of common stock. Dilution in pro forma net tangible book value represents the difference between the 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 giving effect to this offering.
Our historical net tangible book value (deficit) as of September 30, 2022 was $(5.6) million, or $(0.38) per share of our common stock. Our historical net tangible book value (deficit) represents our total tangible assets less total liabilities, which excludes deferred offering costs of $0.3 million. Historical net tangible book value (deficit) per share is our historical net tangible book value (deficit) divided by the number of shares of our common stock outstanding as of September 30, 2022.
Pro forma net tangible book value represents our total tangible assets (total assets less intangible assets) less total liabilities, divided by the pro forma number of outstanding shares of common stock. As of September 30, 2022, after giving effect to the Preferred Conversion and the Notes Conversion, our pro forma net tangible book value was $ million, or $ per share. After giving effect to the sale and issuance of shares of our common stock in this offering at an assumed initial public offering price of $ per share, the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the underwriting discount and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2022 would have been approximately $ million, or $ per share. This represents an immediate increase in pro forma as adjusted net tangible book value of $ per share to our existing stockholders and an immediate dilution of $ per share to new investors participating in this offering.
The following table illustrates this dilution on a per share basis to new investors:
Assumed initial public offering price per share of common stock |
|
|
|
|
|
$ |
|
|
Historical net tangible book value (deficit) per share of common stock as of September 30, 2022 |
|
|
|
|
|
$ |
(0.38 |
) |
Pro forma increase in net tangible book value per share of common stock as of September 30, 2022 attributable to the pro forma transactions described above |
|
$ |
|
|
|
|
|
|
Pro forma net tangible book value per share of common stock as of September 30, 2022 before giving to effect this offering |
|
|
|
|
|
|
|
|
Increase per share of common stock attributable to this offering |
|
$ |
|
|
|
|
|
|
Pro forma net tangible book value per share of common stock, as adjusted to give effect to this offering |
|
|
|
|
|
|
|
|
Dilution in pro forma net tangible book value per share of common stock to new investors |
|
|
|
|
|
$ |
|
|
The dilution information discussed above is illustrative only and may change based on the actual initial public offering price and other terms of this offering.
A $1.00 decrease in the assumed initial public offering price of $ per share (the midpoint of the price range set forth on the cover page of this prospectus) would decrease our pro forma as adjusted net tangible book value as of September 30, 2022 after this offering by approximately $ , or approximately $ per share, and would increase dilution to investors in this offering by approximately $ per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. A $1.00 increase in the assumed initial public offering price of $ per share (the midpoint of the price range set forth on the cover page of this prospectus) would decrease our pro forma as adjusted net tangible book value as of September 30, 2022 after this offering by approximately $ , or approximately $ per share, and would decrease dilution to investors in this offering by approximately $ per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. An increase of 1,000,000 in the number of shares we are offering would increase our pro forma as adjusted net tangible book value as of September 30, 2022 after this offering by approximately $ , or approximately $ per share, and would increase dilution to investors in this offering by approximately $ per share, assuming the assumed initial public offering price per share remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us. A decrease of 1,000,000 in the number of shares we are offering would decrease our pro forma as adjusted net tangible book value as of September 30, 2022 after this offering by approximately $ , or approximately $ per share, and would decrease dilution to investors in this offering by approximately $ per share, assuming the assumed initial public offering price per share remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us.
53
If the underwriters exercises their option to purchase additional shares of our common stock in full, the pro forma as adjusted net tangible book value after this offering would be $ per share, the increase in pro forma net tangible book value per share would be $ and the dilution per share to new investors would be $ per share, in each case 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 following table summarizes, as of September 30, 2022, on the pro forma as adjusted basis described above, the differences between the number of shares purchased from us, the total consideration paid to us in cash and the average price per share that existing stockholders and new investors paid for such shares. The calculation below is 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, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
|
Shares Purchased |
|
|
Total Consideration |
|
|
Average Price Per |
||||||
|
|
Number |
|
Percent |
|
|
Amount |
|
Percent |
|
|
Share |
||
Existing stockholder |
|
|
|
% |
|
|
$ |
|
% |
|
|
$ |
||
New investors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
100 |
% |
|
$ |
|
|
100 |
% |
|
$ |
The above table gives effect to the pro forma transactions described above and excludes:
|
• |
525,049 shares of our common stock issuable upon the exercise of the Series A Placement Agent Warrants outstanding as of September 30, 2022; |
|
• |
shares of our common issuable upon the exercise of the Note Placement Agent Warrants outstanding as of September 30, 2022; |
|
• |
1,771,743 shares of common stock reserved for future issuance under our share option plans as of September 30, 2022 as described in “Executive Compensation—Incentive Arrangements”; |
|
• |
2,725,757 shares of common stock issuable upon the exercise of stock options outstanding as of September 30, 2022, at a weighted average exercise price of $0.32 per share; and |
|
• |
shares of common stock issuable upon exercise of the underwriters’ warrants to be issued upon consummation of this offering at an exercise price equal to 125% of the offering price paid by investors in this offering. |
54
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 operating results together with our financial statements and the related notes appearing at the end of this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth in the section of the prospectus captioned “Risk Factors” and elsewhere in this prospectus, our actual results may differ materially from those anticipated in these forward-looking statements.
Overview
We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells (“Tregs”). Tregs are a subpopulation of T-lymphocytes consisting of CD4+CD25high hFOXP3+ cells that suppress inflammatory responses. Tregs were first discovered in 1995 by Dr. Shimon Sakaguchi and since their discovery, multiple lines of research have contributed to elucidate Treg biology and its role in health and disease. Tregs and their transcription factors have been shown to be essential to maintaining cellular homeostasis by regulating autoimmune and inflammatory responses and maintaining self-tolerance in mammals. Dysfunctional Tregs underlie numerous disease states, and this cellular dysfunction is driven by the chronic inflammatory environment and high levels of oxidative stress commonly observed in certain diseases. Further, the degree of Treg dysfunction is correlated with the severity and progression of serious and life-threatening conditions. These and other recent advances in the understanding of Treg biology, have made this subset of T lymphocytes an important therapeutic target, which we believe may provide new treatments for serious diseases.
We have built a diversified product candidate pipeline that includes both ex vivo and in vivo approaches intended to restore the suppressive and immunomodulatory functions of Tregs. Our product candidate pipeline is based on our three distinct therapeutic modalities: autologous Treg cell therapy, allogeneic Treg-derived exosomes and Treg-enhancing biologics. “Allogeneic” means the treatment of a patient with human cells derived from a donor other than the patient, where such donor is genetically non-identical. We are initially focused on developing our Treg-based therapies for neurodegenerative, autoimmune and metabolic diseases where Treg dysfunction has been identified to be an important pathophysiological component of the disease and where new and effective therapies are urgently needed.
Since our inception in 2020, we have generated preclinical and clinical data in multiple models and diseases. Our autologous Treg cell therapy program has completed a Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis, or ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline.
Since our inception in April 2020, our operations have consisted of developing our clinical and preclinical product candidates and we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We have funded our operations primarily through private convertible preferred stock offerings and convertible debt financing. Our net losses were $4.9 million and $9.1 million for the year ended December 31, 2021 and the nine months ended September 30, 2022, respectively. As of September 30, 2022, we had an accumulated deficit of $14.8 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
|
• |
continue our ongoing and planned research and development of our product candidates; |
|
• |
initiate nonclinical studies and clinical trials for any additional product candidates that we may pursue; |
|
• |
continue to scale up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and potential commercialization; |
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
|
• |
develop, maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know-how; |
55
|
• |
acquire or in-license other product candidates and technologies; |
|
• |
add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; |
|
• |
incur additional legal, accounting, investor relations and other expenses associated with operating as a public company. |
Furthermore, upon the closing of this offering, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Following this offering, we will need to raise substantial additional capital to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we plan to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to secure adequate additional funding, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more product candidates or delay our pursuit of potential in-licenses or acquisitions. The financial statements included elsewhere in this prospectus have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business and do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
The COVID-19 Pandemic and its Impacts on Our Business
The COVID-19 pandemic continues to present substantial public health and economic challenges around the world, and to date has led to the implementation of various responses, including government-imposed quarantines, stay-at-home orders, travel restrictions, mandated business closures and other public health safety measures.
We continue to closely monitor the impact of the COVID-19 pandemic on all aspects of our business, including how it has and will continue to impact our operations and the operations of our suppliers, vendors and business partners, and may take further precautionary and preemptive actions as may be required by federal, state or local authorities.
Beyond the impact on our pipeline, the extent to which COVID-19 ultimately impacts our business, results of operations and financial condition will depend on future developments, which remain highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the emergence of new variants, new information that may emerge concerning the severity of COVID-19 or the effectiveness of actions taken to contain COVID-19 or treat its impact, including vaccination campaigns, among others. If we or any of the third parties with whom we engage, however, were to experience any additional shutdowns or other prolonged business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material adverse impact on our business, financial condition and results of operations. Although to date, our business has not been materially impacted by COVID-19, it is possible that our clinical development timelines could be negatively affected by COVID-19, which could materially and adversely affect our business, financial condition and results of operations. See “Risk Factors—Risks Related to Our Business, Financial Condition and Capital Requirements—The recent and ongoing COVID-19 pandemic could materially affect our operations, as well as the business or operations of third parties with whom we conduct business” for additional discussion of the potential adverse impact of the COVID-19 pandemic on our business, financial condition and results of operations.
Components of Results of Operations
Revenue
To date, we have not recognized any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
56
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our therapeutic candidates. We expense research and development costs as incurred, including:
|
• |
Expenses incurred to conduct discovery-stage laboratory work and preclinical studies including supplies, reagents, chemicals as well as external costs of funding research performed by third parties including consultants, academic and other institutions and clinical research organizations (“CROs”) that conduct our preclinical and nonclinical studies; |
|
• |
activities being performed under our sponsored research arrangement with Houston Methodist; |
|
• |
personnel expenses, including salaries, benefits and stock-based compensation expense for our employees engaged in research and development functions; |
|
• |
clinical trial expenses and related clinical expenses to obtain regulatory approval of our therapeutic candidates including costs of research performed by third parties, costs associated with CRO’s that conduct our clinical trials, costs to operate, manage, and monitor investigative sites and clinical, regulatory, manufacturing and other professional services; |
|
• |
clinical expenses incurred under agreements with contract manufacturing organizations, or CMOs, or incurred directly by us for manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical study and clinical trial materials; |
|
• |
fees paid to consultants who assist with research and development activities; |
|
• |
expenses related to regulatory activities, including filing fees paid to regulatory agencies; and |
|
• |
allocated expenses for facility costs, including rent, utilities, depreciation and maintenance. |
We classify and evaluate our research and development expenses in two dimensions: clinical and preclinical, and external and internal. We do not further classify or evaluate our internal research and development expenses by product candidate or by Series as these expenses primarily relate to compensation, materials and supplies, and other costs which are deployed across multiple therapeutic modalities, multiple product candidates, and multiple therapeutic areas under development.
Once a product candidate has received approval from the FDA of its IND application, we consider it a clinical product candidate. For each of our clinical product candidates, we report or will report external development costs and other external research and development costs attributable to such clinical product candidates. These external development costs include: fees paid to CROs, CMOs and research laboratories, process development, manufacturing and clinical development activities. Any internal research and development expenses associated with clinical product candidates are captioned as internal research and development costs as described in the paragraph above.
Until such time as a product candidate has received approval of its IND application, we consider it a preclinical product candidate. Each of our preclinical product candidates is being developed on one of our three therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes; and (3) autologous Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301 and COYA 302, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101. For our preclinical candidates we report external development costs and other external research and development costs collectively by Series. These external development costs include: fees paid to CROs, CMOs and research laboratories, process development, manufacturing and clinical development activities. Preclinical research and development activities often benefit more than one preclinical product candidate within a given Series and so disaggregating the data would neither be practicable or meaningful.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly over the next several years as we increase personnel costs, including stock-based compensation, conduct our clinical trials, including later-stage clinical trials, for current and future product candidates and prepare regulatory filings for our product candidates. As described in the notes to financial statements contained elsewhere in this prospectus, under the terms of our license we may be required to make payments to Methodist if certain milestones are achieved. This could result in significant charges to research and development in the period such milestones become probable of being achieved.
57
In-Process Research and Development
Research and development costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which has no alternative future use. The licenses purchased by us require substantial completion of research and development and regulatory and marketing approval efforts in order to reach technological feasibility. As such, for the period from April 30, 2020 (date of inception) to December 31, 2020, and nine months ended September 30, 2022, the purchase price of licenses acquired was classified as acquired in-process research and development expenses in the statements of operations.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense, for employees and consultants in executive, finance and accounting, legal, operations support, information technology and human resource functions. General and administrative expense also includes corporate facility costs not otherwise included in research and development expense, including rent, utilities, depreciation and maintenance, as well as legal fees related to intellectual property and corporate matters and fees for accounting and consulting services.
We expect that our general and administrative expense will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we anticipate increased costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of the Nasdaq Capital Market and the Securities and Exchange Commission, or SEC, insurance and investor relations costs. If any of our current or future product candidates obtains U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.
Depreciation
Depreciation expense relates to the fixed assets which consist mainly of lab equipment. The lab equipment is depreciated over its estimated useful life of five years.
Interest Expense
Interest expense has consisted primarily of interest expense related to our convertible promissory notes issued in 2020 in connection with the Corporate Reorganization.
Change in Fair Value of Convertible Promissory Notes
Under the fair value election as prescribed by ASC 815, we recognize the qualifying change in fair value of our 2022 convertible promissory notes each reporting period until the notes are settled. Changes in fair value attributable to changes in instruments specific credit risk are recorded in other comprehensive income to the extent they are material.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest earned on our excess cash and federal tax credits.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net operating losses, or NOLs, we have incurred or for our research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our NOLs and tax credits will not be realized. As such, we have a full valuation allowance against all NOLs and tax credits for all periods presented.
58
Results of Operations
Comparison of the nine months ended September 30, 2021 to September 30, 2022
|
|
Nine months ended September 30, |
|
|
|
|
|
|||||
|
|
2021 |
|
|
2022 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,686,328 |
|
|
$ |
3,704,466 |
|
|
$ |
2,018,0138 |
|
In-process research and development |
|
|
- |
|
|
|
135,000 |
|
|
|
135,000 |
|
General and administrative |
|
|
1,579,896 |
|
|
|
3,948,434 |
|
|
|
2,368,538 |
|
Depreciation |
|
|
5,946 |
|
|
|
20,521 |
|
|
|
14,575 |
|
Total operating expenses |
|
|
3,272,170 |
|
|
|
7,808,421 |
|
|
|
4,536,251 |
|
Loss from operations |
|
|
(3,272,170 |
) |
|
|
(7,808,421 |
) |
|
|
(4,536,251 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of convertible promissory notes |
|
|
- |
|
|
|
(1,376,030) |
|
|
|
(1,376,030) |
|
Other income, net |
|
|
10,050 |
|
|
|
47,343 |
|
|
|
37,293 |
|
Net loss |
|
$ |
(3,262,120 |
) |
|
$ |
(9,137,108 |
) |
|
$ |
(5,874,988 |
) |
Research and Development Expenses
Research and development expenses increased by $2.0 million from $1.7 million for the nine months ended September 30, 2021 to $3.7 million for the nine months ended September 30, 2022. The increase was mainly due to increasing our clinical trial expenses as well as an increase in headcount to support our continued trials. For our clinical product candidates (COYA 101), we track our external research and development expenses on a candidate-by-candidate basis. For our preclinical product candidates, we track our external research and development expenses in aggregate by Series. External research and development expenses include fees paid to CROs, CMOs and research laboratories in connection with our pre-clinical development, process development, manufacturing and clinical development activities. We do not further classify or evaluate our internal research and development expenses by product candidate or by Series as these expenses primarily relate to compensation, materials and supplies, and other costs which are deployed across multiple therapeutic modalities, multiple product candidates, and multiple therapeutic areas under development.
Research and development expenses disaggregated and classified by clinical and preclinical, and external and internal expenses are summarized in the table below:
|
|
Nine months ended September 30, |
|
|||||
|
|
2021 |
|
|
2022 |
|
||
External costs: |
|
|
|
|
|
|
|
|
Clinical product candidates: |
|
|
|
|
|
|
|
|
COYA 101 |
|
$ |
475,434 |
|
|
$ |
291,838 |
|
Pre-clinical product candidates: |
|
|
|
|
|
|
|
|
COYA 200 Series |
|
|
177,350 |
|
|
|
808,969 |
|
COYA 300 Series |
|
|
- |
|
|
|
298,010 |
|
Sponsored research |
|
|
826,005 |
|
|
|
1,242,083 |
|
Internal costs: |
|
|
|
|
|
|
|
|
Internal research and development expenses, including stock-based compensation |
|
|
207,539 |
|
|
|
1,063,566 |
|
Total |
|
$ |
1,686,328 |
|
|
$ |
3,704,466 |
|
In-Process Research and Development
During the nine months ended September 30, 2022, we entered into a license agreement with ARScience Biotherapeutics, Inc. Under the terms of the license agreement, we paid a $0.1 million for an option to receive the license and the benefits of all the provisions of the license agreement, which was expensed as in-process research and development expense. We had no such in-process research and development license fees in 2021. Upon written notice by us to ARScience Biotherapeutics, Inc. within 90 days of the execution date, ARScience Biotherapeutics, Inc. will automatically be deemed to have granted the licenses described in the agreement and the additional economic terms of the agreement will apply.
59
General and Administrative Expenses
General and administrative expenses increased by $2.4 million from $1.6 million for the nine months ended September 30, 2021 to $3.9 million for the nine months ended September 30, 2022. The increase was primarily due to an increase in personnel related expenses due to increases in employee headcount and an increase in our professional fees and consulting fees as we expanded our operations to support our research and development efforts.
Change in fair value of convertible promissory notes
The fair value of the convertible promissory notes increased by $1.4 million during the nine months ended September 30, 2022 primarily due to changes in estimates regarding the probability and time to conversion.
For the Period from April 30, 2020 (date of inception) to December 31, 2020 and the Year Ended December 31, 2021
The following table sets forth our results of operations for the period from April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021:
|
|
Period From |
|
|
|
|
|
|
|
|
|
|
|
|
April 30, 2020 (Date of Inception) to |
|
|
Year Ended |
|
|
|
|
|
||
|
|
December 31, |
|
|
December 31, |
|
|
|
|
|
||
|
|
2020 |
|
|
2021 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,969 |
|
|
$ |
2,542,135 |
|
|
$ |
2,518,166 |
|
In-process research and development |
|
|
225,000 |
|
|
|
- |
|
|
|
(225,000 |
) |
General and administrative |
|
|
445,800 |
|
|
|
2,312,042 |
|
|
|
1,866,242 |
|
Depreciation |
|
|
- |
|
|
|
16,133 |
|
|
|
16,133 |
|
Total operating expenses |
|
|
694,769 |
|
|
|
4,870,310 |
|
|
|
4,175,541 |
|
Loss from operations |
|
|
(694,769 |
) |
|
|
(4,870,310 |
) |
|
|
(4,175,541 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(38,976 |
) |
|
|
- |
|
|
|
38,976 |
|
Other income (expense), net |
|
|
550 |
|
|
|
(21,482 |
) |
|
|
(22,032 |
) |
Net loss |
|
$ |
(733,195 |
) |
|
$ |
(4,891,792 |
) |
|
$ |
(4,158,597 |
) |
Research and Development Expenses
Research and development expenses increased by $2.5 million from $23,969 for the period from April 30, 2020 (date of inception) to December 31, 2020 to $2.5 million for the year ended December 31, 2021. The increase was mainly due to the commencement of pre-clinical and clinical trials beginning in December 2020. For our clinical product candidates (COYA 101), we track our external research and development expenses on a candidate-by-candidate basis. For our preclinical product candidates, we track our external research and development expenses in aggregate by Series. External research and development expenses include fees paid to CROs, CMOs and research laboratories in connection with our pre-clinical development, process development, manufacturing and clinical development activities. We do not further classify or evaluate our internal research and development expenses by product candidate or by Series as these expenses primarily relate to compensation, materials and supplies, and other costs which are deployed across multiple therapeutic modalities, multiple product candidates, and multiple therapeutic areas under development.
60
Research and development expenses disaggregated and classified by clinical and preclinical, and external and internal expenses are summarized in the table below:
|
|
Period From |
|
|
|
|
|
|
April 30, 2020 (Date of Inception) to |
|
Year Ended |
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2020* |
|
2021 |
|
|
External costs: |
|
|
|
|
|
|
Clinical product candidates: |
|
|
|
|
|
|
COYA 101 |
$ |
- |
|
$ |
633,417 |
|
Pre-clinical product candidates: |
|
|
|
|
- |
|
COYA 200 Series |
|
- |
|
|
334,363 |
|
Sponsored research |
|
- |
|
|
1,145,615 |
|
Internal costs: |
|
|
|
|
|
|
Internal research and development expenses, including stock-based compensation |
|
- |
|
|
428,740 |
|
Total |
$ |
- |
|
$ |
2,542,135 |
|
*There was minimal research and development expense during the period from April 30, 2020 (date of inception) to December 31, 2020 and as such, amounts for that period are not included in the table above.
In-Process Research and Development
In October 2020, we entered into the Methodist License with Methodist to make, sell and sublicense products and services using the intellectual property and know-how of Methodist. As part of the Methodist License, we issued 750,000 shares of our common stock with an estimated fair value of $0.2 million, all of which was expensed as in-process research and development expense for the period from April 30, 2020 (date of inception) to December 31, 2020. We had no such in-process research and development license fees in 2021.
General and Administrative Expenses
General and administrative expenses increased by $1.9 million from $0.4 million for the period from April 30, 2020 (date of inception) to December 31, 2020 to $2.3 million for the year ended December 31, 2021. The increase was primarily due to an increase in personnel related expenses due to increases in employee headcount as well as an increase in our professional fees and consulting fees as we expanded our operations to support our research and development efforts.
Liquidity and Capital Resources
Overview
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through September 30, 2022 we have funded our operations through the sale of convertible promissory notes and convertible preferred stock. As of September 30, 2022 we had $8.7 million in cash and cash equivalents and had an accumulated deficit of $14.8 million. We expect our existing cash and cash equivalents, together with the anticipated proceeds from this offering, to enable us to fund our operating expenses and capital expenditure requirements into . We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Funding Requirements
Our primary use of cash is to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
61
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
|
• |
the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; |
|
• |
the costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; |
|
• |
the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates; |
|
• |
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; |
|
• |
the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; |
|
• |
expenses needed to attract and retain skilled personnel; |
|
• |
costs associated with being a public company; |
|
• |
the costs required to scale up our clinical, regulatory and manufacturing capabilities; |
|
• |
the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and |
|
• |
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval. |
Following this offering, we will need significant additional funds to meet operational needs and capital requirements for clinical trials, other research and development expenditures, and business development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. 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 acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated:
|
|
|
|
|
|
|
|
|
|
Period From |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 30, 2020 (Date of Inception) to |
|
|
Year Ended |
|
||
|
|
Nine Months Ended September 30, |
|
|
December 31, |
|
|
December 31, |
|
|||||||
|
|
2021 |
|
|
2022 |
|
|
2020 |
|
|
2021 |
|
||||
Cash used in operating activities |
|
$ |
(2,885,915 |
) |
|
$ |
(5,016,279 |
) |
|
$ |
(391,266 |
) |
|
$ |
(3,903,268 |
) |
Cash used in investing activities |
|
|
(136,804 |
) |
|
|
(135,000 |
) |
|
|
- |
|
|
|
(136,804 |
) |
Cash provided by financing activities |
|
|
1,000 |
|
|
|
9,461,949 |
|
|
|
9,112,100 |
|
|
|
(340,584 |
) |
Net (decrease) increase in cash and cash equivalents |
|
$ |
(3,021,719 |
) |
|
$ |
4,310,670 |
|
|
$ |
8,720,834 |
|
|
$ |
(4,380,656 |
) |
62
Operating Activities
During the nine months ended September 30, 2021, we used $2.9 million of cash in operating activities. Cash used in operating activities reflected our net loss of $3.3 million, offset by a $0.2 million net decrease in our operating assets and liabilities and noncash charges of $0.2 million related to stock-based compensation. The primary use of cash was to fund our operations related to the development of our product candidates.
During the nine months ended September 30, 2022, we used $5.0 million of cash in operating activities. Cash used in operating activities reflected our net loss of $9.1 million, offset by a $1.5 million net decrease in our operating assets and liabilities and noncash charges of $2.7 million, which consisted of debt issuance costs, depreciation, change in fair value of convertible debt, acquired in-process research and development and stock-based compensation. The primary use of cash was to fund our operations related to the development of our product candidates.
During the period from April 30, 2020 to December 31, 2020, we used $0.4 million of cash in operating activities. Cash used in operating activities reflected our net loss of $0.7 million, offset by a $0.1 million net decrease in our operating assets and liabilities and noncash charges of $0.3 million, which consisted of $0.1 million in interest and $0.2 million in stock issued for a license agreement. The primary use of cash was to fund our operations related to the development of our product candidates.
During the year ended December 31, 2021, we used $3.9 million of cash in operating activities. Cash used in operating activities reflected our net loss of $4.9 million, offset by a $0.7 million net decrease in our operating assets and liabilities and noncash charges of $0.2 million, which consisted of depreciation and $0.2 million in stock-based compensation. The primary use of cash was to fund our operations related to the development of our product candidates.
Investing Activities
During the nine months ended September 30, 2021, we used $0.1 million of cash for the purchase of property and equipment. During the nine months ended September 30, 2022, we used $0.1 million of cash for the purchase of in-process research and development. During the year ended December 31, 2021, we used $0.1 million of cash for the purchase of property and equipment.
Financing Activities
During the nine months ended September 30, 2021, we received $1,000 from the purchase of our founders shares.
During the nine months ended September 30, 2022, financing activities provided $9.5 million of cash, primarily from the issuance of our 2022 convertible promissory notes, slightly offset by the payment of issuance costs of $1.0 million.
During the period from April 30, 2020 to December 31, 2020, financing activities provided $9.1 million of cash, which consisted of $9.0 million from the sale of our Series A convertible preferred stock and $0.1 million from the issuance of convertibles notes. During the year ended December 31, 2021, we used $0.3 million of cash for the payment of the offering costs from the sale of our Series A convertible preferred stock in December 2020.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. We do not engage in off-balance sheet financing arrangements. In addition, we do not engage in trading activities involving non-exchange traded contracts. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
Critical Accounting Policies
This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to prepaid/accrued research and development expenses and include fair value of the Company’s convertible promissory notes (see Notes 3 and 7 to our unaudited financial statements found elsewhere in this prospectus), equity and related inputs, including discount for lack of marketability and volatility, used to estimate the fair value of the grant date fair value of stock options (see Note 10 to our audited financial statements found elsewhere in this prospectus). We base our estimates on historical
63
experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 to our audited financial statements included elsewhere in this prospectus, we believe the following accounting policies are the most critical to the judgments and estimates used in the preparation of our financial statements.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates. We expense research and development costs as incurred.
We accrue an expense for preclinical studies and clinical trial activities performed by our vendors based upon estimates of the proportion of work completed. We determine the estimates by reviewing contracts, vendor agreements and purchase orders, and through discussions with our internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the prepaid/accrual accordingly. Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Stock-Based Compensation
We measure compensation expense for all stock-based awards based on the estimated fair value of the stock-based awards on the grant date. We use the Black-Scholes option pricing model to value our stock option awards. We recognize compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. We have not issued awards for which vesting is subject to a market or performance conditions.
The Black-Scholes option-pricing model requires the use of subjective assumptions that include the expected stock price volatility and the fair value of the underlying common stock on the date of grant. See Note 10 to our audited financial statements and Note 8 to our unaudited interim financial statements included elsewhere in this prospectus for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted.
Estimating the Fair Value of Common Stock
We are required to estimate the fair value of the common stock underlying our stock-based awards when performing the fair value calculations using the Black-Scholes option pricing model. Because our common stock is not currently publicly traded, the fair value of the common stock underlying our stock options has been determined on each grant date by our board of directors, with input from management, considering our most recently available third-party valuation of common shares.
The third-party valuations of our common stock were performed using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants, Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation. In addition, our board of directors considered various objective and subjective factors to estimate the estimated fair value of our common stock, including:
|
• |
the prices of our preferred stock sold to outside investors in arm’s length transactions, and the rights, preferences and privileges of our preferred stock as compared to those of our common stock, including the liquidation preferences of our preferred stock; |
|
• |
the estimated value of each security both outstanding and anticipated; |
|
• |
the anticipated capital structure, which will directly impact the value of the currently outstanding securities; |
|
• |
our results of operations and financial position; |
64
|
|
• |
the status of our research and development efforts; |
|
• |
the composition of, and changes to, our management team and board of directors; |
|
• |
the lack of liquidity of our common stock as a private company; |
|
• |
our stage of development and business strategy and the material risks related to our business and industry; |
|
• |
external market conditions affecting the life sciences and biotechnology industry sectors; |
|
• |
U.S. and global economic conditions; |
|
• |
the likelihood of achieving a liquidity event for the holders of our common stock, such as an initial public offering, or IPO, or a sale of our company, given prevailing market conditions; and |
|
• |
the market value and volatility of comparable companies. |
In determining the estimated fair value of common stock, our board of directors considered the subjective factors discussed above in conjunction with the most recent valuations of our common stock that were prepared by an independent third party. The independent valuation prepared as of January 5, 2021 was utilized by our board of directors when determining the estimated fair value of common stock for the awards granted in 2021. The independent valuation prepared as of April 5, 2022 was utilized by our board of directors when determining the estimated fair value of common stock for the awards granted in the second quarter of 2022. Our board of directors, relying in part on these third-party valuations, determined valuations of our common stock of $0.30 per share as of January 5, 2021 and $0.61 per share as of April 5, 2022 and such valuation by the board of directors was used for the purposes of determining the stock-based compensation expense.
Retrospective reassessment of fair value of common stock for financial reporting purposes
As part of the preparation of the financial statements necessary for inclusion in this prospectus, we reassessed for financial reporting purposes, on a retrospective basis, the fair value of our common stock for each share-based award granted in 2021, which had an original fair value of $0.19 per share. In their review of our calendar year 2021 financial reporting, the Board and management noted, among many important factors, the Company’s rapid progress over the course of the year in its research and development programs, clinical programs, and overall business strategy. While this progress could not have been reasonably anticipated during interim assessments of fair value, at year end the Board and management judged that a reassessment was appropriate. For purposes of this reassessment, we evaluated our original inputs and the methodologies used to determine our enterprise value, the methods we used to allocate enterprise value and the timing of those valuations. The Board determined a reassessed fair value of $0.30 per share. We utilized the above reassessed fair value of $0.30 per share to determine the stock-based compensation expense which is recorded in our financial statements.
The following table summarizes by grant date the number of shares of common stock subject to stock options granted from April 30, 2020 (date of inception), as well as the associated per share exercise price and the estimated fair value per share of our common stock as of the grant date:
Grant Date |
|
Number of options Granted |
|
|
Exercise price per share of common stock |
|
|
Estimated fair value per share of common stock (1) |
|
|||
February 22,2021 |
|
|
1,140,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
March 31, 2021 |
|
|
100,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
April 10, 2021 |
|
|
100,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
May 17, 2021 |
|
|
60,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
May 24, 2021 |
|
|
15,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
June 7, 2021 |
|
|
100,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
June 10, 2021 |
|
|
100,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
October 31, 2021 |
|
|
376,135 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
November 15, 2021 |
|
|
35,000 |
|
|
$ |
0.19 |
|
|
$ |
0.30 |
|
June 28, 2022 |
|
|
862,500 |
|
|
$ |
0.61 |
|
|
$ |
0.61 |
|
(1) |
The estimated fair value of options reflects the weighted average fair value of options granted on each grant date, determined using the Black-Scholes option-pricing model. |
65
Based on an assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, the aggregate intrinsic value of vested and unvested stock options outstanding as of September 30, 2022 was $ million and $ million, respectively.
Following the closing of this offering, the fair value of our common stock will be the closing price of our common stock on the Nasdaq Capital Market as reported on the date of the grant.
Estimating the Fair Value of Convertible Promissory Notes
We have elected the fair value option for the accounting for our convertible promissory notes issued in 2022 and utilized an independent third-party valuation specialist to assist management in measuring the fair value. The fair value of the Convertible Promissory Notes is determined using a scenario-based analysis that estimates the fair value based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the noteholders, including various IPO, settlement, equity financing, corporate transaction and dissolution scenarios.
Commitments and contingencies, including convertible promissory notes, license and sponsored research agreements
Convertible Promissory Notes
In April 2022, we issued $10.5 million of unsecured Convertible Promissory Notes, as amended on (the “Notes”), which bear interest at an annual rate of 6.0%, paid in kind, and have a maturity date of June 30, 2024. The Notes will automatically convert into shares of common stock in connection with the closing of this offering. The Notes will convert at the lesser of (i) the price per share calculated by dividing $60.0 million by the fully diluted capitalization at the time of conversion (the “Conversion Cap”); or (ii) 80% of the price paid per share paid by the cash investors in a “Qualified Equity Financing” (as defined in the Notes). The Notes will also convert upon the closing of a change of control into shares of Common Stock at a conversion price equal to the lesser of the Conversion Cap and eighty percent (80%) of the price per share paid to the holders of our common stock set forth in the definitive agreement pursuant to which the change of control will occur.
We may not prepay the Notes without the prior written consent of the holders of a majority of the outstanding aggregate principal of the Notes.
On issuance, we elected to account for the Notes at fair value in accordance with ASC 815 with any changes in fair value being recognized through the statements of operations until the Notes are settled. Changes in fair value attributable to changes in instruments specific credit risk are recorded in other comprehensive income to the extent they are material.
Patent Know How and License Agreement with The Methodist Hospital
In September 2022, we entered into an Amended and Restated Patent Know How and License Agreement, effective as of October 2020 (the “Methodist License Agreement”), with The Methodist Hospital (“Methodist”) to make, sell and sublicense products and services using the intellectual property and know-how of Methodist. As part of the Methodist License Agreement, we will pay Methodist a four-figure license maintenance fee annually until the first sale of licensed product occurs. The term of the Methodist License Agreement is effective until no intellectual property patent rights remain, unless terminated sooner by (1) bankruptcy or insolvency, (2) the failure by us to monetize the intellectual property within five years of the date of the agreement (further discussed below), (3) due to breach of contract, or (4) at our election for any or no reason.
In addition to the equity issuance and reimbursement of patent related expenses, we agreed to make contingent milestone payments to Methodist on a Licensed Product-by-Licensed Product or Licensed Service-by-Licensed Service basis upon the achievement of certain development, approval and sales milestones (i) related to the treatment of ALS totaling up to $325,000 in the aggregate, and (ii) related to the treatment of each other indication (that is not ALS) totaling between $212,500 and up to $425,000 in the aggregate per indication. We are also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, royalties (subject to customary reductions) equal to 1% to 10% of annual worldwide net sales of such licensed product during a defined royalty term. The applicable royalty percentage increases as Licensed Products are used to treat from one to more than three indications and if a given Licensed Product utilizes only T-reg cell therapy or is a combination of both T-reg cell therapy and exosomes. Therefore, the lowest tier is paid when there is only a single indication being addressed with a single product. The highest tier is paid only on combination products where there are three or more indications being served. We are also required to pay a low single digit percentage for certain licensed services. We are required to pay royalties at between 10%-20% of sublicense revenue. Commencing on January 1, 2025, the minimum amount which will be owed by us once commercialization occurs is $50,000 annually.
66
In September 2022, we amended the Methodist License Agreement to provide that in the event we sublicenses products and services covered by the Methodist License Agreement, then royalties owing to Houston Methodist would be computed as a percentage of payments received by us from the sublicensee. In addition, the termination provisions were amended to provide that Houston Methodist may only terminate the Methodist License Agreement, among other things, in the event that after five years we are not “Actively Attempting to Develop or Commercialize,” as such term is defined in the Methodist License Agreement.
Sponsored Research Agreement with Houston Methodist Research Institute
In February 2021, we executed a Sponsored Research Agreement, as amended (the “SRA”) with Houston Methodist Research Institute (“HMRI”), a Texas nonprofit corporation and an affiliate of Methodist, which can be extended or renewed by mutual agreement. Pursuant to the SRA, we agreed to fund $1.5 million in research in the area of neurodegenerative diseases through February 2022. We subsequently amended the SRA to extend the term through February 2025, which includes an annual funding commitment of $1.5 million per year. As of September 15, 2022, we have provided notice to HMRI regarding termination of the SRA in expectation that a reduced yearly budget be negotiated post termination. For the 90-day period commencing after the termination date of the SRA, we are responsible for reimbursing HMRI for accrued expenses incurred by HMRI. During this 90-day period, we intend to negotiate a new SRA with HMRI.
ARScience License Agreement
On August 23, 2022 (the “Execution Date”), we entered into a License Agreement (the “ARS License Agreement”) with ARScience Biotherapeutics, Inc. (“ARS”) pursuant to which ARS granted us an option to, if we choose to exercise such option, to acquire an exclusive, royalty-bearing license for two patents regarding certain formulations of hrIL-2 (the product that serves as the basis for COYA 301), with the right to grant sublicenses through multiple tiers under these patents (the “ARS Option”). In consideration for the ARS Option, we paid ARS a one-time, non-refundable, non-creditable option fee of $100,000.
In addition, we may also owe tiered payments to ARS based on our achievement of certain developmental milestones. Under the ARS License Agreement, we will pay an aggregate of $13.25 million in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. We will then pay an aggregate of $11.6 million in developmental milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement), we will pay an aggregate of $11.75 million in developmental milestone payments. We will then pay an aggregate of $5.85 million in developmental milestone payments for each Mono Product in each subsequent new indication, and we will owe an aggregate of $5.85 million if all developmental milestones are achieved for each new indication. We will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event we sublicense our rights under the ARS License Agreement, we will owe royalties on sublicense income within the range of 10% to 20%. To date, the $100,000 option fee is the only payment made to ARS under ARS License Agreement.
Recent Accounting Pronouncements
See Note 2 to our audited financial statements and Note 2 in our unaudited interim financial statements found elsewhere in this prospectus for a description of recent accounting pronouncements applicable to our financial statements.
67
Overview
We are a clinical-stage biotechnology company focused on developing proprietary medicinal products to modulate the function of regulatory T cells (“Tregs”). Tregs are a subpopulation of T-lymphocytes consisting of CD4+CD25high hFOXP3+ cells that suppress inflammatory responses. Tregs and their transcription factors are essential to maintain homeostasis by regulating autoimmune and inflammatory responses and maintaining self-tolerance in mammals. Treg dysfunction is an important component in the pathophysiology of serious neurodegenerative, autoimmune, and metabolic diseases, for which we believe new and effective therapies are urgently needed.
Tregs were discovered in 1995 by Dr. Shimon Sakaguchi and since their discovery, multiple lines of research have contributed to elucidate Treg biology and their role in health and disease. Initial scientific evidence revealed the key mechanisms linking the function of Tregs to autoimmune and chronic inflammatory diseases. Following these key discoveries, the role of Tregs was also identified in progressive neurogenerative diseases.
Understanding the biology of healthy Tregs and the role of dysfunctional Tregs across different disease categories, has made this subset of T lymphocytes a relevant therapeutic target, which we believe may provide new treatments for serious diseases.
Since our inception in 2020, we have generated preclinical and clinical data in multiple models and diseases. Our autologous Treg cell therapy program has completed Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis, or ALS. The clinical data from these initial studies has served as an important confirmation of the immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline.
Our initial developmental programs are focused on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases of high unmet medical need. Our diversified candidate pipeline includes both ex vivo and in vivo approaches intended to restore the suppressive and immunomodulatory functions of Tregs. Our product candidate pipeline is based on our three therapeutic modalities: (1) Treg-enhancing biologics; (2) Treg-derived exosomes; and (3) autologous Treg cell therapy. The product candidates utilizing our Treg-enhancing biologics are collectively referred to as the “300 Series.” The product candidates utilizing our Treg-derived exosomes are collectively referred to as the “200 Series.” The product candidates utilizing our autologous Treg cell therapy are collectively referred to as the “100 Series.” Currently, our 300 Series product candidates include COYA 301 and COYA 302, our 200 Series product candidates include COYA 201 and COYA 206, and our 100 Series product candidate is COYA 101.
We believe our product candidate pipeline has the potential to address the unmet need of serious diseases in multiple therapeutic areas. Our multiple development programs, which we are conducting simultaneously, may reduce the risk profile of our operations and enhances our chance of achieving regulatory approval and commercialization for one or multiple of our product candidates.
68
Our business strategy is to advance our multiple therapeutic modalities and product candidates simultaneously, which we believe sets the foundation for accomplishing multiple development milestones overtime, with the goal of ultimately delivering new and effective products for patients and their families.
Our Pipeline
The core of our approach and strategy is to leverage our three Treg-modifying therapeutic modalities to advance the standard of care for neurodegenerative and autoimmune diseases. Building on our initial findings from our autologous Treg cell therapy modality, our goal is to offer patients therapies that improve outcomes of neurodegenerative, autoimmune, and metabolic diseases.
Our Strategy
Our strategy is to discover, develop, manufacture, and commercialize proprietary medicinal products that enhance the function of Tregs. We intend for our product candidates to address unmet medical needs, principally in neurodegenerative, autoimmune, and metabolic diseases.
We believe we can differentiate ourselves from other Treg companies by combining our understanding of Treg cell biology and the diseases where Treg cellular dysfunction is considered a likely driver of pathology with our three distinct therapeutic modalities: (i) Treg-enhancing biologics, (ii) Treg-derived exosomes, and (iii) autologous Treg cell therapy.
Key elements of our strategy include:
|
1. |
Advance the development COYA 301. Our goal is to advance COYA 301, our biologic product candidate, for the treatment of FTD by initiating IND-enabling studies, followed by clinical trials. FTD is a relatively rare form of dementia that impacts younger individuals, for which no treatment is currently available. |
|
2. |
Advance the development of COYA 302. Our goal is to advance COYA 302, a biologic product candidate combination that aims to suppress inflammation via administration of a fusion protein in conjunction with COYA 301, a biologic that aims to enhance Treg function. We believe this combination has synergistic impacts in enhancing Treg function. We aim to develop this combination in neurodegenerative and autoimmune diseases. |
|
3. |
Advance other product candidates by initiating IND-enabling studies. Our goal is to advance our T-reg derived exosome product candidates by conducting IND-enabling preclinical studies of COYA 201 for biodistribution and for scleroderma and hepatic inflammation and fibrosis. |
|
4. |
Leverage our in-licensed technology to advance our Treg exosome therapies. We expect to begin developing the next generation of our Treg exosome therapies (COYA 206) utilizing technology we have in-licensed from Carnegie Mellon University which we believe may enable Treg exosomes to be homed to proteins of interest while delivering select payload into targeted cells. We believe COYA 206 provides a material advantage to our Treg-derived exosome therapeutic modality by |
69
|
allowing targeting of these exosomes to proteins of interest. There are diseases that may be driven by certain proteins and the ability to home in on these proteins may make COYA 206 more selective to that condition. Obtaining preclinical data illustrating this targeted approach is an important initiative for us. |
|
5. |
Continue to develop our cell therapy product through Phase 2. Our goal is to advance COYA 101, our autologous cell therapy for the treatment of ALS, into Phase 2b clinical trials, provided we receive non-dilutive funding in the form of a grant from a government organization, or by partnering with an established pharmaceutical company. We currently anticipate that grant funding, or other non-dilutive funding, in the amount of approximately $3 million would be sufficient begin advancing COYA 101 into a Phase 2b trial. This amount is an estimate and may be subject to change. |
|
6. |
Expand our pipeline by identifying and developing additional product candidates and identifying additional target indications. We intend to develop other biologics and biologic combinations intended to ameliorate inflammation and lack of self-tolerance that characterize certain neurodegenerative, and autoimmune diseases. |
|
7. |
Selectively enter into new discovery relationships with premier research institutions and commercial partners. We expect to have ongoing discussion with third-party pharmaceutical companies about their interest in partnering with us for the ongoing development and commercialization of certain of our development programs. |
|
8. |
Expand our manufacturing capabilities. Continue ongoing development and optimization of our manufacturing capabilities of Treg cellular therapeutics, exosomes, engineered exosomes, and biologics. |
Our Team
We have assembled a highly experienced management team and board of directors to execute on our mission to advance the standard of care for neurodegenerative, metabolic and autoimmune diseases. Our team has a proven track record in developing, launching, and marketing multiple drug products.
Our Chief Executive Officer and Chairman of the Board, Howard Berman, Ph.D., has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. His experience offers him a strong combination of business acumen and scientific credibility with the ability to assess, quantify, and bridge both disciplines. Our President and Chief Medical Officer, Adrian Hepner, M.D., Ph.D., has over 35 years of global experience in clinical research and drug development, including the development and implementation of the clinical and regulatory strategy for several products from early stage through successful U.S. New Drug Application (“BLA”) and EU regulatory filings and approvals. Our Chief Financial Officer and Chief Operating Officer, David Snyder, has over 25 years’ experience as the Chief Financial Officer of both private and public companies.
Regulatory T cells (Tregs)
In 1995, a subpopulation of suppressor T cells was identified that expressed CD4 and was named regulatory T cells (Tregs). CD4 is found on the surface of certain cells and plays a key role in maintaining homeostasis, a state of balance among all the body systems needed for the body to survive and function correctly, in the immune system. CD4+ T cells are commonly divided into two distinct lineages: Treg cells and conventional T helper (Th) cells (Pro-Inflammatory Cells).
Conventional Th cells are crucial in shaping the immune response, whether it is protection against a pathogen, a cytotoxic attack on tumor cells, or an unwanted response to self-antigens in the context of autoimmunity. Th cells control the adaptive immune system. The adaptive immune system includes the effectors cells of the cellular immune responses, the T lymphocytes, which mature in the thymus, and antibody-producing cells, the B lymphocytes, which arise in the bone marrow. Th cells control the adaptive immune system by activating, in an antigen-specific fashion, other effector cells such as CD8+ cytotoxic T cells (which are important for immune defense against intracellular pathogens), B cells (that are responsible for producing antibodies), and macrophages (white blood cells that stimulate the action of other immune system cells). By functioning in an antigen-specific fashion, the Th cell is capable of stimulating an immune response.
70
Tregs main function is the suppression and termination of pro-inflammatory immune responses. Tregs suppress both innate and adaptive immune reactions detrimental to the host, downregulate pro- inflammatory cytokine (a type of protein that is made by certain immune and non-immune cells and has an effect on the immune system) production, and can suppress the activation/expansion of CD4+CD25– effector T lymphocytes (Teffs). Immune homeostasis is reached when there is a balance between the number of functional Tregs and pro-inflammatory T cells. See the below figure for a visual representation:
Healthy Tregs Tregs are important anti-inflammatory immune cells involved in homeostasis. Tregs act on multiple immune cells to down-regulate the release of pro-inflammatory cytokines. |
|
The Significant Role of Tregs in Neurodegenerative, Autoimmune, and Metabolic Diseases
Dysfunctional Tregs underlie many diseases, and this cellular dysfunction is driven by the chronic inflammatory environment and high levels of oxidative stress commonly observed in numerous diseases. Additionally, the degree of Treg dysfunction is associated with the severity and progression of serious and life-threatening conditions, for which we believe new and effective therapies are urgently needed.
Since the discovery of Tregs in 1995, we have continued the development and research of Tregs by leveraging the scientific discoveries of Dr. Stanley Appel and his research team at Houston Methodist Hospital (“Methodist”) in Houston, Texas. We have entered into an exclusive Patent and Know How License Agreement with Methodist, and we continue to work with them in support of their research through an exclusive Sponsored Research Agreement.
Recent scientific evidence from Dr. Appel demonstrates that dysregulation of the immune system negatively impacts the severity and progression of neurodegenerative conditions. We believe Dr. Appel’s work demonstrates the role of Treg dysfunction in serious conditions such as amyotrophic lateral sclerosis (“ALS”), Alzheimer’s disease (“AD”), and frontotemporal dementia (“FTD”).
In particular, Dr. Appel discovered that Tregs are both reduced in numbers and function in these patients suffering from neurodegenerative diseases, and more marked reduction could be associated with more rapid disease progression. In addition, scientific evidence indicates an association between Treg dysfunction and the pathophysiology of autoimmune and metabolic conditions, such as liver inflammation and fibrosis and systemic sclerosis (“SSc”), also known as scleroderma.
71
An increased ratio of pro-inflammatory T cells to functional Tregs leads to a disrupted immune homeostasis. See the below figure for a visual representation:
|
Dysfunctional Tregs When Tregs become dysfunctional, a cytokine-mediated inflammatory state can arise leading to neurodegenerative, autoimmune, and metabolic diseases. |
|
Our Biologics Therapeutic Modality (the 300 Series)
Our growing expertise and clinical experience decoding Treg biology and the critical role of Tregs in the pathophysiology of neurodegenerative, autoimmune, and metabolic diseases, provide the basis for the research and development of innovative biologics and biologic combinations intended to enhance Treg function in vivo for the treatment of diseases of high unmet medical need.
COYA 301
COYA 301 is a biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo for the treatment of FTD, an orphan disease of high unmet need. We believe an increased ratio of functional Tregs shifts the balance in-vivo in favor of anti-inflammatory Tregs to pro-inflammatory cells. See the below figure for a visual representation:
We are developing biologics and biologic combinations intended to ameliorate the inflammation and lack of self-tolerance that characterize certain neurodegenerative and autoimmune diseases, by increasing Treg suppressive and immunomodulatory functions.
COYA 301’s subcutaneous administration allows patients to be dosed in their homes, which we believe provides convenience and pharmacoeconomic advantages over existing products requiring administration in a hospital setting.
72
Overview of FTD
FTD is a group of disorders that occur when nerve cells in the frontal and temporal lobes of the brain are lost. This causes the lobes to shrink. FTD can affect behavior, personality, language, and movement. These disorders are among the most common dementias that strike at younger ages. Symptoms typically start between the ages of 40 and 65, but FTD can strike younger adults and those who are older. FTD affects men and women equally, and its prevalence in the United States is about 60,000 cases. There are no currently approved products to prevent, cure or slow the progression of FTD. In light of the severe nature of FTD and the high unmet need due to the lack of treatments, our strategy is to simultaneously develop COYA 301 for the treatment of FTD. We believe this maximizes our chances of developing a successful product candidate. As the development of each of these product candidates progresses, we will periodically assess which product candidate or candidates presents our best opportunity for clinical success and will adjust our strategy accordingly.
As in other types of dementia, mounting evidence supports the role of neuroinflammation in the progression of FTD, including cortical inflammation and cell activation. In addition, available data suggest an overlap between FTD and autoimmune disease in patients with altered blood glycoproteins.
Development Status
We are conducting CMC activities and IND-enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials to evaluate the safety and efficacy of COYA 301 for the treatment of FTD. We expect to initiate the initial Phase 1 clinical trial in the first half of 2023 which will evaluate the safety, pharmacokinetics, and biological activity of COYA 301.
We believe data from the FTD development program may support the development of COYA 301 for additional indications, administered as monotherapy or as adjunctive therapy to current standard of care. In preclinical in vitro testing, COYA 301 has shown an ability to enhance Treg function and to restore immune system homeostasis. We conducted studies in 2021 that show that Treg suppressive function is significantly decreased in FTD compared to healthy controls. Scientific evidence demonstrates that COYA 301 plays a key role in the development, expansion, activity, and survival of Tregs. This study was designed to evaluate Treg function in patients with FTD and was conducted by Dr. Appel and his team at Houston Methodist Hospital in 2021. This was a non-interventional study in which no treatment was administered, therefore efficacy and safety endpoints were not part of the assessment. The study included 22 patients and 13 matching healthy controls. Demographics of FTD patients and controls were comparable for age and sex. Mean (SD) age in the FTD group was 67.6 (8.2) years compared to 68.4 (7.5) in the controls. The proportion of women in the FTD group was 59% and 54% in the controls.
Treg percent suppressive function on the proliferation of responder T lymphocytes was assessed by [3H]-thymidine incorporation. Difference in Treg suppressive function between groups was determined using one-way ANOVA. This was an non-interventional study and no investigational treatment was administered, and no study subject experienced a serious adverse event. Results of a study conducted by Dr. Stanley Appel and his team at The Houston Methodist Hospital show that Treg suppressive function in FTD patients was significantly lower compared to healthy subjects (Table 1, which is based on our internally generated data); which we believe is unsurprising given that the homeostasis of the immune system is negatively impacted in FTD.
Table 1.
Percentage Treg Suppressive Function in FTD and Healthy Subjects |
||
|
FTD (N=22) |
Healthy Controls (N=13) |
Mean (SD) (%) |
31.62 (26.05) |
54.52 (20.40) |
p-value=0.019 |
We believe our preclinical data, in connection with the data from this non-interventional clinical study in FTD patients, support that enhancing Tregs’ suppressive function may have the potential to reduce the pro-inflammatory response driving neurodegeneration and disease progression in FTD.
We intend to explore partnerships with other pharmaceutical and biotechnology companies that own strategic compounds that could potentially be suitable candidates for safe and effective new combination therapies with COYA 301.
73
COYA 302
Our second biologic product candidate, COYA 302, is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. COYA 302 is a combination of COYA 301 and a fusion protein. These two mechanisms may be additive or synergistic in suppressing inflammation. We believe the immunomodulatory fusion protein selectively inhibits the activation of pro-inflammatory effector T cells and macrophages down-regulating the secretion of pro-inflammatory cytokines, while COYA 301 enhances and expands Tregs in-vivo. The combination of these two approaches is intended to further shift the balance in favor of anti-inflammatory Tregs to pro-inflammatory cells in-vivo. See the below figure for a visual representation:
Development Status
We are conducting CMC activities and IND-enabling toxicology studies to support the filing of an IND and the initiation of clinical trials of COYA 302 for the treatment of a neurodegenerative disease and an autoimmune disease. We expect to begin the initial Phase 1 clinical trial in a neurodegenerative disease in the second half of 2023 which will evaluate the safety, pharmacokinetics, and biological activity of COYA 302. The Phase 1 clinical trial in an autoimmune disease is expected to start in the first half of 2024; the study will evaluate the safety, pharmacokinetics, and biological activity of COYA 302.
In vitro assays, done in an in vitro clinical study conducted by Dr. Appel and his team at Houston Methodist Hospital (using commercially available products) showed that ex vivo expanded human Tregs exhibited greater suppression of T responder (“Tresp”) proliferation after exposure to the fusion protein component of COYA 302. In a separate assay, the addition of the fusion protein to ex vivo expanded human Tregs showed incremental suppression in the production of IL-6 by M1 proinflammatory macrophages.
Following the in vitro testing, COYA 302 was evaluated in two open-label proof of concept academic clinical studies, also conducted by Dr. Appel and his team at Houston Methodist Hospital using commercially available products. The first study was conducted in three patients with Alzheimer’s disease. Patients received COYA 302 over a four-month period and were assessed for cognitive status, Treg suppression function, and safety and tolerability. Cognitive function was measured with the Mini-Mental State Examination (MMSE) test, and patients exhibited a stable or slightly improved MMSE score at the end of the study, compared to baseline. Consistent with the positive observation in cognitive status, the three patients showed an increase in their Treg suppressive function over the course of the treatment with COYA 302, compared to baseline values prior to initiation of treatment. In addition, COYA 302 was well tolerated, no serious adverse events were reported, and no patient discontinued the study due to safety reasons. This study was not powered to assess statistical significance.
The second open-label study in four patients with amyotrophic lateral sclerosis (ALS) is ongoing. Study assessments include functional status, as measured with the Revised ALS Functional Rating Scale (ALSFRS-R), Treg suppressive function, serum biomarkers, and safety and tolerability. Interim results at six months after initiation of treatment with COYA 302 showed that ALSFRS-R scores remained stable or slightly improved over the course of treatment, compared to ALSFRS-R scores at baseline prior to initiation of treatment. On average, the four patients exhibited a mean increase of 2.25 points in the ALSFRS-R score. The ALSFRS-R scoring range is 0 to 48, with higher scores representing a better functional status. Similarly, all patients showed an increase in Treg suppressive function, compared to baseline. Treg function was measured in vitro by assessing the ability of Tregs to suppress the proliferation of T effector cells. Consistent with the observations in ALSFRS-R score and Treg suppressive function, the serum levels of biomarkers of inflammation and oxidative stress remained stable or showed a decline across the four patients. Serum levels of oxidized low density lipoprotein (“ox-LDL”) exhibited a mean decline of 24 U/L, and levels of 4-hydroxynonenal (“4-HNE”) declined approximately 7 ng/mL. At the time of the six-month data cut-off, COYA 302 was well tolerated, no serious adverse events were reported, and no patient discontinued the study due to safety concerns. This study was not powered to assess statistical significance.
74
Our Treg-Derived Exosomes Therapeutic Modality (the 200 Series)
We are developing a Treg-derived exosome therapeutic modality consisting of both allogeneic Treg-derived exosomes and antigen derived Treg-directed exosomes that we believe may have unique advantages due to their nanosized (having dimensions limited to nanometers) and non-cell characteristics and to the potential for customization. Treg-derived exosomes are manufactured following the expansion and conversion of Tregs. The Treg exosomes are nanovesicles, tiny sacs released by cells that carry chemical messages between cells, produced by the Tregs and released to the bloodstream and different tissues to communicate with other cells, including pro-inflammatory T and B cells. Treg exosomes contain different types of cargo, such as proteins, lipids and nucleic acids, and have suppressive contact-mediated receptors and proteins that are typically present on the parent Tregs, allowing them to efficiently modulate the immune and inflammatory responses.
We have filed intellectual property claims on the contents of the exosomes, namely the micro RNAs that are reproducibly represented from batch to batch. Many of these micro RNAs confer anti-inflammatory functionality as a mechanism of action and we believe may explain the exosomes’ immunomodulatory function. The exosome field is an emerging and new area at present and understanding the functional aspects of the exosomes is an important but evolving regulatory aspect. We have filed intellectual property claims for compositions of matter that teach the reproducible micro RNA contents. To date, no patents have been issued.
We have developed technology to collect large volumes of Treg exosomes from the tissue culture media that is utilized in the Treg conversion and expansion process. One of the potential limitations of anti-inflammatory Treg cells is that they could be susceptible to the noxious, pro-inflammatory environment observed in some serious and progressive conditions, with the possibility of being converted to a dysfunctional Treg phenotype. Because Treg exosomes are not cells and are end-stage differentiated, they cannot be phenotypically changed, which is the shifting from a type of cell to another type of cell, by the inflammatory environment. In addition, Treg exosomes’ very small size (between 30-200 nm) makes them able to readily reach sites of inflammation and cross biological barriers in the body, including the blood-brain barrier. See the below image for a visual representation of a Treg exosome.
We believe our data demonstrates the anti-inflammatory activity of Treg exosomes in in vitro assays and in vivo animal models of acute inflammation and ALS, following intravenous and intranasal administration. Further, we believe our research demonstrates that Treg exosomes exhibit greater anti-inflammatory potency than mesenchymal exosomes, as demonstrated in research recently published in the journal Frontiers of Immunology. Mesenchymal exosomes are extracellular vesicles that are derived from mesenchymal
75
stem cells which are a heterogeneous population of cells that are isolated from various tissues, including bone marrow, adipose tissue, umbilical cords, and even urine.
We believe these Treg exosomes provide an extensive arsenal of suppressive signaling components and anti-inflammatory mediators that are potentially able to suppress pro-inflammatory cascades in the body, including the brain.
We are currently conducting multiple preclinical studies in animal models of autoimmune disease and toxicology IND-enabling Good Laboratory Practices (“GLP”) studies intended to support the filing of an IND necessary to initiate a first-in-human Treg exosome trial using an allogeneic method of treatment. We are currently conducting multiple preclinical studies in animal models of autoimmune disease to support the filing of an IND necessary to initiate a first-in-human Treg exosome trial using an allogeneic method of treatment. While we maintain internal preclinical research and development activities in exosomes generally, we are simultaneously investigating alternative exosome technologies developed by academic institutions or commercial enterprises which we may be able to access, through external partnerships, licensing, and/or strategic collaborations.
Our allogeneic Treg exosome product candidate, COYA 201, is being developed following Treg conversion and expansion from healthy donors. We believe the manufacturing process under GMP conditions to date has shown consistent batch-to-batch comparability and adequate long-term stability. In addition, we believe the proprietary manufacturing and cryopreservation processes are highly efficient and will be able to supply a 12-month treatment for five patients from a single manufacturing run.
COYA 201
We believe that our Treg exosome modality for allogeneic use allows targeting multiple indications in the neurodegenerative, autoimmune, and metabolic therapeutic categories.
In evaluations of our Treg exosome product in a preclinical lupus nephritis model in mice, COYA 201 was administered at different dose levels and was well tolerated and no fatalities were observed at the administered dose of 1x1010 exosomes (low dosage level). However, as part of this dose-escalation study, as a result of toxicity when administered in extremely high doses (1x1011 exosomes, or ten times the low dosage level) administered twice weekly, death in six animals (out of a total of 12) was observed. Dose escalation studies are standard in the early development of new treatments and the assessment of the “maximum tolerated dose” and identification of the dose that produces lethality in 50% of animals, are also common studies in early preclinical development. The primary endpoint of this study was proteinuria (amount of protein in urine) to assess renal function. The primary endpoint The primary endpoint of this study was proteinuria (amount of protein in urine) to assess renal function. The primary endpoint was not met. Currently, the side effect profile of our product candidates in humans is unknown. We continue to evaluate different potential indications to advance the development of COYA 201 into clinical studies. Following the completion of the preclinical studies in different animal models of disease, we will evaluate the data to potentially conduct further preclinical studies and to select a potential clinical indication for human studies.
COYA 201 is being evaluated in a mouse model of scleroderma.
Overview of Scleroderma
Scleroderma, also known as systemic sclerosis, is an autoimmune disease affecting the skin and other organs of the body, meaning that the body’s immune system is causing inflammation and other abnormalities in these tissues. There are two main types of scleroderma: localized scleroderma and systemic scleroderma. Systemic scleroderma is the most serious form of the disease, and can affect the skin, muscles, joints, blood vessels, lungs, kidneys, heart and other organs. Localized scleroderma usually affects only the skin, although it can affect the muscles, joints and bones. It does not affect internal organs.
The main finding in scleroderma is thickening and tightening of the skin and inflammation and scarring of many body parts, leading to problems in the lungs, kidneys, heart, intestinal system, and other areas.
Scleroderma is relatively rare. About 75,000 to 100,000 people in the U.S. have this disease; most are women between the ages of 30 and 50. There is presently no cure for scleroderma, and current interventions are limited to symptomatic treatment.
Scientific evidence shows numerical and functional changes of Tregs in scleroderma patients, including decreased frequencies and/or impaired function of circulating Tregs. Moreover, an imbalance between T helper cells and Tregs has been identified in patients with scleroderma, which is thought to contribute to the progression of the disease.
76
Development Status
We are conducting a preclinical study in a well-established animal model of systemic scleroderma, intended to evaluate the biological activity and potential efficacy of COYA 201 administered intravenously and intranasally. This study will involve a bleomycin induced systemic scleroderma mouse model. The overall study design will involve 15 animals/group, in 4 groups- vehicle, low dose exosome, high dose exosome, and saline. The endpoints measured will include skin punch weight, skin histopathology, and lung histopathology. We believe the evaluation of routes of administration to deliver COYA 201 through atomization directly into the lungs may provide alternative treatment options for patients with chronically progressive diseases. Results from this initial animal study will be used to guide the next steps in the early phases of this development program.
COYA 201 has been tested in an in vitro humanized model of hepatic inflammation and fibrosis.
Overview of Hepatic Inflammation and Fibrosis
Because the liver plays a central role in metabolism of lipids and glucose, liver inflammation is closely related to metabolic disorders such as nonalcoholic fatty liver disease (“NAFLD”), which affects up to 40% of Western adult populations. NAFLD includes a spectrum of diseases ranging from isolated hepatic steatosis to nonalcoholic steatohepatitis (“NASH”), the progressive form of the disease characterized by inflammation, cellular injury, and fibrosis, which can lead to cirrhosis and hepatocarcinoma.
The accumulation of lipid deposits in hepatocytes leads to production of proinflammatory cytokines that triggers the development of liver inflammation and fibrosis. Tregs play a critical role in regulating inflammatory processes in NASH, while T helper type 17 (“Th17”) might functionally oppose Treg-mediated responses.
Therefore, we believe Treg exosomes may have the potential to effectively modulate the inflammatory processes by enhancing anti-inflammatory mechanisms and modifying the pathogenesis of the disease.
Development Status
We have conducted an initial preclinical study in a humanized model of liver inflammation and fibrosis to evaluate the biological activity of COYA 201. This is a cellular liver model involving co-culture of primary human hepatocytes, Kupffer cells, liver endothelial cells, and stellate cells and will be evaluated across multiple groups, vehicle control, low dose exosomes, high dose exosomes, and saline solution. The primary objectives of this study were the assessment of inflammation, measured by the levels of released pro-inflammatory cytokines, and fibrosis, measured by the release of procollagen by the hepatic cells. We observed a significant decrease in the secretion of pro-inflammatory cytokines and a significant increase in the secretion of anti-inflammatory cytokines. The study met its primary objectives by demonstrating that COYA 201 was biologically active in this model. Results from this study will guide the next steps in the early development of this program.
COYA 206
As part of our Treg exosome development programs, we are developing our next generation of antigen directed Treg-derived exosome product candidates and in June 2022 we executed an option agreement allowing us to acquire exclusive worldwide rights to a novel and proprietary technology enabling exosome engineering from Carnegie Mellon University (the “Carnegie Mellon Option Agreement”).
The Carnegie Mellon Option Agreement involves the intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids (“EPHs”), a tether-based exosome functionalization strategy that enables Treg exosomes
77
to be homed to proteins of interest, while delivering select payloads into targeted cells. See the below image for a visual representation of a tethering exosome.
Functionalized exosomes with an immunomodulatory protein, FasL, have demonstrated their biological activity both in vitro and in vivo. FasL-functionalized exosomes, when bioprinted on a collagen matrix, allows spatial induction of cell death in tumor cells and, when injected in mice, suppresses proliferation of pro-inflammatory T cells.
Schematic Representation of Functionalized Targeted Treg Exosomes
78
We believe this proprietary technology sets the foundation to produce targeted Treg exosome therapeutics that are directed to epitopes, the part of an antigen molecule to which an antibody attaches itself, and proteins of interest, while delivering growth factors, drugs or other cargo, representing an innovative technology that could be advantageous relative to other Treg directed therapeutic modalities.
We are working on the characterization of the EPHs and are planning to do target validation following completion of this work to select product candidates and indications for future development.
Our Autologous Regulatory T Cells (Tregs) Therapeutic Modality (the 100 Series)
COYA 101
Our autologous Treg cell therapy product candidate COYA 101 has completed Phase 1 and Phase 2a studies and we believe the data from these trials provide us the information needed to design a well-powered and well-controlled confirmatory clinical study to evaluate the safety and efficacy of COYA 101 for the treatment of ALS.
Our cell therapy technology is being developed to address Treg dysfunction in the context of the pathophysiology driven by chronic neuroinflammation in patients with neurodegenerative diseases. COYA 101 is being developed as a treatment for patients with serious neurological disorders. The proposed initial indication for COYA 101 is treatment of amyotrophic lateral sclerosis (ALS). We have been granted orphan drug designation (“ODD”) for the active moiety or the principal molecular structural features in the United States for COYA 101 for the treatment of ALS.
Generally, if a drug with an ODD subsequently receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug and indication for that time period, except in limited circumstances. The applicable period is seven years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for Orphan Drug Designation or if the drug is sufficiently profitable such that market exclusivity is no longer justified.
Overview of ALS
ALS is, a rare devastating and fatal neurodegenerative disease characterized by rapid and hard to stop progression, affecting approximately 20,000 patients in the United States. ALS, also known as Lou Gehrig’s disease, attacks nerve cells, called motor neurons, that control voluntary muscles. When these cells die, voluntary muscle control and movement are lost. This leads to progressive weakness and disability. People living with ALS eventually lose their strength, ability to move their arms, legs, and body, and the ability to breathe on their own. In most cases, their minds remain sharp and alert. The average life expectancy for people with ALS is two to five years from diagnosis, although 50% of patients die within 2.5 years of symptoms onset. We believe ALS constitutes a clear unmet medical need, as currently available products only provide limited benefit to some patients.
Development Status
Phase 1 Clinical Data
Based upon an open-label Phase 1 clinical study in ALS patients, in which administration of repeated infusions were associated with stabilization of ALS progression over the course of the treatment period during the first and second infusion cycles over 6 and 12 weeks, respectively, we believe the results of the Phase 1 trial support that repeat intravenous administration of Treg infusions are well tolerated and able to achieve a therapeutic response.
This Phase 1 study was a first-in-human proof-of concept trial in 3 patients with ALS, conducted under an Investigator-Initiated IND Application. The primary endpoint of the study was to assess the safety and tolerability of COYA 101 in patients with ALS. Secondary endpoints were Treg supportive function and Treg numbers assessed in peripheral blood and preliminary clinical efficacy, as assessed with the Revised ALS Functional Rating Scale (“ALSFRS-R”) and the Appel ALS Scale (“AALS”). This initial Phase 1 study was conducted as a proof-of-concept trial and was not powered to assess statistical significance. Results of this Phase 1 study showed a slowing of disease progression over the course of each cycle of Treg intravenous infusions as measured by standard clinical ALS scales, which were also correlated with increased Treg suppressive function. All patients demonstrated an increase in Treg suppressive function, slowing of functional decline, and stable respiratory function over the course of two Tregs infusion cycles of 6 weeks (first cycle) and 12 weeks duration (second cycle). Treatment with COYA 101 was well tolerated in all patients. Results of this Phase 1 study were published in Neurology: Neuroimmunology & Neuroinflammation.
This included 3 ALS patients exhibiting a different rate of decline (as measured with the ALSFRS-R) prior to initiation of the Treg infusions. During the first infusion cycle (marked with red triangles in Figure 1) Tregs were administered every 2 weeks, and
79
during the second infusion cycle (marked with green squares in Figure 1) a few months later, Tregs were administered every 4 weeks. Over the course of the infusion cycles and during the period between Tregs infusions, the subjects received concomitant low-dose IL-2 subcutaneously 3 times per week.
Regardless of their pre-study rate of decline using the ALSFRS-R scale, all 3 patients stopped or slowed the clinical progression of the disease at each Treg infusion cycle, as shown in the figure below.
COYA 101 Phase 1 Study. ALSFRS-R Scores Over Time by Patient (N=3).
Adapted from Thonhoff et al. (Neurol Neuroimmunol Neuroinflamm 2018;5:e465).
We believe that the ability to maintain a plateau representing no decline in physical function for up to 8 weeks during the first infusion cycle and again for up to 12 weeks during the second infusion cycle with COYA 101 treatment indicates that COYA 101 may have the ability to be a disease-modifying therapy by slowing or stopping ALS disease progression.
Further, treatment did not aggravate or speed up the decline in loss of physical function between or after COYA 101 treatment. The noted decline in physical function between and after treatment was attributed to expected disease progression.
More specifically, in the Phase 1 study the three participants represented a wide range of disease progression rates, the rates of decline were comparable between the lead-in phases and the post-infusion phases for each round of Treg infusions. The average slopes of the lead-in phases were calculated from the baseline clinical evaluation about 1 month before the initial Treg infusion to the clinical evaluation on the day of the initial Treg infusion for each round. The post-infusion phases were calculated from the clinical evaluations performed 2 weeks after the last Treg infusion for each round to the subsequent clinical evaluation. Average slopes provided below (of all 3 patients) are reported as Mean ± Std. Dev. in AALS points/week.
In addition, all three patients underwent prospective evaluation of blood biomarkers of inflammation and oxidative stress, in order to identify whether clinical responses to treatment correlated with changes in these markers. Over the course of the first administration cycle of COYA 101 infusions, low and stable levels of oxidized low-density lipoprotein (ox-LDL) were observed, which correlated with patient clinical stabilization. After the first infusion cycle, over a subsequent six-month washout period during which COYA 101 was not administered, patients exhibited clinical decline and increased levels of ox-LDL. Following the wash-out period, a second cycle of COYA 101 was administered and, as during the first cycle, low levels of ox-LDL were observed correlating with clinical stabilization.
At the end of the study and after cessation of treatment, ox-LDL were elevated consistent with concurrent patient decline.
As observed with ox-LDL, serum levels of acute phase proteins (“APPs”), such as soluble CD14, lipopolysaccharide binding protein (“LBP”), and C-reactive protein (“CRP”), were stabilized during COYA 101 administrations, but rose during the washout period and again after therapy was discontinued.
80
We believe this Phase 1 study provided initial evidence supporting that Treg cell therapy has the potential to suppress peripheral oxidative stress and the accompanying circulating pro-inflammatory APPs, which may serve as peripheral biomarkers for monitoring clinical efficacy of immunomodulating therapies. Results of the biomarker data from this Phase 1 study were published in Annals of Neurology (Beers et al, 2022).
Phase 2a Clinical Data
Following the results of the Phase 1 study, a double-blind placebo-controlled investigator-initiated Phase 2a trial in ALS patients was conducted over 24 weeks. This study was filed under the same academic IND. The double-blind study was followed by an open-label extension study over additional 24 weeks in which all patients received Tregs. The objectives of the Phase 2a study were to evaluate the biological activity, safety and tolerability, and preliminary clinical efficacy of COYA 101 administered intravenously every 4 weeks. Clinical efficacy was measured with a validated tool, the Revised ALS Functional Rating Scale (“ALSFRS-R”), and respiratory function was assessed with the Maximum Inspiratory Pressure (“MIP”) test. The study was conducted at 2 clinical sites in the United States (Massachusetts General Hospital in Boston, Massachusetts, and the Houston Methodist Hospital in Houston, Texas).
The planned enrollment of 12 patients was negatively impacted by the COVID-19 pandemic. A total of 6 ALS patients were included in the double-blind portion of the study (3 patients received COYA 101 and 3 patients received placebo). Patients receiving COYA 101 showed an adequate tolerability profile, comparable to patients receiving placebo. The very limited sample size of the double-blind portion of the study did not allow for a meaningful efficacy analysis.
However, all 6 patients who completed the 24-week double-blind study rolled over into the open-label extension for additional 24 weeks. In order to increase the sample size that was negatively impacted by the COVID-19 pandemic, two additional patients were included in the open-label portion of the study. Assessment of ALSFRS-R scores over the 24-week open-label showed that 75% (6 of 8) of patients stopped or slowed disease progression. Consistent with the observations from the Phase 1 study, evaluation of pro-inflammatory and oxidative stress serum biomarkers over the course of the study suggests that levels of certain biomarkers correlate with disease progression and may also serve to prospectively identify ALS patients that may experience greater therapeutic response with COYA 101 treatment. Results of this Phase 2a study have been published in a peer-reviewed journal.
Disease progression was documented in each participant by the ALSFRS-R over the duration of the 24-week OLE. The timing of the Treg infusions was depicted by the vertical dotted lines with the corresponding Treg dosages. The baseline ALSFRS-R value for the OLE was taken at week 26 for the 6 participants who went through the DB and week 0 for the two participants who entered directly into the OLE. The total change in the ALSFRS-R was calculated after 24 weeks. Six of the eight patients showed intermediate to no progression of the ALSFRS-R (average of -2.7 points). Two of the eight patients showed rapid progression (average of -10.5 points). The following figure illustrates the numerical difference in ALSFRS-R scores over the course of the OLE previously described for the two subgroups of patients. The limited and unbalanced number of patients in each group does not allow for a meaningful statistical comparison. Accordingly, no p-values are available.
ALS Disease Progression in COYA 101 OLE Study (N=8)
From Thonhoff et al, 2022.
81
Treg suppressive function was assessed in each patient at screening, 4 weeks after the second infusion of a 1x dose of Tregs (week 34), 4 weeks after the second infusion of a 2x dose (week 42), and 4 weeks after the second infusion of a 3x dose (week 50). (B) Treg numbers were assessed in each patient at screening, 4 weeks after the second infusion of a 1x dose of Tregs (week 34), 4 weeks after the second infusion of a 2x dose (week 42), and 4 weeks after the second infusion of the 3x dose (week 50). Data were depicted as visit-specific estimates ± standard error and were compared for progression of continuous endpoints using a shared-baseline, linear mixed model. A p value < 0.05 was considered statistically significant, as depicted by the asterisk in the below image.
Treg Suppressive Function and Numbers in COYA 101 OLE Study (N=8)
From Thonhoff et al, 2022.
Treatment with COYA 101 was well tolerated, consistent with the tolerability profile observed in the Phase 1 study. No subject receiving COYA 101 experienced a serious adverse event or discontinued the study.
The study results have been recently published in the peer-reviewed journal Neurology, Neuroimmunology & Neuroinflammation in an article titled “Combined Regulatory T-Lymphocyte and IL-2 Treatment Is Safe, Tolerable, and Biologically Active for 1 Year in Persons With Amyotrophic Lateral Sclerosis.”
To meet the needs of this Phase 2a study, we developed an optimized Tregs manufacturing process to produce at least 2 billion Treg cells from each study participant. Our proprietary Treg manufacturing process had to overcome numerous challenges associated with Treg instability to maintain robust Treg expansion despite long-term cryopreservation, while preserving phenotypic characteristics, stability, sterility and functionality. We believe the process optimization also allows for cryopreservation and thawing while retaining adequate cell numbers and suppressive function over a long period of time, resulting in the supply of sufficient Tregs from a single run to meet the dosing level and monthly infusion scheme over 12 months.
Manufacturing Activity
COYA 101 is an autologous cell therapy that requires individual manufacturing of each patient-specific batch. After undergoing leukapheresis, a laboratory procedure in which white blood cells are separated from a sample of blood, each patient-specific sample is processed for Treg cell isolation, conversion to functional Treg phenotype, expansion to therapeutic dose, and cryopreservation, to be re-thawed for infusion at a given outpatient facility.
COYA 101 manufacturing has undergone extensive process optimization since the Phase 2a academic trial, in order to lock down scaled-up chemistry, manufacturing, and controls (“CMC”) manufacturing capabilities to be able to successfully approach next steps in the development of COYA 101 and potential commercialization, if approved by FDA. We do not believe that manufacturing scalability or the costs thereof represent a material barrier to our ability advance COYA 101 through its prospective clinical studies.
Our management team is comprised of technical experts, with years of experience with FDA and industry, and understand how to navigate the CMC processes and regulatory landscape. This team will lead us through the process of scaling our Treg cell therapy GMP manufacturing processes, including automation steps, closed door systems and analytical capabilities, to optimize production and reduce cost of goods.
82
Development Status
After completion of the two investigator-initiated clinical studies, we had a pre-IND meeting with the FDA. We had a Type B meeting (pre-IND) with CBER/FDA, and the FDA provided written responses on November 5, 2021. The main objective of the pre-IND meeting was to gather all necessary FDA feedback as early as possible to be able to address the FDA’s requirements in the industry-sponsored IND submission. In its responses, the FDA provided clear guidance for the GMP manufacturing of COYA 101 for a well-controlled industry-sponsored study, and also provided insight for design of the clinical protocol for the next clinical study.
Our goal is to advance COYA 101 into a Phase 2b clinical trial. However, we currently believe that we are best served by utilizing our available cash to advance COYA 301, COYA 302, COYA 201 and COYA 206 candidates before beginning a Phase 2b clinical trial of COYA 101. The costs associated with such a Phase 2b trial would significantly impede our ability to advance COYA 301, COYA 302, COYA 201 and COYA 206 before we can reasonably judge which product candidates and which therapeutic modalities may have the most potential. However, based on our pre-clinical results to date, we maintain as a goal advancing COYA 101 into a Phase 2b trial via non-dilutive funding sources. We believe a grant or other non-dilutive funding in the amount of approximately $3 million would be sufficient for us to begin advancing COYA 101 into a Phase 2b trial. In the event we receive such grant funding, or we receive non-dilutive financing from some other source, we would expect to begin the Phase 2b of COYA 101 and would incur Phase 2b clinical trial expenses for Coya 101 not otherwise covered by the non-dilutive financing. We believe that the expenses required to advance Coya 101 net of any grant would be limited and that we can continue to make appropriate progress in advancing COYA 301, COYA 302, COYA 201 and COYA 206, albeit not at the same rate if we did not devote resources to COYA 101. If we are unable to receive such a grant or any other grant we may apply and qualify for in the future, or we are unable to find a suitable strategic partner with whom we can collaborate on terms that are favorable to us, or at all, we may delay or terminate the clinical development of COYA 101.
Manufacturing
Industrial CMC Process Using Bioreactors
We have developed a proprietary and efficient ex vivo manufacturing process that isolates millions of dysfunctional Tregs from a patient and converts and expands these cells into billions of highly functional Tregs that are neuroprotective and immunosuppressive.
This unique approach does not require genetic manipulation and has been automated into bioreactor modules which permit faster vein-to-vein times. The bioreactor produces up to 3 billion functional Treg cells from each patient-specific sample within 10-14 days from start of expansion. We believe the viable cells have potent Treg suppressive function and display a unique and reproducible phenotype. which confers the enhanced functional activity of the expanded and converted cells.
Cryopreservation Technology
We have developed proprietary technology to cryopreserve the expanded and converted functional Treg cells via the CTreg™ modality. We believe this is the first cryopreservation modality in the Treg cell therapy field that has been clinically tested and validated, allowing for long-term monthly infusions while maintaining viability and suppressive function. We believe, in progressive neurodegenerative diseases, one-time infusions of Tregs will not suffice and a cryopreservation step permits long-term repeat dose treatment of patients. This cryopreservation process allows for one manufacturing run to produce enough cells for up to 12 months of treatment.
Expanded Tregs Unique Phenotype
We have also shown that the expanded Treg cells are characterized by a unique phenotype, compared to the baseline dysfunctional Tregs, which confers the enhanced functional Treg activity. Moreover, the novel phenotype is maintained upon cryopreservation and re-thawing. The phenotype has been well characterized by both proteomics and flow cytometry.
iscEXO™
We have also developed the technology to isolate and expand highly neuroprotective and immunomodulatory Treg-derived exosomes through our proprietary iscEXO™ (immunosuppressive cell exosome) modality.
We believe our proprietary Treg cell manufacturing process generates exosome-rich batches that contain large amounts of Treg exosomes. Optimization of a cutting-edge, proprietary exosome isolation technology using tangential flow filtration provides for the scaled isolation, concentration, and buffer exchange of liters of exosome-rich product in a short period of time.
83
Our efficient GMP manufacturing process has demonstrated batch-to-batch reproducibility and comparable critical quality attributes, and in vitro and in vivo testing have shown Treg-conserved markers and function in the Treg-derived exosome product, including suppression and inhibition of proliferation of activated pro-inflammatory cells.
Following manufacturing and packaging, Treg exosomes can maintain their structural integrity during prolonged periods of storage under frozen conditions. Importantly, the suppressive function of the Treg exosomes can be maintained over the long-term stability testing under frozen conditions and after multiple freeze-thaw cycles.
Key Milestones
We will continue to conduct research and development activities for our various product candidates and indications over the course of 2022-2024. Our anticipated developmental milestones are provided below.
The dates reflected in the foregoing are estimates only, and there can be no assurances that the events included will be completed on the anticipated timeline presented, or at all. Further, there can be no assurance that we will be successful in the development of any of our current product candidates or any other product candidate we may develop in the future, or that any of our current product candidates, or any other product candidate we may develop in the future, will receive FDA approval for any indication.
Competition
We believe the ability of our product candidates to enhance Treg function ex vivo (Treg cell therapy and Treg exosomes) and in vivo (biologics), potentially resulting in amelioration of the chronic and progressive inflammatory environment that underlies certain serious diseases, represents a meaningful competitive advantage and may benefit us in our goal of successfully developing novel and highly effective treatments for neurodegenerative, autoimmune, and metabolic diseases. We believe our Treg exosomes are significantly more potent in suppressing inflammation than mesenchymal cell derived exosomes. Moreover, we are developing technology in conjunction with Carnegie Mellon University to target Treg exosomes to proteins of interest while loading with cargo of interest, requiring no genetic manipulation, while CAR Treg approaches require genetic manipulation. Moreover, Treg exosomes are end stage differentiated and cannot be converted in-vivo to a dysfunctional state, unlike cells. Our Treg cell therapy is a polyclonal product that requires no genetic manipulation. Moreover, we have developed bioreactors to shorten the time to obtain the final product (within 10-12 days). Finally, we have developed the ability to cryopreserve Treg cells and rethaw while maintaining full functional potency, allowing for chronic dosing from one patient manufacturing run. We believe our biologic is unique in that it enhances Treg function in-vivo without the need for ex-vivo manipulation, and the biologic is a simple to administer injection in a prefilled syringe that is intended for in home administration.
However, the pharmaceutical industry is intensely competitive and subject to rapid and significant technological change. We will continue to face competition from various global pharmaceutical, biotechnology, specialty pharmaceutical and generic drug companies that engage in drug development activities.
84
Many of our competitors have similar products that focus on the same diseases and conditions that our current and future pipeline product candidates address and may address in the future. Many of our competitors have greater financial flexibility to deploy capital in certain areas as well as more commercial and other resources, marketing and manufacturing organizations, and larger research and development staff. As a result, these companies may be able to pursue strategies or approvals that we are not able to finance or otherwise pursue and may receive FDA, or other applicable regulatory approvals more efficiently or rapidly than us. Also, our competitors may have more experience in marketing and selling their products post-approval and gaining market acceptance more quickly.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Our product candidates could become less competitive if our competitors are able to license or acquire technology that is more effective or less costly and thereby offer an improved or a cheaper alternative to our product candidates.
Competitor companies developing Biologic approaches to enhancing Tregs, leveraging IL-2 formulations, include: Amgen (AMGN) (IL-2 mutein for GVHD and autoimmune diseases), Nektar (NKTR) (Pegylated IL-2 for autoimmune diseases), Merck (MRK) (IL-2 mutein for autoimmune diseases), Xencor (XNCR) (IL-2 Fc Fusion Protein for autoimmune diseases), Selecta Biosciences (SELB) (recombinant IL-2 + ImmTOR for autoimmune diseases), Cue Bipharma (CUE) (IL-2 bispecific for GVHD and autoimmune diseases), and Moderna (MRNA) (LNP encapsulated mRNA based therapeutic encoding IL-2 for autoimmune diseases).
Competitor companies developing Treg based cellular therapeutics include: Abata Therapeutics (CAR Treg for autoimmune diseases), Sonoma Therapeutics (CAR Treg for autoimmune diseases), Sangamo (SGMO) (CAR Treg for Renal Disease, IBD), TrexBio (Treg cell therapy for Immunology/Inflammation), Mozart Therapeutics (CD8 Treg cell modulators for Celiac Disease/IBD), Gentibio (Treg cell therapy generated from T-effector cells for T1 Diabetes), Kyverna (Autologous and Allogeneic Tregs for autoimmune diseases), Cellenkos (Allogeneic umbilical cord blood Tregs for multiple conditions), AZ Therapies (Allogeneic CAR Tregs for CNS Diseases), and Quell Therapeutics (Autologous CAR Tregs for liver transplantation, T1 Diabetes and ALS).
To our knowledge, there exists no other Treg-derived exosome competitor. However, there exists other cell derived exosome competitors including: Evox Therapeutics (Mesenchymal Derived Exosomes), Capricor Therapeutics (Cardiosphere Derived Exosomes), and Exopharm (Platelet Derived Exosomes), and Rion (Platelet Derived Exosomes).
We expect any product candidates that we develop and commercialize will compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payors. We also expect to face competition in our efforts to identify appropriate collaborators or partners to help commercialize our product candidate portfolio in our target commercial markets.
Intellectual Property and Protection
As of October 1, 2022, our patent estate derived from our relationship with The Houston Methodist Hospital include one patent family, comprised of two pending U.S. provisional patent applications, one U.S. non-provisional patent application, five foreign patent applications, and four pending Patent Cooperation Treaty (“PCT”) applications, each co-owned with or in-licensed from The Houston Methodist Hospital. These patent applications are directed to our Treg and exosome compositions and methods of use, methods of Treg and exosome manufacture, and methods of in vivo Treg expansion via combination therapies, among other things. If any patents issue from or claim priority to these patent applications, the patents are expected to expire in 2040 and 2042, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. All of our Houston Methodist Hospital patents have composition and method claims, with the exception of a biomarker patent, which has only method claims.
In addition, our patent estate derived from our relationship with ARScience Biotherapeutics, Inc. (described below) includes one published patent application and one provision patent application. The patents are expected to expire in 2041 and 2043, respectively, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The ARScience Biotherapeutics, Inc. patents have composition, method, and utility claims.
Finally, our patent estate derived from our relationship with Carnegie Mellon includes one pending patent application. The patent, if granted, would be expected to expire in 2043, without giving effect to any potential patent term extensions or patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Carnegie Mellon patent has method claims.
On October 6, 2020, we entered into a Patent and Know How License Agreement, as amended from time to time (the “Methodist License Agreement”), with The Methodist Hospital (“Methodist”), pursuant to which Methodist granted us an exclusive license, with
85
the right to sublicense, under certain patent rights and know-how related to regulatory T-cell (“Treg”) technology to develop and commercialize products and/or services for the diagnosis, prevention or treatment of ALS, Alzheimer’s disease, or other human diseases or conditions (such products, “Licensed Products” and such services, “Licensed Services”). The Licensed Products comprise all of our current product candidates. Methodist also granted us an exclusive right of reference with respect to the existing IND and all related data and documentation generated in connection with the Existing IND. The last to expire licensed patent under the Methodist License Agreement is scheduled to expire on September 16, 2042.
In consideration of the rights and licenses granted to us by Methodist under the Methodist License Agreement, we agreed to (i) reimburse Methodist for costs incurred in connection with filing and prosecution of existing patent applications (as of , 2022, we have reimbursed Methodist for $233,256 in patent related expenses); (ii) pay Methodist an annual $5,000 license maintenance fee; and (iii) we issued 750,000 shares of our common stock to Methodist and the equivalent amount of shares to the inventors of the licensed patent rights in proportion to a ratio provided by Methodist. We are obligated to use commercially reasonable efforts to (a) continue to develop, seek to obtain and maintain regulatory approval, and if regulatory approval is achieved, to commercialize at least one Licensed Product or Licensed Service; and (b) achieve certain development milestones as set forth in the Methodist License Agreement. The Methodist License Agreement also contains termination provisions typical of agreements of this type including the ability of Methodist to terminate the license in the event that we or a subsequent sublicensee is not “Actively Attempting to Develop or Commercialize” (as defined in the Methodist License Agreement) for a continuous period of 6 months anytime beginning October 2, 2025.
Pursuant to the Methodist License Agreement, we agreed to make contingent milestone payments to Methodist on a Licensed Product-by-Licensed Product or Licensed Service-by-Licensed Service basis upon the achievement of certain development, approval and sales milestones (i) related to the treatment of ALS totaling up to $325,000 in the aggregate, and (ii) related to the treatment of each other indication (that is not ALS) totaling between $212,500 and up to $425,000 in the aggregate per indication. As of , 2022 no milestone payments have been accrued or paid in connection with the Methodist License Agreement.
Pursuant to the Methodist License Agreement, we are also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, royalties (subject to customary reductions) up to 10% of annual worldwide net sales of such licensed product during a defined royalty term. The applicable royalty percentage increases as Licensed Products are used to treat from only one to more than three indications and if a given Licensed Product utilizes only T-reg cell therapy or is a combination of both T-reg cell therapy and exosomes. Therefore, the lowest tier is paid when there is only a single indication being addressed with a single product. The lowest tier is paid on combination products where there are three or more indications being served. We are also required to pay a low single digit percentage for certain licensed services. We are required to pay mid-teens royalties on sublicense revenue. Commencing on January 1, 2025, the minimum amount which will be owed by us once commercialization occurs is $50,000 annually.
Our obligation to pay royalties (a) starts with the first commercial sale of the Licensed Product or provision of the Licensed Service after obtaining regulatory approval for the subject Licensed Product or Licensed Service and (b) ends either (1) immediately, if no valid claim within the licensed patent rights covers the subject Licensed Product or Licensed Service in the applicable country exists at such time, or (2) if at least one valid claim exists at such time, then when no remaining valid claim within the licensed patent rights covers the subject Licensed Product or Licensed Service in the applicable country. As of , 2022 no royalty payments have been accrued or paid in connection with the Methodist License Agreement.
ARScience Biotherapeutics, Inc. License Agreement
On August 23, 2022 (the “Execution Date”), we entered into a License Agreement (the “ARS License Agreement”) with ARScience Biotherapeutics, Inc. (“ARS”) pursuant to which ARS granted us an option to, if we choose to exercise such option, an exclusive, royalty-bearing license for two patents regarding certain formulations of hrIL-2 (the product that serves as the basis for COYA 301), with the right to grant sublicenses through multiple tiers under these patents (the “ARS Option”). In consideration for the ARS Option, we paid ARS a one-time, non-refundable, non-creditable option fee of $100,000.
The ARS Option may be exercised by written notice to ARS (an “Option Exercise Notice”) at any time beginning on the Execution Date and continuing for a period 90 days following the Execution Date (“Initial Option Exercise Period”). If ARS fails to provide, within five days of written request by us, any materials or information related to the agreement requested by us to complete our diligence during the Initial Option Exercise Period, then we may extend the Initial Option Exercise Period by written notice to ARS by one day for each day ARS fails to provide such materials or information within such 5-day period (the “Extended Option Exercise Period”). As of the date of delivery of an Option Exercise Notice (such date of delivery, the “Effective Date”), ARS will automatically be deemed to have granted to us the licenses and all provisions of the ARS License Agreement and the ARS License Agreement will be deemed to be effective as of the Effective Date. Within 10-days of the Effective Date, we must pay ARS a mid-six-figure up-front fee.
In addition, we may also owe tiered payments to ARS based on our achievement of certain developmental milestones. Under the ARS License Agreement, we will pay an aggregate of $13.25 million in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. We will then pay an aggregate of $11.6 million in developmental
86
milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement) we will pay an aggregate of $11.75 million in developmental milestone payments. We will then pay an aggregate of $5.85 million in developmental milestone payments for each Mono Product in each subsequent new indication, we will owe an aggregate of $5.85 million if all developmental milestones are achieved for each new indication. We will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event we sublicense our rights under the ARS License Agreement, we will owe royalties on sublicense income within the range of 10% to 20%. To date, the $100,000 option fee is the only payment made to ARS under ARS License Agreement.
The ARS License Agreement contains customary termination provisions for cause, insolvency, convenience and cessation of development or commercialization. Termination for cause permits either party to terminate the ARS License Agreement upon written notice of a material breach that remains uncured after 90 days. If either party files for protection under bankruptcy or insolvency laws among other things, the other party may terminate the ARS License Agreement upon written notice. We are entitled to terminate the ARS License Agreement at our sole discretion at any time with 120 days’ prior written notice. Lastly, in the event that we do not conduct material development or commercialization activities (as set forth in the agreement) for any products over a continuous period of 24 months, then ARS may terminate the ARS License Agreement upon 60 days’ written notice to us. If we do not exercise the ARS Option to license products under the ARS License Agreement during the Initial Option Exercise Period, or any Extended Option Exercise Period, as applicable, then the agreement will automatically terminate with no action taken by either of the parties.
This ARS License Agreement will continue, on a product-by-product and country-by-country basis, until (i) with respect to products we commercialize, the expiration of the royalty term applicable to such product and such country and (ii) with respect to products commercialized by a sublicensee, our receipt of all payments that may become due under the applicable sublicense, and will expire in its entirety upon the expiration of the last royalty term and payment under any such sublicense, as applicable.
The ARS License Agreement also provides that within 90 days of the Effective Date, we and ARS will enter into a supply agreement whereby ARS will provide us with GMP supply of those products described in the ARS License Agreement. We expect that this exclusive supply agreement will permit us to acquire GMP quality manufactured products at the lesser of (a) cost (to be defined in the definitive supply agreement) plus 10% and (b) a fixed per unit price for the duration of the agreement.
Carnegie Mellon Option Agreement
On June 24, 2022, we entered into a Material Transfer Agreement and Option (the “CMU Option Agreement”) with Carnegie Mellon University (“CMU”), pursuant to which CMU granted us a nonexclusive license to use certain of CMU’s technology and materials relating to exosome modification (the “Materials”) and practice under certain CMU patent rights related to such Materials (the “Patent”), in each case for our research and evaluation purposes. We agreed to pay CMU a five-digit fee in consideration of the preparation and distribution costs associated with making the Materials. Pursuant to the CMU Option Agreement, CMU also granted us an option (the “CMU Option”) to negotiate an exclusive license to use and commercialize products and services based on the Materials and to practice under the Patent for exosome and cellular therapeutic applications. In consideration of the CMU Option, we agreed to pay CMU (i) a five-digit fee, and (ii) any out of pocket fees or expenses incurred by CMU for the filing, prosecution or maintenance of the Patent or any U.S. patents comprising the Materials during the nine-month CMU Option period. As of October 1, 2022, we have not exercised the CMU Option with respect to the Materials and Patent.
The CMU Option Agreement will continue in effect until the earliest of (i) nine months from the date of execution, (ii) our permanent cessation of use of CMU’s technology and materials, or (iii) 30 days after we have received from CMU written notice of our breach of the Option Agreement, if we fail to cure such breach within 30 days of such notice.
Pursuant to a Biologics Material Transfer Agreement (the “CMU Materials Agreement”), entered into simultaneously with the CMU Option Agreement, CMU has the right to develop and modify the Materials for non-commercial purposes. If CMU desires to develop the Materials for Commercial Purposes (as defined in the CMU Materials Agreement), CMU must negotiate a commercial license with us, but we have no obligation to grant a commercial license to our ownership in the Materials to CMU. CMU is free to file patent applications claiming inventions made by CMU through the use of the Materials but must notify us upon the filing of such patent(s). Further, no patent application can be filed by CMU that would inhibit our ability to use the Materials. If any patent is filed or granted, CMU has agreed to assign to us any and all patent rights that include rights to make, use or sell the Materials. The CMU Materials Agreement will terminate upon the earliest of: (i) when the Materials become generally available from third parties, (ii) on completion of CMU’s activities related to the Purpose (as defined in the Option Agreement), or (iii) by us on 30 days’ notice.
87
Patent Rights
COYA 101 Intellectual Property Portfolio
IP Title: Regulatory T Cell Compositions and Methods for Treating Neurodegenerative Diseases
Anticipated Expiry: December 2040
Claims: Composition and Method
Type of Patent: Licensed
Entered National Phase: June 2022
Jurisdictions: Pending National Phase: Canada, Australia, Mexico, Japan, Hong Kong, Europe, United States
IP Title: Methods for Producing Regulatory T Cell Populations, Treg Compositions, and Methods for Treatment
Anticipated Expiry: June 2042
Claims: Composition and Method
Type of Patent: Licensed
US Provisional Pending
Pending PCT: National Phase filing deadline: December 2023
Jurisdiction: Pending National Phase: United States
IP Title: Serum Immune Based Biomarkers for use in ALS Therapy
Anticipated Expiry: September 2042
Claims: Composition and Method
Type of Patent: Licensed
Pending PCT: National Phase deadline: To Be Determined
Jurisdiction: Pending National Phase: United States
COYA 201 Intellectual Property Portfolio
IP Title: Regulatory T Cell Extracellular Vesicle Compositions and Methods
Anticipated Expiry: February 2042
Claims: Composition and Method
Type of Patent: Licensed
Pending PCT: National Phase filing deadline: August 2023
Jurisdiction: United States
IP Title: Methods for Producing Regulatory T Cell Populations, Treg Compositions, and Methods for Treatment.
Anticipated Expiry: June 2042
Claims: Composition and Method
Type of Patent: Licensed
88
US Provisional Pending
Pending PCT: National Phase filing deadline: December 2023
Jurisdiction: United States
COYA 206 Intellectual Property Portfolio
IP Title: Extracellular Vesicle Functionalization Using Oligonucleotide Tethers
Anticipated Expiry: February 2040
Claims: Method
Type of Patent: Licensed
Patent awaiting examination
Jurisdictions Filed: United States
COYA 301 Intellectual Property Portfolio
IP Title: Therapeutically Active Aldesleukin Highly Stable in Liquid Pharmaceutical Compositions
Anticipated Expiry: February 2043
Claims: Composition and Method
Type of Patent: Licensed
Patent awaiting examination
Jurisdictions Filed: United States, Canada, Korea, Japan, European Union, China, Singapore, Israel
IP Title: Low Dose Interleukin-2 Formulations
Anticipated Expiry: February 2043-2045
Claims: Composition and Method
Type of Patent: Licensed
Jurisdiction: Provisional Pending: United States
Government Regulation
The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs. We, along with our vendors, contract research organizations and contract manufacturers, will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates. The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.
In the U.S., the FDA regulates drug products under the Federal Food, Drug, and Cosmetic Act, or FD&C Act, as amended, its implementing regulations and other laws. If we fail to comply with applicable FDA or other requirements at any time with respect to product development, clinical testing, approval or any other legal requirements relating to product manufacture, processing, handling, storage, quality control, safety, marketing, advertising, promotion, packaging, labeling, export, import, distribution, or sale, we may become subject to administrative or judicial sanctions or other legal consequences. These sanctions or consequences could include, among other things, the FDA’s refusal to approve pending applications, issuance of clinical holds for ongoing studies, withdrawal of approvals, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.
89
The process required by the FDA before our product candidates are approved as drugs for therapeutic indications and may be marketed in the U.S. generally involves the following:
|
• |
completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice, or GLP, requirements; |
|
• |
submission to the FDA of an IND application, which must become effective before clinical trials may begin; |
|
• |
approval by an institutional review board, or IRB, or independent ethics committee at each clinical trial site before each trial may be initiated; |
|
• |
performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication; |
|
• |
submission to the FDA of an NDA or BLA; |
|
• |
a determination by the FDA within 60 days of its receipt of an NDA or BLA, to accept the filing for review; |
|
• |
potential FDA audit of the clinical trial sites that generated the data in support of the NDA or BLA; |
|
• |
payment of user fees for FDA review of the NDA or BLA; and |
|
• |
FDA review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the U.S. |
Preclinical Studies and Clinical Trials for Drugs
Before testing any drug in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GLP requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data must be submitted to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin. Some long-term preclinical testing may continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research patients will be exposed to unreasonable health risks, and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Submission of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND.
The clinical stage of development involves the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirement that all research patients provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating effectiveness. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trial are minimized and are reasonable related to the anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative, and must monitor the clinical trial until completed. The FDA, the IRB or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trials to public registries. Information about clinical trials, including clinical trials results, must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website.
A sponsor who wishes to conduct a clinical trial outside of the U.S. may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor can submit data from the clinical trial to the FDA in support of a BLA. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted under an IND if the trial was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.
90
Clinical trials to evaluate therapeutic indications to support BLAs for marketing approval are typically conducted in three sequential phases, which may overlap.
|
• |
Phase I—Phase I clinical trials involve initial introduction of the investigational product into healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, excretion the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness. |
|
• |
Phase II—Phase II clinical trials typically involve administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. |
Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of a BLA.
Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA. Written IND safety reports must be submitted to the FDA and the investigators fifteen days after the trial sponsor determines the information qualifies for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for human volunteers and any clinically important increase in the severity or rate of a serious suspected adverse reaction over that listed in the investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing the drug product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product candidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity of the final drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Marketing Approval for Drugs
Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. A BLA must contain proof of the drug’s safety and efficacy. The marketing application may include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA. FDA approval of a BLA must be obtained before a drug may be marketed in the U.S.
The FDA reviews all submitted NDAs before it accepts them for filing and may request additional information rather than accepting the NDA for filing. The FDA must make a decision on accepting a BLA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA. The FDA reviews a BLA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity. Under the goals and polices agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of a new molecular entity NDA and respond to the applicant, and six months from the filing date of a new molecular entity NDA for priority review. The FDA does not always meet its PDUFA goal dates for standard or priority NDAs, and the review process is often extended by FDA requests for additional information or clarification.
Further, under PDUFA, as amended, each NDA must be accompanied by a user fee. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
91
The FDA also may require submission of a Risk Evaluation and Mitigation Strategy, or REMS, program to ensure that the benefits of the drug outweigh its risks. The REMS program could include medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk-minimization tools.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, which reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving a BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.
After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or preclinical testing in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Even if the FDA approves a product, depending on the specific risk(s) to be addressed it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
Orphan Drug Designation and Exclusivity
Under the Orphan Drug Act of 1983, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the U.S., or if it affects more than 200,000 individuals in the U.S., there is no reasonable expectation that the cost of developing and making the product available in the U.S. for the disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting a BLA. Orphan designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, though companies developing orphan products are eligible for certain incentives, including tax credits for qualified clinical testing and waiver of application fees.
If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to a seven-year period of marketing exclusivity during which the FDA may not approve any other applications to market the same therapeutic agent for the same indication, except in limited circumstances, such as a subsequent product’s showing of clinical superiority over the product with orphan exclusivity or where the original applicant cannot produce sufficient quantities of product. Competitors, however, may receive approval of different therapeutic agents for the indication for which the orphan product has exclusivity or obtain approval for the same therapeutic agent for a different indication than that for which the orphan product has exclusivity. Orphan product exclusivity could block the approval of one of our products for seven years if a competitor obtains approval for the same therapeutic agent for the same indication before we do, unless we are able to demonstrate that our product is clinically superior. If an orphan designated product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan exclusivity. Further, orphan drug exclusive marketing rights in the U.S. may be lost if the FDA later determines that the request for designation was materially defective or the manufacturer of the approved product is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
92
Expedited Development and Review Programs for Drugs
The FDA maintains several programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening diseases or conditions. These programs include Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval, and the purpose of these programs is to either expedite the development or review of important new drugs to get them to patients earlier than under standard FDA development and review procedures.
A new drug is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such disease or condition. Fast Track designation provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed, meaning that the agency may review portions of the marketing application before the sponsor submits the complete application, as well as Priority Review, discussed below.
In addition, a new drug may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation provides all the features of Fast Track designation in addition to intensive guidance on an efficient drug development program beginning as early as Phase I, and FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.
Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for additional FDA programs intended to expedite the review and approval process, including Priority Review designation and Accelerated Approval. A product is eligible for Priority Review if it has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition. Under Priority Review, the FDA must review an application in six months compared to ten months for a standard review.
Additionally, products are eligible for Accelerated Approval if they can be shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality which is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
Accelerated Approval is usually contingent on a sponsor’s agreement to conduct additional post-approval studies to verify and describe the product’s clinical benefit. The FDA may withdraw approval of a drug or indication approved under Accelerated Approval if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, unless otherwise informed by the FDA, the FDA currently requires, as a condition for Accelerated Approval, that all advertising and promotional materials that are intended for dissemination or publication within 120 days following marketing approval be submitted to the agency for review during the pre-approval review period, and that after 120 days following marketing approval, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval do not change the scientific or medical standards for approval or the quality of evidence necessary to support approval but may expedite the development or review process.
U.S. Post-Approval Requirements for Drugs
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such uses. 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 liability, including investigation by federal and state authorities. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use or first publication. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or BLA supplement, which may require the development of additional data or preclinical studies and clinical trials.
The FDA may impose a number of post-approval requirements as a condition of approval of an BLA. For example, the FDA may require post-market testing, including Phase IV clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.
93
In addition, drug manufacturers and their subcontractors involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our contract manufacturers. Failure to comply with statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual prescription drug product program user fee.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things:
|
• |
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; |
|
• |
safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; |
|
• |
fines, warning letters or holds on post-approval clinical trials; |
|
• |
refusal of the FDA to approve applications or supplements to approved applications, or withdrawal of product approvals; |
|
• |
product seizure or detention, or refusal to permit the import or export of products; |
|
• |
consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; or mandated modification of promotional materials and labeling and issuance of corrective information. |
Other Regulatory Matters
Manufacturing, sales, promotion and other activities of product candidates following product approval, where applicable, or commercialization are also subject to regulation by numerous regulatory authorities in the U.S. in addition to the FDA, which may include the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agencies.
Healthcare Reform
In March 2010, Congress passed the Affordable Care Act, or the ACA, a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of health spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry, and impose additional policy reforms. The ACA, for example, contains provisions that subject products to potential competition by lower-cost products and may reduce the profitability of products through increased rebates for drugs reimbursed by Medicaid programs; address a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increase the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; establish annual fees and taxes on manufacturers of certain branded prescription drugs; and create a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
Since its enactment, there have been judicial, administrative, executive and Congressional legislative challenges to certain aspects of the ACA. The Supreme Court upheld the ACA in the main challenge to the constitutionality of the law in 2012. Specifically, in June 2021, the Supreme Court held that the individual mandate and corresponding penalty was constitutional because it would be considered a tax by the federal government. The Supreme Court also upheld federal subsidies for purchasers of insurance through federally facilitated exchanges in a decision released in June 2015.
Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed and enacted bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the U.S. government, state legislatures, and foreign governments have shown significant interest in implementing cost containment programs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid healthcare costs. For example, the U.S. government has passed legislation requiring pharmaceutical manufacturers to provide
94
rebates and discounts to certain entities and governmental payors to participate in federal healthcare programs. Congress has continually explored legislation intended to address the cost of prescription drugs. Notably, the major committees of jurisdiction in the Senate (Finance Committee, Health, Education, Labor and Pensions Committee, and Judiciary Committee), regularly evaluate and hold hearings on legislation intended to address various elements of the prescription drug supply chain and prescription drug pricing. Proposals include a significant overhaul of the Medicare Part D benefit design efforts to cap the increase in drug prices, create drug price transparency, curb anti-competitive behavior, and efforts to allow the Secretary of the Department of Health and Human Services to negotiate drug prices with prescription drug manufacturers. While we cannot predict what proposals may ultimately become law, the elements under consideration could significantly change the landscape in which the pharmaceutical market operates. The former Trump administration took several regulatory steps and proposed numerous prescription drug cost control measures. Similarly, the Biden administration has identified promoting competition and lowering drug prices as a priority.
These initiatives recently culminated in the enactment of the Inflation Reduction Act (“IRA”), in August 2022, which, among other things, will allow the U.S. Department of Health and Human Services (“HHS”) to negotiate the selling price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, although this will only apply to high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics). The negotiated prices, which will first become effective in 2026, will be capped at a statutory ceiling price representing a significant discount from average prices to wholesalers and direct purchasers. The law will also, beginning in October 2023, penalize drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum, and 20% once the out-of-pocket maximum has been reached. Although these discounts represent a lower percentage of enrollees’ costs than the current discounts required below the out-of-pocket maximum (that is, in the “donut hole” phase of Part D coverage), the new manufacturer contribution required above the out-of-pocket maximum could be considerable for very high-cost patients and the total contributions by manufacturers to a Part D enrollee’s drug expenses may exceed those currently provided. Further, the law incentivizes the manufacture of biosimilars and vaccine uptake, and limits the Part B or Part D insulin copayment to $35 per month. The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. These provisions will take effect progressively starting in 2023, although they may be subject to legal challenges.
At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including restrictions or prohibitions on certain marketing practices, reporting of specified categories of remuneration provided to health care practitioners, and reporting and justification of price increases greater than a specified level. In some cases, states have designed programs to encourage importation from other countries and bulk purchasing, though the federal government has not yet approved any such plans. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for pharmaceuticals and other healthcare products and services, which could result in reduced demand for our product candidates.
Individual states in the U.S. have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Additionally, we may face competition in the United States for our development candidates and investigational medicines, if approved, from therapies sourced from foreign countries that have placed price controls on pharmaceutical products. In the United States, the Medicare Modernization Act, or MMA, contains provisions that call for the promulgation of regulations that expand pharmacists’ and wholesalers’ ability to import cheaper versions of an approved drug and competing products from Canada, where there are government price controls. Further, the MMA provides that these changes to U.S. importation laws will not take effect, unless and until the Secretary of the HHS certifies that the changes will pose no additional risk to the public’s health and safety and will result in a significant reduction in the cost of products to consumers. On September 23, 2020, the Secretary of the HHS made such certification to Congress, and on October 1, 2020, the FDA published a final rule that allows for the importation of certain prescription drugs from Canada. The final rule became effective November 30, 2020. Under the final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the FDA for review and authorization. On September 25, 2020, CMS stated drugs imported by States under this rule will not be eligible for federal rebates under Section 1927 of the Social Security Act and manufacturers would not report these drugs for “best price” or Average Manufacturer Price purposes. Since these drugs are not considered covered outpatient drugs, CMS further stated it will not publish a National Average Drug Acquisition Cost for these drugs. Separately, the FDA also issued a final guidance document outlining a pathway for manufacturers to obtain an additional National Drug Code, or NDC, for an FDA-approved drug that was originally intended to be marketed in a foreign country and that was authorized for sale in that foreign country. The market implications of the final rule and guidance are unknown at this time. Proponents of drug reimportation may attempt to pass legislation that would directly allow reimportation under certain circumstances. Legislation or regulations allowing the reimportation of drugs, if enacted, could decrease the price we receive for any products that we may develop and adversely affect our future revenues and prospects for profitability. Individual states in the U.S. have also been increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
95
From time to time, legislation is drafted, introduced, and passed in Congress that could significantly change the statutory provisions governing the sale, marketing, coverage, and reimbursement of products regulated by CMS or other government agencies. In addition to new legislation, CMS regulations and policies are often revised or interpreted by the agency in ways significantly affecting our business and our products.
Other Healthcare Laws and Regulations
If we obtain regulatory approval of our products, we may be subject to various federal and state laws targeting fraud and abuse in the healthcare industry. These laws may impact, among other things, our proposed sales and marketing strategies. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. These laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security, and physician sunshine laws and regulations.
The federal Anti-Kickback Statute prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or paying remuneration (a term interpreted broadly to include anything of value, including, for example, gifts, discounts and credits), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, an item or reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. Violations of the federal Anti-Kickback Statute can result in significant civil monetary and criminal penalties, per kickback plus three times the amount of remuneration and a prison term per violation. Further, violation of the federal Anti-Kickback Statute can also form the basis for False Claims Act liability (discussed below). 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. In addition, many states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only government programs.
Additionally, the civil False Claims Act (the “FCA”) prohibits knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S. government. Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result in very significant monetary penalties, for each false claim and treble the amount of the government’s damages. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The federal government continues to use the FCA, and the accompanying threat of significant liability, in its investigations and prosecutions of pharmaceutical and biotechnology companies throughout the U.S. Such investigations and prosecutions frequently involve, for example, the alleged promotion of products for unapproved uses and other sales and marketing practices. The government has obtained multi-million and multi-billion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with the FCA and other applicable fraud and abuse laws.
We may be subject to the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services. Federal government price reporting laws require manufacturers to calculate and report complex pricing metrics to government programs.
The U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, includes a fraud and abuse provision referred to as the HIPAA All-Payor Fraud Law, which imposes criminal and civil liability for executing 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 statute or specific intent to violate it in order to have committed a violation.
We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, including the final omnibus rule published on January 25, 2013, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. Many
96
states also have laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
We may also be subject to federal transparency laws, including the federal Physician Payment Sunshine Act, which was part of the ACA and requires manufacturers of certain drugs and biologics, among others, to track and disclose payments and other transfers of value they make to U.S. physicians and teaching hospitals, as well as physician ownership and investment interests in the manufacturer. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners. This information is subsequently made publicly available in a searchable format on a CMS website. Failure to disclose required information may result in civil monetary penalties for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission. Certain states also mandate implementation of compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and/or other healthcare providers.
As noted above, analogous state laws and regulations, such as, state anti-kickback and false claims laws may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures. There are also state and local laws that require the registration of pharmaceutical sales representatives.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations 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 these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, imprisonment, exclusion of drugs from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource consuming and can divert a company’s attention from the business.
Government Regulation of Drugs Outside of the United States
To market any product outside of the U.S., we would need to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization or identification of an alternate regulatory pathway, manufacturing, commercial sales and distribution of our products. For instance, in the United Kingdom and the European Economic Area, or the EEA (comprised of the 27 EU Member States plus Iceland, Liechtenstein and Norway), medicinal products must be authorized for marketing by using either the centralized authorization procedure or national authorization procedures.
|
• |
Centralized procedure—If pursuing marketing authorization of a product candidate for a therapeutic indication under the centralized procedure, following the opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use, or, CHMP, the European Commission issues a single marketing authorization valid across the EEA. The centralized procedure is compulsory for human medicines derived from biotechnology processes or advanced therapy medicinal products (such as gene therapy, somatic cell therapy and tissue engineered products), products that contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune diseases and other immune dysfunctions, viral diseases, and officially designated orphan medicines. For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketing authorization to the European Medicines Agency, or EMA, as long as the medicine concerned contains a new active substance not yet authorized in the EEA, is a significant therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health in the EEA. Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP. Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major |
97
|
public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is 150 days, excluding clock stops. |
|
• |
National authorization procedures—There are also two other possible routes to authorize products for therapeutic indications in several countries, which are available for products that fall outside the scope of the centralized procedure: |
|
• |
Decentralized procedure—Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one EU country of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the centralized procedure. |
|
• |
Mutual recognition procedure—In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance with the national procedures of that country. |
|
• |
Following authorization through either procedure, additional marketing authorizations can be sought from other EU countries in a procedure whereby the countries concerned recognize the validity of the original, national marketing authorization. |
In the EEA, new products for therapeutic indications that are authorized for marketing (i.e., reference products) qualify for eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic or biosimilar applicants from relying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing authorization in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until ten years have elapsed from the initial authorization of the reference product in the EU. The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The criteria for designating an “orphan medicinal product” in the EEA are similar in principle to those in the U.S. In the EEA a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication. During this ten-year orphan market exclusivity period, no marketing authorization application shall be accepted, and no marketing authorization shall be granted for a similar medicinal product for the same indication. An orphan product can also obtain an additional two years of market exclusivity in the EU for pediatric studies. The ten-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if (i) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior; (ii) the applicant consents to a second orphan medicinal product application; or (iii) the applicant cannot supply enough orphan medicinal product.
Similar to the United States, the various phases of non-clinical and clinical research in the European Union are subject to significant regulatory controls.
The Clinical Trials Directive 2001/20/EC, the Directive 2005/28/EC on GCP and the related national implementing provisions of the individual EU Member States govern the system for the approval of clinical trials in the European Union. Under this system, an applicant must obtain prior approval from the competent national authority of the EU Member State in which the clinical trial is to be conducted. Furthermore, the applicant may only start a clinical trial at a specific trial site after the competent ethics committee has issued a favorable opinion. The clinical trial application must be accompanied by, among other documents, an investigational medicinal product dossier (the “Common Technical Document”) with supporting information prescribed by Directive 2001/20/EC, Directive 2005/28/EC, where relevant the implementing national provisions of the individual EU Member States and further detailed in applicable guidance documents.
In April 2014, the new Clinical Trials Regulation, (EU) No 536/2014 (the “Clinical Trials Regulation”) was adopted. It is expected that the new Clinical Trials Regulation will apply following confirmation of full functionality of the Clinical Trials Information System, or CTIS, the centralized European Union portal and database for clinical trials foreseen by the regulation, through an independent audit. The regulation becomes applicable six months after the European Commission publishes notice of this confirmation. The Clinical Trials Regulation will be directly applicable in all the EU Member States, repealing the current Clinical Trials Directive 2001/20/EC. Conduct of all clinical trials performed in the European Union will continue to be bound by currently applicable provisions until the new Clinical Trials Regulation becomes applicable. The extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation will depend on when the Clinical Trials Regulation becomes applicable and on the duration of the individual clinical
98
trial. If a clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable the Clinical Trials Regulation will at that time begin to apply to the clinical trial. The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined application procedure via a single-entry point, the “EU portal”; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned). Part II is assessed separately by each Member State concerned. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU Member State. However, overall related timelines will be defined by the Clinical Trials Regulation.
The collection and use of personal health data in the European Union, previously governed by the provisions of the Data Protection Directive, is now governed by the General Data Protection Regulation, or the GDPR, which became effective on May 25, 2018. While the Data Protection Directive did not apply to organizations based outside the EU, the GDPR has expanded its reach to include any business, regardless of its location, that provides goods or services to residents in the EU. This expansion would incorporate any clinical trial activities in EU members states. The GDPR imposes strict requirements on controllers and processors of personal data, including special protections for “sensitive information” which includes health and genetic information of data patients residing in the EU. GDPR grants individuals the opportunity to object to the processing of their personal information, allows them to request deletion of personal information in certain circumstances, and provides the individual with an express right to seek legal remedies in the event the individual believes his or her rights have been violated. Further, the GDPR imposes strict rules on the transfer of personal data out of the European Union to the U.S. or other regions that have not been deemed to offer “adequate” privacy protections. Failure to comply with the requirements of the GDPR and the related national data protection laws of the European Union Member States, which may deviate slightly from the GDPR, may result in fines of up to 4% of global revenues, or €20,000,000, whichever is greater. As a result of the implementation of the GDPR, we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules.
There is significant uncertainty related to the manner in which data protection authorities will seek to enforce compliance with GDPR. For example, it is not clear if the authorities will conduct random audits of companies doing business in the EU, or if the authorities will wait for complaints to be filed by individuals who claim their rights have been violated. Enforcement uncertainty and the costs associated with ensuring GDPR compliance are onerous and may adversely affect our business, financial condition, results of operations and prospects.
Should we utilize third-party distributors, compliance with such foreign governmental regulations would generally be the responsibility of such distributors, who may be independent contractors over whom we have limited control.
We are subject to numerous foreign, federal, state and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship and end-of-life handling or disposition of products, and environmental protection, including those governing the generation, storage, handling, use, transportation and disposal of hazardous or potentially hazardous materials. Some of these laws and regulations require us to obtain licenses or permits to conduct our operations. Environmental laws and regulations are complex, change frequently and have tended to become more stringent over time. Although the costs to comply with applicable laws and regulations, including requirements in the U.S. and the European Union relating to the restriction of use of hazardous substances in products, have not been material, we cannot predict the impact on our business of new or amended laws or regulations or any changes in the way existing and future laws and regulations are interpreted or enforced, nor can we ensure we will be able to obtain or maintain any required licenses or permits.
U.S. Patent Term Restoration
Depending upon the timing, duration and specifics of FDA approval of our future product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit restoration of the patent term of up to five years as compensation for patent term lost during the FDA regulatory review process. Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. The patent-term restoration period is generally one-half the time between the effective date of an IND and the submission date of an BLA plus the time between the submission date of an 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 drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we may apply for restoration of patent term for our currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
99
The Biologics Price Competition and Innovation Act of 2009
The Biologics Price Competition and Innovation Act of 2009 ("BPCIA") significantly changes the regulatory environment for biologics.
The BPCIA includes, among other provisions:
|
● |
A 12-year exclusivity period from the date of first licensure, or BLA approval, of the reference product, during which approval of a 351(k) application referencing that product may not be made effective; |
|
● |
A four-year exclusivity period from the date of first licensure of the reference product, during which a 351(k) application referencing that product may not be submitted; and |
|
● |
An exclusivity period for certain biological products that have been approved through the 351(k) pathway as interchangeable biosimilars. |
The BPCIA also establishes procedures for identifying and resolving patent disputes involving applications submitted under section 351(k) of the PHSA.
THE BPCIA also created an abbreviated approval pathway for biological products shown to be highly similar to, or interchangeable with, an FDA-licensed reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.
Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
The BPCIA is complex and its interpretation and implementation by the FDA remains unpredictable. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate effect, implementation, and meaning of the BPCIA is subject to uncertainty.
Disclosure of Clinical Trial Information
Sponsors of clinical trials of FDA-regulated products, including biological products, are required to register and disclose certain clinical trial information on the website www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation, trial sites and investigators, and other aspects of a clinical trial are then made public as part of the registration. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of clinical trials can be delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of clinical development programs as well as clinical trial design.
Pediatric Information
Under the Pediatric Research Equity Act (“PREA”), BLAs or supplements to BLAs 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 biological product is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not apply to any biological product with orphan product designation except a product with a new active ingredient that is a molecularly targeted cancer product intended for the treatment of an adult cancer and directed at a molecular target determined by FDA to be substantially relevant to the growth or progression of a pediatric cancer that is subject to a BLA submitted on or after August 18, 2020.
The Best Pharmaceuticals for Children Act (“BPCA”) provides a six-month extension of any non-patent exclusivity for a biologic if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating to the use of a new drug or biologic in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe. Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers.
Employees
We currently have six employees, three of whom are primarily engaged in research, development, manufacturing, and regulatory activities, and three of whom are primarily engaged in financial, corporate development, and business development activities.
100
All of our employees are full time employees. We plan to hire additional personnel, as needed, to perform administration, finance, product development, preclinical, clinical, regulatory and business development functions. None of our employees is represented by a labor union and we believe our relations with our employees are good. We anticipate that the number of employees may grow as we continue to advance our current product pipeline or if we develop new product candidates in the future.
In addition, we utilize and will continue to utilize consultants, clinical research organizations and third parties to perform our preclinical and clinical studies, manufacturing, and other technical functions.
Our human capital objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards.
Facilities
We currently conduct business operations from our virtual headquarters in Houston, Texas. We have intentions to move into a physical corporate headquarters following the completion of this offering.
Legal Matters
We are not currently subject to any material legal proceedings; however, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.
101
Directors and Executive Officers
The following table sets forth the names, ages and positions of our directors and executive officers as of the date of this prospectus.
Name |
|
|
Age |
|
|
Position |
Howard Berman, Ph.D |
|
|
49 |
|
|
Chief Executive Officer, Director |
David Snyder |
|
|
62 |
|
|
Chief Financial Officer, Chief Operating Officer |
Adrian Hepner, M.D., Ph.D |
|
|
61 |
|
|
President, Chief Medical Officer |
Ann Lee |
|
|
61 |
|
|
Director |
Anabella Villalobos |
|
|
63 |
|
|
Director |
Hideki Garren |
|
|
58 |
|
|
Director |
Dov Goldstein |
|
|
54 |
|
|
Director |
Except for the Voting Agreement (as defined below), which will terminate upon the closing of the offering, there are no arrangements or understandings between our directors and executive officers and any other person pursuant to which any director or officer was or is to be selected as a director or officer.
Executive Officers
Dr. Howard Berman, Ph.D., has been Chairman and our Chief Executive Officer since he co-founded the Company in 2020. Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. Dr. Berman gained corporate experience with increasing responsibilities and positions as a Medical Science Liaison at AbbVie Inc. (NYSE:ABBV) where he spent April 2013 to June 2020 launching Venetoclax in chronic lymphocytic leukemia and later, supporting numerous solid tumor assets. He also served in leadership roles at Novartis Pharmaceuticals Corporation (NYSE:NVS) (“Novartis”) from June 2003 to January 2006 and later Eli Lilly and Company (NYSE:LLY) where he was the scientific point of contact between the company and key opinion leaders for development and initiation of collaborations, clinical trials and investigator-initiated trials. Dr. Berman began his career at the University of Texas MD Anderson Cancer Center in the technology transfer division where he was responsible for assessing the market, patent, and scientific merits of numerous oncology-based technology platforms in order to ascertain their commercial viability He received a Bachelor in Biology from the University of Michigan and a Masters and Ph.D. in Neuroscience and Pharmacology from Weill Cornell Medical School. Dr. Berman was chosen as a director due to his unique combination of business acumen and scientific credibility and his ability to assess, quantify, and bridge both disciplines.
David Snyder, has been our Chief Financial Officer and Chief Operating Officer since March 2022. Prior to joining Coya, Mr. Snyder served as the Chief Financial Officer of DisperSol Technologies, LLC and its wholly owned subsidiary, Austhera BioSciences, Inc., from September 2020 to February 2022. Prior to joining DisperSol/Austhera, from July 2014 to September 2020, Mr. Snyder was the Chief Financial Officer of Exicure, Inc. (Nasdaq: XCUR), a company developing nucleic acid therapeutics. From May 2008 to July 2014, he was the Chief Financial Officer of Cellular Dynamics, Inc. (Nasdaq: ICEL), a company developing ipsc-based stem cell tools and primary cell therapeutics. From 2007-2008, Mr. Snyder served as Senior Vice President of Finance, Site Vice President and Chief Financial Officer of Roche NimbleGen, Inc. Prior to 2007, Mr. Snyder was Chief Financial Officer of companies in real estate, software, and manufacturing. Early in his career Mr. Snyder worked for financial and real estate investor Sam Zell. He received his Bachelor of Arts, summa cum laude, from Ottawa University and his M.B.A. with high honors from the Harvard Business School, where he was designated a George Fisher Baker Scholar.
Dr. Adrian Hepner, M.D., Ph.D. has been our Chief Medical Officer since November 2021. Dr. Hepner has over 30 years of global experience in clinical research and drug development, including the development and implementation of the clinical and regulatory strategy for several products from early stage through successful BLA and EU regulatory filings and approvals. Dr. Hepner’s pharmaceutical industry experience includes over 20 years of elevating leadership roles in drug development. He previously served as Chief Medical Officer and Head of R&D at Pharnext from August 2020 to October 2021, and as Executive Vice President and Chief Medical Officer at Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) from January 2015 to July 2020. He has also held the positions of Vice President of Clinical Research at Avanir Pharmaceuticals, Inc., where he had a critical role in the development and approval of Nuedexta, a first-in-class product for the treatment of pseudobulbar affect, Vice President of Clinical Research and Medical Affairs at BioDelivery Sciences International, Inc. (“BDSI”) from July 2013 to December 2014, where he led the regulatory process for the first buccal film approved for the maintenance treatment of opioid dependence. In addition, he had a critical role in the commercial launch of the product.
102
Prior to BDSI, Dr. Hepner was senior medical director at UCB BioSciences, Inc. from 2006 to 2012, where he was responsible for global development projects in the central nervous system therapeutic area and led global clinical research projects in Latin America for Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) from 2000 to 2006. Dr. Hepner has authored multiple publications, holds several patents and spent 17 years as a practicing physician specializing in neuropsychiatry. Dr. Hepner completed visiting research physician experiences in the Department of Psychiatry at Harvard Medical School, the Department of Neurology at the National Institute of Mental Health, and a post-doctoral fellowship in neuropharmacology at the University of Ottawa. Dr. Hepner received his M.D., and Ph.D., from Universidad de Buenos Aires.
Directors
Dr. Anabella Villalobos, Ph.D., has been a director since May 2021. As head of Biotherapeutics and Medicinal Sciences at Biogen Inc. (Nasdaq:BIIB) (“Biogen”), Dr. Villalobos is responsible for the delivery of high-quality, differentiated drug candidates that advance through the clinic to become transformative medicines. Additionally, she has built a new gene therapy unit, setting the initial direction of effort including hiring the first team. Prior to Biogen, Dr. Villalobos was at Pfizer for 28 years where she most recently served as Vice President of Medicinal Synthesis Technologies and Neuroscience Medicinal Chemistry. As the leader of several medicinal chemistry groups throughout her tenure at Pfizer Inc. (NYSE:PFE)(“Pfizer”), Dr. Villalobos’ teams delivered more than 30 candidates which showed increased survival to the clinic. Dr. Villalobos obtained her B.S. in Chemistry at the University of Panama and her Ph.D. in Medicinal Chemistry at the University of Kansas where she was a Fulbright-Hayes fellow. She was a National Institutes of Health Postdoctoral Fellow at Yale University in synthetic organic chemistry for two years. Dr. Villalobos was chosen as a director due to her keen insight into drug development, particularly in neuroscience. We believe Dr. Vilalobos' counsel and strategic guidance with respect to our product candidate pipeline and research and clinical programs will be vital to our success.
Dr. Ann Lee, Ph.D., has been a director since June 2021. Dr. Lee is currently the Chief Technical Officer at Prime Medicine, Inc., a position she has held since October 2021. From November 2019 to July 2021, Dr. Lee led teams responsible for the development of new cell therapy processes and technologies, manufacturing cell therapy products, designing new facilities, and building the global supply chain at Bristol Myer Squibb (NYSE:BMY)(“BMS”). Previously, from November 2017 to April 2018, she served as Executive Vice President of Technical Operations at Juno Therapeutics, which was acquired by BMS via Celgene Corporation. Prior to Juno Therapeutics, Inc., from January 2010 to November 2017, Dr. Lee served as Senior Vice President, and then as Head of Global Technical Development at F. Hoffman-La Roche (“Roche”). She was responsible for developing and delivering all clinical stage products in Roche’s global pipeline, as well as technology transfers and technical support for all commercial products. Prior to Roche, from June 1989 to September 2005, she was at Merck & Co., Inc. (MYSE:MRK), where she led and developed new vaccines and technologies in research and development, and then was responsible as VP for process engineering and technical operations at 10 chemical sites around the world. Over the course of her career, she has contributed to the development of hundreds of new investigational drugs, and the licensure and commercialization of 25 new vaccines and medicines, with the most recent being two new CAR-T cell products for blood cancers. Dr. Lee has authored over 40 scientific publications and holds several patents. She is a member of the National Academy of Engineering, fellow of American Academy of Arts and Sciences, American Institute of Medical and Biological Engineering, and member of the Washington State Academy of Sciences. She serves on the Board of Directors for American Institute of Chemical Engineers, the Alliance of Regenerative Medicine, and JW (Cayman) Therapeutics Co. Ltd. (since 2020). She earned her undergraduate degree from Cornell University and a masters and Ph.D. in Biochemical Engineering with a concentration in molecular biophysics and biochemistry from Yale University. Dr. Lee was chosen as a director due to her thought leadership in cell therapy and biologics. She is an accomplished biotech executive with extensive experience and accomplishments in vaccines, biologics, small molecules and cell therapy development and manufacturing and she will guide us on all matters related to manufacturing and CMC.
Dr. Hideki Garren, M.D., Ph.D., has been a director since June 2021. Dr. Garren has 20 years of experience in the biopharmaceutical industry, spanning all aspects of novel drug development from discovery, to early-stage clinical trials, to late-stage clinical trials, to commercialization. Since April 2021, Dr. Garren has served as the Chief Medical Officer for Prothena Biosciences, Inc. (Nasdaq:PRTA), a late-stage clinical company with expertise in protein dysregulation, focusing on rare peripheral amyloid and neurodegenerative diseases. From 2013 to 2020, he served as VP, Global Head of Neuroimmunology for Roche & Genentech Inc., where he led the teams that conducted the Ocrevus® Phase III trials for multiple sclerosis and Enspryng™ Phase III trials for the rare disease neuromyelitis optica spectrum disorder. Prior to Roche, between 2011 and 2013, Dr. Garren held the role of Executive Director, Translational Medicine Expert in Neuroscience with Novartis. Dr. Garren also served as Co-Founder, Executive Vice President, Chief Scientific Officer, and Chief Operating Officer of Bayhill Therapeutics, Inc., a company he started in 2002 based on a technology platform he co-invented while at Stanford University. He served as adjunct clinical faculty in the Department of Neurology at Stanford University from 1997 to 2009. Dr. Garren earned his Bachelor of Science degree from the California Institute of Technology and his M.D. and Ph.D. from the University of California Los Angeles. Dr. Garren was chosen as a director due to his expertise in neuroimmunology and clinical development. Dr. Garren will provide valuable guidance on the design and structure of clinical trials that we plan to conduct.
Dr. Dov Goldstein, M.D., has been a director since March 2021. Dr. Goldstein brings over 20 years of strategic financial and operational experience within the healthcare sector. He currently serves as the Chief Financial Officer of BioAge Labs, a position he has held since November, 2021. Prior to that, from 2020-2021, he served as the Chief Financial Officer and Chief Business Officer of
103
Indapta Therapeutics, a biotechnology company focused on developing and commercializing a proprietary, off-the-shelf, allogeneic FcRy-deficient natural killer (G-NK) cell therapy to treat multiple types of cancer. From 2018-2020, he was Chief Executive Officer of RIGImmune, Inc. Prior to that he served as the Chief Financial Officer at Schrödinger, Inc. (Nasdaq:SDGR) from 2017 to 2018. Dr. Goldstein held various leadership roles at Aisling Capital, a private investment firm, from 2006 to 2017, serving as its Managing Partner from 2014 to 2017. Dr. Goldstein served as the Chief Financial Officer of Loxo Oncology, Inc.(“Loxo Oncology”) between 2014 and 2015. From 2000 to 2005, Dr. Goldstein served as Chief Financial Officer of Vicuron Pharmaceuticals, Inc. (“Vicuron”), raising over $250 million in equity financings, facilitating company partnership transactions and participating in the M&A process when Vicuron was acquired by Pfizer for $1.9 billion. Prior to joining Vicuron, he was Director of Venture Analysis at HealthCare Ventures LLC. Dr. Goldstein currently serves on the board of Directors of NeuBase Therapeutics, Inc. (Nasdaq:NBSE) and Gain Therapeutics, Inc. (Nasdaq:GANX) where he serves on each company’s audit committee as audit committee chair. He previously served as a director for ADMA Biologics Inc (Nasdaq:ADMA), Loxo Oncology, Esperion Therapeutics, Inc. (Nasdaq:ESPR), Durata Therapeutics, Inc., Cempra, Inc. and a number of private companies. He received a Bachelor of Science in biological sciences from Stanford University, an MBA from Columbia Business School and an M.D. from Yale School of Medicine. Dr. Goldstein was chosen as a director due to his extensive financial experience in the biotechnology capital markets, as an investor and as a CFO. He will help guide us in the transition from a private company to a public company and provide counsel on our growth strategies and business development activities.
Election of Officers
Each executive officer serves at the discretion of our board of directors and holds office until his or her successor is duly appointed or until his or her earlier resignation or removal. There are no family relationships among any of our directors or executive officers.
Composition of the Board of Directors
Upon the completion of this offering, our board of directors will consist of seven members. Our directors will hold office until their successors have been elected and qualified or until the earlier of their resignation or removal.
In accordance with the terms of our restated certificate of incorporation and bylaws that will become effective upon the completion of this offering, our board of directors will be divided into three classes, class I, class II and class III, with each class serving staggered three-year terms. Upon the expiration of the term of a class of directors, directors in that class will be eligible to be elected for a new three-year term at the annual meeting of stockholders in the year in which their term expires. Our directors will be divided among the three classes as follows:
|
• |
The Class I director will be Dr. Hideki Garren; his term will expire at the first annual meeting of stockholders to be held after the closing of this offering; |
|
• |
The Class II directors will be Dr. Anabella Villalobos and Dr. Dov Goldstein; their terms will expire at the second annual meeting of stockholders to be held after the closing of this offering; and |
|
• |
The Class III directors will be Dr. Howard Berman and Dr. Ann Lee; their terms will expire at the third annual meeting of stockholders to be held after the closing of this offering. |
We expect that any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors. The division of our board of directors into three classes with staggered three-year terms may delay or prevent a change of our management or a change in control.
Our Amended Charter and Amended Bylaws that will become effective upon the completion of this offering provide that the authorized number of directors may be changed only by resolution of our board of directors. Our Amended Charter and Amended Bylaws that will become effective upon the completion of this offering also provide that our directors may be removed only for cause, and that any vacancy on our board of directors, including a vacancy resulting from an enlargement of our board of directors, may be filled only by vote of a majority of our directors then in office, even if less than a quorum, or by a sole remaining director.
We have no formal policy regarding board diversity. Our priority in selection of board members is identification of members who will further the interests of our stockholders through his or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board members, knowledge of our business and understanding of the competitive landscape.
Director Independence
The Nasdaq Stock Market LLC requires a majority of a listed company’s board of directors to be comprised of independent directors within one year of listing. In addition, the rules require that, subject to specified exceptions and phase in periods following the initial public offering, each member of a listed company’s audit, compensation and nominating and corporate governance committees be independent under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Audit committee members must also
104
satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act and compensation committee members must also satisfy the independence criteria set forth in Rule 10C-1 under the Exchange Act. Under the Nasdaq Listing Rules, a director will only qualify as an “independent director” if, among other things, in the opinion of the listed company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
In order to be considered independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee: (1) accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries; or (2) otherwise be an affiliated person of the listed company or any of its subsidiaries. In order to be considered independent for purposes of Rule 10C-1, the board must consider, for each member of a compensation committee of a listed company, all factors specifically relevant to determining whether a director has a relationship to such company which is material to that director’s ability to be independent from management in connection with the duties of a compensation committee member, including, but not limited to: (1) the source of compensation of the director, including any consulting, advisory or other compensatory fee paid by such company to the director; and (2) whether the director is affiliated with the company or any of its subsidiaries or affiliates.
Our board of directors has determined that Dr. Ann Lee, Dr. Anabella Villalobos, Dr. Hideki Garren and Dr. Dov Goldstein are “independent” as defined under Nasdaq rules and the Exchange Act rules and regulations.
Background and Experience of Directors
Upon completion of this offering, our Nominating and Corporate Governance Committee will be responsible for reviewing with our board of directors, on an annual basis, the appropriate characteristics, skills, and experience required for the board of directors as a whole and its individual members. In evaluating the suitability of individual candidates (both new candidates and current members), the Nominating and Corporate Governance Committee, in recommending candidates for election, and the board of directors, in approving (and, in the case of vacancies, appointing) such candidates, will take into account many factors, including the following:
|
• |
personal and professional integrity; |
|
• |
ethics and values; |
|
• |
experience in corporate management, such as serving as an officer or former officer of a publicly held company; |
|
• |
experience in the industries in which we compete; |
|
• |
experience as a board member or executive officer of another publicly held company; |
|
• |
diversity of background and expertise and experience in substantive matters pertaining to our business relative to other board members; |
|
• |
conflicts of interest; and |
|
• |
practical and mature business judgment. |
Our board of directors has established an Audit Committee, a Compensation Committee, and a Nominating and Corporate Governance Committee. Our board of directors may establish other committees to facilitate the management of our business. The composition and functions of each committee are described below. Members serve on these committees until their resignation or until otherwise determined by our board of directors. Each of these committees operate under a charter that has been approved by our board of directors, which will be available on our website.
Audit Committee
Our Audit Committee will consist of Dr. Dov Goldstein, Dr. Hideki Garren, and Dr. Ann Lee, with Dr. Dov Goldstein serving as the Chairperson of the Audit Committee. Our board of directors has determined that the three directors that will serve on our Audit Committee are independent within the meaning of the Nasdaq Marketplace Rules and Rule 10A-3 under the Exchange Act. In addition, our board of directors has determined that Dr. Dov Goldstein qualifies as an audit committee financial expert within the meaning of SEC regulations and The Nasdaq Marketplace Rules. Our audit committee will be responsible for, among other things:
|
• |
selecting and hiring our independent auditors, and approving the audit and non-audit services to be performed by our independent auditors; |
|
• |
assisting the board of directors in evaluating the qualifications, performance, and independence of our independent auditors; |
|
• |
assisting the board of directors in monitoring the quality and integrity of our financial statements and our accounting and financial reporting; |
|
• |
assisting the board of directors in monitoring our compliance with legal and regulatory requirements; |
|
• |
reviewing with management and our independent auditors the adequacy and effectiveness of our internal control over financial reporting processes; |
105
|
• |
assisting the board of directors in monitoring the performance of our internal audit function; |
|
• |
reviewing with management and our independent auditors our annual and quarterly financial statements; |
|
• |
reviewing and overseeing all transactions between us and a related person for which review or oversight is required by applicable law or that are required to be disclosed in our financial statements or SEC filings, and developing policies and procedures for the committee’s review, approval and/or ratification of such transactions; |
|
• |
establishing procedures for the receipt, retention, and treatment of complaints received by us regarding accounting, internal accounting controls, or auditing matters and the confidential, anonymous submission by our employees of concerns regarding questionable accounting or auditing matters; and |
|
• |
preparing the audit committee report that the rules and regulations of the SEC require to be included in our annual proxy statement. |
The SEC rules and the Nasdaq rules require us to have one independent audit committee member upon the listing of our common stock on the Nasdaq, a majority of independent directors within 90 days of the effective date of the registration statement, and all independent audit committee members within one year of the effective date of the registration statement. Dr. Dov Goldstein, Dr. Hideki Garren and Dr. Ann Lee each qualify as an independent director under the corporate governance standards of the Nasdaq and the independence requirements of Rule 10A-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Compensation Committee
Our Compensation Committee will consist of Dr. Dov Goldstein, Dr. Anabella Villalobos and Dr. Ann Lee, with Dr. Anabella Villalobos serving as the Chairperson of the Compensation Committee. The compensation committee will be responsible for, among other things:
|
• |
reviewing and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officer, evaluating our Chief Executive Officer’s performance in light of those goals and objectives, and, either as a committee or together with the other independent directors (as directed by the board of directors), determining and approving our Chief Executive Officer’s compensation level based on such evaluation; |
|
• |
reviewing and approving, or making recommendations to the board of directors with respect to, the compensation of our other executive officers, including annual base salary, bonus and equity-based incentives, and other benefits; |
|
• |
reviewing and recommending to the board of directors the compensation of our directors; |
|
• |
reviewing and discussing with management our “Compensation Discussion and Analysis” disclosure required by SEC rules; |
|
• |
preparing the compensation committee report required by the SEC to be included in our annual proxy statement; and |
|
• |
reviewing and making recommendations with respect to our equity and equity-based compensation plans. |
Nominating and Corporate Governance Committee
Our Nominating and Corporate Governance Committee will consist of Dr. Dov Goldstein, Dr. Anabella Villalobos and Dr. Hideki Garren, with Dr. Hideki Garren serving as the Chairperson of the Compensation Committee. The nominating and corporate governance committee will be responsible for, among other things:
|
• |
assisting our board of directors in identifying prospective director nominees and recommending nominees to the board of directors; |
|
• |
overseeing the evaluation of the board of directors and management; |
|
• |
reviewing developments in corporate governance practices and developing and recommending a set of corporate governance guidelines; and |
|
• |
recommending members for each committee of our board of directors. |
Compensation Committee Interlocks and Insider Participation
None of our executive officers serves as a member of the board of directors or compensation committee (or other committee performing equivalent functions) of any entity that has one or more executive officers serving on our board of directors or compensation committee.
Code of Ethics
Upon the effectiveness of this offering, we will adopt a new Code of Business Conduct and Ethics that applies to all of our officers, directors, and employees, including our principal executive officer, principal financial officer, principal accounting officer, and controller, or persons performing similar functions, which will be posted on our website at https://www.coyatherapeutics.com. Our Code of Business Conduct and Ethics is a “code of ethics,” as defined in Item 406(b) of Regulation S-K. We will make any legally required disclosures regarding amendments to, or waivers of, provisions of our code of ethics on our website. The information contained in, or that can be accessed through, our website is not incorporated by reference and is not part of this prospectus.
106
EXECUTIVE AND DIRECTOR COMPENSATION
The following section provides compensation information pursuant to the scaled disclosure rules applicable to “emerging growth companies” under the rules of the SEC, including reduced narrative and tabular disclosure obligations regarding executive compensation.
Our named executive officers for the fiscal year ended December 31, 2021, which consist of our current Chief Executive Officer and our two other most highly compensated executive officers who were serving as executive officers as of December 31, 2021 (other than our principal executive officer), are as follows:
|
• |
Howard Berman, Ph.D., our President and Chief Executive Officer; |
|
• |
David Snyder, our Chief Financial Officer and Chief Operating Officer; and |
|
• |
Adrian Hepner, M.D., Ph.D., our Chief Medical Officer. |
Summary Compensation Table
The following table shows the compensation earned by each of our named executive officers for the year ended December 31, 2021 and does not reflect the stock split which will occur prior to this closing of this offering. Our compensation packages for the named executive officers consist primarily of base salary, annual cash bonus and a stock option grant.
Name and Principal Position |
|
Year |
|
Salary ($) |
|
|
|
Bonus ($) |
|
|
Option Awards ($) (1) |
|
|
Total ($) |
|
||||
Howard Berman, Ph.D. President and Chief Executive Officer |
|
2021 |
|
$ |
300,000 |
|
|
|
$ |
60,000 |
|
|
|
— |
|
|
$ |
360,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Snyder (2) Chief Financial Officer and Chief Operating Officer |
|
2021 |
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adrian Hepner, M.D., Ph.D. (3) Chief Medical Officer |
|
2021 |
|
$ |
17,708 |
|
(4) |
|
|
— |
|
|
$ |
47,643 |
|
|
$ |
65,351 |
|
(1) |
Amounts reflect the full grant date fair value of stock options granted during the year ended December 31, 2021 computed in accordance with ASC Topic 718, rather than the amounts paid to or realized by the named individual. We provide information regarding the assumptions used to calculate the value of the option awards in Note 8 to our financial statements included in this prospectus. |
(2) |
Mr. Snyder joined us in April 2022. |
(3) |
Dr. Hepner joined us in November 2021. |
(4) |
Reflects proration based on Dr. Hepner’s November 2021 start date. |
Employment Agreements with Named Executive Officers
Howard Berman
Dr. Berman serves as our Chief Executive Officer pursuant to an Executive Employment Agreement, dated December 15, 2020, as amended (the “Berman Employment Agreement”). Pursuant to the Berman Employment Agreement, Dr. Berman is entitled to a base salary of $450,000 per year, subject to periodic review in accordance with our procedures for adjusting salaries for similarly situated employees, and may be adjusted in the sole discretion of the Company.
Dr. Berman is eligible to receive an annual bonus, targeted at 20% of base salary, upon the achievement of objectives to be determined by the Company. Dr. Berman is also entitled to an allowance of $500 a month for the use of a car. Dr. Berman is entitled to participate in all employee benefit plans and programs available to our employees.
The Berman Employment Agreement has an initial term of two years and will automatically renew for one year terms after the initial term has elapsed, unless either party terminates the agreement upon 30 days’ notice from the end of the initial or extended term. If we terminate the agreement for Cause (as defined in the Berman Employment Agreement), all of our obligations will cease. If we terminate the agreement without Cause, and Dr. Berman is not terminated due to death or Disability (as defined in the Berman Employment Agreement), Dr. Berman will continue to receive his base salary for 12 months, subject to Dr. Berman’s execution of a severance and general release agreement for our benefit.
107
Adrian Hepner
Dr. Hepner serves as our President, Chief Medical Officer pursuant to an Executive Employment Agreement, dated November 1, 2021 (the “Hepner Employment Agreement”). Pursuant to the Hepner Employment Agreement, Dr. Hepner is entitled to a base salary of $425,000 per year, subject to periodic review in accordance with our procedures for adjusting salaries for similarly situated employees, and may be adjusted in our sole discretion.
Dr. Hepner is eligible to receive an annual bonus, targeted at 35% of base salary, upon the achievement of objectives to be determined by the Company. In connection with the execution of the Hepner Employment Agreement, Dr. Hepner received an option grant exercisable for 250,757 shares of our common stock. Dr. Hepner is entitled to participate in all employee benefit plans and programs available to our employees.
The Hepner Employment Agreement has an initial term of two years and will automatically renew for one year terms after the initial term has elapsed, unless either party terminates the agreement upon 30 days’ notice from the end of the initial or extended term. If we terminate the agreement for Cause (as defined in the Hepner Employment Agreement), all obligations of the Company will cease. If we terminate the agreement without Cause, and Dr. Hepner is not terminated due to death or Disability (as defined in the Hepner Employment Agreement), Dr. Hepner will continue to receive his base salary for nine months, subject to Dr. Hepner’s execution of a severance and general release agreement for our benefit.
David Snyder
Mr. Snyder serves as our Chief Financial Officer and Chief Operating Officer pursuant to an Executive Employment Agreement, dated March 14, 2022 (the “Snyder Employment Agreement”). Pursuant to the Snyder Employment Agreement, Mr. Snyder is entitled to a base salary of $350,000 per year, subject to periodic review in accordance with our procedures for adjusting salaries for similarly situated employees, and may be adjusted in our sole discretion.
Mr. Snyder is eligible to receive an annual bonus, targeted at 35% of base salary, upon the achievement of objectives to be determined by the Company. In connection with the execution of the Snyder Employment Agreement, Mr. Snyder received an option grant exercisable for 500,000 shares of our common stock. Mr. Snyder is entitled to participate in all employee benefit plans and programs available to our employees.
The Snyder Employment Agreement has an initial term of two years and will automatically renew for one year terms after the initial term has elapsed, unless either party terminates the agreement upon 30 days’ notice from the end of the initial or extended term. If we terminate the agreement for Cause (as defined in the Snyder Employment Agreement), all obligations of the Company will cease. If we terminate the agreement without Cause, and Mr. Snyder is not terminated due to death or Disability (as defined in the Snyder Employment Agreement), Mr. Snyder will continue to receive his base salary for nine months, subject to Mr. Snyder’s execution of a severance and general release agreement for our benefit.
Potential Payments Upon Termination or Change in Control
Other than under Messrs. Berman’s and Snyder’s employment agreements (described above in “—Employment Agreements with Named Executive Officers”), we have no plans, agreements or arrangements that provide for payment to our named executive officers in connection with termination of employment or a change in our control.
The Amended and Restated Coya Therapeutics, Inc. 2021 Equity Incentive Plan
Our Board and management believe that the effective use of stock-based long-term incentive compensation is vital to our ability to achieve strong performance in the future. Accordingly, on January 25, 2021 the Board adopted the Coya Therapeutics, Inc. 2021 Equity Incentive Plan, which our stockholders approved on February 5, 2021.
On October __, 2022, the Company’s Board of Directors amended and restated the 2021 Equity Incentive Plan, which our stockholders approved on October __, 2022 (the “Amended and Restated Equity Plan”) to:
|
• |
Increase the number of shares of the Company’s common stock authorized to be issued under the Amended and Restated Equity Plan to 6,500,000, all of which are available for grant as Incentive Stock Options (as described below); |
|
|
• |
Add an “evergreen” feature to automatically increase the number of shares of the Company’s common stock available under the Amended and Restated Equity Plan as described further below; and |
|
|
• |
Extend the expiration date of the Amended and Restated Equity Plan to October __, 2032. |
|
108
|
|
Summary of the Amended and Restated 2021 Equity Incentive Plan
The following is a summary of the material features of the Amended and Restated Equity Plan and is qualified in its entirety by reference to the full text of the Amended and Restated Equity Plan. Capitalized terms used in this summary and not otherwise defined shall have the meaning set forth in the Amended and Restated Equity Plan.
The Amended and Restated Equity Plan is intended to enable us to secure and retain the types of employees, consultants and directors who will contribute to our long-range success, and provide incentives for such persons to exert maximum efforts for the success of the Company by aligning their interests with those of our stockholders. Awards that may be granted under the Amended and Restated Plan include: (a) Incentive Stock Options (within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended); (b) Nonstatutory Stock Options (Incentive Stock Options and Nonstatutory Stock Options together referred to as “Options”); (c) Stock Appreciation Rights (“SARs”); (d) Restricted Stock Awards; (e) Restricted Stock Unit (“RSU”) Awards (f) Performance Awards (payable in shares or cash); and (g) Other Awards (all as defined in the Amended and Restated Equity Plan, and collectively, “Awards”).
The Amended and Restated 2021 Equity Plan reserves 6,500,000 shares of our common stock for the grant of Awards, all of which may be granted as Incentive Stock Options. Pursuant to the Amended and Restated Equity Plan’s “evergreen” feature, the number of shares of common stock reserved for issuance will automatically increase on the first day of each fiscal year commencing with January 1, 2023 and on the first day of each fiscal year thereafter until the date the Amended and Restated Equity Plan expires, by an amount equal to four percent (4%) of the total number of shares of our common stock outstanding on the last day of the preceding fiscal year, unless the Board determines before an annual increase takes effect that no increase will be made or a lesser increase.
Shares subject to Awards that are forfeited, or expire, as well as shares subject to Awards that are settled in cash, and shares that are reacquired by the Company in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of an Award, are added back to the shares reserved for issuance under the Plan and may be subject to new Awards under the Amended and Restated Equity Plan.
As of September 30, 2022, awards have been granted with respect to 2,886,135 shares of our common stock. All such Awards have been granted as Options.
The Amended and Restated Equity Plan is administered by our Board, or in the Board’s sole discretion, by a committee appointed by the Board (the Board or such committee being referred to as the “plan administrator”). The plan administrator has full authority to establish rules and regulations for the administration of the Amended and Restated Equity Plan, including to determine (i) the persons to whom and the time or times at which Awards may be granted; to determine the type and number of Awards to be granted; (ii) the number of shares of common stock to which an Award may relate; and (iii) the terms, conditions, restrictions and performance criteria of Awards. The plan administrator has authority to modify (reprice) the purchase price or the exercise price of any outstanding Award. Such repricings may be implemented without stockholder approval. The Board may, to the extent permitted by law, delegate to one or more officers the authority to grant Options and SARs to employees who are not officers.
The following describes the types of Awards that may be made under the Amended and Restated Equity Plan. The Amended and Restated Equity Plan also contains provisions with respect to payment of exercise prices, vesting and expiration of Awards, transferability of Awards, and various other terms, conditions, and limitations, as further described in the Amended and Restated Equity Plan.
Stock Options. Nonstatutory Stock Options may be granted to our employees, consultants and directors, while Incentive Stock Options may be granted only to our employees. The exercise price of all Options granted under the Amended and Restated Equity Plan will be determined by the plan administrator. With limited exceptions, the exercise price per share of any Option may not be less than 100% of the fair market value of our common stock on the grant date. The maximum term of all stock options granted under the Amended and Restated Equity Plan will be determined by the plan administrator, but may not exceed ten years. However, the exercise price for Incentive Stock Options granted to any stockholder who is designated to be a “Ten Percent Shareholder” under the Amended and Restated Equity Plan must be at least 110% of the fair market value of the common stock on the date of the grant and such Options must expire no later than five years after the grant date. Each Option will vest and become exercisable at such time and subject to such terms and conditions as determined by the plan administrator in the applicable individual stock option agreement. To the extent that the aggregate fair market value (determined at the time of grant) of common stock with respect to which Incentive Stock Options are exercisable for the first time by any option holder during any calendar year exceeds $100,000, the options or portions thereof which exceed such limit shall be treated as Nonstatutory Stock Options.
An Option may be granted with a right to exercise it before it becomes exercisable (referred to as an early exercise right). If exercised early, the shares of common stock acquired may be subject to a repurchase right in favor of the Company.
109
Unless the applicable stock option agreement provides otherwise, in the event of an optionee’s termination of employment or service, stock options will be treated as follows: (i) if the termination is for any reason other than for cause, disability or death, vested options generally will remain exercisable until three months after termination and then expire, (ii) if the termination is on account of the optionee’s disability or death, vested options generally will remain exercisable until one year after termination and will then expire and (iii) if the termination is for cause, all options, whether vested or unvested, will expire as of the date of such termination. Unless the applicable stock option agreement provides otherwise, any options that were not vested and exercisable on the date of any termination of employment or service for any reason will expire as of the date of such termination.
SARs. A SAR granted under the Amended and Restated Equity Plan entitles its holder to receive, at the time of exercise, an amount per share equal to the excess of the fair market value (at the date of exercise) of a share of our common stock over the base price of the SAR. With limited exceptions, each SAR will be granted with a base price that is not less than 100% of the fair market value of a share of our common stock on the grant date. The maximum term of SARs granted under the Amended and Restated Equity Plan will be determined by the plan administrator, but may not exceed ten years. The plan administrator may determine to settle the exercise of a SAR in shares of common stock, cash or any combination thereof.
Restricted Stock and RSUs. Restricted stock and RSUs may be granted under the Amended and Restated Equity Plan. RSUs may be settled in shares of common stock or cash, in the discretion of the plan administrator. The plan administrator will determine the purchase price, vesting schedule and performance objectives, if any, applicable to the grant of restricted stock and RSUs. If the restrictions, performance objectives or other conditions determined by the plan administrator are not satisfied, the restricted stock and RSUs will be forfeited. Subject to the provisions of the Amended and Restated Equity Plan and applicable individual award agreements, the plan administrator has the sole discretion to provide for the lapse of restrictions in installments or the acceleration or waiver of restrictions (in whole or part) under certain circumstances, including the attainment of certain performance goals, a participant’s termination of employment or service or a participant’s death or disability. The rights of restricted stock and RSU holders upon a termination of employment or service will be set forth in individual award agreements.
Recipients of restricted stock will generally have all of the rights of a stockholder during the restricted period, including the right to vote and, to the extent specifically provided in an agreement award, receive dividends declared with respect to such stock (provided that dividends will only be paid out upon vesting of the shares to which they are attributable unless the award agreement provides otherwise). During the restricted period, participants with RSUs will generally not have any rights of a stockholder, but may be credited with dividend equivalent rights if the applicable individual award agreement so provides. Dividend equivalent amounts with respect to restricted stock or RSUs will be subject to the same restrictions, conditions and risks of forfeiture as the underlying restricted stock or RSU.
Performance Awards. Performance Awards under the Amended and Restated Equity Plan may be payable in shares of common stock and/or cash, contingent on the attainment during the applicable performance period of certain performance goals, as determined by the plan administrator and set forth in an individual’s award agreement.
Other Awards. Other forms of Awards valued in whole or in part by reference to, or otherwise based on, shares of our common stock may be granted under the Amended and Restated Equity Plan. The plan administrator will determine the terms and conditions of such other awards, including the number of shares of common stock to be granted pursuant to such other awards, the manner in which such other awards will be settled (e.g., in shares of common stock or cash), and the conditions to the vesting and payment of such other awards.
Equitable Adjustments. In the event of a merger, consolidation, reclassification, recapitalization, spin-off, spin-out, repurchase, reorganization, special or extraordinary dividend or other extraordinary distribution (whether in the form of shares of common stock, cash or other property), combination, exchange of shares, or other change in corporate structure affecting the shares of common stock, an equitable substitution or proportionate adjustment shall be made, at the sole discretion of the plan administrator, in (i) the aggregate number of shares of common stock reserved for issuance under the Amended and Restated Equity Plan, (ii) the kind and number of securities subject to, and the exercise price or base price of, any outstanding Options and SARs granted under the Amended and Restated Equity Plan, and (iii) the kind, number and purchase price of shares of common stock, or the amount of cash or amount or type of property, subject to outstanding Restricted Stock Awards, RSU Awards, Performance Awards and Other Awards granted under the Amended and Restated Equity Plan.
Change in Control. In accordance with the Amended and Restated Equity Plan, subject to the terms of any individual award agreement, the Board may, among other things, take one or more of the following actions in connection with a Change in Control (as defined in the Amended and Restated Equity Plan): (i) arrange for the surviving corporation or acquiring corporation to assume or continue Awards, (ii) cause any or all outstanding Awards to become vested and, if applicable, allow the holder of an Option or SAR to exercise such Option or SAR prior to the Change in Control and forfeit such Option or SAR if not exercised before the Change in Control, (iii) cancel an Award, to the extent not vested or not exercised prior to the Change in Control, in exchange for such cash consideration, if any, as the Board considers appropriate; or (iv) terminate an Award at or immediately prior to the closing of the Change in Control in exchange for a payment, in such form as may be determined by the Board, equal to the excess, if any, of the value of the property the participant would have received on the exercise of the Award immediately prior to the Change in Control, over any exercise price.
110
Tax Withholding. Each recipient of an Award will be required to make arrangements satisfactory to the plan administrator regarding payment of the amount of applicable taxes required by law to be withheld with respect to any Award granted under the Amended and Restated Equity Plan. With the approval of the plan administrator, an individual may satisfy the foregoing requirement by either electing to have us withhold from delivery of shares of common stock, cash or other property, as applicable, or by delivering already owned unrestricted shares of common stock, in each case, having a value not exceeding the applicable taxes to be withheld and applied to the tax obligations. We may also use any other method of obtaining the necessary payment or proceeds, as permitted by law, to satisfy our withholding obligation with respect to any award.
Clawback Rights. All Awards granted under the Amended and Restated Equity Plan are subject to recoupment in accordance with any clawback policy that the Company adopts pursuant to listing standards of any national securities exchange or association on which the Company’s securities are listed or as is otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other applicable law. In addition, the Board may impose such other clawback, recovery or recoupment provisions as the Board deems appropriate.
Amendment and Termination. The Amended and Restated Equity Plan provides the Board with authority to amend, alter or terminate the Amended and Restated Equity Plan, but no such action may materially impair the rights of any participant with respect to outstanding Awards without the participant’s consent. Stockholder approval of any such action will be obtained if required to comply with applicable law or regulation.
Plan Term. The Amended and Restated Equity Plan will terminate on the tenth anniversary of the date the Board adopted the Amended and Restated Equity Plan (although awards granted before that time will remain outstanding in accordance with their terms).
Employee benefits plans
We currently provide broad-based health and welfare benefits that are available to all of our employees, including our named executive officers, including medical, dental, and vision insurance.
Outstanding equity awards at fiscal year-end table
|
|
|
|
|
|
Option Awards |
|
||||||||||||||
Name |
|
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 |
|
|||||
Howard Berman |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Snyder |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Chief Financial Officer and Chief Operating Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adrian Hepner |
|
|
— |
|
|
|
250,757 |
|
(1) |
|
|
— |
|
|
$ |
0.19 |
|
|
11/1/2031 |
|
|
Chief Medical Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
The option reported herein vests over a two year period from grant date, subject to Dr. Hepner’s continued service to us on each vesting date. The option will vest as to 50% on the one year anniversary of the grant date and then in 12 equal monthly installments thereafter. Subject to Dr. Hepner’s continued service to us through a Change in Control (as defined in the Amended and Restated Equity Plan), the option will fully vest upon such Change of Control. |
Director Compensation
The following table provides certain information concerning compensation for each person who served as a non-employee member of our board of directors during the year ended December 31, 2021. Other than as set forth in the table and described more fully below, we did not pay any compensation, make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of our board of directors in 2021. During fiscal year 2021, Howard Berman, our President and Chief Executive Officer, served as a member of our board of directors and received no additional compensation for his services as a member of our board of directors. See the section titled “Executive Compensation” for more information about Dr. Berman’s
111
compensation for fiscal year 2021. We reimburse non-employee members of our board of directors for reasonable travel and out-of-pocket expenses incurred in attending meetings of our board of directors and committees of our board of directors.
Name |
|
Fees Earned or Paid in Cash ($) |
|
|
Stock Awards ($) |
|
|
Option Awards ($)(1) |
|
|
|
Non-Equity Incentive Plan Compensation ($) |
|
|
Change in Pension Value and Nonqualified Deferred Compensation Earnings |
|
|
All other Compensation ($) |
|
|
Total ($) |
|
|||||||
Ann Lee |
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
(2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
Anabella Villalobos |
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
(2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
Dov Goldstein |
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
(2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
Hideki Garren |
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
(2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
19,000 |
|
(1) |
Amounts reflect the full grant date fair value of stock options granted during 2021 computed in accordance with ASC Topic 718, rather than the amounts paid to or realized by the named individual. |
(2) |
The option reported herein will vest over a three year period, subject to the holder’s continued service to us through each vesting date. The option will vest as to 1/36th on each monthly anniversary of the date of grant, such that the option will fully vest on the third anniversary of the date of grant. Subject to the holder’s continued service through a Change in Control (as defined in the Amended and Restated Equity Plan), the option will fully vest upon such Change in Control. |
Non-Employee Director Compensation Policy
Effective upon the closing of this offering, our board of directors has adopted a non-employee director compensation policy that is designed to enable us to attract and retain, on a long-term basis, highly qualified non-employee directors. Pursuant to this policy our board members will each receive $40,000 per year ($60,000 for Chairman of the Board, so long as that position is held by a non-employee director), each member of the Audit Committee receives an additional $7,500 per year ($15,000 for the Chairperson), each member of the Compensation Committee receives an additional $5,000 per year ($10,000 for the Chairperson), and each member of the Nominating and Corporate Governance Committee receives an additional $3,750 per year ($7,500 for the Chairperson). Any compensation to be paid under this policy may be made in stock options, at our discretion.
Our board of directors has also adopted an equity compensation policy pursuant to which board members shall automatically be granted stock options to purchase 10,000 shares of our common stock upon joining the board of directors, and on January 1 of each year, each then serving non-employee director shall be automatically granted stock options to purchase 5,000 shares of our common stock. These stock options shall fully vest upon the anniversary of their granting, have a term of ten years and shall have an exercise price equal to 100% of the fair market value of a share of common stock on the date of grant. All options to be granted under this policy will be granted pursuant to our Amended and Restated Equity Plan.
112
The following table sets forth information with respect to the beneficial ownership of our common stock as of , 2022, both before and after giving effect to the closing of the offering, by:
|
• |
each person known by us to own beneficially more than 5% of any class of our outstanding shares of common stock; |
|
• |
each of the directors and named executive officers individually; and |
|
• |
all of our directors and named executive officers as a group. |
The amounts and percentages of our common stock beneficially owned are reported on the basis of SEC regulations governing the determination of beneficial ownership of securities. Under SEC rules, a person is deemed to be a “beneficial” owner of a security if that person has or shares voting power or investment power, which includes the power to dispose of or to direct the disposition of such security. A person is also deemed to be a beneficial owner of any securities of which that person has a right to acquire beneficial ownership within 60 days. Securities that can be so acquired are not deemed to be outstanding for purposes of computing any other person’s percentage. Under these rules, more than one person may be deemed to be a beneficial owner of securities as to which such person has no economic interest.
Our determination of the percentage of beneficial ownership prior to this offering gives effect to Preferred Conversion into an aggregate of shares of our common stock, the Notes Conversion into an aggregate of shares of our common stock upon the closing of this offering, and the -for- split of our common stock and is based on shares of our common stock outstanding as of , 2022. Our determination of beneficial ownership after this offering is based on shares of our common stock outstanding after closing of the offering and assumes the underwriters exercise their option to purchase up to shares of common stock. Unless otherwise indicated, the business address of each such beneficial owner is c/o Coya Therapeutics, Inc., 5850 San Felipe St. Suite 500 Houston, TX 77057.
Each of the stockholders listed has sole voting and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject to community property laws where applicable.
|
|
Shares of Common Stock Beneficially Owned Before This Offering |
|
Shares of Common Stock Beneficially Owned After This Offering |
||||||
Name of Beneficial Owners |
|
Number |
|
|
% |
|
Number |
|
% |
|
Executive Officers and Directors: |
|
|
|
|
|
|
|
|
|
|
Howard Berman (1)(2) |
|
|
5,350,000 |
|
|
|
|
|
|
|
Adrian Hepner (3) |
|
260,794 |
|
|
* |
|
|
|
|
|
Ann Lee (4) |
|
|
52,777 |
|
|
* |
|
|
|
|
Anabella Villalobos (5) |
|
|
52,777 |
|
|
* |
|
|
|
|
Dov Goldstein (6) |
|
|
52,777 |
|
|
* |
|
|
|
|
Hideki Garren (7) |
|
|
52,777 |
|
|
* |
|
|
|
|
David Snyder (8) |
|
|
291,562 |
|
|
* |
|
|
|
|
All executive officers and directors as a group (7 persons) |
|
|
6,068,976 |
|
|
|
|
|
|
|
Other 5% Stockholders |
|
|
|
|
|
|
|
|
|
|
Shawn Milemore Titcomb (9) |
|
|
2,051,106 |
|
|
|
|
|
|
|
Jani Tuomi |
|
|
2,250,000 |
|
|
|
|
|
|
|
Bertex LLC (1)(2) |
|
|
5,350,000 |
|
|
|
|
|
|
|
Andrea Goldstein |
|
|
1,700,000 |
|
|
|
|
|
|
|
* |
Represents beneficial ownership of less than 1%. |
(1) |
Howard Berman, our Chief Executive Officer and director is the managing director of Bertex LLC. Due to Dr. Berman’s controlling relationship with Bertex LLC, he may be deemed to have sole voting and dispositive control over the shares of our common stock owned by Bertex LLC. As a result, Dr. Berman may be deemed to beneficially own the shares of our common stock held by Bertex LLC. |
(2) |
Includes 5,350,000 shares of our common stock owned by Bertex LLC, of which Dr. Berman is the managing director. |
(3) |
Excludes options exercisable for 239,963 shares of our common stock owned by Dr. Hepner that are not exercisable within 60 days of the date of this prospectus. |
(4) |
Includes options exercisable for 52,777 shares of our common stock owned by Dr. Lee that are exercisable within 60 days of this prospectus. Excludes options exercisable for 47,223 shares of our common stock owned by Dr. Lee that are not exercisable within 60 days of the date of this prospectus. |
113
(5) |
Includes options exercisable for 52,777 shares of our common stock owned by Dr. Villalobos that are exercisable within 60 days of this prospectus. Excludes options exercisable for 47,223 shares of our common stock owned by Dr. Villalobos that are not exercisable within 60 days of the date of this prospectus. |
(6) |
Includes options exercisable for 52,777 shares of our common stock owned by Dr. Goldstein that are exercisable within 60 days of this prospectus. Excludes options exercisable for 47,223 shares of our common stock owned by Dr. Goldstein that are not exercisable within 60 days of the date of this prospectus. |
(7) |
Includes options exercisable for 52,777 shares of our common stock owned by Dr. Garren that are exercisable within 60 days of this prospectus. Excludes options exercisable for 47,223 shares of our common stock owned by Dr. Garren that are not exercisable within 60 days of the date of this prospectus. |
(8) |
Excludes options exercisable for 208,438 shares of our common stock owned by Mr. Snyder that are not exercisable within 60 days of the date of this prospectus. |
(9) |
Includes (i) 1,808,670 shares of our common stock owned by the Shawn Milemore Titcomb Revocable Trust, of which Mr. Titcomb is the trustee (the “Titcomb Trust”), (ii) 92,638 shares of common stock issuable upon conversion of our Series A Preferred Stock owned by the Titcomb Trust, and (iii) 149,798 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days of this prospectus, owned by Mr. Titcomb. The address of Mr. Titcomb is c/o Allele Capital Partners LLC, 900 N Federal Highway Ste 400, Boca Raton, FL 33432. |
114
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Our policy is to enter into transactions with related parties on terms that, on the whole, are no more favorable, or no less favorable, than those available from unaffiliated third parties. Based on our experience in the business sectors in which we operate and the terms of our transactions with unaffiliated third parties, we believe that all of the transactions described below met this policy standard at the time they occurred. The following is a description of material transactions, or series of related material transactions, since January 1, 2020, to which we were or will be a party and in which the other parties included or will include our directors, executive officers, holders of more than 5% of our voting securities or any member of the immediate family of any of the foregoing persons. Other than as described below, there have not been, nor are there any currently proposed, transactions or series of similar transactions to which we have been or will be a party other than compensation arrangements, which are described where required under the section entitled “Executive and Director Compensation.”
Corporate Reorganization
On November 3, 2020 and November 14, 2020, Nicoya Health, Inc. (“Nicoya”) issued convertible promissory notes with an aggregate principal amount of $150,000 (collectively, the “Promissory Notes”). The Promissory Notes bore interest at 6.0% per annum. The principal and accrued interest under the Promissory Notes converted into an aggregate of 138,969 shares of Coya Series A Preferred Stock in the Series A Preferred Stock Financing (defined below) at a discount to the price per share of other investors in the Series A Preferred Stock Financing.
On December 22, 2020, Nicoya merged with and into Coya Therapeutics, Inc., with Coya as the surviving company (the “Merger”). In connection with the Merger, each share of Nicoya common stock was converted into the right to receive one share of Coya common stock. An aggregate of 10,750,000 shares of our common stock were issued to holders of Nicoya common stock in connection with the Merger. The table below sets forth the aggregate shares of common stock issued to our related parties in the Merger:
Participant (1) |
|
Common Stock |
|
|
Bertex, LLC |
|
|
5,500,000 |
|
Jani Tuomi |
|
|
2,500,000 |
|
Andrea Goldstein |
|
|
2,000,000 |
|
(1) |
Additional details regarding these stockholders and their equity holdings are provided under the caption “Principal Stockholders.” |
Immediately after the completion of the Merger, on December 22, 2020, we issued and sold an aggregate of 7,361,744 shares of Series A Preferred Stock, which amount excludes the 138,969 shares of Series A Preferred Stock issued upon conversion of the Promissory Notes, in exchange for $9,850,017.39 (the “Series A Preferred Financing”). A trust for which Shawn Titcomb is trustee participated in the Series A Preferred Financing and was issued 92,638 shares of Series A Preferred Stock at $1.349 per share in connection with the conversion of $100,000 of the Promissory Notes. Mr. Titcomb is the owner of more than 5% of our outstanding shares of capital stock.
Series A Placement Agent
In connection with the Series A Preferred Financing, we paid to Tribal Capital Markets, LLC (the “Placement Agent”) (i) a cash fee of 7% of the gross proceeds raised in the Series A Preferred Financing, and (ii) reimbursement of expenses of $50,000. In addition, we issued to designees of the Placement Agent, for nominal consideration, warrants to purchase 525,049 shares of our common stock, or 7% of the number of shares of common stock underlying the Series A Preferred Stock sold in the offering (the “Series A Placement Agent Warrants”) at an exercise price equal to $1.61 per share, or 120% of the price per share of Series A Preferred Stock paid by investors in the Series A Preferred Financing. The Series A Placement Agent Warrants provide for a cashless exercise right and are exercisable for a period of five years from December 22, 2020. Mr. Titcomb, an owner of more than 5% of our capital stock, was a managing director of the Placement Agent.
Strategic Advisory Agreement
In connection with our Series A Preferred Financing, we entered into a non-exclusive strategic advisory agreement with Allele Capital Partners LLC (“Allele”), a strategic advisory and investment firm, at $10,000 per month. Mr. Titcomb, an owner of more than 5% of our capital stock, is the Co-Founder and Chief Executive Officer of Allele. The agreement with Allele will terminate upon consummation of this offering.
Investors’ Rights Agreement
In connection with the Series A Preferred Financing, we entered into an Investors’ Rights Agreement (the “IRA”), which provides, among other things, that certain holders of our capital stock, including Allele, Dr. Berman and Mr. Tuomi, have the right to
115
demand that we file a registration statement or request that their shares of our capital stock be covered by a registration statement that we are otherwise filing. Shawn Titcomb, who is a 5% or more owner of the Company, is affiliated with Allele. See “Description of Capital Stock—Registration Rights” for additional information regarding these registration rights.
Right of First Refusal
In connection with the Corporate Reorganization, and the Series A Preferred Financing, we entered into certain agreements with certain holders of our capital stock, including a right of first refusal and co-sale agreement. Pursuant to the right of first refusal and co-sale agreement, we or our assignees have a right to purchase shares of our capital stock which stockholders propose to sell to other parties. This right will terminate at the consummation of this offering. Shawn Titcomb, who is a 5% of more owner of the Company, is affiliated with Allele, who is party to the right of first refusal and co-sale agreement, along with Dr. Berman and Mr. Tuomi.
Voting Agreement
In connection with the Corporate Reorganization, the Series A Preferred Financing, and the Convertible Note Offering, we entered into certain agreements with certain holders of our capital stock, including a voting agreement (as amended, the “Voting Agreement”). Pursuant to the Voting Agreement, among other things: our board of directors shall be comprised of five (5) members consisting of: (i) one person designated by the holders of a majority of the Series A Preferred Stock, who is currently Dov Goldstein; (ii) the Chief Executive Officer, who is currently Howard Berman; (iii) two persons designated by the holders of a majority of our common stock, who are currently Ana Villalobos and Ann Lee; and (iv) one person not otherwise an affiliate of the Company or of any investor who is mutually acceptable to the holders of a majority of the outstanding shares of Series A Preferred Stock and Common Stock, who is currently Hideki Garren. Upon consummation of this offering, the Voting Agreement will terminate and none of our stockholders will have any special rights regarding the election or designation of members of our board of directors. Mr. Titcomb, an owner of more than 5% of our capital stock, and is affiliated with Allele, is party to the Voting Agreement.
Equity Incentive Plan
For a description of our equity incentive plans with members of our board of directors and executive officers, see “Executive and Director Compensation—Coya Therapeutics Inc. Amended and Restated 2021 Equity Incentive Plan.”
Indemnification Agreements
Upon the closing of this offering, we will enter into Indemnification Agreements with each of our current directors and executive officers. The Indemnification Agreements will provide for indemnification against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending or completed actions, suits or other proceedings, subject to certain limitations. The Indemnification Agreements will also provide for the advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to be entitled to indemnification by us. The Indemnification Agreements will set forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that will apply to any dispute between us and an indemnitee arising under the Indemnification Agreements.
There is no pending litigation or proceeding naming any of our directors or officers to which indemnification is being sought, and we are not aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.
Consulting Agreement
In December 2020, we entered into a consulting arrangement with Jani Tuomi, an owner of more than 5% of our capital stock. The consulting arrangement, under which Mr. Tuomi provided consulting services related to business development activities, provided for a fee to Mr. Tuomi of $12,500 a month and such fee was changed to $7,500 a month in December 2021. The consulting arrangement was terminated in May 2022. We paid an aggregate of $170,000 pursuant to the consulting arrangement.
Policies and Procedures for Related Party Transactions
Our board of directors expects to 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 transactions involving us and “related persons.” For the purposes of this policy, “related persons” will include our executive officers, directors, director nominees, and their immediate family members, and stockholders owning five percent or more of our outstanding common stock and their immediate family members.
116
The policy will cover, with certain exceptions set forth in Item 404 of Regulation S-K under the Securities Act, any transaction, arrangement, or relationship, or any series of similar transactions, arrangements, or relationships in which we were or are to be a participant, where the amount involved exceeds $120,000 and a related person has or will have a direct or indirect material interest, including, without limitation, purchases of goods or services by or from the related person or entities in which the related person has a material interest, indebtedness, guarantees of indebtedness, and employment by us of a related person. In reviewing and approving any such transactions, our audit committee is tasked to consider all relevant facts and circumstances, including, but not limited to (i) whether the transaction is on terms comparable to those that could be obtained in an arm’s length transaction with an unrelated party; (ii) the extent of the related person’s interest in the transaction; (iii) the benefits to the Company; (iv) the impact on a director’s independence in the event the related person is a director, an immediately family member of a director or an entity in which a director is a partner, shareholder or executive officer; (v) the availability of other sources for comparable products or services; (vi) the terms of the transaction; and (vii) the terms available to unrelated third parties.
All related-party transactions may only be consummated if our audit committee has approved or ratified such transaction in accordance with the guidelines set forth in the policy. Any member of the audit committee who is a related person with respect to a transaction under review will not be permitted to participate in the deliberations or vote respecting approval or ratification of the transaction. However, such director may be counted in determining the presence of a quorum at a meeting of the audit committee that considers the transaction. All of the transactions described in this section occurred prior to the adoption of this policy.
117
DESCRIPTION OF CERTAIN INDEBTEDNESS
The following is a summary of certain of our indebtedness that is currently outstanding. The following descriptions do not purport to be complete and are qualified in their entirety by reference to the agreements and related documents referred to herein, copies of which have been filed as exhibits to the registration statement of which this prospectus forms a part.
Convertible Promissory Notes
In April 2022, we issued $10.5 million of unsecured Convertible Promissory Notes, as amended on (the “Notes”), which bear interest at an annual rate of 6.0%, paid in kind in shares of our common stock, and have a maturity date of June 30, 2024.
Conversion. The Notes will automatically convert into shares of common stock upon a “qualified equity financing” or upon a change of control. A “Qualified Equity Financing” is defined as the offer and sale for cash of any equity securities that results in aggregate gross proceeds to us of at least $ . A Change of Control is defined as (i) the sale or disposition of all or substantially all of our assets to a third party; (ii) the acquisition by a third party of more than 50% of our outstanding voting capital stock; or (iii) the merger or consolidation of us with or into a third party, unless the holders of our voting capital stock hold at least 50% of the voting capital stock of the acquiring third party or the surviving entity immediately after the merger or consolidation.
Upon a Qualified Equity Financing , the Notes will convert at the lesser of (i) the price per share calculated by dividing $60.0 million by the fully diluted capitalization at the time of conversion (the “Conversion Cap”); or (ii) 80% of the price paid per share paid by the cash investors in the Qualified Equity Financing. The Notes will also convert upon the closing of a Change of Control into shares of Common Stock at a conversion price equal to the lesser of the Conversion Cap and 80% of the price per share paid to the holders of our common stock set forth in the definitive agreement pursuant to which the Change of Control occurs.
Prepayment. We may not prepay the Notes without the prior written consent of the holders of a majority of the outstanding aggregate principal of the Notes.
Events of Default. For the borrowings under the Notes, an Event of Default consists of one or more of the following:
|
• |
Our failure to pay any obligation in excess of $100,000, either individually or in the aggregate, when the same becomes due and payable and such failure continues after the applicable grace period, if any, specified in the agreement or instrument giving rise to such obligation or obligations; or |
|
• |
Our failure to perform or observe in all material respects any of our covenants or agreements in the Notes and the failure continues for 10 days after our knowledge of such failure or our receipt by a holder of written notice of such failure. |
118
General
As of the closing of this offering our authorized capital stock will consist of 100,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
We are selling shares of common stock in this offering ( shares if the underwriters exercises their over-allotment option in full). All shares of our common stock outstanding upon consummation of this offering will be fully paid and non-assessable.
Based upon the assumed initial public offering price of $ per share, the midpoint of the estimated price range set forth on the cover page of this prospectus, and after giving effect to the Preferred Conversion and the Notes Conversion, as of the closing of this offering, there will be shares of our common stock outstanding held by stockholders of record, and no shares of our preferred stock outstanding.
The following description of our capital stock and provisions of our Amended Charter and Amended Bylaws, which will become effective in connection with this offering, are summaries and are qualified by reference to the Amended Charter and Amended Bylaws that will become effective prior to the pricing of this offering. Copies of these documents will be filed with the SEC as exhibits to our registration statement, of which this prospectus forms a part. The description of our capital stock reflects changes to our capital structure that will occur upon the closing of this offering.
Common Stock
Holders of shares of our common stock are entitled to one vote for each share held of record on all matters on which stockholders are entitled to vote generally, including the election or removal of directors elected by our stockholders generally. The holders of our common stock do not have cumulative voting rights in the election of directors.
Holders of shares of our common stock are entitled to receive dividends when, as and if declared by our board of directors out of funds legally available therefor, subject to any statutory or contractual restrictions on the payment of dividends and to any restrictions on the payment of dividends imposed by the terms of any outstanding preferred stock.
Upon our liquidation, dissolution or winding up and after payment in full of all amounts required to be paid to creditors and to the holders of preferred stock having liquidation preferences, if any, the holders of shares of our common stock will be entitled to receive our remaining assets available for distribution on a pro rata basis.
All shares of our common stock that will be outstanding at the time of the consummation of the offering will be fully paid and non-assessable. The common stock will not be subject to further calls or assessments by us. Holders of shares of our common stock do not have preemptive, subscription, redemption or conversion rights. There will be no redemption or sinking fund provisions applicable to the common stock. The rights powers, preferences and privileges of our common stock will be subject to those of the holders of any shares of our preferred stock or any other series or class of stock we may authorize and issue in the future.
Warrants
Series A Placement Agent Warrants
In connection with our Series A Preferred Financing, we issued to our placement agent in the Series A Preferred Financing warrants to purchase 525,049 shares of our common stock, or 7% of the number of shares of common stock underlying the Series A Preferred Stock sold in the offering (the “Series A Placement Agent Warrants”) at an exercise price equal to $1.61 per share, or 120% of the price per share of Series A Preferred Stock paid by investors in the Series A Preferred Financing. The Series A Placement Agent Warrants provide for a cashless exercise right and are exercisable for a period of five years from December 22, 2020.
Convertible Note Placement Agent Warrants
In connection with the issuance of the Notes, we paid to the placement agent for the offering a cash fee of equal to 7% of the gross proceeds raised in the Notes offering and we issued warrants to purchase shares of our common stock in an amount equal to 7% of the aggregate number of shares of common stock issuable upon the conversion of the Notes issued in the offering (the “Note Placement Agent Warrants”). The Note Placement Agent Warrants have a term of five years from the date of issuance, an exercise price equal to 120% of the per share price paid by investors in the Qualified Equity Financing, and contain the ability to be exercised on a cashless in certain circumstances. A “Qualified Equity Financing” means the offer and sale for cash of any of our equity securities and that results in aggregate gross proceeds to us of at least $20.0 million.
119
Preferred Stock
No shares of preferred stock will be issued or outstanding immediately after the offering contemplated by this prospectus. Our Amended Charter authorizes our board of directors to establish one or more series of preferred stock (including convertible preferred stock). Unless required by law or any stock exchange, the authorized shares of preferred stock will be available for issuance without further action by the holders of our common stock. Our board of directors is able to determine, with respect to any series of preferred stock, the powers (including voting powers), preferences and relative, participating, optional or other special rights, and the qualifications, limitations or restrictions thereof, including, without limitation:
|
• |
the designation of the series; |
|
• |
the number of shares of the series, which our board of directors may, except where otherwise provided in the preferred stock designation, increase (but not above the total number of authorized shares of the class) or decrease (but not below the number of shares then outstanding); |
|
• |
whether dividends, if any, will be cumulative or non-cumulative and the dividend rate of the series; |
|
• |
the dates at which dividends, if any, will be payable; |
|
• |
the redemption or repurchase rights and price or prices, if any, for shares of the series; |
|
• |
the terms and amounts of any sinking fund provided for the purchase or redemption of shares of the series; |
|
• |
the amounts payable on shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding-up of our affairs; |
|
• |
whether the shares of the series will be convertible into shares of any other class or series, or any other security, of us or any other entity, and, if so, the specification of the other class or series or other security, the conversion price or prices or rate or rates, any rate adjustments, the date or dates as of which the shares will be convertible and all other terms and conditions upon which the conversion may be made; |
|
• |
restrictions on the issuance of shares of the same series or of any other class or series; and |
|
• |
the voting rights, if any, of the holders of the series. |
We could issue a series of preferred stock that could, depending on the terms of the series, impede or discourage an acquisition attempt or other transaction that some, or a majority, of the holders of our common stock might believe to be in their best interests or in which the holders of our common stock might receive a premium over the market price of the shares of our common stock. Additionally, the issuance of preferred stock may adversely affect the rights of holders of our common stock by restricting dividends on the common stock, diluting the voting power of the common stock or subordinating the liquidation rights of the common stock. As a result of these or other factors, the issuance of preferred stock could have an adverse impact on the market price of our common stock.
Registration Rights
The IRA provides that certain holders of our Series A Preferred Stock and Convertible Promissory Notes, including, but not limited to, certain holders of at least 5% of our capital stock and entities affiliated with certain of our directors and officers, have certain registration rights, as set forth below. The registration rights set forth in the IRA will expire one year following the completion of this offering, or, with respect to any particular stockholder, when such stockholder is able to sell all of its shares pursuant to Rule 144 of the Securities Act during any 90-day period. We will pay the registration expenses (other than underwriting discounts and commissions) of the holders of the shares registered pursuant to the registrations described below. The IRA does not provide for any maximum cash penalties or any penalties connected with delays in registering the resale of these shares of our common stock.
In connection with this offering, we expect that each stockholder that has registration rights will agree not to sell or otherwise dispose of any securities without the prior written consent of the Representative for a period of 180 days after the date of this prospectus, subject to certain terms and conditions and early release of certain holders in specified circumstances. See “Shares Eligible for Future Sale—Lock-Up Agreements” for additional information regarding such restrictions.
Demand Registration Rights
After the completion of this offering, the holders of an aggregate of shares of our common stock will be entitled to certain demand registration rights. At any time beginning on the earlier of December 22, 2023 and six months after the effective date of this registration statement, the holders of at least 50% of our then-outstanding shares of common stock entitled to certain demand registration rights may request that we register the resale of all or a portion of their shares. Such request for registration must cover securities the aggregate offering price of which, after payment of underwriting discounts and commissions, would exceed $5,000,000. We will not be required to effect more than two registrations on Form S-1 within any 12-month period.
120
Piggyback Registration Rights
After the completion of this offering, in the event that we propose to register the offering and sale of any of our securities under the Securities Act, either for our own account or for the account of other security holders, in connection with such offering the holders of an aggregate of shares of our common stock will be entitled to certain piggyback registration rights allowing the holder to include their shares in such registration, subject to certain marketing and other limitations. As a result, whenever we propose to file a registration statement under the Securities Act, other than with respect to (i) a registration relating to the sale of securities to service providers of the company or a subsidiary pursuant to a stock option, stock purchase 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 (as defined in the IRA) or (iv) a registration in which the only offering being registered is of common stock issuable upon conversion of debt securities that are also being registered, the holders of these shares are entitled to notice of the registration and have the right, subject to certain limitations, to include their shares in the registration. In an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions, to limit the number of shares such holders may include.
Registration on Form S-3
After the completion of this offering, the holders of an aggregate of shares of our common stock will be entitled to certain Form S-3 registration rights. The holders of at least 30% of our shares of common stock entitled to certain Form S-3 registration rights can make a request that we register the offering and sale of their shares on Form S-3 if we are qualified to file a registration statement on Form S-3 and if the reasonably anticipated aggregate gross proceeds of the shares offered would equal or exceed $3,000,000. We will not be required to effect more than two registrations on Form S-3.
Expiration of Registration Rights
The registration rights granted under the IRA will terminate after the earlier of the first anniversary of the completion of this offering, or with respect to any holder of registrable securities, the date on which all of such holder’s shares can be sold without registration in reliance on Rule 144 under the Securities Act.
Annual Stockholder Meetings
Our Amended Bylaws will provide that annual stockholder meetings will be held at a date, time and place as designated by our board of directors, the chairman of our board of directors, or our chief executive officer. To the extent permitted under applicable law, we may conduct meetings by remote communications, including by webcast.
Anti-Takeover Effects of Our Amended and Restated Certificate of Incorporation and Amended Bylaws and Certain Provisions of Delaware Law
Our Amended Charter, Amended Bylaws and the DGCL will contain provisions that are intended to enhance the likelihood of continuity and stability in the composition of our board of directors. These provisions are intended to avoid costly takeover battles, reduce our vulnerability to a hostile or abusive change of control and enhance the ability of our board of directors to maximize stockholder value in connection with any unsolicited offer to acquire us. However, these provisions may have an anti-takeover effect and may delay, deter or prevent a merger or acquisition of our company by means of a tender offer, a proxy contest or other takeover attempt that a stockholder might consider in its best interest, including those attempts that might result in a premium over the prevailing market price for the shares of common stock held by stockholders.
Authorized but Unissued Capital Stock
Upon completion of this offering, we will have shares of capital stock authorized under our Amended Charter, consisting of shares of common stock with a par value of $0.0001 per share and shares of preferred stock with a par value of $0.0001 per share. As of the date of this prospectus, after giving effect to the automatic conversion of all of our outstanding shares of preferred stock into an aggregate of shares of our common stock and the conversion of our outstanding Notes into an aggregate of shares of common stock upon the closing of this offering, there will be shares of common stock outstanding. In addition, as of the date of this prospectus, we had outstanding options to purchase an aggregate of shares of our common stock under the Amended and Restated Equity Plan, at a weighted average exercise price equal to $per share. Our authorized but unissued shares of common stock and preferred stock are available for issuance without further action by our stockholders, unless such action is required by applicable law or the rules of any stock exchange or automated quotation system on which our securities may be listed or traded in the future.
121
Potential Effects of Authorized but Unissued Stock
Pursuant to our Amended Charter that will become effective upon the closing of this offering, we will have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.
The existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest extent permissible under the Delaware General Corporation Law and subject to any limitations set forth in our certificate of incorporation. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions 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 acquiring, a majority of our outstanding voting stock.
Business Combinations
We are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the following exceptions:
|
• |
before such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; |
|
• |
upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
|
• |
on or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. |
In general, Section 203 defines “business combination” to include the following:
|
• |
any merger or consolidation involving the corporation and the interested stockholder; |
|
• |
any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
|
• |
subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
|
• |
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; or |
|
• |
the receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or through the corporation. |
In general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s affiliates and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own, 15% or more of the outstanding voting stock of the corporation.
No Cumulative Voting
Under Delaware law, the right to vote cumulatively does not exist unless the certificate of incorporation specifically authorizes cumulative voting. Our Amended Charter does not authorize cumulative voting. Therefore, stockholders holding a majority of the shares of our stock entitled to vote generally in the election of directors will be able to elect all our directors.
122
Special Stockholder Meetings
Our Amended Charter will provide that special meetings of our stockholders may be called at any time only by or at the direction of the board of directors, the chairman of the board of directors or our chief executive officer. Our Amended Bylaws prohibit the conduct of any business at a special meeting other than as specified in the notice for such meeting. These provisions may have the effect of deferring, delaying, or discouraging hostile takeovers, or changes in control or management of our company.
Director Nominations and Stockholder Proposals
Our Amended Bylaws establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors. In order for any matter to be “properly brought” before a meeting, a stockholder will have to comply with advance notice requirements and provide us with certain information. Generally, to be timely, a stockholder’s notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the immediately preceding annual meeting of stockholders. However, in the event that the date of the annual meeting is more than 30 days before or more than 70 days after the anniversary date, notice by the stockholder must be delivered not earlier than the close of business on the 120th day prior to the annual meeting and not later than the close of business on the later of the 90th day prior to the annual meeting or the 10th day following the day on which public announcement of the date of the meeting is first made by us.
Our Amended Bylaws also specify requirements as to the form and content of a stockholder’s notice. Our Amended Bylaws allow the chairman of the meeting at a meeting of the stockholders to adopt rules and regulations for the conduct of meetings that may have the effect of precluding the conduct of certain business at a meeting if the rules and regulations are not followed. These provisions may also defer, delay, or discourage a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to influence or obtain control of the company.
Amendment of Amended and Restated Certificate of Incorporation or Bylaws
The DGCL provides generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s certificate of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as the case may be, requires a greater percentage. Upon consummation of this offering, our bylaws may be amended or repealed by a majority vote of our board of directors or by the affirmative vote of the holders of at least 66 2/3% of the votes which all our stockholders would be entitled to cast in any annual election of directors. In addition, the affirmative vote of the holders of at least 66 2/3% of the votes which all our stockholders would be entitled to cast in any election of directors will be required to amend or repeal or to adopt any provisions inconsistent with any of the provisions of our certificate described above.
The foregoing provisions of our Amended Charter and Amended Bylaws could discourage potential acquisition proposals and could delay or prevent a change in control. These provisions are intended to enhance the likelihood of continuity and stability in the composition of our board of directors and in the policies formulated by our board of directors and to discourage certain types of transactions that may involve an actual or threatened change of control. These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal. The provisions also are intended to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect of discouraging others from making tender offers for our shares and, as a consequence, they also may inhibit fluctuations in the market price of our shares of common stock that could result from actual or rumored takeover attempts. Such provisions also may have the effect of preventing changes in our management or delaying or preventing a transaction that might benefit you or other minority stockholders.
Dissenters’ Rights of Appraisal and Payment
Under the DGCL, with certain exceptions, our stockholders will have appraisal rights in connection with a merger or consolidation of us. Pursuant to the DGCL, stockholders who properly request and perfect appraisal rights in connection with such merger or consolidation will have the right to receive payment of the fair value of their shares as determined by the Delaware Court of Chancery.
123
Stockholders’ Derivative Actions
Under the DGCL, any of our stockholders may bring an action in our name to procure a judgment in our favor, also known as a derivative action, provided that the stockholder bringing the action is a holder of our shares at the time of the transaction to which the action relates or such stockholder’s stock thereafter devolved by operation of law.
Choice of Forum
Our Amended Charter will provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for any stockholder 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 current or former director, officer or other employee of the Company or the Company’s stockholders, (iii) any action asserting a claim against the Company or any director or officer of the Company arising pursuant to, or a claim against the Company or any director or officer of the Company, with respect to the interpretation or application of any provision of, the DGCL, our certificate of incorporation or bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine, except for, in each of the aforementioned actions, any claims to which the Court of Chancery of the State of Delaware determines it lacks jurisdiction. This provision will not apply to claims arising under the Exchange Act, or for any other federal securities laws which provide for exclusive federal jurisdiction. However, the exclusive forum provision provides that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Therefore, this provision could apply to a suit that falls within one or more of the categories enumerated in the exclusive forum provision and that asserts claims under the Securities Act, inasmuch as Section 22 of the Securities Act 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. There is uncertainty as to whether a court would enforce such an exclusive forum provision with respect to claims under the Securities Act.
We note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.
Officers and Directors
The DGCL authorizes corporations to limit or eliminate the personal liability of directors to corporations and their stockholders for monetary damages for breaches of directors’ fiduciary duties, subject to certain exceptions. Our Amended Charter includes a provision that eliminates the personal liability of directors for monetary damages to the corporation or its stockholders for any breach of fiduciary duty as a director, except to the extent such exemption from liability or limitation thereof is not permitted under the DGCL. The effect of these provisions is to eliminate the rights of us and our stockholders, through stockholders’ derivative suits on our behalf, to recover monetary damages from a director for breach of fiduciary duty as a director, including breaches resulting from grossly negligent behavior. However, exculpation does not apply to any breaches of the director’s duty of loyalty, any acts or omissions not in good faith or that involve intentional misconduct or knowing violation of law, any authorization of dividends or stock redemptions or repurchases paid or made in violation of the DGCL, or for any transaction from which the director derived an improper personal benefit.
Our Amended Bylaws generally provide that we must indemnify and advance expenses to our directors and officers to the fullest extent authorized by the DGCL. We also are expressly authorized to carry directors’ and officers’ liability insurance providing indemnification for our directors, officers and certain employees for some liabilities. We believe that these indemnification and advancement provisions and insurance are useful to attract and retain qualified directors and executive officers.
The limitation of liability, indemnification and advancement provisions in our Amended Charter and Amended Bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duty.
These provisions also may have the effect of reducing the likelihood of derivative litigation against directors and officers, even though such an action, if successful, might otherwise benefit us and our stockholders. In addition, your investment may be adversely affected to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
There is currently no pending material litigation or proceeding involving any of our directors, officers or employees for which indemnification is sought.
124
Indemnification Agreements
We will enter into an indemnification agreement with each of our directors and executive officers as described in “Certain Relationships and Related Person Transactions—Indemnification of Officers and Directors.” Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors or executive officers, we have been informed that in the opinion of the SEC such indemnification is against public policy and is therefore unenforceable.
Transfer Agent and Registrar
The transfer agent and registrar for shares of our common stock will be Computershare Shareowner Services.
Listing
We have applied to list our common stock on the Nasdaq Capital Market under the symbol “COYA.”
125
U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR NON-U.S. HOLDERS
The following is a summary of U.S. federal income tax considerations generally applicable to the ownership and disposition of our common stock by a Non-U.S. Holder (as defined below) that acquires such stock in this offering and that holds such stock as a capital asset (generally, property held for investment). This summary does not address all aspects of U.S. federal income taxation that may be relevant to a particular Non-U.S. Holder in light of its individual circumstances or the U.S. federal income tax consequences applicable to Non-U.S. Holders that are subject to special rules, such as controlled foreign corporations, passive foreign investment companies, corporations that accumulate earnings to avoid U.S. federal income tax, banks or other financial institutions, tax-exempt organizations (including private foundations), U.S. expatriates, broker-dealers and traders in securities or currencies, or Non-U.S. Holders that hold common stock as part of a “straddle,” “hedge,” “conversion transaction,” or other integrated investment.
This summary is based on provisions of the Code, U.S. Treasury Regulations promulgated thereunder, and administrative and judicial interpretations thereof, all as in effect on the date hereof, and all of which are subject to change or differing interpretation, possibly with retroactive effect. This summary does not describe any U.S. state, local or Non-U.S. income or other tax consequences (including estate, gift and Medicare contribution tax consequences) of owning and disposing of our common stock.
For purposes of this summary, the term “Non-U.S. Holder” means a beneficial owner of our common stock that is, for U.S. federal income tax purposes, neither a partnership nor an entity or arrangement treated as a partnership for U.S. federal income tax purposes nor any of the following:
|
• |
a citizen or individual resident of the United States; |
|
• |
a corporation, or other entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States or any political subdivision thereof; |
|
• |
an estate the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or |
|
• |
a trust if (a) a United States court is able to exercise primary supervision over the trust’s administration and one or more U.S. persons have the authority to control all of the trust’s substantial decisions, or (b) the trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S. person. |
If a partnership (including any 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 such partnership will generally depend upon the status of the partner and the activities of the partnership. Partnerships and their partners should consult their tax advisers as to the U.S. federal income tax consequences to them of an investment in our common stock in their particular circumstances.
EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS TAX ADVISER REGARDING THE U.S. FEDERAL, STATE, LOCAL, AND NON-U.S. INCOME AND OTHER TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK.
Distributions
Distributions on our common stock will generally be treated as dividends to the extent such distributions are paid from our current or accumulated earnings and profits as determined for U.S. federal income tax purposes. Any such distributions in excess of our current and accumulated earnings and profits will be treated first as a return of capital to the extent of the holder’s adjusted tax basis in our common stock and thereafter as capital gain from the sale or exchange of such common stock.
The gross amount of dividends paid to a Non-U.S. Holder with respect to our common stock will generally be subject to U.S. federal withholding tax at a rate of 30% (or such lower rate as may be prescribed by an applicable income tax treaty), unless the dividends are effectively connected with the Non-U.S. Holder’s conduct by the Non-U.S. Holder of a trade or business within the United States (and, if required by an applicable income tax treaty, are attributable to a permanent establishment maintained by such Non-U.S. Holder in the United States). Dividends effectively connected with a Non-U.S. Holder’s conduct of a U.S. trade or business (and, if required by an applicable income tax treaty, attributable to a U.S. permanent establishment) will generally not be subject to U.S. withholding tax if the Non-U.S. Holder complies with applicable certification and disclosure requirements (generally, by providing an IRS Form W-8ECI (or appropriate successor or replacement forms)).
Instead, such dividends generally will be subject to U.S. federal income tax on a net income basis in the same manner in which citizens and residents of the United States are subject to U.S. federal income tax. Corporate Non-U.S. Holders may be subject to an additional “branch profits tax” at a rate of 30% (or such lower rate as may be specified by an applicable income tax treaty) on its “effectively connected earnings and profits,” subject to certain adjustments.
An eligible Non-U.S. Holder may obtain a reduced rate of withholding under an applicable income tax treaty by providing a properly executed IRS Form W-8BEN or IRS Form W-8BEN-E (or any appropriate successor or replacement forms), as applicable, certifying that it is not a U.S. person as defined under the Code and that it is entitled to benefits under the treaty or, if such Non-U.S. Holder’s common stock is held through certain foreign intermediaries or foreign partnerships, by satisfying the relevant certification requirements of applicable Treasury regulations.
126
A Non-U.S. Holder eligible for a reduced rate of or exemption from U.S. federal withholding tax 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 advisers regarding their entitlement to benefits under an applicable income tax treaty and the specific manner of claiming the benefits of the treaty.
Sale, exchange, or other taxable disposition
A Non-U.S. Holder will generally not be subject to U.S. federal income or withholding tax with respect to gain recognized on the sale, exchange, or other taxable disposition of our common stock unless
|
(i) |
the gain is effectively connected with such Non-U.S. Holder’s conduct of a trade or business within the United States (and, if required by an applicable tax treaty, is attributable to a permanent establishment maintained by such Non-U.S. Holder in the United States), in which case, the Non-U.S. Holder will be subject to U.S. federal income tax on such gain on a net income basis in the same manner in which citizens or residents of the United States are subject to U.S. federal income tax and, in the case of corporate Non-U.S. Holders, may also be subject to an additional “branch profits tax” at a rate of 30% (or such lower rate as may be specified by an applicable income tax treaty); |
|
(ii) |
in the case of a Non-U.S. Holder that is a non-resident alien individual, such Non-U.S. Holder is present in the United States for 183 or more days in the taxable year of disposition and certain other conditions are met, in which case the Non-U.S. Holder will generally be subject to a flat income tax at a rate of 30% (or lower applicable treaty rate) on any capital gain recognized on the disposition of our common stock, which may be offset by certain U.S. source capital losses; or |
|
(iii) |
we are or have been a “United States real property holding corporation” (“USRPHC”) for U.S. federal income tax purposes at any time within the shorter of the five-year period ending on the date of such sale, exchange, or other taxable disposition or the period that such Non-U.S. Holder held our common stock and either (a) our common stock was not treated as regularly traded on an established securities market at any time during the calendar year in which the sale, exchange, or other taxable disposition occurs, or (b) such Non-U.S. Holder owns or owned (actually or constructively) more than 5% of our common stock at any time during the shorter of the two periods mentioned above. We believe it is not, has not been and does not anticipate becoming a USRPHC for U.S. federal income tax purposes. |
Foreign account tax compliance act (“FATCA”)
Provisions of the Code commonly known as “FATCA” may require withholding at a rate of 30% on dividends in respect of our common stock held by or through certain foreign financial institutions (including investment funds), unless such institution (i) enters into, and complies with, an agreement with the Treasury Department to report, on an annual basis, information with respect to interests in, and accounts maintained by, the institution to the extent such interests or accounts are held by certain U.S. persons and by certain non-U.S. entities that are wholly or partially owned by U.S. persons and to withhold on certain payments or (ii) complies with an intergovernmental agreement between the United States and an applicable foreign country to report such information to its local tax authority, which will exchange such information with the U.S. authorities. An intergovernmental agreement between the United States and an applicable foreign country may modify these requirements. Accordingly, the entity through which our common stock is held will affect the determination of whether such withholding is required. Similarly, dividends in respect of our common stock held by an investor that is a non-financial non-U.S. entity that does not qualify under certain exemptions will be subject to withholding at a rate of 30%, unless such entity either (i) certifies that such entity does not have any “substantial United States owners” or (ii) provides certain information regarding the entity’s “substantial United States owners,” which we or the applicable withholding agent will in turn provide to the Treasury Department. We will not pay any additional amounts to holders in respect of any amounts withheld. Prospective investors should consult their tax advisors regarding the possible implications of this withholding tax on an investment in our common stock.
THIS DISCUSSION OF U.S. FEDERAL INCOME TAX CONSIDERATIONS IS NOT INTENDED TO BE, AND SHOULD NOT BE CONSTRUED AS, TAX ADVICE. THE FOREGOING SUMMARY IS NOT A SUBSTITUTE FOR A SPECIFIC ANALYSIS OF THE TAX CONSIDERATIONS APPLICABLE TO A PROSPECTIVE HOLDER OF THE OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK, WHICH ANALYSIS MAY BE COMPLEX AND WILL DEPEND ON THE HOLDER’S SPECIFIC SITUATION. EACH PROSPECTIVE HOLDER SHOULD CONSULT A TAX ADVISOR REGARDING THE PARTICULAR FEDERAL, STATE, LOCAL, AND NON-U.S. TAX CONSIDERATIONS APPLICABLE TO PROSPECTIVE HOLDERS OF THE OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK.
127
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our common stock. No prediction is made as to the effect, if any, future sales of shares, or the availability for future sales of shares, will have on the market price of our common stock prevailing from time to time. The sale of substantial amounts of our common stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of our common stock.
Upon consummation of this offering, we will have outstanding shares of common stock (or shares of common stock if the underwriters’ option to purchase additional shares of common stock is exercised in full). The shares of common stock sold in this offering will be freely tradable without restriction or further registration under the Securities Act, except for any common stock held by our “affiliates,” as defined in Rule 144, which would be subject to the limitations and restrictions described below.
The remaining shares of common stock will be “restricted securities” under Rule 144.
Subject to the lock-up agreements described below and the provisions of Rule 144 and 701 under the Securities Act, these restricted securities will be available for sale in the public market as follows:
Date Available for Sale |
Shares Eligible for Sale |
Description |
Date of Prospectus |
|
Shares sold in the offering that are not subject to a lock-up |
90 Days after Date of Prospectus |
|
Shares held for at least six months and are saleable under Rules 144 and 701 that are not subject to a lock-up |
180 Days after Date of Prospectus |
|
Lock-up released; shares saleable under Rules 144 and 701 |
In addition, of the 398,199 shares of our common stock that are issuable upon the exercise of stock options outstanding as of the date of this prospectus, 205,738 options to purchase shares of common stock were exercisable as of that date, and upon exercise these shares will be eligible for sale subject to the lock-up agreements described below and/or Rules 144 and 701 under the Securities Act.
Registration Statement on Form S-8
We intend to file one or more registration statements on Form S-8 under the Securities Act to register shares of our common stock or securities convertible into or exchangeable for shares of our common stock issued pursuant to our 2021 Equity Plan. Any such registration statement on Form S-8 will automatically become effective upon filing. Accordingly, shares of common stock registered under such registration statement will be available for sale in the open market, subject to any vesting restrictions or the lock-up restrictions and Rule 144 limitations applicable to affiliates described below.
Registration Rights
Pursuant to our IRA, after the completion of this offering, the holders of up to shares of our common stock, or certain transferees, will be entitled to certain rights with respect to the registration of the offer and sale of those shares under the Securities Act. See “Description of Capital Stock—Registration Rights” for a description of these registration rights. If the offer and sale of these shares of our Common Stock are registered, the shares will be freely tradable without restriction under the Securities Act, subject to the Rule 144 limitations applicable to affiliates, and a large number of shares may be sold into the public market.
Lock-Up of Our Common Stock
Pursuant to a Lock-Up Agreement (the “Lock-Up Agreement”), we, all of our directors and officers, and holders of substantially all of our outstanding common stock, have agreed with the underwriters, subject to certain exceptions, not to (i) offer, sell, contract to sell, pledge, grant any option to purchase, lend or otherwise dispose of any shares of common stock, or any options or warrants to purchase any shares of common stock or any securities convertible into, exchangeable for or that represent the right to receive shares of common stock (such options, warrants or other securities, collectively, “Derivative Instruments”), including without limitation any such shares or Derivative Instruments now owned or hereafter acquired; (ii) engage in any hedging or other transaction or arrangement (including, without limitation, any short sale or the purchase or sale of, or entry into, any put or call option, or combination thereof, forward, swap or any other derivative transaction or instrument, however described or defined) which is designed to or which reasonably could be expected to lead to or result in a sale, loan, pledge or other disposition or transfer of any of the economic consequences of ownership, in whole or in part, directly or indirectly, of any shares of common stock or Derivative Instruments, whether any such transaction or arrangement (or instrument provided for thereunder) would be settled by delivery of common stock or other securities, in cash or otherwise (any such sale, loan, pledge or other disposition, or transfer of economic consequences, a “Transfer”) or (iii) otherwise publicly announce any intention to engage in or cause any action or activity described in clause (i) above or transaction or arrangement
128
described in clause (ii) above during the period from the date of this prospectus continuing through the date 180 days after the date of this prospectus (the “Lock-Up Period”), except with the prior written consent of the underwriters. Currently, the underwriters have no current intention to release the aforementioned holders of our common stock from the lock-up restrictions described above. Our Lock-Up Agreement will provide for certain exceptions. See “Underwriting.”
Rule 144
In general, under Rule 144 as currently in effect, once we have been subject to the public company reporting requirements of Section 13 or Section 15(d) of the Exchange Act for at least 90 days, a person who is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days preceding a sale and who has beneficially owned the shares of our common stock proposed to be sold for at least six months is entitled to sell those shares without complying with the manner of sale, volume limitation or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares of common stock proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person would be entitled to sell those shares of common stock without complying with any of the requirements of Rule 144.
In general, under Rule 144, as currently in effect, our affiliates or persons selling shares of our common stock on behalf of our affiliates are entitled to sell upon expiration of the Lock-Up Agreements described above, within any three-month period, a number of shares of common stock that does not exceed the greater of:
|
• |
1% of the number of shares of our common stock then outstanding, which will equal approximately shares of our common stock immediately after this offering assuming no exercise of the underwriters’ over-allotment option; and |
|
• |
the average weekly trading volume of our common stock on the stock exchange on which our shares our listed during the four calendar weeks preceding the filing of a notice on Form 144 with respect to that sale. |
Sales under Rule 144 by our affiliates or persons selling shares of our common stock on behalf of our affiliates are also subject to certain manner-of-sale provisions and notice requirements and to the availability of current public information about us.
Rule 701
Rule 701 generally allows a stockholder who purchased shares of our capital stock pursuant to a written compensatory plan or contract and who is not deemed to have been an affiliate of our company during the immediately preceding 90 days to sell these shares in reliance upon Rule 144, but without being required to comply with the public information, holding period, volume limitation or notice provisions of Rule 144. Rule 701 also permits affiliates of our company to sell their Rule 701 shares under Rule 144 without complying with the holding period requirements of Rule 144. All holders of Rule 701 shares, however, are required to wait until 90 days after the date of this prospectus before selling those shares pursuant to Rule 701. Moreover, all Rule 701 shares are subject to Lock-Up Agreements with the underwriters as described above and in the section titled “Underwriting” and will not become eligible for sale until the expiration of those agreements.
We have entered into an underwriting agreement with Chardan Capital Markets, LLC, as representative of the several underwriters named below (the “Representative”), dated , 2022, with respect to the shares of our common stock subject to this offering. Subject to the terms and conditions in the underwriting agreement, we have agreed to sell to the underwriters, and the underwriters have agreed to purchase from us on a firm commitment basis, the number of shares of our common stock set forth opposite its name in the table below:
Underwriter |
|
Number of Shares |
Chardan Capital Markets, LLC |
|
|
Newbridge Securities Corporation |
|
|
Total |
|
|
The underwriting agreement provides that the obligation of the underwriters to purchase all of the shares being offered to the public is subject to approval of legal matters by counsel and the satisfaction of other conditions. These conditions include, among others, the continued accuracy of representations and warranties made by us in the underwriting agreement, delivery of legal opinions and the absence of any material changes in our assets, business or prospects after the date of this prospectus. The underwriters are obligated to purchase all of our shares of common stock in this offering, other than those covered by the option described below, if they purchase any of our shares of common stock.
The underwriters have advised us that they propose to offer the common stock directly to the public at the public offering prices listed on the cover page of this prospectus. In addition, the underwriters may offer some of the shares to other securities dealers at such price less a concession of $ per share. The underwriters may allow, and certain dealers may re-allow, a discount from the
129
concession not in excess of $ per share to certain brokers and dealers. After the initial offering of the common stock, the public offering price or any other term of the offering by the underwriters may be changed by the representative of the underwriters.
Pursuant to the underwriting agreement, we have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act, or to contribute to payments which the underwriters or other indemnified parties may be required to make in respect of any such liabilities.
Over-Allotment Option
In addition to the discount set forth in the above table, we have granted to the underwriters an option, exercisable not later than 30 days after the date of this prospectus, to purchase up to an additional 15% of the shares of common stock firmly committed in this offering at the public offering price, less the underwriting discount, set forth on the cover page of this prospectus. The underwriters may exercise the option solely to cover over-allotments, if any, made in connection with this offering. If any additional shares of our common stock are purchased pursuant to the over-allotment option, the underwriters will offer these additional shares of our common stock on the same terms as those on which the other shares of common stock are being offered hereby.
Commissions and Expenses
The following table provides information regarding the amount of the underwriting discounts and commissions to be paid to the underwriters by us. These amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares of common stock from us.
|
|
Per Share |
|
Total Without Option |
|
Total With Option |
Underwriting discounts and commissions paid by us(1) |
|
$ |
|
$ |
|
$ |
Proceeds, before expenses, to us |
|
$ |
|
$ |
|
$ |
(1) |
The underwriting discount is 7.0% of the gross proceeds received from the sale of shares to all purchasers in the offering. |
The estimated offering expenses payable by us, exclusive of the underwriting discounts and commissions, are approximately $ , which includes the Company’s legal, accounting and printing costs and various other fees associated with registration of the offering of our common stock. We have also agreed to reimburse the underwriters for their reasonable out-of-pocket expenses actually incurred in the offering, including fees and disbursements of legal counsel to the underwriters, in an amount up to $195,000.
Representative’s Warrants
Upon the closing of this offering, we have agreed to issue to the Representative and to Newbridge Securities Corporation (“Newbridge”) warrants, or the “representative’s warrants,” to purchase a number of shares of common stock equal to an aggregate of 7% of the total shares sold in this public offering. The representative’s warrants will be exercisable at a per share exercise price equal to 125% of the public offering price per share of common stock sold in this offering. The representative’s warrants are exercisable at any time and from time to time, in whole or in part, during the three-and-½-year period commencing six months after the effective date of the registration statement related to this offering.
The representative’s warrants and the shares of common stock underlying the representative’s 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. None of the Representative, Newbridge, or permitted assignees under such rule, may sell, transfer, assign, pledge, or hypothecate the representative’s warrants or the securities underlying the representative’s warrants, nor will the Representative or Newbridge engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the representative’s warrants or the underlying shares for a period of 180 days from the effective date of the registration statement. Additionally, the representative’s warrants may not be sold transferred, assigned, pledged or hypothecated for a 180-day period following the effective date of the registration statement except to any underwriter and selected dealer participating in this offering and their bona fide officers or partners. The representative’s warrants will provide for adjustment in the number and price of the representative’s warrants and the shares of common stock underlying such representative’s warrants in the event of recapitalization, merger, stock split or other structural transaction, or a future financing undertaken by us.
Lock-Up Agreements
Each of our officers, directors and holders of substantially all of our outstanding common stock have agreed, subject to certain exceptions, not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any securities of
130
the Company for a period of six (6) months from the date of this prospectus, without the prior written consent of the Representative. We and any of our successors have agreed that for a period of six (6) months we will not (i) 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, lend or otherwise transfer or dispose, directly or indirectly, any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of capital stock or (ii) file or cause to be filed any registration statement with the Securities and Exchange Commission relating to the offering of any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of our capital stock, other than Registration Statements on Form S-8, and subject to certain other exceptions or (iii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of capital stock of the Company, whether any such transaction described in clause (i), (ii) or (iii) above is to be settled by delivery of shares of capital stock of the Company or such other securities, in cash or otherwise.
The Representative may, in its sole discretion and at any time or from time to time, release all or any portion of the common stock or other securities subject to the lock-up agreement. Any determination to release any common stock would be based upon a number of factors at the time of determination, which may include the market price of the common stock, the liquidity of the trading market of the common stock, general market conditions, the number of shares of common stock or other securities proposed to be sold or otherwise transferred and the timing, purposes and terms of the proposed sale or other transfer. The Representative do not have any present intention, agreement or understanding, implicit or explicit, to release any of the shares of common stock or other securities subject to the lock-up agreements prior to the expiration of the lock-up period described above.
Right of First Refusal
Subject to certain conditions, we granted the Representative, for a period of 18 months after the date of this prospectus, a right of first refusal to act as book-running manager or lead placement agent, with at least 25% of the economics, for any and all future public and private equity offerings of the Company. In accordance with FINRA Rule 5110(g)(6)(A), such right of first refusal shall not have a duration of more than three years from the commencement of sales of this offering.
Stabilization
Until the distribution of shares of common stock is complete, SEC rules may limit the ability of the underwriters to bid for and purchase shares of our common stock. As an exception to these rules, underwriters are permitted to engage in certain transactions which stabilize the price of the shares of common stock, which may include short sales, covering transactions and stabilizing transactions. Short sales involve sales of shares of common stock in excess of the number of shares to be purchased by the underwriters in the offering, which creates a short position. “Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional shares of common stock from us in the offering. An underwriter may close out any covered short position by either exercising its option to purchase additional shares of common stock or purchasing shares of common stock in the open market. In determining the source of shares of common stock to close out the covered short position, an underwriter will consider, among other things, the price of shares of common stock available for purchase in the open market as compared to the share price at which the underwriters may purchase through its option to purchase additional shares. “Naked” short sales are any sales in excess of such option. The underwriters must close out any naked short position by purchasing shares of common stock in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the shares of common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of the shares of common stock made by the underwriters in the open market prior to the completion of the offering.
The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to another underwriter a portion of the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such underwriter in stabilizing or short covering transactions.
Neither we nor the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above might have on our shares of common stock. Any of these activities may have the effect of preventing or retarding a decline in the market price of our shares of common stock. They may also cause the price of the shares of common stock to be higher than the price that would otherwise exist in the open market in the absence of these transactions. If an underwriter commences any of these transactions, it may discontinue them at any time without notice.
We expect that delivery of the shares will be made to investors on or about , 2022 (such settlement being referred to as “T+2”).
In the ordinary course of their various business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (which may include bank loans and/or credit default swaps) for their own account and for the accounts of their clients and may at any time hold long and short positions in such securities and instruments. Such investments and securities activities may involve securities and/or
131
instruments of ours or our affiliates. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.
Electronic Prospectus
This prospectus may be made available in electronic format on Internet sites or through other online services maintained by the underwriters or their affiliates. In those cases, prospective investors may view offering terms online and may be allowed to place orders online. Other than this prospectus in electronic format, any information on the underwriters’ or its affiliates’ websites and any information contained in any other website maintained by the underwriters or any affiliate of any of the underwriters is not part of this prospectus or the registration statement of which this prospectus forms a part has not been approved and/or endorsed by us or the underwriters and should not be relied upon by investors.
Additional Relationships
The underwriters and their affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. The underwriters and their affiliates may provide from time to time in the future in the ordinary course of their business certain commercial banking, financial advisory, investment banking and other services to us for which they will be entitled to receive customary fees and expenses.
The validity of the issuance of the shares of common stock offered hereby will be passed upon for us by Lowenstein Sandler LLP, New York, New York. McGuireWoods LLP, New York, New York, is representing the underwriters.
Our financial statements as of December 31, 2020 and 2021 appearing in this prospectus and the related registration statement have been audited by Weaver and Tidwell, L.L.P, an independent registered public accounting firm, as set forth in their report thereon appearing elsewhere herein, and are included in reliance on such report given on the authority of such firm as experts in accounting and auditing.
132
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock offered by this prospectus. This prospectus, filed as part of the registration statement, does not contain all of the information set forth in the registration statement and its exhibits and schedules. You can find further information about us in the registration statement and its exhibits and schedules. Statements in this prospectus about the contents of any contract, agreement or other document are not necessarily complete and, in each instance, we refer you to the copy of such contract, agreement or document filed as an exhibit to the registration statement, with each such statement being qualified in all respects by reference to the document to which it refers. The SEC maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. You may inspect these reports and other information without charge at the SEC’s website (http://www.sec.gov).
Upon the completion of this offering, we will become subject to the informational requirements of the Exchange Act, as amended, and will be required to file periodic current reports, proxy statements and other information with the SEC. You will be able to inspect this material without charge at the SEC’s website. We intend to furnish our stockholders with annual reports containing financial statements audited by an independent accounting firm.
In addition, following the completion of this offering, we will make the information filed with or furnished to the SEC available free of charge through our website (http://www.coyatherapeutics.com) as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The information contained in, or that can be accessed through, our website is not incorporated by reference and is not part of this prospectus.
133
COYA THERAPEUTICS, INC.
Index to Audited Financial Statements
|
Page |
F-2 |
|
Balance Sheets as of December 31, 2020 and December 31, 2021 |
F-4 |
F-5 |
|
F-6 |
|
F-7 |
|
F-8 |
Index to Condensed Unaudited Interim Financial Statements
|
Page |
Condensed Balance Sheets as of December 31, 2021 and September 30, 2022 (Unaudited) |
F-22 |
F-23 |
|
F-24 |
|
F-25 |
|
F-26 |
F-1
Report of Independent Registered Public Accounting Firm
Board of Directors and Shareholders
Coya Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Coya Therapeutics, Inc. as of December 31, 2020 and 2021, and the related statements of operations, stockholders’ equity, and cash flows for the period from April 30, 2020 (date of inception) to December 31, 2020 and the year ended December 31, 2021, 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 Coya Therapeutics, Inc. as of December 31, 2020 and 2021, and the results of its operations and its cash flows for the period ended December 31, 2020 and the year ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the entity will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred losses and negative cash flows from operations since inception, and will require substantial additional financing to fund its operations and to commercially develop its product candidates. These factors raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the entity’s management. Our responsibility is to express an opinion on Coya Therapeutics, Inc.’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 Coya Therapeutics, Inc. 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 auditing standards of the Public Company Accounting Oversight Board (United States) and in accordance with auditing standards generally accepted in the United States of America. 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. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, 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. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current year audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) related to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Grant Date Fair Value of Stock Options Granted – Refer to Note 10 of the financial statements
Critical Accounting Matter Description
The Company issued stock options to employees, directors and consultants as compensation for services rendered, or to be rendered. The Company estimated the grant date fair value of the stock options issued, which is in part, based on the fair value of the Company’s common shares on the grant date. As there was no liquid market for the Company’s securities, management was required to estimate the fair value of the common shares. Determination of the related value required certain estimates and significant assumptions, including an appropriate discount for lack of marketability.
F-2
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the accounting for the transaction included the following:
|
• |
We obtained an understanding of the design and implementation of management’s controls around the issuance of the stock options and related valuation. |
|
• |
The valuation of the common shares was based on a valuation analysis prepared by a third party specialist engaged by management. We obtained and evaluated management’s analysis, and performed audit procedures that included, among others, assessing the completeness of the awards granted and evaluating the methodologies used to estimate the fair value of the awards granted and the significant assumptions described above. Our procedures also included evaluating the key terms and conditions of awards granted to assess the accounting treatment for a sample of awards and testing the clerical accuracy of the calculation of the expense recorded. Additionally, for certain awards issued by the Company, we involved our internal valuation specialists to assess the valuation methodologies and significant assumptions used in estimating the fair value of the awards. |
Weaver and Tidwell, L.L.P.
We have served as Coya Therapeutics, Inc.'s auditor since 2021.
Austin, Texas
March 15, 2022
F-3
|
|
December 31, |
|
|||||
|
|
2020 |
|
|
2021 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,720,834 |
|
|
$ |
4,340,178 |
|
Subscription receivable |
|
|
1,000 |
|
|
|
- |
|
Prepaids and other current assets |
|
|
27,267 |
|
|
|
244,080 |
|
Total current assets |
|
|
8,749,101 |
|
|
|
4,584,258 |
|
Fixed assets, net |
|
|
- |
|
|
|
120,671 |
|
Deferred financing costs |
|
|
- |
|
|
|
87,181 |
|
Total assets |
|
$ |
8,749,101 |
|
|
$ |
4,792,110 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
447,121 |
|
|
$ |
857,567 |
|
Accrued expenses |
|
|
- |
|
|
|
290,816 |
|
Total current liabilities |
|
|
447,121 |
|
|
|
1,148,383 |
|
Total liabilities |
|
|
447,121 |
|
|
|
1,148,383 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.0001 par value: 7,500,713 authorized, issued and outstanding as of December 31, 2020 and December 31, 2021 , respectively (liquidation value of $10,035,954 as of December 31, 2021) |
|
|
8,793,637 |
|
|
|
8,793,637 |
|
Common stock, $0.0001 par value; 30,000,000 shares authorized; 14,750,000 and 14,751,666 shares issued and outstanding as of December 31, 2020 and December 31, 2021, respectively |
|
|
1,475 |
|
|
|
1,475 |
|
Additional paid-in capital |
|
|
240,063 |
|
|
|
473,602 |
|
Accumulated deficit |
|
|
(733,195 |
) |
|
|
(5,624,987 |
) |
Total stockholders' equity |
|
|
8,301,980 |
|
|
|
3,643,727 |
|
Total liabilities and stockholders' equity |
|
$ |
8,749,101 |
|
|
$ |
4,792,110 |
|
The accompanying notes are an integral part of these financial statements.
F-4
|
|
Period From |
|
|
|
|
|
|
|
|
April 30, 2020 (Date of Inception) to |
|
|
Year Ended |
|
||
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2020 |
|
|
2021 |
|
||
Research and development |
|
$ |
23,969 |
|
|
$ |
2,542,135 |
|
In-process research and development |
|
|
225,000 |
|
|
|
- |
|
General and administrative |
|
|
445,800 |
|
|
|
2,312,042 |
|
Depreciation |
|
|
- |
|
|
|
16,133 |
|
Total operating expenses |
|
|
694,769 |
|
|
|
4,870,310 |
|
Loss from operations |
|
|
(694,769 |
) |
|
|
(4,870,310 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(38,976 |
) |
|
|
- |
|
Other income (expense), net |
|
|
550 |
|
|
|
(21,482 |
) |
Net loss |
|
$ |
(733,195 |
) |
|
$ |
(4,891,792 |
) |
Per share information: |
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.33 |
) |
Weighted-average shares of common stock outstanding, basic and diluted |
|
|
10,470,408 |
|
|
|
14,750,415 |
|
The accompanying notes are an integral part of these financial statements.
F-5
STATEMENTS OF STOCKHOLDERS’ EQUITY
|
|
Convertible Preferred Stock |
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Total |
|
|||||||
|
|
Series A |
|
|
Common Stock |
|
|
Paid-In |
|
|
Accumulated |
|
|
Stockholders' |
|
|||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity |
|
|||||||
Balance, April 30, 2020 (date of inception) |
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Common stock issued to founders |
|
|
- |
|
|
|
- |
|
|
|
10,000,000 |
|
|
|
1,000 |
|
|
|
- |
|
|
|
- |
|
|
|
1,000 |
|
Common stock issued upon Merger |
|
|
- |
|
|
|
- |
|
|
|
4,000,000 |
|
|
|
400 |
|
|
|
- |
|
|
|
- |
|
|
|
400 |
|
Common stock issued in connection with license agreement |
|
|
- |
|
|
|
- |
|
|
|
750,000 |
|
|
|
75 |
|
|
|
224,925 |
|
|
|
- |
|
|
|
225,000 |
|
Sale of Series A convertible preferred stock, net of issuance costs of $1,230,215 |
|
|
7,361,744 |
|
|
|
8,604,661 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
8,604,661 |
|
Fair value of warrants issued in conjunction with Series A convertible preferred stock |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
15,138 |
|
|
|
- |
|
|
|
15,138 |
|
Issuance of Series A convertible preferred stock upon settlement of convertible promissory notes and derivative liability |
|
|
138,969 |
|
|
|
188,976 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
188,976 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(733,195 |
) |
|
|
(733,195 |
) |
Balance as of December 31, 2020 |
|
|
7,500,713 |
|
|
|
8,793,637 |
|
|
|
14,750,000 |
|
|
|
1,475 |
|
|
|
240,063 |
|
|
|
(733,195 |
) |
|
|
8,301,980 |
|
Exercise of stock options |
|
|
- |
|
|
|
- |
|
|
|
1,666 |
|
|
|
- |
|
|
|
317 |
|
|
|
- |
|
|
|
317 |
|
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
233,222 |
|
|
|
- |
|
|
|
233,222 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,891,792 |
) |
|
|
(4,891,792 |
) |
Balance as of December 31, 2021 |
|
|
7,500,713 |
|
|
$ |
8,793,637 |
|
|
|
14,751,666 |
|
|
$ |
1,475 |
|
|
$ |
473,602 |
|
|
$ |
(5,624,987 |
) |
|
$ |
3,643,727 |
|
The accompanying notes are an integral part of these financial statements.
F-6
|
|
Period From |
|
|
|
|
|
|
|
|
April 30, 2020 (Date of Inception) to |
|
|
Year Ended |
|
||
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2020 |
|
|
2021 |
|
||
Operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(733,195 |
) |
|
$ |
(4,891,792 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Fair value of common stock issued for license agreement |
|
|
225,000 |
|
|
|
- |
|
Stock-based compensation |
|
|
- |
|
|
|
233,222 |
|
Depreciation |
|
|
- |
|
|
|
16,133 |
|
Noncash interest, including amortization of redemption feature |
|
|
38,976 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
- |
|
|
|
- |
|
Prepaids and other current assets |
|
|
(27,267 |
) |
|
|
(216,813 |
) |
Accounts payable |
|
|
105,220 |
|
|
|
665,166 |
|
Accrued expenses |
|
|
- |
|
|
|
290,816 |
|
Net cash used in operating activities |
|
|
(391,266 |
) |
|
|
(3,903,268 |
) |
Investing activities: |
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
|
- |
|
|
|
(136,804 |
) |
Net cash used in investing activities |
|
|
- |
|
|
|
(136,804 |
) |
Financing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of Series A convertible preferred stock, net of issuance costs |
|
|
8,961,700 |
|
|
|
- |
|
Proceeds from issuance of convertible notes |
|
|
150,000 |
|
|
|
- |
|
Proceeds from founders for subscription receivable |
|
|
- |
|
|
|
1,000 |
|
Proceeds from the exercise of stock options |
|
|
- |
|
|
|
317 |
|
Proceeds from Merger |
|
|
400 |
|
|
|
- |
|
Payment for Series A offerings costs |
|
|
- |
|
|
|
(341,901 |
) |
Net cash provided by (used in) financing activities |
|
|
9,112,100 |
|
|
|
(340,584 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
8,720,834 |
|
|
|
(4,380,656 |
) |
Cash and cash equivalents at beginning of period |
|
|
- |
|
|
|
8,720,834 |
|
Cash and cash equivalents at end of period |
|
$ |
8,720,834 |
|
|
$ |
4,340,178 |
|
Supplemental schedule of non-cash activities: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock offerings costs in accounts payable |
|
$ |
341,901 |
|
|
$ |
- |
|
Fair value of common stock issued for license agreement |
|
$ |
225,000 |
|
|
$ |
- |
|
Fair value of common stock warrants issued in Series A convertible preferred stock financing |
|
$ |
15,138 |
|
|
$ |
- |
|
Subscription receivable from founders |
|
$ |
1,000 |
|
|
$ |
- |
|
Deferred financing costs in accounts payable |
|
$ |
- |
|
|
$ |
87,181 |
|
The accompanying notes are an integral part of these financial statements.
F-7
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
1. Organization and description of business
Coya Therapeutics, Inc. (“Coya”, or the “Company”) is a clinical stage cell therapy company formed for the purpose of licensing intellectual properties, assisting in the research and development, and commercializing Regulatory T-Cell (“Treg”) therapies for the treatment of neurodegenerative diseases.
The Company was formed as a Delaware Corporation on November 23, 2020 for the purpose of merging with Nicoya Health, Inc. (“Nicoya”). Nicoya was formed on April 30, 2020 (date of inception). Nicoya merged with and into Coya Therapeutics, Inc. on December 22, 2020 (the “Merger”). Coya was the surviving legal entity. At the time of the Merger, there were 4,000,000 shares of Coya common stock and 10,750,000 shares of Nicoya common stock. All common stock of Nicoya was converted to common shares of Coya on a one-to-one conversion rate, and Nicoya ceased to exist. Though Coya was the surviving legal entity, it was a newly-formed legal entity formed for the sole purposes of the Merger, and its net assets consisted of an immaterial amount of cash. Accordingly, the Merger was treated as a capital transaction with Nicoya issuing common stock for the net assets of Coya, which were comprised of $400 in cash. The activities and positions of the pre-Merger Nicoya entity are the financial statements reflecting the continuing entity.
Going Concern and Liquidity
The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $5,624,987 as of December 31, 2021. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates. No assurance can be given that any such financing will be available when needed or that the Company’s research and development efforts will be successful.
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern, which requires management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued (or when applicable, one year after the date that the financial statements are available to be issued). As of December 31, 2021, the Company had cash and cash equivalents of $4,340,178, which is expected to enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2022, at which time the Company will need to secure additional funding. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects. As a result of these factors, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued.
The accompanying financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Management is currently evaluating different strategies to obtain the required funding of future operations. These strategies may include, but are not limited to, additional funding from current investors, funding from new investors including strategic corporate investors, and an initial public offering and additional registrations of the Company’s common stock. There can be no assurance these future funding efforts will be successful.
Risks and uncertainties
The Company is subject to a number of risks associated with companies at a similar stage, including dependence on key individuals, competition from similar products and larger companies, volatility of the industry, ability to obtain adequate financing to support growth, the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company, and general economic conditions.
F-8
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
In December 2019, a novel strain of coronavirus disease (“COVID-19”) was reported and in March 2020, the World Health Organization characterized COVID -19 as a global pandemic. The COVID-19 pandemic has forced international, federal, state, and local governments to enforce prohibitions of non-essential activities. The Company has been impacted by COVID-19 since inception. The extent and duration of the adverse impact of COVID-19 on the Company over the longer term remains uncertain and dependent on future developments that cannot be accurately predicted at this time.
As the impact of COVID-19 continues to evolve, estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require increased judgment. These estimates and assumptions may change in future periods and will be recognized in the financial statements as new events occur and additional information becomes known. To the extent the Company’s actual results differ materially from those estimates and assumptions, the Company’s future financial statements could be affected.
2. Basis of presentation and significant accounting policies
Basis of presentation
The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB.
Use of estimates
The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary.
Significant areas that require management’s estimates include fair value of the Company’s equity and related inputs, including discount for lack of marketability and volatility, used to estimate the fair value of the common stock issued under the license agreement (Note 8) and the grant date fair value of stock options (Note 10), useful life of fixed assets and accrued research and development expenses.
Segment information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment.
Fair value of financial instruments
Management believes that the carrying amounts of the Company’s cash equivalents, accounts payable, and accrued expenses approximate fair value due to the short-term nature of those instruments.
F-9
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
Concentration of credit risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents.
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in a money market account.
Deferred financing costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process debt financing as deferred financing costs until such financing is consummated. After consummation of the debt financing, these costs are recorded as a reduction of the carrying value of the debt issued. Debt financing costs will be amortized to interest expense over the term of debt. Should the in-process debt financing be abandoned, the deferred financing costs will be expensed immediately as a charge to operating expenses in the accompanying statements of operations. The Company had $0 and $87,181 in deferred financing costs as of December 31, 2020 and December 31, 2021, respectively.
Convertible notes and derivative liability
In connection with the issuance of the convertible notes in November 2020 (Note 7), the Company had identified redemption features that required bifurcation into an embedded derivative, which was recorded as a derivative liability on the balance sheet until the derivative was settled as part of the sale of Series A Convertible Preferred Stock.
Upon issuance of the convertible notes, the Company bifurcated the redemption feature, and each note was recorded at cost, net of debt discount. The discount on each note was amortized as interest expense to the date such note was converted using the effective interest rate method and was reflected as interest expense in the statements of operations.
Research and development costs
Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, regulatory compliance costs, and personnel and stock-based compensation expenses. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record a net prepaid or accrued expense relating to these costs.
Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use.
F-10
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
Patent costs
The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs of $242,196 and $10,000 were incurred during the period from April 30, 2020 (date of inception) to December 31, 2020, and the year ended December 31, 2021, respectively, which are included in general and administrative expenses in the accompanying statements of operations.
Stock-based compensation
The Company measures share-based employee and nonemployee awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards. The Company accounts for forfeitures in the period in which they occur.
Estimating the fair value of share-based awards requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, and, for stock options, the expected life of the options and stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in estimating the fair value of share-based awards represent management’s estimate and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards.
The expected term of the stock options is estimated using the “simplified method” as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected term of the option. The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock.
Fixed assets
Fixed assets, which consist mainly of lab equipment, are carried at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful life of the assets. Research medical equipment is depreciated over the asset’s estimated useful lives of five years.
Long-Lived Assets
Long-lived assets, such as fixed assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Considerable management judgment is necessary to estimate discounted future cash flows. Accordingly, actual results could vary significantly from such estimates.
The Company did not recognize any impairment of long‑lived assets during the period from April 30, 2020 (date of inception) to December 31, 2020, or the year ended December 31, 2021.
F-11
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
Leases
The Company accounts for leases in accordance with ASC 842, Leases (“ASC 842”). At contract inception, the Company determines if an arrangement is or contains a lease. A lease conveys the right to control the use of an identified asset for a period of time in exchange for consideration. If an arrangement is determined to be or contain a lease, the lease is assessed for classification as either an operating or finance lease at the lease commencement date, defined as the date on which the leased asset is made available for use by the Company, based on the economic characteristics of the lease.
When determining the expected accounting lease term, the Company includes the noncancellable lease term, together with periods covered by (i) an option to extend the lease if the Company is reasonably certain to exercise such option, (ii) an option to terminate the lease if the Company is reasonably certain not to exercise such option and (iii) an option to extend or not terminate the lease where the exercise of such option is controlled by the lessor. The Company has elected the short-term lease exemption, which allows the Company to not recognize lease liabilities and right-of-use assets arising from lease arrangements with lease terms of twelve months or less.
In May 2021, the Company entered into an agreement to lease medical research equipment. Rent expense for this short-term lease for the period from April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021 was $0 and $150,686, respectively.
Income taxes
Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities, and the expected benefits of net operating loss and income tax credit carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2020 and 2021, the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest, or penalties in the accompanying financial statements. Although there are no unrecognized income tax benefits, when applicable, the Company’s policy is to report interest and penalties related to unrecognized income tax benefits as a component of income tax expense.
Net loss per share
Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, common stock warrants and stock options, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, potentially dilutive securities are not included in the calculation when the impact is anti-dilutive. The Company’s convertible preferred stock entitles the holder to participate in dividends and earnings of the Company, and, if the Company were to recognize net income, it would have to use the two-class method to calculate earnings per share. The two-class method is not applicable during periods with a net loss, as the holders of the convertible preferred stock have no obligation to fund losses.
F-12
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
|
|
December 31, |
|
|||||
|
|
2020 |
|
|
2021 |
|
||
Series A Convertible Preferred Stock |
|
|
7,500,713 |
|
|
|
7,500,713 |
|
Common stock warrants |
|
|
525,049 |
|
|
|
525,049 |
|
Stock options |
|
|
- |
|
|
|
2,024,469 |
|
|
|
|
8,025,762 |
|
|
|
10,050,231 |
|
Amounts in the above table reflect the common stock equivalents.
Recently adopted accounting pronouncements
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), with guidance regarding the accounting for and disclosure of leases. The update requires lessees to recognize the liabilities related to all leases, including operating leases, with a term greater than 12 months on the balance sheet. This update also requires lessees and lessors to disclose key information about their leasing transactions. The Company early adopted this standard on April 30, 2020 (date of inception), and the adoption did not have any impact on its financial statements and its disclosures as the Company had no lease agreements as of the date of adoption.
In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (ASC 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (ASC 815 – 40) (“ASU 2020-06”). ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in ASC 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification by removing certain conditions in ASC 815-40-25. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted this standard on January 1, 2021, and the adoption did not have a material impact on its financial statements and its disclosures.
Recently issued but not yet adopted accounting pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective for the Company as of January 1, 2023. The Company is currently evaluating the impact of this ASU and does not expect that adoption of this standard will have a material impact on its financial statements and related disclosures.
In December 2019, the FASB issued ASU No. 2019-12 Simplifying the Accounting for Income Taxes (Topic 740), which simplifies various aspects related to accounting for income taxes. The amendment also improves consistent application of and simplifies GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The guidance is effective for the Company’s interim and annual reporting periods beginning after December 15, 2021, with early adoption permitted. The Company does not believe that the adoption of this guidance will have a material impact on its financial statements and related disclosures.
F-13
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
3. Fair value measurements
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:
|
• |
Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. |
|
• |
Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. |
As further discussed in Note 7, the Company had identified redemption features that required bifurcation into an embedded derivative. The derivative liability was considered a Level 3 liability because its fair value measurement was based, in part, on significant inputs not observed in the market. The fair value of the derivative at issuance was $37,500, and there was no change in the fair value of the derivative liability from issuance in November 2020 through the date in which the liability was settled in December 2020. The Company did not have assets or liabilities that were measured at fair value on a recurring basis as of December 31, 2020 and 2021.
Cash and cash equivalents are Level 1 assets as of December 31, 2020 and 2021.
4. Prepaids and other current assets
Prepaids and other current assets consist of:
|
|
December 31, |
|
|||||
|
|
2020 |
|
|
2021 |
|
||
Prepaid research and development |
|
$ |
27,627 |
|
|
$ |
200,000 |
|
Prepaid insurance |
|
|
- |
|
|
|
10,033 |
|
Prepaid other |
|
|
- |
|
|
|
34,047 |
|
|
|
$ |
27,627 |
|
|
$ |
244,080 |
|
5. Fixed assets, net
Fixed assets, net consist of:
|
December 31, |
|
|||||
|
2020 |
|
|
2021 |
|
||
Lab equipment |
$ |
- |
|
|
$ |
136,804 |
|
|
|
- |
|
|
|
136,804 |
|
Less: accumulated depreciation |
|
- |
|
|
|
(16,133 |
) |
|
$ |
- |
|
|
$ |
120,671 |
|
Depreciation expense for the period from April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021 was $0 and $16,133, respectively.
F-14
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
6. Accrued expenses
Accrued expenses consist of:
|
|
December 31, |
|
|||||
|
|
2020 |
|
|
2021 |
|
||
Accrued research and development |
|
$ |
- |
|
|
$ |
163,557 |
|
Accrued payroll |
|
|
- |
|
|
|
105,000 |
|
Accrued expenses other |
|
|
- |
|
|
|
22,259 |
|
|
|
$ |
- |
|
|
$ |
290,816 |
|
In November 2020, the Company issued convertible notes (“Notes”) with a principal amount of $150,000 in exchange for cash proceeds of $150,000. This included the issuance of $100,000 to a trust which is affiliated with the owners of Coya prior to the Merger. These Notes accrued interest at a rate of 6.0% per year and had stated maturity dates of 18 months from the date of issuance. These Notes included a mandatory conversion option, whereby upon the issuance of preferred securities of $5,000,000 or greater to investors (“Qualified Financing”), the outstanding principal and interest would automatically be converted into the preferred securities offered by the Company a price equal to 80% of the price per share in the associated offering. The Company accounted for the conversion upon a Qualified Financing event as a bifurcated redemption feature as settlement under this feature would be in a variable number of shares and at a substantial discount. The value of this redemption feature was determined to be $37,500 upon the issuance of the Notes and was recorded as a discount to the carrying value of the Notes, which was amortized through interest expense until the date of conversion.
Upon the issuance of Series A Convertible Preferred Stock (“Series A”) as described in Note 9, the outstanding principal and interest of $151,476 as well as the fair value of the redemption feature of $37,500 was reclassified into Series A. The remaining unamortized discount of was charged to interest expense on the date of the conversion.
8. Commitments and contingencies, including license and sponsored research agreements
License Agreement
On October 6, 2020 (“Effective Date”), the Company entered into an exclusive Patent Know How and License Agreement, as amended from time to time (“Methodist License”) with The Methodist Hospital (“Methodist”) to make, sell and sublicense products and services using the intellectual property and know-how of Methodist. As part of the Methodist License, the Company issued 750,000 shares of the Company's common stock with an estimated fair value of $225,000, all of which was expensed as in-process research and development expense in the accompanying statements of operations for the period from April 30, 2020 (date of inception) to December 31, 2020. The Company also reimbursed Methodist for $232,256 and $10,000 in patent related expenses, which are included in the general and administrative expenses in the accompanying statements of operations for the period from April 30, 2020 (date of inception) to December 31, 2020 and the year ended December 31, 2021, respectively. The Company also will pay Methodist a license maintenance fee of $5,000 annually until the first sale of licensed product occurs. The term of the Methodist License is effective until no intellectual property patent rights remain, unless terminated sooner by (1) bankruptcy, (2) the failure of the Company to monetize the intellectual property within five years of the date of the agreement (further discussed below), (3) due to breach of contract, or (4) at the election of the Company for any or no reason. The Company is required to achieve certain milestones, or Methodist will have the right to terminate the agreement or convert the license to a non-exclusive license. These milestones include, but are not limited to, requirements for the Company to; (1) create a plan to develop a manufacturing process for the licensed products or services with adequate product quality and controls for the then-current stage of clinical evaluation within 12 months of the Effective Date, (2) establish manufacturing capabilities for a licensed product or service, when such capability is needed, (3) if Methodist completes the primary endpoint(s) of the ongoing Phase 2a Trial and conducts a successful end-of-phase 2 meeting with the Food and Drug Administration (FDA), the Company must initiate phase 2b or phase 3 clinical trial for a licensed product or service within 24 months of the Effective Date or as soon as reasonably possible; and (4) within 48 months of the Effective Date, complete the primary endpoint(s) of either a phase 2(b) or 3 clinical trial for a licensed product or service.
F-15
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
In addition to the equity issuance and reimbursement of patent related expenses, the Methodist License requires the Company to make payments of up to $425,000 per product candidate in aggregate upon the achievement of specific development and regulatory milestone events by such licensed product. The Company is also required to pay Methodist, on a licensed product-by-licensed product and country-by-country basis, tiered royalties (subject to customary reductions) equal to high-single digit to low-double digit percentages of annual worldwide net sales of such licensed product during a defined royalty term. The Company is also required to pay a low single digit percentage for certain licensed services. The minimum amount which will be owed by the Company once commercialization occurs is $50,000 annually.
Sponsored Research Agreement
In February 2021, the Company entered into a one-year Sponsored Research Agreement (“SRA”) with Houston Methodist Research Institute (“HRMI”), a Texas nonprofit corporation and an affiliate of Methodist, which can be extended or renewed by mutual agreement. Under the SRA, the Company agreed to fund up to $1,547,094 in research in the area of neurodegenerative diseases performed by HRMI. In return, the Company will gain expanded access to data methods and know-how per the SRA, and, if the research produces intellectual property, the Company will have all first rights to the intellectual property. The Company incurred $1,295,828 in research and development expenses under the SRA during the year ended December 31, 2021. As of December 31, 2021, the Company’s remaining funding commitment under the SRA is $251,266.
Employment contracts
The Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined in the agreements. In addition, in the event of termination of employment following a change in control, as defined in each agreement, either by the Company without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately vested.
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. There are no matters currently outstanding.
9. Convertible preferred stock and stockholders’ equity
Convertible preferred stock
In December 2020, the Company sold 7,361,744 shares of Series A for $1.338 per share resulting in net proceeds of $8,604,661 and converted $188,976 of the Notes into 138,969 shares of Series A.
The following is a summary of the rights, preferences, and terms of the Series A:
Dividends
Holders of Series A, in preference to holders of any other class or series of the Company’s stock, are entitled to dividends only when declared by the Board of Directors, but such will accrue at a rate of 8% of the original issuance price prior to and in preference to any declaration of other dividends. No dividends were declared or paid from inception through December 31, 2021.
Voting
Each share of Series A shall be entitled to cast the number of votes equal to the number of whole shares of common stock into which such shares of Series A are convertible as of the record date for determining stockholders entitled to vote on such matter. Generally, holders of the Series A shall vote together with the holders of common stock as a single class and on an as converted into common stock basis. The Company’s Board of Directors has five members. The holders of the Series A preferred stock are entitled to elect one of the Directors, the holders of common stock are entitled to elect two Directors, one Director shall be the Chief Executive Officer of the Company, and one independent Director is an individual that is mutually acceptable to holders of the majority of the common stock.
F-16
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
Liquidation preference
In the event of a liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or in the event of a deemed liquidation event, which includes a sale of the Company as defined in the Company’s articles of incorporation, holders of Series A are entitled to receive, in preference to all other stockholders, the greater of (i) an amount equal to the Series A original issue price of $1.338, plus any dividends declared but unpaid, or (ii) such amount per share as would have been payable had all shares of Series A been converted into common stock. If upon the occurrence of such event, the assets and funds available for distribution are insufficient to pay such holders the full amount to which they are entitled, then the entire assets legally available for distribution shall be distributed ratably among the holders of Series A in proportion to the full amounts to which they would otherwise be entitled. As of December 31, 2021, no dividends have been declared, and the liquidation preference represents the original issue price of $1.338 per share of Series A.
Conversion
Each share of Series A is convertible into common stock at any time at the option of the holder thereof at the conversion price then in effect. The per share conversion price for the Series A is $1.338. All shares of the Series A will automatically convert into common stock at the conversion price then in effect upon a qualified initial public offering of the Company’s common stock in excess of $20,000,000 and a pre-transaction valuation of $50,000,000. These thresholds are reduced to $14,000,000 million and $40,000,000 in a merger scenario.
Redemption
The Series A is subject to redemption under certain deemed liquidation events; however, these events are solely within the control of the Company, and as such, the Series A is classified as permanent equity in the Company’s accompanying balance sheets.
Common stock and common stock warrants
The holders of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. Unless required by law, there shall be no cumulative voting. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment of all preferential amounts required to be paid to the holders of shares of Series A, the remaining funds and assets available for distribution to the stockholders of the Company will be distributed among the holders of shares of common stock, pro rata based on the number of shares of common stock held by each such holder.
In connection with the Series A offering, the Company issued freestanding warrants to purchase 525,049 shares of the Company’s common stock to the placement agent of the Series A offering. These warrants have an exercise price of $1.606 per common share and a term of five years from the date of issuance. These warrants are not redeemable and are generally not transferrable. During its evaluation of equity classification for the Company's common stock warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity. The conditions within ASC 815-40 are not subject to a probability assessment. The warrants do not fall under the liability criteria within ASC 480, Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815 but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. The fair value of these warrants was determined to be $15,138 on the date of issuance and were recorded as a component of additional paid-in capital as part of the Series A offering.
10. Stock-based compensation
In January 2021, the Company adopted the 2021 Equity Incentive Plan (“2021 Plan”). The 2021 Plan provides for the granting of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, equity appreciation rights, performance awards, and other equity-based awards. The Company's employees, officers, independent directors, and other persons are eligible to receive awards under the 2021 Plan. As of December 31, 2021, 2,300,000 shares of the Company’s common stock were authorized to be issued, of which 273,865 shares were available for future issuance.
F-17
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
The amount, terms of grants, and exercisability provisions are determined and set by the Company's Board of Directors or compensation committee. The Company measures employee stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company recognized $233,222 in stock-based compensation expense during the year ended December 31, 2021, of which $47,451 was classified as general and administrative expense and $185,771 was classified as research and development expense.
Stock options
The Company has issued service-based stock options that generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board of Directors. Vesting generally occurs over a period of not greater than four years.
The following table summarizes the activity for the year ended December 31, 2021:
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
average remaining |
|
|
Aggregate |
|
|||
|
|
|
|
|
|
average |
|
|
contractual |
|
|
intrinsic |
|
|||
|
|
Options |
|
|
exercise price |
|
|
term (years) |
|
|
value |
|
||||
Outstanding at January 1, 2021 |
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
- |
|
Granted |
|
|
2,026,135 |
|
|
|
0.19 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,666 |
) |
|
|
0.19 |
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2021 |
|
|
2,024,469 |
|
|
$ |
0.19 |
|
|
|
9.3 |
|
|
|
222,692 |
|
Exercisable at December 31, 2021 |
|
|
1,185,834 |
|
|
$ |
0.19 |
|
|
|
9.2 |
|
|
|
130,442 |
|
Vested and expected to vest at December 31, 2021 |
|
|
2,024,469 |
|
|
$ |
0.19 |
|
|
|
9.3 |
|
|
|
222,692 |
|
|
|
Number of Shares |
|
|
Weighted average fair value |
|
||
Non-vested shares at January 1, 2021 |
|
|
- |
|
|
$ |
- |
|
Awarded |
|
|
2,026,135 |
|
|
$ |
0.22 |
|
Forfeited |
|
|
- |
|
|
$ |
- |
|
Vested |
|
|
(945,832 |
) |
|
$ |
- |
|
Non-vested shares at December 31, 2021 |
|
|
1,080,303 |
|
|
|
|
|
As of December 31, 2021, the unrecognized compensation cost was $211,593, and will be recognized over an estimated weighted-average amortization period of 2.7 years.
The fair value of options is estimated using the Black-Scholes option pricing model, which takes into account inputs such as the exercise price, the estimated fair value of the underlying common stock at the grant date, expected term, estimated stock price volatility, risk-free interest rate, and dividend yield. The fair value of stock options granted during the year ended December 31, 2021 was determined using the methods and assumptions discussed below.
|
• |
The expected term of employee stock options with service-based vesting is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin (“SAB”) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. |
|
• |
The expected stock price volatility is based on historical volatility of comparable public entities within the Company’s industry, which were commensurate with the expected term assumption as described in SAB No. 107. |
|
• |
The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term. |
F-18
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
|
• |
The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. |
|
• |
As the Company’s common stock has not been publicly traded, its Board of Directors periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. |
The grant date fair value of each option grant for the year ended December 31, 2021 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions:
Risk-free interest rate |
|
|
|
|
0.9 |
% |
Expected term (years) |
|
|
|
|
5.5 |
|
Expected volatility |
|
|
|
|
79.26 |
% |
Expected dividend yield |
|
|
|
|
- |
|
Estimated fair value of the Company's common stock per share |
|
|
|
$ |
0.30 |
|
The Company has incurred losses since inception and has not recorded current or deferred income taxes.
A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows:
Rate reconciliation: |
|
Period from April 30, (Date of Inception) to December 31, 2020 |
|
|
December 31, 2021 |
|
||
Federal tax benefit at statutory rate |
|
(21.0)% |
|
|
(21.0)% |
|
||
Permanent differences |
|
|
1.1 |
|
|
|
0.70 |
|
Change in valuation allowance |
|
|
19.9 |
|
|
|
20.3 |
|
Total provision |
|
|
0 |
% |
|
|
0 |
% |
Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for years in which differences are expected to reverse.
F-19
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
Significant components of the Company's deferred tax assets for federal income taxes consisted of the following (in thousands):
|
|
December 31, |
|
|||||
Deferred tax assets |
|
2020 |
|
|
2021 |
|
||
Startup costs |
|
$ |
76,120 |
|
|
$ |
557,038 |
|
Capitalized license fees |
|
|
47,250 |
|
|
|
44,100 |
|
Share-based compensation |
|
|
- |
|
|
|
43,868 |
|
Net operating losses |
|
|
22,415 |
|
|
|
494,955 |
|
Change in valuation allowance |
|
|
(145,785 |
) |
|
|
(1,137,603 |
) |
Deferred tax assets, net of valuation allowance |
|
$ |
- |
|
|
$ |
2,358 |
|
Deferred tax liabilities |
|
|
|
|
|
|
|
|
Fixed assets |
|
$ |
- |
|
|
$ |
(2,358 |
) |
Subtotal |
|
|
- |
|
|
|
(2,358 |
) |
Net deferred tax assets |
|
$ |
- |
|
|
$ |
- |
|
As December 31, 2021, the Company has net operating loss carryforwards for federal income tax purposes of approximately $2,356,929 which are available to offset future federal taxable income. These net operating loss carryforwards have no expiration.
In assessing the recoverability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company has determined that it is more likely than not that certain future tax benefits may not be realized as a result of current and future income. Accordingly, a valuation allowance has been recorded against all of the Company’s deferred tax assets.
Net operating loss and tax credit carry-forwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50% as defined under Sections 382 and 383 in the Internal Revenue Code, which could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the Company’s value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has not yet conducted a study to determine if any such limitation exists.
The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. The Company had no interest or penalties related to uncertain tax positions. All tax years of the Company from inception are open to examination by federal tax and state tax authorities. To the extent utilized in future years’ tax returns, net operating loss carryforwards as of December 31, 2021 will remain subject to examination until utilized. The Company has not been informed by any tax authorities for any jurisdiction that any of its tax years is under examination as of December 31, 2021.
12. Related party transactions
In 2020, the Company issued a $100,000 convertible note payable to a trust affiliated with the pre-Merger owner(s) of Coya, as further described in Note 7.
In connection with the issuance of the Company’s Series A, the Company incurred $704,750 placement agent fees which were paid to an affiliate of the pre-Merger owners of Coya Therapeutics, Inc. As described in Note 9, the placement agent also received warrants for the purchase of 525,049 shares of the Company’s common stock.
Additionally, the Company has entered into a consulting arrangement with the pre-Merger owner of Coya Therapeutics, Inc., whereby the Company pays a monthly consulting and advisory fee of $10,000, which commenced in January 2021.
F-20
COYA THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2020 AND 2021
In December 2020, the Company entered into a consulting arrangement with a founder. For the period April 30, 2020 (date of inception) to December 31, 2020 and for the year ended December 31, 2021 and, the Company paid $12,500 and $127,500 of consulting fees, respectively.
13. Subsequent events
The Company has evaluated subsequent events from the balance sheet date through March 15, 2022, the date at which the financial statements were issued, and has determined that there are no such events to report outside of the below:
In February 2022, the SRA, which is further described in Note 8 was amended to extend the agreement an additional two years.
F-21
|
|
December 31, |
|
|
September 30, |
|
||
|
|
2021 |
|
|
2022 |
|
||
|
|
|
|
|
|
(unaudited) |
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,340,178 |
|
|
$ |
8,650,848 |
|
Prepaids and other current assets |
|
|
244,080 |
|
|
|
55,250 |
|
Total current assets |
|
|
4,584,258 |
|
|
|
8,706,098 |
|
Fixed assets, net |
|
|
120,671 |
|
|
|
100,151 |
|
Deferred financing costs |
|
|
87,181 |
|
|
|
258,248 |
|
Total assets |
|
$ |
4,792,110 |
|
|
$ |
9,064,497 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
857,567 |
|
|
$ |
1,313,746 |
|
Accrued expenses |
|
|
290,816 |
|
|
|
1,263,057 |
|
Total current liabilities |
|
|
1,148,383 |
|
|
|
2,576,803 |
|
Convertible promissory notes |
|
|
- |
|
|
|
11,845,000 |
|
Total liabilities |
|
|
1,148,383 |
|
|
|
14,421,803 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity (deficit): |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.0001 par value: 7,500,713 authorized, issued and outstanding as of December 31, 2021 and September 30, 2022 (liquidation value of $10,035,954 as of September 30, 2022) |
|
|
8,793,637 |
|
|
|
8,793,637 |
|
Common stock, $0.0001 par value; 30,000,000 shares authorized; 14,751,666 and 14,752,500 shares issued and outstanding as of December 31, 2021 and September 30, 2022, respectively |
|
|
1,475 |
|
|
|
1,475 |
|
Additional paid-in capital |
|
|
473,602 |
|
|
|
609,677 |
|
Accumulated deficit |
|
|
(5,624,987 |
) |
|
|
(14,762,095 |
) |
Total stockholders' equity (deficit) |
|
|
3,643,727 |
|
|
|
(5,357,306 |
) |
Total liabilities and stockholders' equity (deficit) |
|
$ |
4,792,110 |
|
|
$ |
9,064,497 |
|
The accompanying notes are an integral part of these condensed unaudited interim financial statements.
F-22
CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2021 |
|
|
2022 |
|
||
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,686,328 |
|
|
$ |
3,704,466 |
|
In-process research and development |
|
|
- |
|
|
|
135,000 |
|
General and administrative |
|
|
1,579,896 |
|
|
|
3,948,434 |
|
Depreciation |
|
|
5,946 |
|
|
|
20,521 |
|
Total operating expenses |
|
|
3,272,170 |
|
|
|
7,808,421 |
|
Loss from operations |
|
|
(3,272,170 |
) |
|
|
(7,808,421 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of convertible promissory notes |
|
|
- |
|
|
|
(1,376,030) |
|
Other income, net |
|
|
10,050 |
|
|
|
47,343 |
|
Net loss |
|
$ |
(3,262,120 |
) |
|
$ |
(9,137,108 |
) |
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.62 |
) |
Weighted-average shares of common stock outstanding, basic and diluted |
|
|
14,750,000 |
|
|
|
14,752,314 |
|
The accompanying notes are an integral part of these condensed unaudited interim financial statements.
F-23
COYA THERAPEUTICS, INC.
CONDENSED UNAUDITED INTERIM STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
|
|
Convertible Preferred Stock |
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Total |
|
|||||||
|
|
Series A |
|
|
Common Stock |
|
|
Paid-In |
|
|
Accumulated |
|
|
Stockholders' |
|
|||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity |
|
|||||||
Balance, December 31, 2020 |
|
|
7,500,713 |
|
|
$ |
8,793,637 |
|
|
|
14,750,000 |
|
|
$ |
1,475 |
|
|
$ |
240,063 |
|
|
$ |
(733,195 |
) |
|
$ |
8,301,980 |
|
Exercise of stock options |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
206,588 |
|
|
|
- |
|
|
|
206,588 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,262,120 |
) |
|
|
(3,262,120 |
) |
Balance as of September 30, 2021 |
|
|
7,500,713 |
|
|
$ |
8,793,637 |
|
|
|
14,750,000 |
|
|
$ |
1,475 |
|
|
$ |
446,651 |
|
|
$ |
(3,995,315 |
) |
|
$ |
5,246,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Preferred Stock |
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Total Stockholders' |
|
|||||||
|
|
Series A |
|
|
Common Stock |
|
|
Paid-In |
|
|
Accumulated |
|
|
Equity |
|
|||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
(Deficit) |
|
|||||||
Balance, December 31, 2021 |
|
|
7,500,713 |
|
|
$ |
8,793,637 |
|
|
|
14,751,666 |
|
|
$ |
1,475 |
|
|
$ |
473,602 |
|
|
$ |
(5,624,987 |
) |
|
$ |
3,643,727 |
|
Exercise of stock options |
|
|
- |
|
|
|
- |
|
|
|
834 |
|
|
|
- |
|
|
|
158 |
|
|
|
- |
|
|
|
158 |
|
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
135,917 |
|
|
|
- |
|
|
|
135,917 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(9,137,108 |
) |
|
|
(9,137,108 |
) |
Balance as of September 30, 2022 |
|
|
7,500,713 |
|
|
$ |
8,793,637 |
|
|
|
14,752,500 |
|
|
$ |
1,475 |
|
|
$ |
609,677 |
|
|
$ |
(14,762,095 |
) |
|
$ |
(5,357,306 |
) |
The accompanying notes are an integral part of these condensed unaudited interim financial statements.
F-24
CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2021 |
|
|
2022 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,262,120 |
) |
|
$ |
(9,137,108 |
) |
Adjustment to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
5,946 |
|
|
|
20,520 |
|
Change in fair value of convertible promissory notes |
|
|
- |
|
|
|
1,376,030 |
|
Stock-based compensation |
|
|
206,588 |
|
|
|
135,917 |
|
Debt issuance costs |
|
|
- |
|
|
|
997,367 |
|
Acquired in-processing research and development |
|
|
- |
|
|
|
135,000 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaids and other assets |
|
|
2,232 |
|
|
|
276,011 |
|
Accounts payable |
|
|
161,439 |
|
|
|
456,179 |
|
Accrued expenses |
|
|
- |
|
|
|
723,805 |
|
Net cash used in operating activities |
|
|
(2,885,915 |
) |
|
|
(5,016,279 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchase of in-process research and development |
|
|
- |
|
|
|
(135,000 |
) |
Purchase of fixed assets |
|
|
(136,804 |
) |
|
|
- |
|
Net cash used in investing activities |
|
|
(136,804 |
) |
|
|
(135,000 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of convertible promissory notes |
|
|
- |
|
|
|
10,468,970 |
|
Payment of deferred financing costs related to the IPO |
|
|
- |
|
|
|
(9,812 |
) |
Payment of debt issuance costs |
|
|
- |
|
|
|
(997,367 |
) |
Proceeds from founders for subscription receivable |
|
|
1,000 |
|
|
|
- |
|
Proceeds from the exercise of stock options |
|
|
- |
|
|
|
158 |
|
Net cash provided by financing activities |
|
|
1,000 |
|
|
|
9,461,949 |
|
Net (decrease) increase in cash and cash equivalents |
|
|
(3,021,719 |
) |
|
|
4,310,670 |
|
Cash and cash equivalents as of beginning of the period |
|
|
8,720,834 |
|
|
|
4,340,178 |
|
Cash and cash equivalents as of end of the period |
|
$ |
5,699,115 |
|
|
$ |
8,650,848 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Deferred financing costs in accrued expenses |
|
$ |
- |
|
|
|
248,436 |
|
The accompanying notes are an integral part of these condensed unaudited interim financial statements.
F-25
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
1. Organization and description of business
Coya Therapeutics, Inc. (“Coya”, or the “Company”) is a clinical stage cell therapy company formed for the purpose of licensing intellectual properties, assisting in the research and development, and commercializing Regulatory T-Cell (“Treg”) therapies for the treatment of neurodegenerative diseases.
Going Concern and Liquidity
The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $14,762,095 as of September 30, 2022. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates. No assurance can be given that any such financing will be available when needed or that the Company’s research and development efforts will be successful.
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern, which requires management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued (or when applicable, one year after the date that the financial statements are available to be issued). As of September 30, 2022, the Company had cash and cash equivalents of $8,650,848. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects. As a result of these factors, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these condensed unaudited financial statements are issued.
The accompanying condensed unaudited interim financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The condensed unaudited interim financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Management is currently evaluating different strategies to obtain the required funding of future operations. These strategies may include, but are not limited to, additional funding from current investors, funding from new investors including strategic corporate investors, and an initial public offering and additional registrations of the Company’s common stock. There can be no assurance these future funding efforts will be successful.
Risks and uncertainties
The Company is subject to a number of risks associated with companies at a similar stage, including dependence on key individuals, competition from similar products and larger companies, volatility of the industry, ability to obtain adequate financing to support growth, the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company, and general economic conditions.
In December 2019, a novel strain of COVID-19 was reported and in March 2020, the World Health Organization characterized COVID -19 as a global pandemic. The COVID-19 pandemic has forced international, federal, state, and local governments to enforce prohibitions of non-essential activities. The Company has been impacted by COVID-19 since inception. The extent and duration of the adverse impact of COVID-19 on the Company over the longer term remains uncertain and dependent on future developments that cannot be accurately predicted at this time.
As the impact of COVID-19 continues to evolve, estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require increased judgment. These estimates and assumptions may change in future periods and will be recognized in the financial statements as new events occur and additional information becomes known. To the extent the Company’s actual results differ materially from those estimates and assumptions, the Company’s future financial statements could be affected.
2. Basis of presentation and significant accounting policies
Basis of presentation
The accompanying condensed unaudited financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB.
F-26
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s balance sheet as of September 30, 2022 and its statements of operations, stockholders’ equity (deficit) and cash flows for the nine months ended September 30, 2021 and 2022. Operating results for the nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. The condensed unaudited interim financial statements, presented herein do not contain the required disclosures under GAAP for annual financial statements. The accompanying condensed unaudited interim financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2021 found elsewhere in this prospectus.
Use of estimates
The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary.
Significant areas that require management’s estimates include fair value of the Company’s convertible promissory notes, the fair value of the Company’s equity and related inputs, including discount for lack of marketability and volatility, used to estimate the fair value of the common stock as an input in the black-scholes option pricing model to determine the grant date fair value of stock options, useful life of fixed assets and accrued research and development expenses.
Fair value of financial instruments
Management believes that the carrying amounts of the Company’s cash equivalents, accounts payable, and accrued expenses approximate fair value due to the short-term nature of those instruments. Convertible promissory notes are recorded at fair value on a recurring basis (Note 3).
Concentration of credit risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents.
Deferred financing costs
The Company capitalizes costs that are directly associated with in-process equity and debt financings until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred financing costs are expensed. As of September 30, 2022, the Company has incurred $258,248 in fees associated with the IPO, which are recognized as deferred financing costs on the balance sheet. The Company elected to account for its 2022 Convertible Promissory Notes (Note 5) using the fair value option under ASC 815, and as such, issuance costs of $997,367 were immediately expensed as a component of general and administrative expense in the unaudited interim statement of operations during the nine months ended September 30, 2022.
Stock-based compensation
The Company measures share-based employee and nonemployee awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards. The Company accounts for forfeitures in the period in which they occur.
Estimating the fair value of share-based awards requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, and, for stock options, the expected life of the options and stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in estimating the fair value of share-based awards represent management’s estimate and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards.
F-27
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
The expected term of the stock options is estimated using the “simplified method” as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected term of the option. The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock.
Income taxes
Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities, and the expected benefits of net operating loss and income tax credit carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of September 30, 2022, the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest, or penalties in the accompanying financial statements. Although there are no unrecognized income tax benefits, when applicable, the Company’s policy is to report interest and penalties related to unrecognized income tax benefits as a component of income tax expense.
Net loss per share
Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, common stock warrants and stock options, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, potentially dilutive securities are not included in the calculation when the impact is anti-dilutive. The Company’s convertible preferred stock entitles the holder to participate in dividends and earnings of the Company, and, if the Company were to recognize net income, it would have to use the two-class method to calculate earnings per share. The two-class method is not applicable during periods with a net loss, as the holders of the convertible preferred stock have no obligation to fund losses.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2021 |
|
|
2022 |
|
||
Series A Convertible Preferred Stock |
|
|
7,500,713 |
|
|
|
7,500,713 |
|
Convertible promissory notes (as converted) |
|
|
- |
|
|
|
5,948,940 |
|
Common stock warrants |
|
|
525,049 |
|
|
|
525,049 |
|
Stock options |
|
|
1,615,000 |
|
|
|
2,725,757 |
|
|
|
|
9,640,762 |
|
|
|
16,700,459 |
|
Amounts in the above table reflect the common stock equivalents.
Recently adopted accounting pronouncements
The Company adopted Accounting Standards Update ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40) (“ASU 2020-06”) on January 1, 2022. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in ASC 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether a qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares.
The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2021. As none of the Company’s 2020 convertible promissory notes were
F-28
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
outstanding, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06.
Recently issued but not yet adopted accounting pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective for the Company as of January 1, 2023. The Company is currently evaluating the impact of this ASU and does not expect that adoption of this standard will have a material impact on its financial statements and related disclosures.
3. Fair value measurements
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:
|
• |
Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. |
|
• |
Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. |
|
• |
Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. |
In accordance with the fair value hierarchy described above, the following table sets forth the Company’s assets and liabilities measured at fair value on a recurring basis:
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note Reference |
|
Input Level |
|
Fair Value |
|
|
Carrying Value |
|
||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents (money market funds) |
|
|
|
|
Level 1 |
|
$ |
4,340,178 |
|
|
$ |
4,340,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note Reference |
|
Input Level |
|
Fair Value |
|
|
Carrying Value |
|
||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents (money market funds) |
|
|
|
|
Level 1 |
|
$ |
8,650,848 |
|
|
$ |
8,650,848 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory notes |
|
|
Note 5 |
|
Level 3 |
|
$ |
11,845,000 |
|
|
$ |
11,845,000 |
|
As further described in Note 5, in April 2022 the Company issued unsecured convertible promissory notes (the “Notes”) to various investors. Due to the number of embedded provisions contained in the Notes, the fair value option, as prescribed by ASC 815, was elected and applied in connection with the preparation of these condensed unaudited financial statements. The fair value of the Notes is determined using a scenario-based analysis that estimates the fair value based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the noteholders, including various IPO, settlement, equity financing, corporate transaction and dissolution scenarios.
The Company adjusts the carrying value of the Notes to their estimated fair value at each reporting date, with qualifying increases or decreases in the fair recorded as change in fair value of convertible promissory notes in the statements of operations.
F-29
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
Changes in the fair value resulting from changes in the instrument-specific credit risk will be presented separately in other comprehensive income, however through September 30, 2022, these changes have not been material to the financial statements. The Company measured the change in fair value related to instrument-specific credit risk by isolating the change in the fair value of the Notes resulting from the change in CCC option-adjusted spreads between measurement dates.
Balance at beginning of year |
|
|
|
|
|
$ |
- |
|
Issuance of convertible promissory notes |
|
|
|
|
|
|
10,468,970 |
|
Fair value adjustments |
|
|
|
|
|
|
1,376,030 |
|
Balance at September 30, 2022 |
|
|
|
|
|
$ |
11,845,000 |
|
4. Accrued expenses
Accrued expenses consist of:
|
|
December 31, 2021 |
|
|
September 30, 2022 |
|
||
Accrued research and development |
|
$ |
163,557 |
|
|
$ |
192,095 |
|
Accrued payroll |
|
|
105,000 |
|
|
|
700,834 |
|
Accrued expenses other, including offering costs |
|
|
22,259 |
|
|
|
370,128 |
|
|
|
$ |
290,816 |
|
|
$ |
1,263,057 |
|
5. Convertible promissory notes
In April 2022, the Company issued $10,468,970 of Notes, which bear interest at an annual rate of 6.0%, paid in kind, and have a maturity date of June 30, 2024. The Notes will automatically convert into shares of conversion securities, which may be preferred stock or common stock, upon a qualified equity financing (“Qualified Equity Financing”) or upon a change of control. A Qualified Equity Financing is defined as the offer and sale for cash of any equity securities that results in aggregate gross proceeds of at least $20,000,000. A change of control is defined as (i) the sale or disposition of all or substantially all of the Company’s assets to a third party; (ii) the acquisition by a third party of more than 50% of the Company’s outstanding voting capital stock; or (iii) the merger or consolidation of the Company unless the holders of the Company’s voting capital stock hold at least 50% of the voting capital stock of the acquiring third party or the surviving entity immediately after the merger or consolidation. Upon a change of control or a Qualified Equity Financing, the Notes will convert at the lesser of (i) the price per share calculated by dividing $60,000,000 by the fully diluted capitalization at the time of conversion; or (ii) 80% of the price paid per share for by the cash investors in the Qualified Equity Financing. The Company may not prepay the Notes without the prior written consent of the holders of a majority of the outstanding aggregate principal of the Notes.
On issuance, the Company elected to account for the Notes at fair value in accordance with ASC 815 with qualifying changes in fair value not related to instrument-specific credit risk being recognized through the statements of operations until the Notes are settled. The fair value of the Notes was determined to be $10,468,970 on issuance, which is the principal amount of the Notes. On issuance, total debt issuance costs of $997,367, of which $697,828 was paid to a related party, were immediately expensed as a component of general and administrative expense in the unaudited interim statements of operations during the nine months ended September 30, 2022. The Company recognized a change in fair value of the Notes of $1,376,030 in the unaudited interim statement of operations during the nine months ended September 30, 2022.
The Company paid its placement agent for this issuance a cash fee of 7% of the gross proceeds raised in the offering of the 2022 Notes. In addition, in exchange for $1,000, the Company agreed that it will issue to the placement agent, upon conversion of the Notes, warrants to purchase shares of common stock of the Company in an amount equal to 7% of the aggregate number of shares of stock issued. The warrants will have a term of five years, an exercise price equal to 120% of the per share price paid by investors in the qualified equity financing and may be exercised on a cashless basis.
F-30
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
6. Commitments and Contingencies
License Agreements
ARScience License Agreement
On August 23, 2022, the Company entered into a Licensing Agreement (“ARS License Agreement”) with ARScience Biotherapeutics, Inc. (“ARS”) ”) pursuant to which ARS granted the Company an option to, if the Company chooses to exercise such option, an exclusive, royalty-bearing license for two patents regarding certain formulations of hrIL-2 (the product that serves as the basis for COYA 301), with the right to grant sublicenses through multiple tiers under these patents (the “ARS Option”). Also, ARS granted to the Company an exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers, under the ARS License Agreement to perform the preclinical activities. The Company is solely responsible for the development and commercialization activities. In consideration for the ARS Option, the Company paid an upfront option fee of $100,000, all of which was expensed as in-process research and development expense in the accompanying statements of operations for the nine months ended September 30, 2022. The term of the AR License Agreement is the royalty term, which is defined as the later of (i) expiration of the last-to-expire valid claim in an ARScience patent that covers such product in such country, (ii) the expiration of all regulatory exclusivity including data exclusivity periods or (iii) the tenth anniversary of the first commercial sale of such product in such country.
In addition to the upfront fee, the Company may also owe tiered payments to ARS based on the Company’s achievement of certain developmental milestones. Under the ARS License Agreement, the Company will pay an aggregate of $13,250,000 in developmental milestone payments for the first Combination Product (as defined in the ARS License Agreement) in a new indication. The Company will then pay an aggregate of $11,600,000 in developmental milestone payments for each Combination Product in each subsequent new indication. Further, for the first Mono Product (as defined In the ARS License Agreement) the Company will pay an aggregate of $11,750,000 in developmental milestone payments. The Company will then pay an aggregate of $5,850,000 in developmental milestone payments for each Mono Product in each subsequent new indication, and an aggregate of $5,850,000 if all developmental milestones are achieved for each new indication. The Company will also owe royalties on net sales of licensed products ranging from low to mid-single digit percentages. In the event the Company sublicenses its rights under the ARS License Agreement, the Company will owe royalties on sublicense income within the range of 10% to 20%.
Methodist Hospital License Agreement Amendment
As discussed in more detail in Note 8 to the audited financial statements included elsewhere in this prospectus, the Company has an agreement with Methodist Hospital to make, sell and sublicense products and services using the intellectual property and know-how of Methodist ("Methodist License Agreement"). In September 2022, the Company amended the Agreement to provide that in the event the Company sublicenses products and services covered by the Agreement, then royalties owing to Houston Methodist would be computed as a percentage of payments received by the Company from the sublicensee ("Sublicense Revenue") and not as a percentage of product or service sales earned by the Sublicensee ("Net Sales"). Prior to the amendment, royalties owed to Houston Methodist, payable by Coya, were calculated based on a percentage of Net Sales irrespective of whether Net Sales were earned by Coya or by the Sublicensee. In addition, the termination provisions were clarified, and now provide that Houston Methodist may only terminate the agreement among other things in the event that after five years, Coya is not "Actively Attempting to Develop or Commercialize" as such term is defined in the License Agreement.
Sponsored Research Agreement
As discussed in more detail in Note 8 to the audited financial statements included elsewhere in this prospectus, the Company has an agreement with Methodist to fund up to $1,547,094 in research in the area of neurodegenerative diseases performed by HRMI. In return, the Company will gain expanded access to data methods and know-how per the SRA, and, if the research produces intellectual property, the Company will have all first rights to the intellectual property. As of September 15, 2022, we have provided notice to HMRI regarding termination of the SRA in expectation that a reduced yearly budget be negotiated post termination. For the 90-day period commencing after the termination date of the SRA, we are responsible for reimbursing HMRI for accrued expenses incurred by HMRI. During this 90-day period, we intend to negotiate a new SRA with HMRI.
F-31
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
7. Convertible preferred stock and stockholders’ equity (deficit)
Convertible preferred stock
In December 2020, the Company sold 7,361,744 shares of Series A for $1.338 per share resulting in net proceeds of $8,604,661 and converted $188,976 of the Notes into 138,969 shares of Series A.
The following is a summary of the rights, preferences, and terms of the Series A:
Dividends
Holders of Series A, in preference to holders of any other class or series of the Company’s stock, are entitled to dividends only when declared by the Board of Directors, but such will accrue at a rate of 8% of the original issuance price prior to and in preference to any declaration of other dividends. No dividends were declared or paid from inception through September 30, 2022.
Voting
Each share of Series A shall be entitled to cast the number of votes equal to the number of whole shares of common stock into which such shares of Series A are convertible as of the record date for determining stockholders entitled to vote on such matter. Generally, holders of the Series A shall vote together with the holders of common stock as a single class and on an as converted into common stock basis. The Company’s Board of Directors has five members. The holders of the Series A preferred stock are entitled to elect one of the Directors, the holders of common stock are entitled to elect two Directors, one Director shall be the Chief Executive Officer of the Company, and one independent Director is an individual that is mutually acceptable to holders of the majority of the common stock.
Liquidation preference
In the event of a liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or in the event of a deemed liquidation event, which includes a sale of the Company as defined in the Company’s articles of incorporation, holders of Series A are entitled to receive, in preference to all other stockholders, the greater of (i) an amount equal to the Series A original issue price of $1.338, plus any dividends declared but unpaid, or (ii) such amount per share as would have been payable had all shares of Series A been converted into common stock. If upon the occurrence of such event, the assets and funds available for distribution are insufficient to pay such holders the full amount to which they are entitled, then the entire assets legally available for distribution shall be distributed ratably among the holders of Series A in proportion to the full amounts to which they would otherwise be entitled. As of September 30, 2022, no dividends have been declared, and the liquidation preference represents the original issue price of $1.338 per share of Series A.
Conversion
Each share of Series A is convertible into common stock at any time at the option of the holder thereof at the conversion price then in effect. If not previously converted, all shares of Series A will automatically convert into common stock at the conversion price then in effect upon a qualified initial public offering of the company’s common stock in excess of $20,000,000 and a pre-transaction valuation of $50,000,000. These thresholds are reduced to $14,000,000 and $40,000,000 in a merger scenario. The per share conversion price for the Series A is $1.338 as of September 30, 2022, subject to anti-dilution adjustments for stock splits, stock dividends, and similar transactions.
Redemption
The Series A is subject to redemption under certain deemed liquidation events; however, these events are solely within the control of the Company, and as such, the Series A is classified as permanent equity in the Company’s accompanying balance sheets.
F-32
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
Common stock and common stock warrants
The holders of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. Unless required by law, there shall be no cumulative voting. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, after the payment of all preferential amounts required to be paid to the holders of shares of Series A, the remaining funds and assets available for distribution to the stockholders of the Company will be distributed among the holders of shares of common stock, pro rata based on the number of shares of common stock held by each such holder.
In connection with the Series A offering, the Company issued freestanding warrants to purchase 525,049 shares of the Company’s common stock to the placement agent of the Series A offering. These warrants have an exercise price of $1.606 per common share and a term of five years from the date of issuance. These warrants are not redeemable and are generally not transferrable. During its evaluation of equity classification for the Company's common stock warrants, the Company considered the conditions as prescribed within ASC 815-40, Derivatives and Hedging, Contracts in an Entity’s own Equity. The conditions within ASC 815-40 are not subject to a probability assessment. The warrants do not fall under the liability criteria within ASC 480, Distinguishing Liabilities from Equity, as they are not puttable and do not represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC 815 but are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent equity if freestanding. The fair value of these warrants was determined to be $15,138 on the date of issuance and were recorded as a component of additional paid-in capital as part of the Series A offering.
8. Stock-based compensation
In January 2021, the Company adopted the 2021 Equity Incentive Plan (“2021 Plan”), as amended. The 2021 Plan provides for the granting of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, equity appreciation rights, performance awards, and other equity-based awards. The Company's employees, officers, independent directors, and other persons are eligible to receive awards under the 2021 Plan. As of September 30, 2022, 4,500,000 shares of the Company’s common stock were authorized to be issued, of which 1,771,743 shares were available for future issuance.
The amount, terms of grants, and exercisability provisions are determined and set by the Company's Board of Directors or compensation committee. The Company measures employee stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company has recorded stock-based compensation in the accompanying statements of operations as follows:
|
|
|
|
Nine Months Ended September 30, |
|
|||||
|
|
|
|
2021 |
|
|
2022 |
|
||
General and administrative |
|
|
|
$ |
32,837 |
|
|
$ |
57,520 |
|
Research and development |
|
|
|
|
173,751 |
|
|
|
78,397 |
|
|
|
|
|
$ |
206,588 |
|
|
$ |
135,917 |
|
Stock options
The Company has issued service-based stock options that generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board of Directors. Vesting generally occurs over a period of not greater than four years.
F-33
COYA THERAPEUTICS, INC.
NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS
The following table summarizes the activity for the periods indicated:
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
||
|
|
|
|
|
|
average |
|
|
average remaining |
|
|
Aggregate |
|
|||
|
|
|
|
|
|
exercise |
|
|
contractual |
|
|
intrinsic |
|
|||
|
|
Options |
|
|
price |
|
|
term (years) |
|
|
value |
|
||||
Outstanding at January 1, 2022 |
|
|
2,024,469 |
|
|
$ |
0.19 |
|
|
|
9.3 |
|
|
|
$222,692 |
|
Granted |
|
|
862,500 |
|
|
|
0.61 |
|
|
|
|
|
|
|
|
|
Forfeited and cancelled |
|
|
(160,378) |
|
|
|
0.19 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(834 |
) |
|
|
0.19 |
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2022 |
|
|
2,725,757 |
|
|
$ |
0.32 |
|
|
|
8.9 |
|
|
|
$782,568 |
|
Exercisable at September 30, 2022 |
|
|
1,269,569 |
|
|
$ |
0.21 |
|
|
|
8.5 |
|
|
|
$512,219 |
|
Vested and expected to vest at September 30, 2022 |
|
|
2,725,757 |
|
|
$ |
0.32 |
|
|
|
8.9 |
|
|
|
$782,568 |
|
As of September 30, 2022, the unrecognized compensation cost was $418,166, and will be recognized over an estimated weighted-average amortization period of 2.0 years.
The fair value of options is estimated using the Black-Scholes option pricing model, which takes into account inputs such as the exercise price, the estimated fair value of the underlying common stock at the grant date, expected term, estimated stock price volatility, risk-free interest rate, and dividend yield. The fair value of stock options granted during the period ended September 30, 2022 was determined using the methods and assumptions discussed below.
|
• |
The expected term of employee stock options with service-based vesting is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin (“SAB”) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. |
|
• |
The expected stock price volatility is based on historical volatility of comparable public entities within the Company’s industry, which were commensurate with the expected term assumption as described in SAB No. 107. |
|
• |
The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term. |
|
• |
The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. |
|
• |
As the Company’s common stock has not been publicly traded, its Board of Directors periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. |
The grant date fair value of each option grant for the period ended September 30, 2022 was estimated using the Black-Scholes option-pricing model using the following weighted-average assumptions:
|
|
|
|
Nine Months Ended September 30, 2022 |
|
|
Risk-free interest rate |
|
|
|
|
3.3 |
% |
Expected term (years) |
|
|
|
|
5.6 |
|
Expected volatility |
|
|
|
|
83.48 |
% |
Expected dividend yield |
|
|
|
|
- |
|
Estimated fair value of the Company's common stock per share |
|
|
|
$ |
0.61 |
|
9. Subsequent events
The Company has evaluated subsequent events from the balance sheet date through November 18, 2022, the date at which the condensed unaudited interim financial statements were issued, and has determined that there are no such events to report.
F-34
Shares
Common Stock
PRELIMINARY PROSPECTUS
Chardan |
|
|
Newbridge Securities Corporation |
, 2022
Through and including , 2022 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to any unsold allotment or subscription.
PART II - INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. |
Expenses of Issuance and Distribution |
The following table sets forth all costs and expenses, other than underwriting discounts and commissions, paid or payable by the Registrant in connection with the sale of the common stock being registered. All amounts shown are estimates except for the SEC registration fee, the FINRA filing fee and the Nasdaq listing fee:
Expenses of Issuance and Distribution ($ thousands) |
|
Amount to be Paid |
|
SEC registration fee |
|
$ |
2,067.28 |
FINRA filing fee |
|
|
* |
Exchange listing fee |
|
|
* |
Printing and engraving expenses |
|
|
* |
Legal fees and expenses |
|
|
* |
Accounting fees and expenses |
|
|
* |
Blue Sky fees and expenses |
|
|
* |
Transfer agent and registrar fees and expenses |
|
|
|
Miscellaneous |
|
|
* |
Total |
|
$ |
* |
* |
To be completed by amendment |
Item 14.Indemnification of Directors and Officers
Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that 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 (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) for unlawful payment of dividends or unlawful stock purchases or redemptions, or (iv) for any transaction from which the director derived an improper personal benefit. Our amended and restated certificate of incorporation will contain such a provision.
Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines, and amounts paid in settlement in connection with specified actions, suits, or proceedings, whether civil, criminal, administrative, or investigative (other than an action by or in the right of the corporation—a “derivative action”), if they acted in good faith and in a manner they reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe their conduct was unlawful. A similar standard is applicable in the case of derivative actions, except that indemnification only extends to expenses (including attorneys’ fees) incurred in connection with defense or settlement of such action, and the statute requires court approval before there can be any indemnification where the person seeking indemnification has been found liable to the corporation. Our amended and restated certificate of incorporation and amended and restated bylaws will contain such a provision.
We have in effect a directors and officers liability insurance policy indemnifying our directors and officers for certain liabilities incurred by them, including liabilities under the Securities Act and the Exchange Act. We pay the entire premium of this policy.
We intend to enter into indemnification agreements with each of our directors and officers that provide the maximum indemnity allowed to directors and officers by Section 145 of the Delaware General Corporation Law and which allow for certain additional procedural protections.
These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities (including reimbursement of expenses incurred) arising under the Securities Act.
Item 15.Recent Sales of Unregistered Securities
Since three years before the date of the initial filing of this registration statement, the Registrant has sold the following securities without registration under the Securities Act:
II-1
In December 2020, the Registrant issued 10,750,000 shares of its common stock in connection with its corporate reorganization with Nicoya Health, Inc.
In December 2020, the Registrant sold an aggregate of 7,500,713 shares of its Series A preferred stock at a purchase price of $1.338 per share for an aggregate purchase price of approximately $10.0 million.
In December 2020, the Registrant issued warrants to purchase 525,049 shares of its common stock, or 7% of the number of shares of common stock underlying the Series A Preferred Stock sold in the December 2020 offering at an exercise price equal to $1.606.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. Unless otherwise specified above, we believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act (and Regulation D promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or under benefit plans and contracts relating to compensation as provided under Rule 701. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed on the share certificates issued in these transactions. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
For a complete description of the transactions described in this Item 15, see “Certain Relationships and Related Party Transactions” in the accompanying prospectus.
Item 16.Exhibits and Financial Statement Schedules
|
(a) |
Exhibits. |
A list of exhibits required to be filed under this item is set forth on the Exhibit Index of this registration statement and is incorporated in this Item 16(a) by reference.
|
(b) |
Financial Statement Schedules. |
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 underwriters at the completion specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
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 provisions referenced in Item 14 of this registration statement, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission 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 hereunder, 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 of whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes that:
(a)For purposes of determining any liability under the Securities Act, 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.
(b)For the purpose of determining any liability under the Securities Act, 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-2
Exhibit Number |
|
Description |
1.1 |
|
Form of Underwriting Agreement(a) |
2.1 |
|
|
3.1 |
|
Certificate of Incorporation of Coya Therapeutics, Inc., as currently in effect(d) |
3.2 |
|
|
3.3 |
|
By-laws of Coya Therapeutics, Inc., as currently in effect(d) |
3.4 |
|
Form of Amended and Restated By-Laws, to become effective upon completion of this offering(d) |
4.1 |
|
|
4.2 |
|
|
4.3 |
|
Form of Underwriters’ Warrant(a) |
5.1 |
|
Form of Opinion of Lowenstein Sandler LLP(a) |
10.1 |
|
The Amended and Restated Coya Therapeutics, Inc. 2021 Equity Incentive Plan(a)(b) |
10.2 |
|
|
10.3 |
|
|
10.4 |
|
|
10.5 |
|
|
10.6 |
|
|
10.7 |
|
|
10.8 |
|
|
10.9 |
|
|
10.10 |
|
|
10.11 |
|
|
10.12 |
|
|
10.13 |
|
|
10.14 |
|
|
23.1 |
|
|
23.2 |
|
Consent of Lowenstein Sandler LLP (included in Exhibit 5.1)(a) |
24.1 |
|
|
107 |
|
(a) |
To be filed by amendment. |
(b) |
Management contract or compensatory plan or arrangement. |
(c) |
Portions of this exhibit (indicated by asterisks) are omitted in accordance with the rules of the SEC. |
(d) |
Filed herewith. |
II-3
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Houston, State of Texas, on the 18th day of November, 2022.
|
|
COYA THERAPEUTICS, INC. |
|
|
|
|
By: |
/s/ Howard Berman |
|
|
Name: Howard Berman |
|
|
Title: Chief Executive Officer |
II-4
KNOW ALL PERSONS BY THESE PRESENT, that each person whose signature appears below constitutes and appoints Howard Berman and David Snyder, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution for him in any and all capacities, to sign (i) any and all amendments (including post-effective amendments) to this registration statement and (ii) any registration statement or post-effective amendment thereto to be filed with the United States Securities and Exchange Commission pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the United States 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 necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all 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 of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Howard Berman |
|
Chief Executive Officer and Director (Principal Executive Officer) |
|
November 18, 2022 |
Howard Berman |
|
|||
|
|
|
|
|
/s/ David Snyder |
|
Chief Financial Officer (Principal Financial and Accounting Officer) Chief Operating Officer |
|
November 18, 2022 |
David Snyder |
|
|||
|
|
|
|
|
/s/ Ann Lee |
|
Director |
|
November 18, 2022 |
Ann Lee |
|
|||
|
|
|
|
|
/s/ Anabella Villalobos |
|
Director |
|
November 18, 2022 |
Anabella Villalobos |
|
|
||
|
|
|
|
|
/s/ Hideki Garren |
|
Director |
|
November 18, 2022 |
Hideki Garren |
|
|
||
|
|
|
|
|
/s/ Dov Goldstein |
|
Director |
|
November 18, 2022 |
Dov Goldstein |
|
|||
|
|
|
|
|
II-5
Exhibit 2.1
AGREEMENT AND PLAN OF MERGER
BY AND AMONG
COYA THERAPEUTICS, INC.
AND
NICOYA HEALTH, INC. DATED AS
OF DECEMBER 22, 2020
TABLE OF CONTENTS
|
Page |
||
|
|
||
ARTICLE I THE MERGER |
1 |
||
|
|
|
|
|
1.1 |
The Merger |
1 |
|
|
|
|
|
1.2 |
Closing |
1 |
|
|
|
|
|
1.3 |
Effective Time |
1 |
|
|
|
|
|
1.4 |
Effect of the Merger |
2 |
|
|
|
|
|
1.5 |
Certificate of Incorporation |
2 |
|
|
|
|
|
1.6 |
Bylaws. |
2 |
|
|
|
|
|
1.7 |
Directors of the Surviving Corporation |
2 |
|
|
|
|
|
1.8 |
Officers of the Surviving Corporation |
2 |
|
|
|
|
|
1.9 |
Additional Actions |
2 |
|
|
|
|
ARTICLE II EFFECT OF THE MERGER ON CAPITAL STOCK; EXCHANGE OF CERTIFICATES |
3 |
||
|
|
|
|
|
2.1 |
Effect of the Merger on Capital Stock |
3 |
|
|
|
|
|
2.2 |
Exchange Procedures |
3 |
|
|
|
|
|
2.3 |
Adjustments |
4 |
|
|
|
|
|
2.4 |
Withholding Rights |
5 |
|
|
|
|
|
2.5 |
Lost Certificates |
5 |
|
|
|
|
|
2.6 |
Tax Treatment |
5 |
|
|
|
|
ARTICLE III REPRESENTATIONS AND WARRANTIES OF NICOYA |
5 |
||
|
|
|
|
|
3.1 |
Organization, Good Standing, Corporate Power and Qualification |
5 |
|
|
|
|
|
3.2 |
Capitalization. |
5 |
|
|
|
|
|
3.3 |
Subsidiaries |
6 |
|
|
|
|
|
3.4 |
Authorization |
6 |
|
|
|
|
|
3.5 |
Litigation |
6 |
|
|
|
|
|
3.6 |
Compliance with Other Instruments |
6 |
|
|
|
|
|
3.7 |
Corporate Documents |
6 |
|
|
|
|
|
3.8 |
Financial Statements |
7 |
|
|
|
|
|
3.11 |
Exclusivity of Representations and Warranties |
7 |
|
|
|
|
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF CTI |
7 |
||
|
|
|
|
|
4.1 |
Organization, Good Standing, Corporate Power and Qualification |
7 |
|
|
|
|
|
4.2 |
Capitalization |
8 |
|
|
|
|
|
4.3 |
Subsidiaries |
8 |
-i-
TABLE OF CONTENTS
(continued)
|
|
|
Page |
|
|
|
|
|
4.4 |
Authorization |
8 |
|
|
|
|
|
4.5 |
Litigation |
8 |
|
|
|
|
|
4.6 |
Compliance with Other Instruments |
8 |
|
|
|
|
|
4.7 |
Corporate Documents |
9 |
|
|
|
|
|
4.8 |
Exclusivity of Representations and Warranties |
9 |
|
|
|
|
ARTICLE V COVENANTS |
9 |
||
|
|
|
|
|
5.1 |
Conduct of Business by NICOYA Pending the Closing |
9 |
|
|
|
|
|
5.2 |
Conduct of Business by CTI Pending the Closing |
11 |
|
|
|
|
|
5.3 |
Access to Information |
13 |
|
|
|
|
|
5.4 |
Agreement to Cooperate |
13 |
|
|
|
|
|
5.5 |
Control of Other Party’s Business |
14 |
|
|
|
|
|
5.6 |
Confidentiality |
14 |
|
|
|
|
|
5.7 |
Public Disclosure |
14 |
|
|
|
|
|
5.8 |
Blue Sky Laws |
14 |
|
|
|
|
|
5.9 |
Assignment of Agreements |
15 |
|
|
|
|
|
5.10 |
Directors’ and Officers’ Indemnification and Insurance |
15 |
|
|
|
|
|
5.11 |
Equity Incentive Plan |
15 |
|
|
|
|
ARTICLE VI CONDITIONS TO CLOSING |
15 |
||
|
|
|
|
|
6.1 |
Conditions to Obligations of Each Party |
15 |
|
|
|
|
|
6.2 |
Conditions to Obligations of NICOYA |
16 |
|
|
|
|
|
6.3 |
Conditions to Obligations of CTI |
16 |
|
|
|
|
ARTICLE VII TERMINATION |
17 |
||
|
|
|
|
|
7.1 |
Termination or Abandonment |
17 |
|
|
|
|
|
7.2 |
Effect of Termination. |
17 |
|
|
|
|
ARTICLE VIII MISCELLANEOUS |
18 |
||
|
|
|
|
|
8.1 |
No Survival |
18 |
|
|
|
|
|
8.2 |
Expenses |
18 |
|
|
|
|
|
8.3 |
Counterparts |
18 |
|
|
|
|
|
8.4 |
Governing Law |
18 |
|
|
|
|
|
8.5 |
Jurisdiction; Specific Enforcement |
18 |
|
|
|
|
|
8.6 |
Waiver of Jury Trial |
19 |
-ii-
TABLE OF CONTENTS
(continued)
|
|
|
Page |
|
|
|
|
|
8.7 |
Notices |
19 |
|
|
|
|
|
8.8 |
Assignment; Binding Effect |
20 |
|
|
|
|
|
8.9 |
Severability |
20 |
|
|
|
|
|
8.10 |
Entire Agreement |
20 |
|
|
|
|
|
8.11 |
Amendments; Waivers |
20 |
|
|
|
|
|
8.12 |
Headings |
20 |
|
|
|
|
|
8.13 |
No Third-Party Beneficiaries |
20 |
|
|
|
|
|
8.14 |
Interpretation |
20 |
|
|
|
|
|
8.15 |
Definitions |
21 |
-iii-
AGREEMENT AND PLAN OF MERGER
THIS AGREEMENT AND PLAN OF MERGER (this “Merger Agreement”), dated as of December 22, 2020, is by and between Coya Therapeutics, Inc., a Delaware corporation (“CTI”), and Nicoya Health, Inc., a Delaware corporation (“NICOYA”, and together with CTI, the “Parties”).
RECITALS:
A.The Parties desire to effect a merger of NICOYA with and into CTI pursuant to and in accordance with the provisions of the General Corporation Law of the State of Delaware (“DGCL”).
B.The respective boards of directors and requisite stockholders of CTI and NICOYA have each approved and declared advisable the merger of NICOYA with and into CTI (the “Merger”), upon the terms and subject to the conditions set forth in this Merger Agreement and in accordance with the provisions of the DGCL.
AGREEMENT:
NOW, THEREFORE, in consideration of the foregoing and the mutual agreements herein contained, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
ARTICLE I
THE MERGER
1.1The Merger. Subject to the terms and provisions of this Merger Agreement, and in accordance with the DGCL, at the Effective Time, NICOYA will be merged with and into CTI. Following the Effective Time, CTI will be the surviving corporation (the “Surviving Corporation”) of the Merger and will continue its corporate existence under the laws of the State of Delaware. All references prior to the “Surviving Corporation” prior to the Effective Time shall refer to CTI. At the Effective Time, the separate corporate existence of NICOYA will thereupon cease. The name of the surviving corporation will be “Coya Therapeutics, Inc.”
1.2Closing. Upon the terms and subject to the conditions set forth herein, the closing of the Merger (the “Closing”) will take place at 10:00 a.m., San Diego time, as soon as practicable (and, in any event, within three business days) after the satisfaction or, to the extent permitted hereunder, waiver of all conditions to the Merger set forth in ARTICLE VI (other than those conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or, to the extent permitted hereunder, waiver of all such conditions), unless this Agreement has been terminated pursuant to its terms or unless another time or date is agreed to in writing by the Parties hereto. The Closing shall take place at the offices of Jones Day, 4655 Executive Drive, Suite 1500, San Diego, CA 92121, or remotely by exchange of documents and signatures (or their electronic counterparts), unless another place is agreed to in writing by the Parties hereto. The actual date of the Closing is hereinafter referred to as the “Closing Date.”
1.3Effective Time. Subject to the provisions of this Agreement, at the Closing, CTI and NICOYA will cause a certificate of merger (the “Certificate of Merger”) to be executed, acknowledged and filed with the Secretary of State of the State of Delaware in accordance with the relevant provisions of the DGCL and shall make all other filings or recordings required under the DGCL. The Merger will become effective upon the filing of the Certificate of Merger with the Secretary of State of the State of Delaware in accordance with the provisions of §253 of the DGCL. The date and time when the Merger will become effective is herein referred to as the “Effective Time.”
1.4Effect of the Merger. At the Effective Time, the Merger will have the effects provided for herein and in § 259 of the DGCL. Without limiting the generality of the forgoing, and subject thereto, at the Effective Time, all the property, rights, privileges, immunities, powers, franchises, licenses, and authority of CTI and NICOYA will be vested in the Surviving Corporation, and all debts, liabilities, obligations, restrictions and duties of CTI and NICOYA will become the debts, liabilities, obligations, restrictions and duties of the Surviving Corporation.
1.5Certificate of Incorporation. As of the Effective Time, the certificate of incorporation of CTI (the “Current CTI Certificate of Incorporation”) shall be amended and restated so as to read in its entirety as set forth in Exhibit A (the “Surviving Corporation A&R Certificate of Incorporation”), and, as so amended and restated, shall be the certificate of incorporation of the Surviving Corporation until thereafter duly altered, amended or repealed in accordance with the provisions thereof and applicable law.
1.6Bylaws. As of the Effective Time, the bylaws of CTI (the “CTI Bylaws”) shall be amended and restated so as to read in its entirety as set forth in Exhibit B (the “Surviving Corporation Bylaws”), and, as so amended and restated, shall be the bylaws of the Surviving Corporation until thereafter duly altered, amended or repealed in accordance with the provisions thereof and applicable law.
1.7Directors of the Surviving Corporation. At the Effective Time, each of Howard Berman, Jani Tuomi, Andrea Goldstein and Shawn Titcomb shall be a director of the Surviving Corporation and each such person will serve as a director of the Surviving Corporation until such person’s successor is duly elected and qualified in the manner provided in the Surviving Corporation Bylaws or the Surviving Corporation A&R Certificate of Incorporation, as amended from time to time, or as otherwise provided by law or until such person’s earlier death, resignation or removal in the manner provided in the Surviving Corporation Bylaws or the Surviving Corporation A&R Certificate of Incorporation or as otherwise provided by law.
1.8Officers of the Surviving Corporation. At the Effective Time, Howard Berman shall serve as the Surviving Corporation’s Chief Executive Officer and Andrea Goldstein will serve as the Surviving Corporation’s Chief Medical Officer, with each such person to hold such office in the Surviving Corporation in accordance with the Surviving Corporation Bylaws.
1.9Additional Actions. If, at any time after the Effective Time, the Surviving Corporation will consider or be advised that any further assignments or assurances in law or any other acts are necessary or desirable (a) to vest, perfect or confirm, of record or otherwise, in the Surviving Corporation, title to and possession of any property right of NICOYA acquired or to be acquired by reason of, or as a result of, the Merger, or (b) otherwise to carry out the purpose of this Merger Agreement, NICOYA and its proper officers and directors will be deemed to have granted hereby to the Surviving Corporation an irrevocable power of attorney to execute and deliver all such proper deeds, assignments and assurances in law and to do all acts necessary or proper to vest, perfect or confirm title to and possession of such property or rights in the Surviving Corporation and otherwise to carry out the purposes of this Merger Agreement; and the proper officers and directors of the Surviving Corporation are hereby fully authorized in the name of NICOYA or otherwise to take any and all such action.
- 2 -
ARTICLE II
EFFECT OF THE MERGER ON CAPITAL STOCK;
EXCHANGE OF CERTIFICATES
2.1Effect of the Merger on Capital Stock. At the Effective Time, as a result of the Merger and without any action on the part of CTI or NICOYA or the holder of any capital stock of CTI or NICOYA:
(a)Cancellation of Certain NICOYA Capital Stock. Each share of NICOYA’s common stock, par value $0.0001 per share (“NICOYA Common Stock”), that is owned by CTI or NICOYA (as treasury stock or otherwise) as of immediately prior to the Effective Time (the “Cancelled Shares”) will automatically be cancelled and retired and will cease to exist, and no consideration will be delivered in exchange therefor.
(b)Conversion of NICOYA Common Stock. Each share of NICOYA Common Stock issued and outstanding immediately prior to the Effective Time (other than Cancelled Shares) will be converted into the right to receive: (i) one (1) (the “NICOYA Common Stock Exchange Ratio”) share of the Surviving Corporation’s common stock, par value $0.0001 per share (“Surviving Corporation Common Stock”), (the “NICOYA Common Stock Merger Consideration”); (ii) any cash in lieu of fractional shares of Surviving Corporation Common Stock payable pursuant to Section 2.1(d); and (iii) any dividends or other distributions to which the holder thereof becomes entitled to upon the surrender of such shares of NICOYA Common Stock in accordance with Section 2.2(e).
(c)Cancellation of Shares. At the Effective Time, all shares of NICOYA Common Stock will no longer be outstanding and all shares of NICOYA Common Stock will be cancelled and retired and will cease to exist, and each holder of: (i) a certificate formerly representing any shares of NICOYA Common Stock (each, a “Certificate”); or (ii) any book-entry shares which immediately prior to the Effective Time represented shares of NICOYA Common Stock (each, a “Book-Entry Share”) will cease to have any rights with respect thereto, except the right to receive (A) the Merger Consideration in accordance with Section 2.2 hereof, (B) any cash in lieu of fractional shares of Surviving Corporation Common Stock payable pursuant to Section 2.1(d), and (C) any dividends or other distributions to which the holder thereof becomes entitled to upon the surrender of such shares of NICOYA Common Stock in accordance with Section 2.2(e).
(d)Fractional Shares. No certificates or scrip representing fractional shares of Surviving Corporation Common Stock shall be issued upon the conversion of NICOYA Common Stock pursuant to Section 2.1(b) and such fractional share interests shall not entitle the owner thereof to vote or to any other rights of a holder of shares of Surviving Corporation Common Stock.
2.2Exchange Procedures.
(a)Exchange Agent. The Surviving Corporation shall be the exchange agent (the “Exchange Agent”), and shall act as the agent for the purpose of paying the Merger Consideration for the Certificates and the Book-Entry Shares.
(b)Procedures for Surrender; No Interest. Each holder of shares of NICOYA Common Stock that have been converted into the right to receive the Merger Consideration shall be entitled to receive the Merger Consideration into which such shares of NICOYA Common Stock have been converted pursuant to Section 2.1(b) in respect of the NICOYA Common Stock represented by a Certificate or Book-Entry Share, any cash in lieu of fractional shares which the holder has the right to receive pursuant to Section 2.1(d), and any dividends or other distributions pursuant to Section 2.2(e) upon: (i) surrender to the
- 3 -
Exchange Agent of a Certificate; or (ii) receipt of an “agent’s message” by the Exchange Agent (or such other evidence, if any, of transfer as the Exchange Agent may reasonably request) in the case of Book-Entry Shares; in each case, together with duly completed and validly executed documents as may reasonably be requested by the Exchange Agent. No interest shall be paid or accrued upon the surrender or transfer of any Certificate or Book- Entry Share. Upon payment of the Merger Consideration pursuant to the provisions of this ARTICLE II, each Certificate or Certificates or Book-Entry Share or Book-Entry Shares so surrendered or transferred, as the case may be, shall immediately be cancelled.
(c)Payments to Non-Registered Holders. If any portion of the Merger Consideration is to be paid to a Person other than the Person in whose name the surrendered Certificate or the transferred Book-Entry Share, as applicable, is registered, it shall be a condition to such payment that: (i) such Certificate shall be properly endorsed or shall otherwise be in proper form for transfer or such Book-Entry Share shall be properly transferred; and (ii) the Person requesting such payment shall pay to the Exchange Agent any transfer or other Tax required as a result of such payment to a Person other than the registered holder of such Certificate or Book-Entry Share, as applicable, or establish to the reasonable satisfaction of the Exchange Agent that such Tax has been paid or is not payable.
(d)Full Satisfaction. All Merger Consideration paid upon the surrender of Certificates or transfer of Book-Entry Shares in accordance with the terms hereof shall be deemed to have been paid in full satisfaction of all rights pertaining to the shares of NICOYA Common Stock formerly represented by such Certificate or Book-Entry Shares, and from and after the Effective Time, there shall be no further registration of transfers of shares of NICOYA Common Stock on the stock transfer books of the Surviving Corporation. If, after the Effective Time, Certificates or Book-Entry Shares are presented to the Surviving Corporation, they shall be cancelled and exchanged as provided in this ARTICLE II.
(e)Distributions with Respect to Unsurrendered Shares of NICOYA Common Stock. All shares of Surviving Corporation Common Stock to be issued pursuant to the Merger shall be deemed issued and outstanding as of the Effective Time and whenever a dividend or other distribution is declared by the Surviving Corporation in respect of the Surviving Corporation Common Stock, the record date for which is after the Effective Time, that declaration shall include dividends or other distributions in respect of all shares issuable pursuant to this Agreement. No dividends or other distributions in respect of the Surviving Corporation Common Stock shall be paid to any holder of any unsurrendered share of NICOYA Common Stock until the Certificate (or affidavit of loss in lieu of the Certificate as provided in Section 2.4) or Book-Entry Share is surrendered for exchange in accordance with this Section 2.2. Subject to the effect of applicable Laws, following such surrender, there shall be issued or paid to the holder of record of the whole shares of Surviving Corporation Common Stock issued in exchange for shares of NICOYA Common Stock in accordance with this Section 2.2, without interest: (i) at the time of such surrender, the dividends or other distributions with a record date after the Effective Time theretofore payable with respect to such whole shares of Surviving Corporation Common Stock and not paid; and (ii) at the appropriate payment date, the dividends or other distributions payable with respect to such whole shares of Surviving Corporation Common Stock with a record date after the Effective Time but with a payment date subsequent to surrender.
2.3Adjustments. Without limiting the other provisions of this Agreement, if at any time during the period between the date of this Agreement and the Effective Time, any change in the outstanding shares of NICOYA Common Stock or CTI Common Stock shall occur (other than the issuance of additional shares of capital stock of NICOYA or CTI as permitted by this Agreement), including by reason of any reclassification, recapitalization, stock split (including a reverse stock split), or combination, exchange, readjustment of shares, or similar transaction, or any stock dividend or distribution paid in stock, the Exchange Ratios and any other amounts payable pursuant to this Agreement shall be appropriately adjusted to reflect such change; provided, however, that this sentence shall not be construed to permit NICOYA or CTI to take any action with respect to its securities that is prohibited by the terms of this Agreement.
- 4 -
2.4Withholding Rights. The Surviving Corporation shall be entitled to deduct and withhold from the consideration otherwise payable to any Person pursuant to this ARTICLE II such amounts as may be required to be deducted and withheld with respect to the making of such payment under any Tax Laws. To the extent that amounts are so deducted and withheld by the Surviving Corporation, such amounts shall be treated for all purposes of this Agreement as having been paid to the Person in respect of which the Surviving Corporation made such deduction and withholding.
2.5Lost Certificates. If any Certificate shall have been lost, stolen, or destroyed, upon the making of an affidavit of that fact by the Person claiming such Certificate to be lost, stolen, or destroyed and, if required by the Surviving Corporation, the posting by such Person of a bond, in such reasonable amount as the Surviving Corporation may direct, as indemnity against any claim that may be made against it with respect to such Certificate, the Exchange Agent will issue, in exchange for such lost, stolen, or destroyed Certificate, the Merger Consideration to be paid in respect of the shares of NICOYA Common Stock formerly represented by such Certificate as contemplated under this ARTICLE II.
2.6Tax Treatment. For U.S. federal income Tax purposes, it is intended that the Merger qualify as a “reorganization” within the meaning of Section 368(a) of the Code, and the regulations promulgated thereunder, that this Agreement will constitute a “plan of reorganization” for purposes of Sections 354 and 361 of the Code.
ARTICLE III
REPRESENTATIONS AND WARRANTIES OF NICOYA
Subject to the disclosures set forth in the NICOYA Disclosure Schedule, NICOYA represents and warrants to CTI as follows. The NICOYA Disclosure Schedule will be arranged in paragraphs corresponding to the lettered and numbered paragraphs contained in this ARTICLE III. Any matter disclosed in any section of the NICOYA Disclosure Schedule shall be considered disclosed for other sections of the NICOYA Disclosure Schedule, but only to the extent such matter on its face would reasonably be expected to be pertinent to a particular section of the NICOYA Disclosure Schedule in light of the disclosure made in such section. The provision of monetary or other quantitative thresholds for disclosure does not and shall not be deemed to create or imply a standard of materiality hereunder.
3.1Organization, Good Standing, Corporate Power and Qualification. NICOYA 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 now conducted and as presently proposed to be conducted. NICOYA 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.
3.2Capitalization.
(a)The authorized capital of the NICOYA consists, on the date hereof, of 20,000,000 shares of NICOYA Common Stock, 10,750,000 shares of which are issued and outstanding immediately prior to the date hereof. All of the outstanding shares of NICOYA Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws.
(b)Subsection 3.2(b) of the NICOYA Disclosure Schedule sets forth the capitalization of NICOYA immediately prior to the date of this Agreement, including the number of shares of issued and outstanding NICOYA Common Stock, including, with respect to restricted NICOYA Common Stock, vesting schedule and repurchase price. Except for the securities and rights described in Subsection 3.2(a) of this Agreement and Subsection 3.2(b) of the NICOYA Disclosure Schedule, there are no outstanding
- 5 -
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 NICOYA any shares of NICOYA Common Stock or any securities convertible into or exchangeable for shares of NICOYA Common Stock.
3.3Subsidiaries. NICOYA 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. NICOYA is not a participant in any joint venture, partnership or similar arrangement.
3.4Authorization. All corporate action required to be taken by the NICOYA Board of Directors and stockholders in order to authorize NICOYA to enter into this Agreement and complete the transactions contemplated hereby (the “Transactions”) has been taken or will be taken prior to the Closing. All action on the part of the officers of NICOYA necessary for the execution and delivery of this Agreement, the performance of all obligations of NICOYA under this Agreement to be performed as of the Closing has been taken or will be taken prior to the Closing. This Agreement constitutes a valid and legally binding obligation of NICOYA, enforceable against NICOYA in accordance with its 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, or (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.
3.5Litigation. There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or to NICOYA’s knowledge, currently threatened against NICOYA or any officer or director of NICOYA. Neither NICOYA nor, to NICOYA’s knowledge, any of its officers or directors 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 or directors, such as would affect NICOYA). There is no action, suit, proceeding or investigation by NICOYA pending or which NICOYA intends to initiate.
3.6Compliance with Other Instruments. NICOYA is not in violation or default (i) of any provisions of its current Certificate of Incorporation (the “NICOYA Certificate of Incorporation”) or its Bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) under any note, indenture or mortgage, or (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 NICOYA Disclosure Schedule, or (v) to its knowledge, of any provision of federal or state statute, rule or regulation applicable to NICOYA, the violation of which would have a Material Adverse Effect. The execution, delivery and performance of this Agreement and the consummation of the Transactions 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 NICOYA or the suspension, revocation, forfeiture, or nonrenewal of any material permit or license applicable to NICOYA.
3.7Corporate Documents. The NICOYA Certificate of Incorporation and Bylaws of NICOYA are in the form provided to CTI. The copy of the minute books of NICOYA provided to CTI 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.
- 6 -
3.8Financial Statements.
(a)NICOYA’s unaudited balance sheet as of December 8, 2020 (the “Balance Sheet”), presents fairly, in all material respects, the financial position of NICOYA as of the date specified. Except (i) as set forth in such Balance Sheet and (ii) for fees of legal and other service providers, NICOYA has no known material liabilities of any kind, whether accrued, absolute, contingent, or otherwise. NICOYA does not know of any facts, circumstances or conditions which could reasonably be expected to have a Material Adverse Effect.
(b)Since the date of NICOYA’s Balance Sheet, there has been no Material Adverse Effect on NICOYA.
3.9Indebtedness. NICOYA (i) has no outstanding Indebtedness, (ii) is not a party to any contract, agreement or instrument, the violation of which, or default under which, by the other party(ies) to such contract, agreement or instrument would result in a Material Adverse Effect, or (iii) is not in violation of any term of or in default under any contract, agreement or instrument relating to any Indebtedness, except where such violations and defaults would not result, individually or in the aggregate, in a Material Adverse Effect.
3.10Intellectual Property. NICOYA owns all right, title and interest in, or possesses enforceable rights to use, all NICOYA Intellectual Property. To NICOYA’s knowledge, it has not infringed upon the rights of others with respect to the NICOYA Intellectual Property and has not received written notice that it has or may have infringed or is infringing upon the rights of others with respect to the NICOYA Intellectual Property, or any written notice of conflict with the asserted rights of others with respect to the NICOYA Intellectual Property. To NICOYA’s knowledge, no others have infringed upon its rights with respect to the NICOYA Intellectual Property. None of the NICOYA Intellectual Property have expired or terminated, or are expected to expire or terminate, within three years from the date of this Agreement.
3.11Exclusivity of Representations and Warranties. Neither NICOYA nor any other Person acting on behalf of NICOYA is making any representation or warranty of any kind or nature whatsoever, oral or written, express or implied (including any representation or warranty relating to the financial condition, results of operations, assets or liabilities of NICOYA, any representation or warranty relating to information from or made available by NICOYA, directors, officers, employees or representatives, whether oral or written, express or implied, or any implied warranty of merchantability or of fitness for a particular purpose), except in each case, for the representations and warranties expressly set forth in this ARTICLE III (as modified by the NICOYA Disclosure Schedule), and NICOYA hereby disclaims any such other representations or warranties. NICOYA makes no representations or warranties to CTI regarding any projection or forecast regarding future results or activities or the probable success or profitability of NICOYA.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF CTI
Subject to the disclosures set forth in the CTI Disclosure Schedule, CTI represents and warrants to NICOYA as follows. The CTI Disclosure Schedule will be arranged in paragraphs corresponding to the lettered and numbered paragraphs contained in this ARTICLE IV. Any matter disclosed in any section of the CTI Disclosure Schedule shall be considered disclosed for other sections of the CTI Disclosure Schedule, but only to the extent such matter on its face would reasonably be expected to be pertinent to a particular section of the CTI Disclosure Schedule in light of the disclosure made in such section. The provision of monetary or other quantitative thresholds for disclosure does not and shall not be deemed to create or imply a standard of materiality hereunder.
4.1Organization, Good Standing, Corporate Power and Qualification. CTI 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 now conducted and as presently proposed to be
- 7 -
conducted. CTI is duly qualified to transact business and is in good standing in each jurisdiction in which its ownership of property or the nature of the business conducted by it makes such qualification necessary, except to the extent that the failure to so qualify would not have a Material Adverse Effect.
4.2Capitalization.
(a)The authorized capital of the CTI consists, on the date hereof, of 4,000,000 shares of CTI Common Stock, all of which are issued and outstanding immediately prior to the date hereof. All of the outstanding shares of CTI Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws.
(b)Subsection 4.2(b) of the CTI Disclosure Schedule sets forth the capitalization of the CTI immediately prior to the date of this Agreement, including the number of shares of issued and outstanding CTI Common Stock, including, with respect to restricted CTI Common Stock, vesting schedule and repurchase price. Except for the securities and rights described in Subsection 4.2(a) of this Agreement and Subsection 4.2(b) of the CTI 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 CTI any shares of CTI Common Stock or any securities convertible into or exchangeable for shares of CTI Common Stock.
4.3Subsidiaries. CTI 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. CTI is not a participant in any joint venture, partnership or similar arrangement.
4.4Authorization. All corporate action required to be taken by the CTI Board of Directors and stockholders in order to authorize CTI to enter into this Agreement and complete the transactions contemplated hereby (the “Transactions”) has been taken or will be taken prior to the Closing. All action on the part of the officers of CTI necessary for the execution and delivery of this Agreement, the performance of all obligations of CTI under this Agreement to be performed as of the Closing has been taken or will be taken prior to the Closing. This Agreement constitutes a valid and legally binding obligation of CTI, enforceable against CTI in accordance with its 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, or (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.
4.5Litigation. There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or to CTI’s knowledge, currently threatened against CTI or any officer or director of CTI. Neither CTI nor, to CTI’s knowledge, any of its officers or directors 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 or directors, such as would affect CTI). There is no action, suit, proceeding or investigation by CTI pending or which CTI intends to initiate.
4.6Compliance with Other Instruments. CTI is not in violation or default (i) of any provisions of the Current CTI Certificate of Incorporation or the CTI Bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) under any note, indenture or mortgage, or (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 CTI Disclosure Schedule, or (v) to its knowledge, of any provision of federal or state statute, rule or regulation applicable to CTI, the violation of which would have a Material Adverse Effect. The execution, delivery and performance of this Agreement and the consummation of the Transactions 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,
- 8 -
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 CTI or the suspension, revocation, forfeiture, or nonrenewal of any material permit or license applicable to CTI.
4.7Corporate Documents. The CTI Current Certificate of Incorporation and Bylaws of CTI are in the form provided to NICOYA. The copy of the minute books of CTI provided to NICOYA 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.
4.8Exclusivity of Representations and Warranties. Neither CTI nor any other Person acting on behalf of CTI is making any representation or warranty of any kind or nature whatsoever, oral or written, express or implied (including any representation or warranty relating to the financial condition, results of operations, assets or liabilities of CTI, any representation or warranty relating to information from or made available by CTI, directors, officers, employees or representatives, whether oral or written, express or implied, or any implied warranty of merchantability or of fitness for a particular purpose), except in each case, for the representations and warranties expressly set forth in this ARTICLE IV (as modified by the CTI Disclosure Schedule), and CTI hereby disclaims any such other representations or warranties. CTI makes no representations or warranties to NICOYA regarding any projection or forecast regarding future results or activities or the probable success or profitability of CTI.
ARTICLE V
COVENANTS
5.1Conduct of Business by NICOYA Pending the Closing. Except for matters set forth in Section 5.1 of the NICOYA Disclosure Schedule or otherwise contemplated by this Agreement (or as required by Law), from the date of this Agreement to the Effective Time, NICOYA shall (i) conduct its business in the ordinary course of business consistent with past practice, and (ii) use commercially reasonable efforts to preserve intact its business organization and goodwill, keep available the services of its present officers, key employees and key independent contractors, and preserve the goodwill and business relationships with customers, suppliers, licensors, licensees and others having business relationships with it. In addition, and without limiting the generality of the foregoing, except for matters set forth in Section 5.1 of the NICOYA Disclosure Schedule or otherwise contemplated by this Agreement, from the date of this Agreement to the Effective Time, NICOYA shall not (unless required by applicable Law or the regulations or requirements of any regulatory organization applicable to NICOYA), do any of the following without the prior written consent of CTI, which consent shall not be unreasonably withheld or delayed:
(a)(i) amend or propose to amend the NICOYA Certificate of Incorporation or Nicoya’s Bylaws or similar governing documents, (ii) split, combine or reclassify its outstanding capital stock or issue or authorize the issuance of any other security in respect or, in lieu of, or in substitution for, shares of its capital stock, (iii) declare, set aside or pay any dividend or distribution payable in cash, stock, property or otherwise, (iv) merge or consolidate with any Person, or (v) enter into any agreement with respect to the voting of its capital stock or other securities held by NICOYA;
(b)issue, sell, pledge or dispose of, or agree to issue, sell, pledge or dispose of, any shares of, or any options, warrants or rights of any kind to acquire any shares of, its capital stock of any class or any debt or equity securities convertible into or exchangeable for such capital stock, except with respect to exercises or conversion of currently outstanding options, warrants or convertible securities;
- 9 -
(c)(i) issue any debt securities, incur, guarantee or otherwise become contingently liable with respect to any indebtedness for borrowed money, or enter into any arrangement having the economic effect of any of the foregoing (other than in connection with accounts payable in the ordinary course of business consistent with past practice), (ii) make any loans, advances or capital contributions to, or investments in, any Person (other than in the ordinary course of business consistent with past practice), (iii) redeem, purchase, acquire or offer to purchase or acquire any shares of its capital stock or any options, warrants or rights to acquire any of its capital stock or any security convertible into or exchangeable for its capital stock other than in connection with the repurchase of shares from employees in connection with termination of employment contracts, (iv) make any material acquisition of any assets or businesses (including by merger, consolidation, acquisition of stock or assets, in-bound license transactions or otherwise), or (v) sell, pledge, assign, dispose of, transfer, lease, securitize or materially encumber any businesses or assets that are material to NICOYA (excluding NICOYA Intellectual Property, which is addressed in Section 5.1(d));
(d)(i) sell, pledge, assign, dispose of, transfer, securitize, lease or materially encumber any NICOYA Intellectual Property, (ii) exclusively license, abandon or fail to maintain any NICOYA Intellectual Property, (iii) grant, extend, amend (except as required in the diligent prosecution of the material NICOYA Intellectual Property), waive or modify any rights in or to any NICOYA Intellectual Property, (iv) fail to diligently prosecute NICOYA’s patent applications, or (v) fail to exercise a right of renewal or extension under any NICOYA license;
(e)(i) enter into any Contract or arrangement that reasonably may result in payments by or liabilities of NICOYA in excess of $100,000 individually or $200,000 in the aggregate in any 12-month period, or which limits or otherwise restricts NICOYA or any of its Affiliates or any successor thereto from engaging or competing in any line of business or in any geographic area or which includes a “most favored nation” or “equally favored nation” or similar provision, (ii) vary its inventory practices in any material respect from its past practices, except as required by GAAP or by Law, or (iii) make any capital expenditure or expenditures (including leases and in-bound licenses) in the aggregate in excess of the aggregate amount set forth in NICOYA’s budgeted amounts set forth on Section 5.1(e) of the NICOYA Disclosure Schedule (other than capital expenditures for unbudgeted repairs and maintenance in the ordinary course of business consistent with past practice);
(f)grant, enter into or amend any employment, severance, change in control, special pay arrangement with respect to termination of employment or other similar arrangements or contract with any directors, officers or employees of NICOYA, except (i) as required pursuant to previously existing contracts, or policies between such current directors, officers or employees and NICOYA, or (ii) pursuant to employment agreements entered into with a Person who is not already an officer of NICOYA in the ordinary course of business and is hired or promoted by NICOYA after the date hereof in the ordinary course of business;
(g)(i) increase the salary, benefits or monetary compensation of any directors, executive officers or employees, or (ii) establish, adopt, enter into, or materially amend any, collective bargaining agreement or bonus, profit sharing, thrift, compensation, stock option, restricted stock, pension, retirement, deferred compensation, employment, termination or severance plan, arrangement, trust, fund, policy or agreement;
(h)(i) accelerate, amend or change the period of exercisability or vesting of options, restricted stock or similar awards under any NICOYA stock plan, or (ii) authorize cash payments in exchange for any options granted under any of such plans except as required by the terms of such plans or any related agreements in effect as of the date hereof;
- 10 -
(i)waive, release, assign, settle or compromise any material claims, or any material litigation or arbitration;
(j)adopt, enter into, or amend any NICOYA Employee Plan to materially increase the benefits or liabilities of any NICOYA Employee Plan or to accelerate the payment of benefits under any NICOYA Employee Plan, except as required pursuant to existing contracts or this Agreement;
(k)change any method or principle of financial accounting in a manner that is inconsistent with past practice, except to the extent required by GAAP;
(l)make any material Tax election or settle or compromise any material Tax liability or refund, or change any annual Tax accounting period or material method of Tax accounting, file any material amendment to a tax return, enter into any closing agreement relating to any material Tax, surrender any right to claim a material Tax refund, or consent to any extension or waiver of the statute of limitations period applicable to any material Tax claim or assessment, in each case, other than as required by Law;
(m)modify, amend or terminate, or waive, release or assign any material rights or claims with respect to any confidentiality or standstill agreement to which NICOYA is a party and which relates to a business combination or other similar extraordinary transaction;
(n)take any action or omit to take any action that is intended or would reasonably be expected to result in any of the conditions to the Merger in ARTICLE VI not being satisfied; or
(o)agree, authorize or otherwise to take any of the foregoing actions.
5.2Conduct of Business by CTI Pending the Closing. Except for matters set forth in Section 5.2 of the CTI Disclosure Schedule or otherwise contemplated by this Agreement (or as required by applicable Law or regulatory organization applicable to CTI), from the date of this Agreement to the Effective Time, CTI shall (i) conduct its business in the ordinary course of business consistent with past practice, and (ii) use commercially reasonable efforts to preserve intact its business organization and goodwill, keep available the services of its present officers, key employees and key independent contractors, and preserve the goodwill and business relationships with customers, suppliers, licensors, licensees and others having business relationships with them. In addition, and without limiting the generality of the foregoing, except for matters set forth in Section 5.2 of the CTI Disclosure Schedule or otherwise contemplated by this Agreement, from the date of this Agreement to the Effective Time, CTI shall not (unless required by applicable Law or regulatory organization applicable to CTI) do any of the following without the prior written consent of NICOYA, which consent shall not be unreasonably withheld or delayed:
(a)(i) except as deemed necessary to effectuate the filing of the Surviving Corporation A&R Certificate of Incorporation and adoption of the Surviving Corporation Bylaws, amend or propose to amend CTI’s Current Certificate of Incorporation or Bylaws or similar governing documents, (ii) split, combine or reclassify its outstanding capital stock or issue or authorize the issuance of any other security in respect or, in lieu of, or in substitution for, shares of its capital stock, (iii) declare, set aside or pay any dividend or distribution payable in cash, stock, property or otherwise, (iv) merge or consolidate with any Person, or (v) enter into any agreement with respect to the voting of its capital stock or other securities held by CTI;
(b)issue, sell, pledge or dispose of, or agree to issue, sell, pledge or dispose of, any shares of, or any options, warrants or rights of any kind to acquire any shares of, its capital stock of any class or any debt or equity securities convertible into or exchangeable for such capital stock, except with respect to exercises or conversion of currently outstanding options, warrants or convertible securities;
- 11 -
(c)(i) issue any debt securities, incur, guarantee or otherwise become contingently liable with respect to any indebtedness for borrowed money, or enter into any arrangement having the economic effect of any of the foregoing (other than in connection with accounts payable in the ordinary course of business consistent with past practice), (ii) make any loans, advances or capital contributions to, or investments in, any Person (other than in the ordinary course of business consistent with past practice), (iii) redeem, purchase, acquire or offer to purchase or acquire any shares of its capital stock or any options, warrants or rights to acquire any of its capital stock or any security convertible into or exchangeable for its capital stock other than in connection with the repurchase of shares from employees in connection with termination of employment contracts, (iv) make any material acquisition of any assets or businesses (including by merger, consolidation, acquisition of stock or assets, in-bound license transactions or otherwise), or (v) sell, pledge, assign, dispose of, transfer, lease, securitize or materially encumber any businesses or assets that are material to CTI (excluding CTI Intellectual Property, which is addressed in Section 5.2(d));
(d)(i) sell, pledge, assign, dispose of, transfer, securitize, lease or materially encumber any CTI Intellectual Property, (ii) exclusively license, abandon or fail to maintain any CTI Intellectual Property, (iii) grant, extend, amend (except as required in the diligent prosecution of the CTI Intellectual Property), waive or modify any rights in or to any CTI Intellectual Property, (iv) fail to diligently prosecute CTI’s patent applications, or (v) fail to exercise a right of renewal or extension under any CTI license;
(e)(i) enter into any Contract or arrangement that reasonably may result in payments by or liabilities of CTI or which limits or otherwise restricts CTI or any of its Affiliates or any successor thereto from engaging or competing in any line of business or in any geographic area or which includes a “most favored nation” or “equally favored nation” or similar provision, (ii) vary its inventory practices in any material respect from its past practices, except as required by GAAP or by Law, or (iii) make any capital expenditure or expenditures (including leases and in-bound licenses) in the aggregate in excess of the aggregate amount set forth in CTI’s budgeted amounts set forth on Section 5.2(e) of the CTI Disclosure Schedule (other than capital expenditures for unbudgeted repairs and maintenance in the ordinary course of business consistent with past practice);
(f)grant, enter into or amend any employment, severance, change in control, special pay arrangement with respect to termination of employment or other similar arrangements or contract with any directors, officers or employees of CTI, except (i) as required pursuant to previously existing contracts, or policies between such current directors, officers or employees CTI, (ii) pursuant to employment agreements entered into with a Person who is not already an officer of CTI in the ordinary course of business and is hired or promoted by CTI after the date hereof in the ordinary course of business;
(g)(i) increase the salary, benefits or monetary compensation of any directors, executive officers or employees, or (ii) establish, adopt, enter into, or materially amend any, collective bargaining agreement or bonus, profit sharing, thrift, compensation, stock option, restricted stock, pension, retirement, deferred compensation, employment, termination or severance plan, arrangement, trust, fund, policy or agreement;
(h)(i) accelerate, amend or change the period of exercisability or vesting of options, restricted stock or similar awards under any CTI stock plan, or (ii) authorize cash payments in exchange for any options granted under any of such plans except as required by the terms of such plans or any related agreements in effect as of the date hereof;
(i)waive, release, assign, settle or compromise any material claims, or any material litigation or arbitration;
- 12 -
(j)adopt, enter into, or amend any CTI Employee Plan to materially increase the benefits or liabilities of any CTI Employee Plan or to accelerate the payment of benefits under any CTI Employee Plan, except as required pursuant to existing contracts or this Agreement;
(k)change any method or principle of financial accounting in a manner that is inconsistent with past practice, except to the extent required by GAAP;
(l)make any material Tax election or settle or compromise any material Tax liability or refund, or change any annual Tax accounting period or material method of Tax accounting, file any material amendment to a tax return, enter into any closing agreement relating to any material Tax, surrender any right to claim a material Tax refund, or consent to any extension or waiver of the statute of limitations period applicable to any material Tax claim or assessment, in each case, other than as required by Law;
(m)modify, amend or terminate, or waive, release or assign any material rights or claims with respect to any confidentiality or standstill agreement to which CTI is a party and which relates to a business combination or other similar extraordinary transaction;
(n) take any action or omit to take any action that is intended or would reasonably be expected to result in any of the conditions to the Merger in ARTICLE VI not being satisfied; or
(o)agree, authorize or otherwise to take any of the foregoing actions.
5.3Access to Information. CTI and NICOYA shall each afford to the other and its representatives reasonable access during normal business hours upon reasonable notice throughout the period prior to the Effective Time to their respective officers, employees, representatives, properties, books, contracts, commitments, files and records and, during such period, shall furnish promptly such information concerning its businesses, properties and personnel as the other party shall reasonably request.
5.4Agreement to Cooperate.
(a)NICOYA and CTI shall each use their commercially reasonable efforts to (i) take, or cause to be taken, all appropriate action, and do, or cause to be done, all things reasonably necessary and proper under applicable Law to consummate and make effective the transactions contemplated hereby as promptly as reasonably practicable, (ii) obtain from any Governmental Entity or any other third Person any consents, licenses, permits, waivers, approvals, authorizations or orders required to be obtained or made by CTI or NICOYA in connection with the authorization, execution and delivery of this Agreement and the consummation of the transactions contemplated hereby, and (iii) as promptly as reasonably practicable, make all reasonably necessary filings, and thereafter make any other required submissions, with respect to this Agreement and the Merger required under any other applicable federal or state securities Laws and any other applicable Law. CTI and NICOYA shall cooperate with each other in connection with the making of all such filings, including providing copies of all such documents to the non-filing party and its advisors prior to filing and, if requested, to accept all reasonable additions, deletions or changes suggested in connection therewith. CTI and NICOYA shall use their commercially reasonable efforts to furnish to each other all information required for any application or other filing to be made pursuant to the rules and regulations of any applicable Law in connection with the transactions contemplated by this Agreement.
(b)Each of CTI and NICOYA shall give any notices to third Persons, and use their commercially reasonable efforts to obtain any third Person consents that are (i) necessary to consummate the transactions contemplated hereby, (ii) disclosed or required to be disclosed in the CTI
- 13 -
Disclosure Schedule or NICOYA Disclosure Schedule, as the case may be, or (iii) required to prevent a Material Adverse Effect from occurring prior to or after the Effective Time. If any party shall fail to obtain any consent from a third Person described in this subsection (b), such party will use its commercially reasonable efforts, and will take any such commercially reasonable actions requested by the other party hereto, to limit the adverse affect upon CTI and NICOYA and their respective businesses resulting, or that could reasonably be expected to result after the consummation of the Merger or the Effective Time, from the failure to obtain such consent.
(c)CTI and NICOYA shall promptly (and, in any event, within two (2) business days) advise the other orally and in writing of any state of facts, event, change, effect, development, condition or occurrence that, individually or in the aggregate, has had or would reasonably be expected to have a Material Adverse Effect. CTI shall give prompt notice to NICOYA, and NICOYA shall give prompt notice to CTI, of (i) any representation or warranty made by it contained in this Agreement that is qualified as to materiality becoming untrue or inaccurate in any respect or any such representation or warranty that is not so qualified becoming untrue or inaccurate in any material respect or (ii) the failure by it to comply with or satisfy in any material respect any covenant, condition or agreement to be complied with or satisfied by it under this Agreement. No such notification shall affect the representations, warranties, covenants or agreements of the parties or the conditions to the obligations of the parties under this Agreement; provided, however, that the recipient of such notice shall, within a five (5) day period following the receipt of such notice, use its commercially reasonable efforts to engage in good faith discussions with the notifying party regarding such notification and the facts and circumstances set forth therein.
5.5Control of Other Party’s Business. Nothing contained in this Agreement shall give any Party, directly or indirectly, the right to control or direct the operations of any other Party prior to the consummation of the Merger. Prior to the consummation of the Merger each Party shall exercise, consistent with the terms and conditions of this Agreement, complete control and supervision over its operations.
5.6Confidentiality. The Parties agree that each shall treat confidentially the terms and conditions of this Agreement and all information provided by each Party to the other regarding its business and operations. All confidential information provided by a Party hereto shall be used by any other Party hereto solely for the purposes of the consummation of this Agreement and the transactions contemplated hereby (the “Transactions”), and, except as may be required in carrying out this Agreement and the Transactions, shall not be disclosed to any third party without the prior consent of such providing Party. The foregoing shall not be applicable to any information that is publicly available when provided or thereafter becomes publicly available other than through a breach of this Agreement, or that is required to be disclosed by judicial or administrative process or otherwise by Law.
5.7Public Disclosure. Unless otherwise contemplated or permitted by this Agreement, CTI and NICOYA shall consult with each other before issuing any press release or otherwise making any public statement or making any other public (or non-confidential) disclosure (whether or not in response to an inquiry) regarding the terms of this Agreement and the transactions contemplated hereby, and neither shall issue any such press release or make any such statement or disclosure without the prior approval of the other (which approval shall not be unreasonably withheld or delayed).
5.8Blue Sky Laws. The Surviving Corporation shall take such steps as may be necessary to comply with the securities and blue sky laws of all jurisdictions applicable to the issuance of the Surviving Corporation Common Stock in connection with the Merger. NICOYA shall use its commercially reasonable efforts to assist the Surviving Corporation to comply with the securities and blue sky laws of all jurisdictions applicable to the issuance of Surviving Corporation Common Stock in connection with the Merger.
- 14 -
5.9Assignment of Agreements. Prior to the Closing, each of the agreements listed on Schedule 5.9 shall be assigned to the Surviving Corporation with effect at the Effective Time.
5.10Directors’ and Officers’ Indemnification and Insurance. Following the Effective Time, the Surviving Corporation shall indemnify and hold harmless, and provide advancement of expenses to, all past and present directors, officers and employees of NICOYA (in all of their capacities) (i) to the same extent such individuals are indemnified or have the right to advancement of expenses as of the date of this Agreement by NICOYA pursuant to the NICOYA Certificate of Incorporation, Bylaws and indemnification agreements, if any, in existence on the date hereof with, or for the benefit of, any directors, officers and employees of NICOYA and (ii) without limitation to subclause (i) above, to the fullest extent permitted by law, in each case for acts or omissions occurring at or prior to the Effective Time (including for acts or omissions occurring in connection with the approval of this Agreement and the consummation of the transactions contemplated hereby). The obligations of CTI under this Section 5.10 shall not be terminated or modified in such a manner as to adversely affect any indemnitee to whom this Section 5.10 applies without the consent of such affected indemnitee (it being expressly agreed that the indemnitees to whom this Section 5.10 applies shall be third party beneficiaries of this Section 5.10).
5.11Equity Incentive Plan. Within sixty (60) days of the Effective Time, the Surviving Corporation shall adopt an equity incentive plan providing for the grant of awards to qualified participants with an unallocated reserve amount equal to Two Million Three Hundred Thousand (2,300,000) shares of Surviving Corporation Common Stock.
ARTICLE VI
CONDITIONS TO CLOSING
6.1Conditions to Obligations of Each Party. The respective obligations of each Party to consummate the Transactions will be subject to the satisfaction at or before the Closing of each of the following conditions, which to the extent permitted by Law may be waived in a written agreement of CTI and NICOYA:
(a)The consummation of the Transactions will not then be restrained, enjoined or prohibited by any Order (whether temporary, preliminary or permanent) and there will not be in effect any Law or regulation enacted, promulgated or deemed applicable to the Transactions by any Governmental Entity in any competent jurisdiction that makes illegal or prohibits the consummation of the Transactions.
(b)This Agreement has been adopted by the requisite stockholder and board of director approvals of each of CTI and NICOYA.
(c) No Material Adverse Effect has occurred since the date of this Agreement and is continuing as of the Closing.
(d)The agreements listed on Schedule 5.9 shall have been assigned to the Surviving Corporation with effect as of the Effective Time.
(e)Each of the third-party consents listed on Schedule 6.1(e) shall have been obtained and be in full force and effect.
(f)There shall be no material pending or threatened litigation or claims against CTI or NICOYA as of the Closing.
(g)Immediately following the Closing, the Surviving Corporation shall have no liabilities.
- 15 -
6.2Conditions to Obligations of NICOYA. The obligations of NICOYA to consummate the Transactions will be subject to the satisfaction at or before the Closing of each of the following conditions, which to the extent permitted by Law may be waived in a written agreement signed by NICOYA:
(a)Each of the representations and warranties made by CTI in this Agreement are true and correct at and as of the Closing Date as if made on that date (except in any case that representations and warranties that expressly speak as of a specified date or time need only be true and correct as of such specified date or time), except where the failure of the representations and warranties made by CTI in this Agreement to be true and correct would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of CTI to consummate the Transactions; provided that for purposes of determining the accuracy of such representations and warranties as of the foregoing dates, all “Material Adverse Effect” and other materiality or similar qualifications limiting the scope of such representations and warranties will be disregarded.
(b)CTI has complied with or performed in all material respects the covenants and obligations that it is obligated to have complied with or performed at or prior to the Closing pursuant to this Agreement except those covenants and obligations to be performed by CTI on the Closing Date, which covenants and obligations CTI shall be committed to, and able to, perform at or prior to the Closing; and
(c)CTI has delivered or caused to be delivered a certificate executed on behalf of CTI by an authorized officer of CTI certifying the satisfaction of the conditions set forth in Sections 6.3(a) and 6.3(b).
(d)Substantially concurrent with the Closing, the initial closing of the PPO with an aggregate purchase price of at least Ten Million Dollars ($10,000,000) shall have been completed on terms acceptable to NICOYA.
(e)There shall be no material adverse change to CTI’s financial condition between the date of the Agreement and the Closing.
6.3Conditions to Obligations of CTI. The obligations of CTI to consummate the Transactions will be subject to the satisfaction at or before the Closing of each of the following conditions, which to the extent permitted by Law may be waived in a written agreement signed by CTI:
(a)Each of the representations and warranties made by NICOYA in this Agreement are true and correct at and as of the Closing Date as if made on that date (except in any case that representations and warranties that expressly speak as of a specified date or time need only be true and correct as of such specified date or time), except where the failure of the representations and warranties made by NICOYA in this Agreement to be true and correct would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of NICOYA to consummate the Transactions; provided that for purposes of determining the accuracy of such representations and warranties as of the foregoing dates, all “Material Adverse Effect” and other materiality or similar qualifications limiting the scope of such representations and warranties will be disregarded.
(b)NICOYA shall have complied with or performed in all material respects the covenants and obligations that it is obligated to have complied with or performed at or prior to the Closing pursuant to this Agreement except those covenants and obligations to be performed by NICOYA on the Closing Date, which covenants and obligations NICOYA shall be committed and able to perform at or prior to the Closing.
(c)NICOYA has delivered or caused to be delivered a certificate executed on behalf of NICOYA by an authorized officer of NICOYA certifying the satisfaction of the conditions set forth in Sections 6.2(a) and 6.2(b).
- 16 -
(d)There shall be no material adverse change to NICOYA’s business between the date of the Agreement and the Closing.
ARTICLE VII
TERMINATION
7.1Termination or Abandonment. Anything in this Agreement to the contrary notwithstanding, this Agreement may be terminated and the Merger may be abandoned at any time prior to the Effective Time (except as otherwise provided below), as follows:
(a)by the mutual written consent of NICOYA and CTI;
(b)by either NICOYA or CTI, if the Effective Time shall not have occurred on or prior to 11:59 p.m., Pacific Time, on January 18, 2020 (the “Initial End Date”); provided, however, that the right to terminate this Agreement pursuant to this Section 7.1(b) shall not be available to any Party whose action or failure to fulfill any obligation under this Agreement proximately caused or resulted in the Effective Time not occurring prior to the Initial End Date, and provided, further, that if on the Initial End Date all of the conditions to Closing, shall have been satisfied or waived (other than those conditions that by their nature are to be satisfied at the Closing, which conditions shall be capable of being satisfied at such time), the Initial End Date will automatically be extended to February 18, 2020 (the “Outside End Date” and together with the Initial End Date, the “End Dates” and each, an “End Date”);
(c)by either the NICOYA or CTI, if a Governmental Entity of competent jurisdiction shall have entered or issued a final and nonappealable Order that remains in effect or shall have adopted or enacted a Law that is final and nonappealable and remains in effect, in either case that permanently restrains, enjoins or makes illegal the consummation of the Merger; provided, however, that the right to terminate this Agreement under this Section 7.1(c) shall not be available to a Party if such Order (or such Order becoming final and nonappealable) was due to the material breach by such Party of any covenant or other agreement of such Party set forth in this Agreement;
(d)by NICOYA (provided that NICOYA is not then in material breach of any representation, warranty, covenant or other agreement contained herein) if (i) CTI has breached any representation, warranty, covenant or other agreement contained in this Agreement, which breach would result in the conditions in ARTICLE VI not being satisfied and (ii) which breach, failure to perform or inaccuracy is either not curable or is not cured by the earlier of (A) the applicable End Date and (B) the date that is 30 business days following written notice from NICOYA to CTI describing such breach or failure in reasonable detail; and
(e)by CTI (provided that CTI is not then in material breach of any representation, warranty, covenant or other agreement contained herein), (i) if NICOYA has breached any representation, warranty, covenant or other agreement contained in this Agreement, which breach would result in the conditions in ARTICLE VI not being satisfied; and (ii) which breach, failure to perform or inaccuracy is either not curable or is not cured by the earlier of (A) the applicable End Date and (B) the date that is 30 business days following written notice from CTI to NICOYA describing such breach or failure in reasonable detail.
The Party seeking to terminate this Agreement pursuant to this Section 7.1 shall give written notice of such termination to the other parties in accordance with Section 8.7, specifying the provision of this Agreement pursuant to which such termination is effected.
7.2Effect of Termination. In the event of termination of this Agreement pursuant to Section 7.1, this Agreement shall terminate (except that the provisions of this Section 7.2 and ARTICLE VIII shall survive any
- 17 -
termination), and there shall be no other Liability on the part of NICOYA, on the one hand, or CTI, on the other hand, to the other except Liability arising out of or resulting from fraud or any Willful Breach of any provision of this Agreement occurring prior to termination (in which case the aggrieved Party shall be entitled to all rights and remedies available at law or in equity).
ARTICLE VIII
MISCELLANEOUS
8.1No Survival. None of the representations, warranties, covenants and agreements in this Agreement or in any instrument delivered pursuant to this Agreement shall survive the Merger, except for covenants and agreements which contemplate performance after the Effective Time or otherwise expressly by their terms survive the Effective Time.
8.2Expenses. Whether or not the Merger is consummated, all costs and expenses incurred in connection with the Merger, this Agreement and the Transactions shall be paid by the Party incurring or required to incur such expenses.
8.3Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument, and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy, electronic delivery or otherwise) to the other Parties. Signatures to this Agreement transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, will have the same effect as physical delivery of the paper document bearing the original signature.
8.4Governing Law. This Agreement, and all claims or causes of action (whether at Law, in contract or in tort or otherwise) that may be based upon, arise out of or relate to this Agreement or the negotiation, execution or performance hereof, shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any choice or conflict of law provision or rule (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware.
8.5Jurisdiction; Specific Enforcement. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed, or were threatened to be not performed, in accordance with their specific terms or were otherwise breached. It is accordingly agreed that, in addition to any other remedy that may be available to it, including monetary damages, each of the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement exclusively in the Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware), and all such rights and remedies at law or in equity shall be cumulative. The Parties further agree that no Party to this Agreement shall be required to obtain, furnish or post any bond or similar instrument in connection with or as a condition to obtaining any remedy referred to in this Section 8.5 and each Party waives any objection to the imposition of such relief or any right it may have to require the obtaining, furnishing or posting of any such bond or similar instrument. In addition, each of the Parties hereto irrevocably agrees that any legal action or proceeding with respect to this Agreement and the rights and obligations arising hereunder, or for recognition and enforcement of any judgment in respect of this Agreement and the rights and obligations arising hereunder brought by the other Party hereto or its successors or assigns, shall be brought and determined exclusively in the Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware). Each of the
- 18 -
Parties hereto hereby irrevocably submits with regard to any such action or proceeding for itself and in respect of its property, generally and unconditionally, to the personal jurisdiction of the aforesaid courts and agrees that it will not bring any action relating to this Agreement or the Merger in any court other than the aforesaid courts. Each of the Parties hereto hereby irrevocably waives, and agrees not to assert, by way of motion, as a defense, counterclaim or otherwise, in any action or proceeding with respect to this Agreement, (i) any claim that it is not personally subject to the jurisdiction of the above named courts, (ii) any claim that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment or otherwise) and (iii) to the fullest extent permitted by applicable Law, any claim that (A) the suit, action or proceeding in such court is brought in an inconvenient forum, (B) the venue of such suit, action or proceeding is improper or (C) this Agreement, or the subject matter hereof, may not be enforced in or by such courts. To the fullest extent permitted by applicable Law, each of the Parties hereto hereby consents to the service of process in accordance with Section 8.7; provided, however, that nothing herein shall affect the right of any Party to serve legal process in any other manner permitted by Law.
8.6Waiver of Jury Trial. EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE MERGER.
8.7Notices. All notices and other communications hereunder shall be in writing in one of the following formats and shall be deemed given (a) upon actual delivery if personally delivered to the Party to be notified if received prior to 5 p.m. in the place of receipt on a business day, otherwise such notice or communication shall be deemed not to have been received until the next succeeding business day; (b) when sent if sent by email or facsimile to the Party to be notified if received prior to 5 p.m. in the place of receipt on a business day, otherwise such notice or communication shall be deemed not to have been received until the next succeeding business day; provided, however, that notice given by email or facsimile shall not be effective unless (i) such notice specifically states that it is being delivered pursuant to this Section 8.7 and (ii) either (A) a duplicate copy of such email or facsimile notice is promptly given by one of the other methods described in this Section 8.7 or (B) the receiving Party delivers a written confirmation of receipt for such notice either by email (excluding “out of office” or similar automated replies) or facsimile or any other method described in this Section 8.7; or (c) when delivered if sent by a courier (with confirmation of delivery) if received prior to 5 p.m. in the place of receipt on a business day, otherwise such notice or communication shall be deemed not to have been received until the next succeeding business day; in each case to the Party to be notified at the following address:
|
If to CTI, to: |
12645 Memorial Drive, Suite F1 #305 |
|
|
Houston, Texas 77024 |
|
|
Attention: President |
|
|
|
|
If to NICOYA or the Surviving Corporation, to: |
|
|
|
|
|
|
12645 Memorial Drive, Suite F1 #305 |
|
|
Houston, Texas 77024 |
|
|
Attention: President |
|
|
|
|
with copies (which shall not constitute notice) to: |
|
|
|
|
|
|
Jones Day |
|
|
4655 Executive Drive, Suite 1500 |
|
|
San Diego, CA 92121-3134 |
|
|
Attention: |
- 19 -
or to such other address as any Party shall specify by written notice so given. All such notices and other communications shall be deemed received on the date of receipt by the recipient thereof if received prior to 5 p.m. in the place of receipt and such day is a business day in the place of receipt. Otherwise, any such notice, request or communication shall be deemed not to have been received until the next succeeding business day in the place of receipt. Any Party to this Agreement may notify any other Party of any changes to the address or any of the other details specified in this paragraph; provided, however, that such notification shall only be effective on the date specified in such notice or five business days after the notice is given, whichever is later. Rejection or other refusal to accept or the inability to deliver because of changed address of which no notice was given shall be deemed to be receipt of the notice as of the date of such rejection, refusal or inability to deliver.
8.8Assignment; Binding Effect. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned or delegated by any of the Parties hereto without the prior written consent of the other Parties. Subject to the first sentence of this Section 8.8, this Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective successors and assigns. Any purported assignment not permitted under this Section 8.8 shall be null and void.
8.9Severability. Any term or provision of this Agreement which is invalid or unenforceable in any jurisdiction shall, as to that jurisdiction, be ineffective to the extent of such invalidity or unenforceability without rendering invalid or unenforceable the remaining terms and provisions of this Agreement in any other jurisdiction. If any provision of this Agreement is so broad as to be unenforceable, such provision shall be interpreted to be only so broad as is enforceable.
8.10Entire Agreement. This Agreement together with the exhibits and schedules hereto constitute the entire agreement, and supersede all other prior agreements and understandings, both written and oral, between the Parties, or any of them, with respect to the subject matter hereof and thereof, and this Agreement is not intended to grant standing to any person other than the Parties hereto.
8.11Amendments; Waivers. Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of a waiver by the Party against whom enforcement is sought, and in the case of an amendment, by CTI and NICOYA. The foregoing notwithstanding, no failure or delay by any Party hereto in exercising any right hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise of any other right hereunder.
8.12Headings. Headings of the Articles and Sections of this Agreement are for convenience of the Parties only and shall be given no substantive or interpretive effect whatsoever. The table of contents to this Agreement is for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
8.13No Third-Party Beneficiaries. Each of NICOYA and CTI agrees that (a) their respective representations, warranties, covenants and agreements set forth herein are solely for the benefit of the other Party hereto, in accordance with and subject to the terms of this Agreement, and (b) except for, after the Effective Time, the right of the NICOYA’s stockholders to receive the Merger Consideration, which shall be enforceable by such holders, this Agreement is not intended to, and does not, confer upon any person other than the Parties hereto any rights or remedies hereunder, including the right to rely upon the representations and warranties set forth herein.
8.14Interpretation. When a reference is made in this Agreement to an Article or Section, such reference shall be to an Article or Section of this Agreement unless otherwise indicated. Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.” The words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement, unless the context otherwise requires. The word “since” when used in this Agreement in reference to a date shall be
- 20 -
deemed to be inclusive of such date. All terms defined in this Agreement shall have the defined meanings when used in any certificate or other document made or delivered pursuant thereto unless otherwise defined therein. The definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms and to the masculine as well as to the feminine and neuter genders of such term. References in this Agreement to specific laws or to specific provisions of laws shall include all rules and regulations promulgated thereunder, and any statute defined or referred to herein or in any agreement or instrument referred to herein shall mean such statute as from time to time amended, modified or supplemented, including by succession of comparable successor statutes. References herein to a person are also to such person’s successors and permitted assigns. All references in this Agreement to “$”or other monetary amounts refer to U.S. dollars. Unless otherwise specifically provided for herein, the term “or” shall not be deemed to be exclusive. Each of the Parties has participated in the drafting and negotiation of this Agreement. If an ambiguity or question of intent or interpretation arises, this Agreement must be construed as if it is drafted by all the Parties, and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of authorship of any of the provisions of this Agreement.
8.15Definitions. As used in this Agreement:
(a)“Action” means any criminal, civil, judicial, or arbitral litigation, mediation, arbitration or suit, commenced, brought, conducted or heard by or before any Governmental Entity.
(b)“Affiliate” means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by, or is under common control with, such first Person. For the purposes of this definition, “control” (including, the terms “controlling,” “controlled by,” and “under common control with”), as applied to any Person, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of that Person, whether through the ownership of voting securities, by Contract, or otherwise.
(c)“Code” means the U.S. Internal Revenue Code of 1986.
(d)“Contracts” means any contracts, agreements, licenses, notes, bonds, mortgages, indentures, leases, or other binding instruments or binding commitments, whether written or oral.
(e)“Environmental Laws” means any law, regulation, or other applicable requirement relating to (a) releases or threatened release of Hazardous Substance; (b) pollution or protection of employee health or safety, public health or the environment; or (c) the manufacture, handling, transport, use, treatment, storage, or disposal of Hazardous Substances.
(f)“Indebtedness” means (A) all indebtedness for borrowed money, (B) all obligations issued, undertaken or assumed as the deferred purchase price of property or services including (without limitation) “Capital Leases” (as defined under U.S. GAAP) (other than trade payables entered into in the ordinary course of business), (C) all reimbursement or payment obligations with respect to letters of credit, surety bonds and other similar instruments, (D) all obligations evidenced by notes, bonds, debentures or similar instruments, including obligations so evidenced incurred in connection with the acquisition of property, assets or businesses, (E) all indebtedness created or arising under any conditional sale or other title retention agreement, or incurred as financing, in either case with respect to any property or assets acquired with the proceeds of such indebtedness (even though the rights and remedies of the seller or bank under such agreement in the event of default are limited to repossession or sale of such property), (F) all monetary obligations under any leasing or similar arrangement which, in connection with GAAP, consistently applied for the periods covered thereby, is classified as a capital lease, (G) all indebtedness referred to in clauses (A) through (F) above secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) any mortgage, lien, pledge, charge, security interest or other encumbrance upon or in any property or assets (including accounts and contract rights) owned by any person, even though the person which owns such assets or property has not assumed or
- 21 -
become liable for the payment of such indebtedness, and (H) except for obligations owed to service providers of in connection with this Agreement and the transactions contemplated herein, all contingent obligations in respect of indebtedness or obligations of others of the kinds referred to in clauses (A) through (G) above.
(g)“Laws” means all applicable federal, state, local and foreign laws, statutes, ordinances, rules, regulations, judgments, orders, injunctions, decrees or agency requirements of Governmental Entities.
(h)“Liability” means any and all debts, liabilities and obligations, whether fixed, contingent or absolute, matured or unmatured, accrued or not accrued, determined or determinable, secured or unsecured, disputed or undisputed, subordinated or unsubordinated, or otherwise
(i)“Governmental Entity” means any U.S. federal, state, local or foreign government, any transnational governmental organization or any court of competent jurisdiction, arbitral, administrative agency or commission or other governmental authority or instrumentality, domestic or foreign, or any national securities exchange or national quotation system or any SRO.
(j)“Material Adverse Effect” means a development with respect to the business, assets (including intangible assets), liabilities, financial condition, property, prospects or results of operations of the Party in question that will have a significant and negative impact thereon.
(k)“Order” means any order, writ, assessment, decision, injunction, decree, ruling, or judgment of a Governmental Entity or arbitrator, whether temporary, preliminary, or permanent.
(l)“Person” means an individual, a corporation, a partnership, a limited liability company, an association, a trust or any other entity, group (as such term is used in Section 13 of the Exchange Act) or organization, including a Governmental Entity, and any permitted successors and assigns of such person.
(m)“Tax” means any federal, state, local or foreign tax, impost, levy, duty, fee or other assessment of any nature whatsoever (including any net income, gross receipts, capital, sales, use, ad valorem, value added, transfer, franchise, profits, inventory, capital stock, license, withholding, payroll, employment, social security, unemployment, excise, severance, stamp, occupation, real or personal property and estimated tax, customs duty, or other tax), together with any interest, penalty or addition to tax imposed by any Governmental Entity responsible for the imposition of any such tax with respect thereto.
(n)“NICOYA Intellectual Property” means all patents, patent applications, patent disclosures and all related continuation, continuation-in-part, divisional, reissue, reexamination, utility model, renewals, extensions, certificate of invention and design patents, patent applications, registrations and applications for registrations, registered and unregistered trademarks, trademark applications, registered and unregistered service marks, service mark applications, tradenames, copyrights, trade secrets, domain names, 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 any and all such cases as are necessary to NICOYA in the conduct of NICOYA’s business as now conducted and as presently proposed to be conducted.
(o)“CTI Intellectual Property” means all patents, patent applications, patent disclosures and all related continuation, continuation-in-part, divisional, reissue, reexamination, utility model, renewals, extensions, certificate of invention and design patents, patent applications, registrations and applications for registrations, registered and unregistered trademarks, trademark applications, registered and
- 22 -
unregistered service marks, service mark applications, tradenames, copyrights, trade secrets, domain names, 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 any and all such cases as are necessary to CTI in the conduct of CTI’s business as now conducted and as presently proposed to be conducted.
(p)“Willful Breach” means a breach that is the result of a willful or intentional act or failure to act where the breaching party knows, or would reasonably be expected to have known, that such act or failure to act is, or would reasonably be expected to result in, a breach.
[Remainder of page intentionally left blank – signature page follows]
- 23 -
IN WITNESS WHEREOF, CTI and NICOYA have caused this Agreement and Plan of Merger to be signed by their respective duly authorized officers as of the date first written above.
COYA THERAPEUTICS, INC. |
||
|
|
|
|
/s/ Howard Berman |
|
By: |
||
Name: |
Howard Berman |
|
Tile: |
Chief Executive Officer |
|
|
|
|
|
|
|
NICOYA HEALTH, INC. |
||
|
|
|
|
/s/ Howard Berman |
|
By: |
||
Name: |
Howard Berman |
|
Tile: |
Chief Executive Officer |
[Signature Page Agreement and Plan of Merger]
AMENDED AND RESTATED
CERTIFICATE OF
INCORPORATION OF
COYA THERAPEUTICS, INC.
First: The name of this corporation is Coya Therapeutics, Inc. (the “Corporation”).
Second: The address of the registered office of the Corporation in the State of Delaware is 251 Little Falls Drive, City of Wilmington, County of New Castle, 19808. The name of its registered agent at such address is Corporation Service Company.
Third: The nature of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law.
Fourth: The total number of shares of all classes of stock which the Corporation shall have authority to issue is (i) 30,000,000 shares of Common Stock, $0.0001 par value per share (“Common Stock”) and (ii) 7,500,713 shares of Preferred Stock, $0.0001 par value per share (the “Preferred Stock”), all of which are hereby designated “Series A Preferred Stock”.
The following is a statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof in respect of each class of capital stock of the Corporation.
A.COMMON STOCK
1.General. The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock set forth herein.
2.Voting. The holders of the Common Stock are entitled to one vote for each share of Common Stock held at all meetings of stockholders (and written actions in lieu of meetings); 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 the Certificate of Incorporation that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to the Certificate of Incorporation or pursuant to the General Corporation Law. There shall be no cumulative voting. The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by (in addition to any vote of the holders of one or more series of Preferred Stock that may be required by the terms of the Certificate of Incorporation) the affirmative vote of the holders of shares of capital stock of the Corporation representing a majority of the votes represented by all outstanding shares of capital stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law.
B.PREFERRED STOCK
The Preferred Stock shall have the following rights, preferences, powers, privileges and restrictions, qualifications and limitations. Unless otherwise indicated, references to “sections” or “subsections” in this Part B of this Article Fourth refer to sections and subsections of Part B of this Article Fourth.
1.Dividends.
1.1Except as set forth in Section 1.2, the holders of then outstanding shares of Preferred Stock shall be entitled to receive, only when, as and if declared by the Board of Directors, out of any funds and assets legally available therefor, dividends at the rate of 8% of the Original Issue Price (as defined below) for each share of Preferred Stock, prior and in preference to any declaration or payment of any other dividend (other than dividends on shares of Common Stock payable in shares of Common Stock). The right to receive dividends on shares of Preferred Stock pursuant to the preceding sentence of this Section 1.1 shall not be cumulative, and no right to dividends shall accrue to holders of Preferred Stock by reason of the fact that dividends on said shares are not declared. Except as set forth in Section 1.2, the Corporation shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Corporation (other than dividends on shares of Common Stock payable in shares of Common Stock) unless (in addition to the obtaining of any consents required elsewhere in this Amended and Restated Certificate of Incorporation) the holders of the Preferred Stock then outstanding shall first receive, or simultaneously receive, in addition to the dividends payable pursuant to the first sentence of this Section 1.1, a dividend on each outstanding share of Preferred Stock in an amount at least equal to (i) in the case of a dividend on Common Stock or any class or series that is convertible into Common Stock, that dividend per share of Preferred Stock as would equal the product of (A) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into Common Stock and (B) the number of shares of Common Stock issuable upon conversion of a share of Preferred Stock, in each case calculated on the record date for determination of holders entitled to receive such dividend or (ii) in the case of a dividend on any class or series that is not convertible into Common Stock, at a rate per share of Preferred Stock determined by (A) dividing the amount of the dividend payable on each share of such class or series of capital stock by the original issuance price of such class or series of capital stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to such class or series) and (B) multiplying such fraction by an amount equal to the Original Issue Price (as defined below); provided that, if the Corporation declares, pays or sets aside, on the same date, a dividend on shares of more than one (1) class or series of capital stock of the Corporation, the dividend payable to the holders of Preferred Stock pursuant to this Section 1 shall be calculated based upon the dividend on the class or series of capital stock that would result in the highest Preferred Stock dividend. The “Original Issue Price” shall mean, with respect to the Series A Preferred Stock, $1.338 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the applicable Preferred Stock.
1.2By May 22, 2022 (the “Financial Statements Requirement Deadline”), the Corporation shall have caused a Public Company Accounting Oversight Board accounting firm applying United States generally accepted accounting principles shall have completed an audit of the Corporation’s financial statements in such a manner as is required for registration of its securities on Form S-1 under the Securities Act of 1933, as amended (the “Financial Statements Requirement”). To the extent that the Corporation does not satisfy its Financial Statements Requirement, the Corporation shall pay, commencing thirty (30) days following the Financial Statements Requirement Deadline and on every thirtieth (30th) day anniversary thereafter (with such amount to be prorated to the extent that the Financial Statements Requirement is achieved during one such 30-day period), each holder of Series A Preferred Stock an amount of cash equal to (x) one-half percent (0.5%) multiplied by (y) the Original Issue Price multiplied by (z) the number of shares of Series A Preferred Stock held by such stockholder; provided, however, that the maximum amount payable to any holder of Series A Preferred Stock shall in no event exceed an amount equal to (x) six percent (6%) multiplied by (y) the Original Issue Price multiplied by (z) the number of shares of Series A Preferred Stock held by such stockholder.
2.Liquidation, Dissolution or Winding Up; Certain Mergers, Consolidations and Asset Sales.
2.1Preferential Payments to Holders of Preferred Stock. In the event of any Deemed Liquidation Event, each series of Preferred Stock then outstanding shall be entitled to be paid out of the assets of the Corporation available for distribution to its stockholders, and in the event of a Deemed Liquidation Event (as defined below), the holders of shares of Preferred Stock then outstanding shall be entitled to be paid out of the consideration payable to stockholders in such Deemed Liquidation Event or any other assets of the Corporation available for distribution to its stockholders, all to the extent permitted by Delaware law governing distributions to stockholders (the “Available Proceeds”), as applicable, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, on a pari passu basis, an amount per share equal to the greater of (i) one times the Original Issue Price, plus any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of such series of Preferred Stock been converted into Common Stock pursuant to Section 4 immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event (the amount payable pursuant to this sentence is hereinafter referred to as the “Preferred Liquidation Amount”). If upon any such liquidation, dissolution or winding up of the Corporation or Deemed Liquidation Event, the assets of the Corporation available for distribution to its stockholders shall be insufficient to pay the holders of shares of Preferred Stock the full amount to which they shall be entitled under this Subsection 2.1, the holders of shares of Preferred Stock shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.
2.2Payments to Holders of Common Stock. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, after the payment in full of all Preferred Liquidation Amounts required to be paid to the holders of
-2-
shares of Preferred Stock, the remaining assets of the Corporation available for distribution to its stockholders or, in the case of a Deemed Liquidation Event, the remaining Available Proceeds or the consideration not payable to the holders of shares of Preferred Stock pursuant to Section 2.1, as the case may be, shall be distributed among the holders of shares of Common Stock, pro rata based on the number of shares held by each such holder.
2.3Deemed Liquidation Events.
2.3.1Definition. Each of the following events shall be considered a “Deemed Liquidation Event” unless the holders of at least a majority of the outstanding shares of Preferred Stock elect otherwise by written notice sent to the Corporation at least ten days prior to the effective date of any such event:
(a)A voluntary or involuntary liquidation, dissolution or winding up of the Corporation;
(b)a merger or consolidation in which
|
(i) |
the Corporation is a constituent party or |
|
(ii) |
a subsidiary of the Corporation is a constituent party and the Corporation issues shares of its capital stock pursuant to such merger or consolidation, |
except any such merger or consolidation involving the Corporation or a subsidiary in which the shares of capital stock of the Corporation outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediately following such merger or consolidation, at least a majority, by voting power, of the capital stock of (1) the surviving or resulting corporation; or (2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation of such surviving or resulting corporation;
(c)the closing of the transfer (whether by merger, consolidation or otherwise), in one transaction or a series of related transactions, to a person or group of affiliated persons (other than an underwriter of this corporation’s securities), of the Corporation’s securities if, after such closing, such person or group of affiliated persons would hold fifty percent (50%) or more of the then outstanding voting stock of this corporation (or the surviving or acquiring entity); or
(d)(1) the sale, lease, transfer, exclusive and irrevocable license or other disposition, in a single transaction or series of related transactions, by the Corporation or any subsidiary of the Corporation of all or substantially all the assets of the Corporation and its subsidiaries taken as a whole or (2) the sale or disposition (whether by merger, consolidation or otherwise, and whether in a single transaction or a series of related transactions) of one or more subsidiaries of the Corporation if all or substantially all of the
-3-
assets of the Corporation and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusive and irrevocable license or other disposition is to a wholly owned subsidiary of the Corporation.
2.3.2Effecting a Deemed Liquidation Event. The Corporation shall not have the power to effect a Deemed Liquidation Event referred to in Subsection 2.3.l(a)(i) unless the agreement or plan of merger or consolidation for such transaction (the “Merger Agreement”) provides that the consideration payable to the stockholders of the Corporation in such Deemed Liquidation Event shall be paid to the holders of capital stock of the Corporation in accordance with Subsections 2.1 and 2.2.
2.3.3Amount Deemed Paid or Distributed. The amount deemed paid or distributed to the holders of capital stock of the Corporation upon any such merger, consolidation, sale, transfer, exclusive license, other disposition or redemption shall be the cash or the value of the property, rights or securities to be paid or distributed to such holders pursuant to such Deemed Liquidation Event. The value of such property, rights or securities shall be determined in good faith by the Board of Directors of the Corporation (the “Board of Directors”).
2.3.4Allocation of Escrow and Contingent Consideration. In the event of a Deemed Liquidation Event pursuant to Subsection 2.3.1, if any portion of the consideration payable to the stockholders of the Corporation is payable only upon satisfaction of contingencies (the “Additional Consideration”), the Merger Agreement shall provide that (a) the portion of such consideration that is not Additional Consideration (such portion, the “Initial Consideration”) shall be allocated among the holders of capital stock of the Corporation in accordance with Subsections 2.1 and 2.2 as if the Initial Consideration were the only consideration payable in connection with such Deemed Liquidation Event; and (b) any Additional Consideration which becomes payable to the stockholders of the Corporation upon satisfaction of such contingencies shall be allocated among the holders of capital stock of the Corporation in accordance with Subsections 2.1 and 2.2 after taking into account the previous payment of the Initial Consideration as part of the same transaction. For the purposes of this Subsection 2.3.4, consideration placed into escrow or retained as a holdback to be available for satisfaction of indemnification or similar obligations in connection with such Deemed Liquidation Event shall be deemed to be Initial Consideration.
3.Voting.
3.1General. On any matter presented to the stockholders of the Corporation for their action or consideration at any meeting of stockholders of the Corporation (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Preferred Stock shall be entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Except as provided by law or by the other provisions of this Amended and Restated Certificate of Incorporation, holders of Preferred Stock shall vote together with the holders of Common Stock as a single class and on an as-converted to Common Stock basis.
-4-
3.2Election of Directors. The holders of record of the shares of Series A Preferred Stock, exclusively and as a separate class, shall be entitled to elect one (1) director of the Corporation (the “Series A Director”); the holders of record of the shares of Common Stock, exclusively and as a separate class, shall be entitled to elect three (3) directors of the Corporation; and the holders of record of the Series A Preferred Stock and the holders of record of Common Stock, voting together as a single class, shall be entitled to elect one (1) mutually acceptable director who is not otherwise an affiliate of the Corporation or any investor in the Corporation; provided, however, for administrative convenience, the initial Series A Director may also be appointed by the Board of Directors in connection with the approval of the initial issuance of Series A Preferred Stock without a separate action by the holders of Series A Preferred Stock. Any director elected as provided in the preceding sentence may be removed without cause by, and only by, the affirmative vote of the holders of the shares of the class or series of capital stock entitled to elect such director or directors, given either at a special meeting of such stockholders duly called for that purpose or pursuant to a written consent of stockholders. If the holders of shares of Series A Preferred Stock or Common Stock, as the case may be, fail to elect a sufficient number of directors to fill all directorships for which they are entitled to elect directors, voting exclusively and as a separate class, pursuant to the first sentence of this Section 3.2, then any directorship not so filled shall remain vacant until such time as the holders of the Series A Preferred Stock or Common Stock, as the case may be, elect a person to fill such directorship by vote or written consent in lieu of a meeting; and no such directorship may be filled by stockholders of the Corporation other than by the stockholders of the Corporation that are entitled to elect a person to fill such directorship, voting exclusively and as a separate class. The holders of record of the shares of Common Stock and of any other class or series of voting stock (including the Preferred Stock), exclusively and voting together as a single class, shall be entitled to elect the balance of the total number of directors of the Corporation. At any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the outstanding shares of the class or series entitled to elect such director shall constitute a quorum for the purpose of electing such director. Except as otherwise provided in this Section 3.2, a vacancy in any directorship filled by the holders of any class or classes or series shall be filled only by vote or written consent in lieu of a meeting of the holders of such class or classes or series or by any remaining director or directors elected by the holders of such class or classes or series pursuant to this Section 3.2.
3.3Preferred Stock Protective Provisions. At any time when at least 3,70,356 shares of Preferred Stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Preferred Stock) are outstanding, the Corporation shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without (in addition to any other vote required by law or this Amended and Restated Certificate of Incorporation) the written consent or affirmative vote of holders of a majority of the then outstanding shares of Preferred Stock (the “Requisite Holders”) given in writing or by vote at a meeting, consenting or voting (as the case may be) separately as a class, 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:
3.3.1liquidate, dissolve or wind-up the business and affairs of the Corporation, effect any other Deemed Liquidation Event, or consent to any of the foregoing;
-5-
3.3.2amend, alter or repeal any prov1S1on of this Amended and Restated Certificate of Incorporation or the Bylaws of the Corporation in a manner that adversely impacts the powers, preferences, or rights of the shares of Preferred Stock;
3.3.3create, or authorize the creation of any additional class or series of capital stock if the same ranks senior to or on parity with the Preferred Stock with respect to the distribution of assets on the liquidation, dissolution or winding up of the Corporation, the payment of dividends and rights of redemption;
3.3.4increase or decrease the authorized number of shares of Preferred Stock;
3.3.5create or hold capital stock in any subsidiary that is not a wholly owned subsidiary of the Corporation or dispose of capital stock of any subsidiary of the Corporation or dispose of all or substantially all of any subsidiary of the Corporation;
3.3.6purchase or redeem (or permit any subsidiary to purchase or redeem) or pay or declare any dividend or make any distribution on, any shares of capital stock of the Corporation that ranks junior to the Preferred Stock other than (i) redemptions of or dividends or distributions on the Preferred Stock as expressly authorized herein, (ii) dividends or other distributions payable on the Common Stock solely in the form of additional shares of Common Stock, (iii) repurchases of stock from former employees, officers, directors, consultants or other persons who performed services for the Corporation or any subsidiary in connection with the cessation of such employment or service at the lower of fair market value or cost as determined by the Board of Directors, or (iv) as otherwise approved by the Board of Directors;
3.3.7create, or authorize the creation of, or issue, or authorize the issuance of any debt security or incur other indebtedness for borrowed money, including but not limited to obligations and contingent obligations under guarantees, or permit any subsidiary to take any such action with respect to any debt security or other indebtedness for borrowed money in excess of an aggregate of $2,000,000, other than purchase money liens, statutory liens of landlords, mechanics, materialmen, workmen, warehousemen and other similar persons, equipment leases, bank lines of credit or trade payables incurred in the ordinary course or unless otherwise approved by the Board of Directors; or
3.3.8increase or decrease the authorized number of directors constituting the Board of Directors.
4.Optional Conversion.
The holders of the Preferred Stock shall have conversion rights as follows (the “Conversion Rights”):
4.1Right to Convert.
4.1.1Conversion Ratio. Each share of Preferred Stock shall be convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and
-6-
nonassessable shares of Common Stock as is determined by dividing the Original Issue Price by the Preferred Conversion Price (as defined below) in effect at the time of conversion. The “Preferred Conversion Price” of any series of Preferred Stock shall initially be equal to the Original Issue Price of such series of Preferred Stock. Each Preferred Conversion Price, and the rate at which shares of Preferred Stock may be converted into shares of Common Stock, shall be subject to adjustment as provided below.
4.1.2Termination of Conversion Rights. In the event of a liquidation, dissolution or winding up of the Corporation or a Deemed Liquidation Event, the Conversion Rights shall terminate at the close of business on the last full day preceding the date fixed for the payment of any such amounts distributable on such event to the holders of Preferred Stock.
4.2Fractional Shares. No fractional shares of Common Stock shall be issued upon conversion of the Preferred Stock. In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of a share of Common Stock as determined in good faith by the Board of Directors. Whether or not fractional shares would be issuable upon such conversion shall be determined on the basis of the total number of shares of Preferred Stock the holder is at the time converting into Common Stock and the aggregate number of shares of Common Stock issuable upon such conversion.
4.3Mechanics of Conversion.
4.3.1Notice of Conversion. In order for a holder of Preferred Stock to voluntarily convert shares of Preferred Stock into shares of Common Stock, such holder shall (a) provide written notice to the Corporation’s transfer agent at the office of the transfer agent for the Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent) that such holder elects to convert all or any number of such holder’s shares of Preferred Stock and, if applicable, any event on which such conversion is contingent and (b), if such holder’s shares are certificated, surrender the certificate or certificates for such shares of Preferred Stock (or, if such registered holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate), at the office of the transfer agent for the Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent). Such notice shall state such holder’s name or the names of the nominees in which such holder wishes the shares of Common Stock to be issued. If required by the Corporation, any certificates surrendered for conversion shall be endorsed or accompanied by a written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or his, her or its attorney duly authorized in writing. The close of business on the date of receipt by the transfer agent (or by the Corporation if the Corporation serves as its own transfer agent) of such notice and, if applicable, certificates (or lost certificate affidavit and agreement) shall be the time of conversion (the “Conversion Time”), and the shares of Common Stock issuable upon conversion of the specified shares shall be deemed to be outstanding of record as of such date. The Corporation shall, as soon as practicable after the Conversion Time (i) issue and deliver to such holder of Preferred Stock, or to his, her or its nominees, a certificate or
-7-
certificates for the number of full shares of Common Stock issuable upon such conversion in accordance with the provisions hereof and a certificate for the number (if any) of the shares of Preferred Stock represented by the surrendered certificate that were not converted into Common Stock, (ii) pay in cash such amount as provided in Subsection 4.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and (iii) pay all declared but unpaid dividends on the shares of Preferred Stock converted.
4.3.2Reservation of Shares. The Corporation shall at all times when the Preferred Stock shall be outstanding, reserve and keep available out of its authorized but unissued capital stock, for the purpose of effecting the conversion of the Preferred Stock, such number of its duly authorized shares of Common Stock as shall from time to time be sufficient to effect the conversion of all outstanding Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient to effect the conversion of all then outstanding shares of the Preferred Stock, the Corporation shall take such corporate action as may be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes, including, without limitation, engaging in best efforts to obtain the requisite stockholder approval of any necessary amendment to this Amended and Restated Certificate of Incorporation. Before taking any action which would cause an adjustment reducing any Preferred Conversion Price below the then par value of the shares of Common Stock issuable upon conversion of the Preferred Stock, the Corporation will take any corporate action which may, in the opinion of its counsel, be necessary in order that the Corporation may validly and legally issue fully paid and non-assessable shares of Common Stock at such adjusted Preferred Conversion Price.
4.3.3Effect of Conversion. All shares of Preferred Stock which shall have been surrendered for conversion as herein provided shall no longer be deemed to be outstanding and all rights with respect to such shares shall immediately cease and terminate at the Conversion Time, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor, to receive payment in lieu of any fraction of a share otherwise issuable upon such conversion as provided in Subsection 4.2 and to receive payment of any dividends declared but unpaid thereon. Any shares of Preferred Stock so converted shall be retired and cancelled and may not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock accordingly.
4.3.4No Further Adjustment. Upon any such conversion, no adjustment to the applicable Preferred Conversion Price shall be made for any declared but unpaid dividends on the Preferred Stock surrendered for conversion or on the Common Stock delivered upon conversion.
4.3.5Taxes. The Corporation shall pay any and all issue and other similar taxes that may be payable in respect of any issuance or delivery of shares of Common Stock upon conversion of shares of Preferred Stock pursuant to this Section 4. The Corporation shall not, however, be required to pay any tax which may be payable in respect of any transfer involved in the issuance and delivery of shares of Common Stock in a name other than that in which the shares of Preferred Stock so converted were registered, and no
-8-
such issuance or delivery shall be made unless and until the person or entity requesting such issuance has paid to the Corporation the amount of any such tax or has established, to the satisfaction of the Corporation, that such tax has been paid.
4.4Adjustments to Preferred Conversion Price for Diluting Issues.
4.4.1Special Definitions. For purposes of this Article Fourth, the following definitions shall apply:
(a)“Option” shall mean rights, options or warrants to subscribe for, purchase or otherwise acquire Common Stock or Convertible Securities.
(b)“Original Issue Date” shall mean the date on which the first share of Series A Preferred Stock was issued.
(c)“Convertible Securities” shall mean any evidences of indebtedness, shares or other securities directly or indirectly convertible into or exchangeable for Common Stock, but excluding Options.
(d)“Additional Shares of Common Stock” shall mean all shares of Common Stock issued (or, pursuant to Subsection 4.4.3 below, deemed to be issued) by the Corporation after the Original Issue Date, other than (1) the following shares of Common Stock and (2) shares of Common Stock deemed issued pursuant to the following Options and Convertible Securities (clauses (1) and (2), collectively, “Exempted Securities”):
|
(i) |
as to any series of Preferred Stock shares of Common Stock, Options or Convertible Securities issued upon conversion thereof or as a dividend or distribution on such series of Preferred Stock; |
|
(ii) |
shares of Common Stock, Options or Convertible Securities issued by reason of a dividend, stock split, split-up or other distribution on shares of Common Stock that is covered by Section 4.5, 4.6, 4.7 or 4.8; |
|
(iii) |
shares of Common Stock or Options issued to employees or directors of, or consultants or advisors to, the Corporation or any of its subsidiaries pursuant to a plan, agreement or arrangement approved by the Board of Directors of the Corporation; |
|
(iv) |
shares of Common Stock or Convertible Securities actually issued upon the exercise of Options or shares of Common Stock actually issued upon the conversion or |
-9-
|
exchange of Convertible Securities, in each case provided such issuance is pursuant to the terms of such Option or Convertible Security; |
|
(v) |
shares of Common Stock, Options or Convertible 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 transaction approved by the Board of Directors of the Corporation; |
|
(vi) |
shares of Common Stock, Options or Convertible Securities issued to suppliers or third party service providers in connection with the provision of goods or services pursuant to transactions approved by the Board of Directors of the Corporation; |
|
(vii) |
shares of Common Stock, Options or Convertible Securities issued in connection with sponsored research, collaboration, technology license, development, OEM, marketing or other similar agreements or strategic partnerships approved by the Board of Directors of the Corporation that do not exceed an aggregate of 5% of the fully diluted capitalization of the Corporation; |
|
(viii) |
securities issued as a unit or together if the exercise or conversion price of the Convertible Securities in the unit or sold with the other securities exceed the Conversion Price then in effect or if the total cash consideration on a per unit or per Convertible Security basis exceeds the Conversion Price then in effect; or |
|
(ix) |
shares of Common Stock or Convertible Securities that the Requisite Holders elect in writing to exclude from the definition of “Additional Shares of Common Stock” for purposes of this Section 4. |
4.4.2No Adjustment of Preferred Conversion Price. No adjustment in any Preferred Conversion Price shall be made as the result of the issuance or deemed
-10-
issuance of Additional Shares of Common Stock if the Corporation receives written notice or consent (either prior to or after such issuance or deemed issuance) from the Requisite Holders (or, in the case of an issuance that would only cause an adjustment of the conversion price of only one or more series of Preferred Stock, upon receipt of written notice or consent from a majority of that series or those series voting together as a single class) agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of such Additional Shares of Common Stock.
4.4.3Deemed Issue of Additional Shares of Common Stock.
(a)If the Corporation at any time or from time to time after the Original Issue Date shall issue any Options or Convertible Securities (excluding Options or Convertible Securities which are themselves Exempted Securities) or shall fix a record date for the determination of holders of any class of securities entitled to receive any such Options or Convertible Securities, then the maximum number of shares of Common Stock (as set forth in the instrument relating thereto, assuming the satisfaction of any conditions to exercisability, convertibility or exchangeability but without regard to any provision contained therein for a subsequent adjustment of such number) issuable upon the exercise of such Options or, in the case of Convertible Securities and Options therefor, the conversion or exchange of such Convertible Securities, shall be deemed to be Additional Shares of Common Stock issued as of the time of such issue or, in case such a record date shall have been fixed, as of the close of business on such record date.
(b)If the terms of any Option or Convertible Security, the issuance of which resulted in an adjustment to any Preferred Conversion Price pursuant to the terms of Subsection 4.4.4, are revised as a result of an amendment to such terms or any other adjustment pursuant to the provisions of such Option or Convertible Security (but excluding automatic adjustments to such terms pursuant to anti-dilution or similar provisions of such Option or Convertible Security) to provide for either (1) any increase or decrease in the number of shares of Common Stock issuable upon the exercise, conversion and/or exchange of any such Option or Convertible Security or (2) any increase or decrease in the consideration payable to the Corporation upon such exercise, conversion and/or exchange, then, effective upon such increase or decrease becoming effective, the Preferred Conversion Price computed upon the original issue of such Option or Convertible Security (or upon the occurrence of a record date with respect thereto) shall be readjusted to such Preferred Conversion Price as would have obtained had such revised terms been in effect upon the original date of issuance of such Option or Convertible Security. Notwithstanding the foregoing, no readjustment pursuant to this clause (b) shall have the effect of increasing any Preferred Conversion Price to an amount which exceeds the lower of (i) the Preferred Conversion Price in effect immediately prior to the original adjustment made as a result of the issuance of such Option or Convertible Security, or (ii) the Preferred Conversion Price that would have resulted from any issuances of Additional Shares of Common Stock (other than deemed issuances of Additional Shares of Common Stock as a result of the issuance of such Option or Convertible Security) between the original adjustment date and such readjustment date.
(c)If the terms of any Option or Convertible Security (excluding Options or Convertible Securities which are themselves Exempted Securities), the issuance of which did not result in an adjustment to any Preferred Conversion Price pursuant
-11-
to the terms of Subsection 4.4.4 (either because the consideration per share (determined pursuant to Subsection 4.4.5) of the Additional Shares of Common Stock subject thereto was equal to or greater than such Preferred Conversion Price then in effect, or because such Option or Convertible Security was issued before the Original Issue Date), are revised after the Original Issue Date as a result of an amendment to such terms or any other adjustment pursuant to the provisions of such Option or Convertible Security (but excluding automatic adjustments to such terms pursuant to anti-dilution or similar provisions of such Option or Convertible Security) to provide for either (1) any increase in the number of shares of Common Stock issuable upon the exercise, conversion or exchange of any such Option or Convertible Security or (2) any decrease in the consideration payable to the Corporation upon such exercise, conversion or exchange, then such Option or Convertible Security, as so amended or adjusted, and the Additional Shares of Common Stock subject thereto (determined in the manner provided in Subsection 4.4.3(a) shall be deemed to have been issued effective upon such increase or decrease becoming effective.
(d)Upon the expiration or termination of any unexercised Option or unconverted or unexchanged Convertible Security (or portion thereof) which resulted (either upon its original issuance or upon a revision of its terms) in an adjustment to any Preferred Conversion Price pursuant to the terms of Subsection 4.4.4, such Preferred Conversion Price shall be readjusted to such Preferred Conversion Price as would have obtained had such Option or Convertible Security (or portion thereof) never been issued.
(e)If the number of shares of Common Stock issuable upon the exercise, conversion and/or exchange of any Option or Convertible Security, or the consideration payable to the Corporation upon such exercise, conversion and/or exchange, is calculable at the time such Option or Convertible Security is issued or amended but is subject to adjustment based upon subsequent events, any adjustment to a Preferred Conversion Price provided for in this Subsection 4.4.3 shall be effected at the time of such issuance or amendment based on such number of shares or amount of consideration without regard to any provisions for subsequent adjustments (and any subsequent adjustments shall be treated as provided in clauses (b) and (c) of this Subsection 4.4.3). If the number of shares of Common Stock issuable upon the exercise, conversion and/or exchange of any Option or Convertible Security, or the consideration payable to the Corporation upon such exercise, conversion and/or exchange, cannot be calculated at all at the time such Option or Convertible Security is issued or amended, any adjustment to a Preferred Conversion Price that would result under the terms of this Subsection 4.4.3 at the time of such issuance or amendment shall instead be effected at the time such number of shares and/or amount of consideration is first calculable (even if subject to subsequent adjustments), assuming for purposes of calculating such adjustment to the Preferred Conversion Price that such issuance or amendment took place at the time such calculation can first be made.
4.4.4Adjustment of Preferred Conversion Price Upon Issuance of Additional Shares of Common Stock. In the event the Corporation shall at any time after the Original Issue Date issue Additional Shares of Common Stock (including Additional Shares of Common Stock deemed to be issued pursuant to Subsection 4.4.3), without consideration or for a consideration per share less than any Preferred Conversion Price in effect immediately prior to such issuance or deemed issuance, then such Preferred Conversion
-12-
Price shall be reduced, concurrently with such issue, to a price (calculated to the nearest one-hundredth of a cent) determined in accordance with the following formula:
CP2 = CP1* (A+ B) + (A+ C).
For purposes of the foregoing formula, the following definitions shall apply:
(a)“CP2” shall mean the applicable Preferred Conversion Price in effect immediately after such issuance or deemed issuance of Additional Shares of Common Stock
(b)“CP1” shall mean the applicable Preferred Conversion Price in effect immediately prior to such issuance or deemed issuance of Additional Shares of Common Stock;
(c)“A” shall mean the number of shares of Common Stock outstanding immediately prior to such issuance or deemed issuance of Additional Shares of Common Stock (treating for this purpose as outstanding all shares of Common Stock issuable upon exercise of Options outstanding immediately prior to such issuance or deemed issuance or upon conversion or exchange of Convertible Securities (including the Preferred Stock) outstanding (assuming exercise of any outstanding Options therefor) immediately prior to such issue);
(d)“B” shall mean the number of shares of Common Stock that would have been issued if such Additional Shares of Common Stock had been issued or deemed issued at a price per share equal to CP1 (determined by dividing the aggregate consideration received by the Corporation in respect of such issue by CP1); and “C” shall mean the number of such Additional Shares of Common Stock issued in such transaction.
4.4.5Determination of Consideration. For purposes of this Subsection 4.4, the consideration received by the Corporation for the issuance or deemed issuance of any Additional Shares of Common Stock shall be computed as follows:
(a)Cash and Property: Such consideration shall:
|
(i) |
insofar as it consists of cash, be computed at the aggregate amount of cash received by the Corporation, excluding amounts paid or payable for accrued interest; |
|
(ii) |
insofar as it consists of property other than cash, be computed at the fair market value thereof at the time of such issue, as determined in good faith by the Board of Directors; and |
-13-
|
(iii) |
in the event Additional Shares of Common Stock are issued together with other shares or securities or other assets of the Corporation for consideration which covers both, be the proportion of such consideration so received, computed as provided in clauses (i) and (ii) above, as determined in good faith by the Board of Directors. |
(b)Options and Convertible Securities. The consideration per share received by the Corporation for Additional Shares of Common Stock deemed to have been issued pursuant to Subsection 4.4.3, relating to Options and Convertible Securities, shall be determined by dividing:
|
(i) |
The total amount, if any, received or receivable by the Corporation as consideration for the issue of such Options or Convertible Securities, plus the minimum aggregate amount of additional consideration (as set forth in the instruments relating thereto, without regard to any provision contained therein for a subsequent adjustment of such consideration) payable to the Corporation upon the exercise of such Options or the conversion or exchange of such Convertible Securities, or in the case of Options for Convertible Securities, the exercise of such Options for Convertible Securities and the conversion or exchange of such Convertible Securities, by |
|
(ii) |
the maximum number of shares of Common Stock (as set forth in the instruments relating thereto, without regard to any prov1s10n contained therein for a subsequent adjustment of such number) issuable upon the exercise of such Options or the conversion or exchange of such Convertible Securities, or in the case of Options for Convertible Securities, the exercise of such Options for Convertible |
-14-
|
Securities and the conversion or exchange of such Convertible Securities. |
4.4.6Multiple Closing Dates. In the event the Corporation shall issue on more than one date Additional Shares of Common Stock that are a part of one transaction or a series of related transactions and that would result in an adjustment to any Preferred Conversion Price pursuant to the terms of Subsection 4.4.4, and such issuance dates occur within a period of no more than ninety (90) days from the first such issuance to the final such issuance, then, upon the final such issuance, such Preferred Conversion Price shall be readjusted to give effect to all such issuances as if they occurred on the date of the first such issuance (and without giving effect to any additional adjustments as a result of any such subsequent issuances within such period).
4.5Adjustment for Stock Splits and Combinations. If the Corporation shall at any time or from time to time after the Original Issue Date effect a subdivision of the outstanding Common Stock, each Preferred Conversion Price in effect immediately before that subdivision shall be proportionately decreased so that the number of shares of Common Stock issuable on conversion of each share of such series shall be increased in proportion to such increase in the aggregate number of shares of Common Stock outstanding. If the Corporation shall at any time or from time to time after the Original Issue Date combine the outstanding shares of Common Stock, each Preferred Conversion Price in effect immediately before the combination shall be proportionately increased so that the number of shares of Common Stock issuable on conversion of each share of such series shall be decreased in proportion to such decrease in the aggregate number of shares of Common Stock outstanding. Any adjustment under this subsection shall become effective at the close of business on the date the subdivision or combination becomes effective.
4.6Adjustment for Certain Dividends and Distributions. In the event the Corporation at any time or from time to time after the Original Issue Date shall make or issue, or fix a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution payable on the Common Stock in additional shares of Common Stock, then and in each such event any Preferred Conversion Price in effect immediately before such event shall be decreased as of the time of such issuance or, in the event such a record date shall have been fixed, as of the close of business on such record date, by multiplying such Preferred Conversion Price then in effect by a fraction:
(1)the numerator of which shall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the close of business on such record date, and
(2)the denominator of which shall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the close of business on such record date plus the number of shares of Common Stock issuable in payment of such dividend or distribution.
Notwithstanding the foregoing (a) if such record date shall have been fixed and such dividend is not fully paid or if such distribution is not fully made on the date fixed therefor, each
-15-
Preferred Conversion Price shall be recomputed accordingly as of the close of business on such record date and thereafter such Preferred Conversion Price shall be adjusted pursuant to this subsection as of the time of actual payment of such dividends or distributions; and (b) that no such adjustment shall be made if the holders of Preferred Stock simultaneously receive a dividend or other distribution of shares of Common Stock in a number equal to the number of shares of Common Stock as they would have received if all outstanding shares of Preferred Stock had been converted into Common Stock on the date of such event.
4.7Adjustments for Other Dividends and Distributions. In the event the Corporation at any time or from time to time after the Original Issue Date shall make or issue, or fix a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution payable in securities of the Corporation (other than a distribution of shares of Common Stock in respect of outstanding shares of Common Stock) or in other property and the provisions of Section 1 do not apply to such dividend or distribution, then and in each such event the holders of Preferred Stock shall receive, simultaneously with the distribution to the holders of Common Stock, a dividend or other distribution of such securities or other property in an amount equal to the amount of such securities or other property as they would have received if all outstanding shares of Preferred Stock had been converted into Common Stock on the date of such event.
4.8Adjustment for Merger or Reorganization, etc. Subject to the provisions of Subsection 2.3, if there shall occur any reorganization, recapitalization, reclassification, consolidation or merger involving the Corporation in which the Common Stock (but not the Preferred Stock) is converted into or exchanged for securities, cash or other property (other than a transaction covered by Subsections 4.4, 4.6 or 1J), then, following any such reorganization, recapitalization, reclassification, consolidation or merger, each share of Preferred Stock shall thereafter be convertible in lieu of the Common Stock into which it was convertible prior to such event into the kind and amount of securities, cash or other property which a holder of the number of shares of Common Stock of the Corporation issuable upon conversion of one share of Preferred Stock immediately prior to such reorganization, recapitalization, reclassification, consolidation or merger would have been entitled to receive pursuant to such transaction; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors) shall be made in the application of the provisions in this Section 4 with respect to the rights and interests thereafter of the holders of the Preferred Stock, to the end that the provisions set forth in this Section 4 (including provisions with respect to changes in and other adjustments of the applicable Preferred Conversion Price) shall thereafter be applicable, as nearly as reasonably may be, in relation to any securities or other property thereafter deliverable upon the conversion of the Preferred Stock.
4.9 Certificate as to Adjustments. Upon the occurrence of each adjustment or readjustment of any Preferred Conversion Price pursuant to this Section 4, the Corporation at its expense shall, as promptly as reasonably practicable but in any event not later than ten (10) days thereafter, compute such adjustment or readjustment in accordance with the terms hereof and furnish to each holder of affected Preferred Stock a certificate setting forth such adjustment or readjustment (including the kind and amount of securities, cash or other property into which such Preferred Stock is convertible) and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, as promptly as reasonably practicable
-16-
after the written request at any time of any holder of Preferred Stock (but in any event not later than ten (10) days thereafter), furnish or cause to be furnished to such holder a certificate setting forth (i) the applicable Preferred Conversion Price then in effect, and (ii) the number of shares of Common Stock and the amount, if any, of other securities, cash or property which then would be received upon the conversion of such Preferred Stock.
4.10Notice of Record Date. In the event:
(a)the Corporation shall take a record of the holders of its Common Stock (or other capital stock or securities at the time issuable upon conversion of the Preferred Stock) for the purpose of entitling or enabling them to receive any dividend or other distribution, or to receive any right to subscribe for or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or
(b)of any capital reorganization of the Corporation, any reclassification of the Common Stock of the Corporation, or any Deemed Liquidation Event; or
(c)of the voluntary or involuntary dissolution, liquidation or winding-up of the Corporation,
then, and in each such case, the Corporation will send or cause to be sent to the holders of the Preferred Stock a notice specifying, as the case may be, (i) the record date for such dividend, distribution or right, and the amount and character of such dividend, distribution or right, or (ii) the effective date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding up is proposed to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or such other capital stock or securities at the time issuable upon the conversion of the Preferred Stock) shall be entitled to exchange their shares of Common Stock (or such other capital stock or securities) for securities or other property deliverable upon such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up, and the amount per share and character of such exchange applicable to the Preferred Stock and the Common Stock. Such notice shall be sent at least ten (10) days prior to the record date or effective date for the event specified in such notice.
5.Mandatory Conversion.
5.1Trigger Events. Upon either (a) the closing of the sale of shares of Common Stock to the public in a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $20,000,000 of gross proceeds to the Corporation and/or its stockholders (not including fees and expenses of the offering, or underwriters’ discounts and commissions) and a pre-transaction valuation of the Corporation of at least $50,000,000 (the “Qualified IPO Value Thresholds”) and in connection with such offering the Common Stock is listed for trading on the Nasdaq Stock Market, the New York Stock Exchange or another exchange or marketplace approved the Board of Directors (a “Qualified IPO”); provided., however, that in the event that (i) all legal and regulatory requirements necessary for the declaration of effectiveness of a registration statement on Form S-1 filed by the Corporation with the Securities and Exchange Commission with respect to the registration of the Corporation’s equity capital stock under the Securities Act of 1933, as
-17-
amended, have been satisfied (other than legal and regulatory requirements that would have been satisfied but for the failure of the underwriters to take customary actions in connection with such offering), and (ii) either (A) the lead underwriter has indicated to the Corporation prior to December 22, 2023 (the “Reference Date”) that it does not reasonably believe that the Qualified IPO Value Thresholds will be achieved before the Reference Date, or (B) the lead underwriter has failed to respond within three (3) business days to a request by the Corporation for a written statement as to whether it can complete an offering that will meet the Qualified IPO Value Thresholds prior to the Reference Date, the Reference Date shall be extended by six (6) months and the “gross proceeds” and “pre-transaction valuation” Qualified IPO Value Thresholds shall be lowered to $15,000,000 and $40,000,000, respectively, (b) the closing of a merger of the Corporation that results in the surviving company being listed on the Nasdaq Stock Market, the New York Stock Exchange or another exchange or marketplace approved the Board of Directors and holding unencumbered net cash of not less than $15,000,000 at the closing of such transaction (a “Qualifying Reverse Merger”), or (c) the date and time, or the occurrence of an event, specified by vote or written consent of the Requisite Holders (the time of such closing or the date and time specified or the time of the event specified in such vote or written consent is referred to herein as the “Mandatory Conversion Time”), then (i) all outstanding shares of Preferred Stock shall automatically be converted into shares of Common Stock, at the then effective conversion rate as calculated pursuant to Subsection 4.1.1, and (ii) such shares may not be reissued by the Corporation.
5.2Procedural Requirements. All holders of record of shares of Preferred Stock shall be sent written notice of the Mandatory Conversion Time and the place designated for mandatory conversion of all such shares of Preferred Stock pursuant to this Section 5. Such notice need not be sent in advance of the occurrence of the Mandatory Conversion Time. Upon receipt of such notice, each holder of shares of Preferred Stock in certificated form shall surrender his, her or its certificate or certificates for all such shares (or, if such holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate) to the Corporation at the place designated in such notice. If so required by the Corporation, any certificates surrendered for conversion shall be endorsed or accompanied by written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or by his, her or its attorney duly authorized in writing. All rights with respect to the Preferred Stock converted pursuant to Subsection 5.1, including the rights, if any, to receive notices and vote (other than as a holder of Common Stock), will terminate at the Mandatory Conversion Time (notwithstanding the failure of the holder or holders thereof to surrender any certificates at or prior to such time), except only the rights of the holders thereof, upon surrender of any certificate or certificates of such holders (or lost certificate affidavit and agreement) therefor, to receive the items provided for in the next sentence of this Subsection 5.2. As soon as practicable after the Mandatory Conversion Time and, if applicable, the surrender of any certificate or certificates (or lost certificate affidavit and agreement) for Preferred Stock, the Corporation shall (a) issue and deliver to such holder, or to his, her or its nominees, a certificate or certificates for the number of full shares of Common Stock issuable on such conversion in accordance with the provisions hereof and (b) pay cash as provided in
-18-
Subsection 4.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and the payment of any declared but unpaid dividends on the shares of Preferred Stock converted. Such converted Preferred Stock shall be retired and cancelled and may not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock accordingly.
6.Redemption. The Preferred Stock shall not be redeemable.
7.Redeemed or Otherwise Acquired Shares. Any shares of Preferred Stock that are acquired by the Corporation or any of its subsidiaries shall be automatically and immediately cancelled and retired and shall not be reissued, sold or transferred. Neither the Corporation nor any of its subsidiaries may exercise any voting or other rights granted to the holders of Preferred Stock following redemption.
8.Waiver. Any of the rights, powers, preferences and other terms of the Preferred Stock set forth herein may be waived on behalf of all holders of Preferred Stock by the affirmative written consent or vote of the Requisite Holders.
9.Notices. Any notice required or permitted by the provisions of this Article Fourth to be given to a holder of shares of Preferred Stock shall be mailed, postage prepaid, to the post office address last shown on the records of the Corporation, or given by electronic communication in compliance with the provisions of the General Corporation Law, and shall be deemed sent upon such mailing or electronic transmission.
Fifth: Subject to any additional vote required by this Amended and Restated Certificate of Incorporation or Bylaws, 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.
Sixth: The number of directors of the Corporation shall, unless otherwise required by law or this Amended and Restated Certificate of Incorporation, be fixed from time to time as provided in the Bylaws of the corporation.
Seventh: Elections of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.
Eighth: 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.
Ninth: 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 or any other law of the State of Delaware is amended after approval by the stockholders of this Article Ninth to authorize corporate action further eliminating or limiting the personal liability of directors,
-19-
then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law as so amended.
Any repeal or modification of the foregoing provisions of this Article Ninth 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.
Tenth: The Corporation shall to the fullest extent permitted by Section 145 of the Delaware General Corporation Law, as the same may be amended or supplemented, or by any successor thereto, indemnify, advance expenses and reimburse any and all persons whom it shall have the power to indemnify under said Section from and against any and all of the expenses, liabilities or other matters referred to in, or covered by said Section. Notwithstanding the foregoing, the indemnification provided for in this Article TENTH shall not be deemed exclusive of any other rights to which those entitled to receive indemnification or reimbursement hereunder may be entitled under any Bylaw of the Corporation, agreement, vote of stockholders or disinterested directors or otherwise. 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 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.
Any amendment, repeal or modification of the foregoing provisions of this Article Tenth shall not (a) adversely affect any right or protection of any director, officer or other agent of the Corporation existing at the time of such amendment, repeal or modification or (b) increase the liability of any director of the Corporation with respect to any acts or omissions of such director, officer or agent occurring prior to, such amendment, repeal or modification.
Eleventh: The Corporation renounces, to the fullest extent permitted by law, any interest or expectancy of the Corporation in, or in being offered an opportunity to participate in, any Excluded Opportunity. An “Excluded Opportunity” is any matter, transaction or interest that is presented to, or acquired, created or developed by, or which otherwise comes into the possession of (i) any director of the Corporation who is not an employee of the Corporation or any of its subsidiaries, or (ii) any holder of Preferred Stock or any partner, member, director, stockholder, employee, affiliate or agent of any such holder, other than someone who is an employee of the Corporation or any of its subsidiaries (collectively, the persons referred to in clauses (i) and (ii) are “Covered Persons”), unless such matter, transaction or interest is presented to, or acquired, created or developed by, or otherwise comes into the possession of, a Covered Person expressly and solely in such Covered Person’s capacity as a director of the Corporation while such Covered Person is performing services in such capacity. Any repeal or modification of this Article Eleventh will only be prospective and will not affect the rights under this Article Eleventh in effect at the time of the occurrence of any actions or omissions to act giving rise to liability. Notwithstanding anything to the contrary contained elsewhere in this Amended and Restated Certificate of Incorporation, the affirmative vote of the Requisite Holders,
-20-
will be required to amend or repeal, or to adopt any provisions inconsistent with this Article Eleventh.
Twelfth: For purposes of Section 500 of the California Corporations Code (to the extent applicable), in connection with any repurchase of shares of Common Stock permitted under this Amended and Restated Certificate of Incorporation from employees, officers, directors or consultants of the Corporation in connection with a termination of employment or services pursuant to agreements or arrangements approved by the Board of Directors (in addition to any other consent required under this Amended and Restated Certificate of Incorporation), such repurchase may be made without regard to any “preferential dividends arrears amount” or “preferential rights amount” (as those terms are defined in Section 500 of the California Corporations Code). Accordingly, for purposes of making any calculation under California Corporations Code Section 500 in connection with such repurchase, the amount of any “preferential dividends arrears amount” or “preferential rights amount” (as those terms are defined therein) shall be deemed to be zero (0).
Thirteenth: Unless this Corporation consents in writing to the selection of an alternative forum, 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 or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the General Corporation Law or the Corporation’s Certificate of Incorporation (as may be amended from time to time), or (iv) any action asserting a claim governed by the internal affairs doctrine, shall be the Court of Chancery in the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware). If any action the subject matter of which is within the scope of the preceding sentence is filed in a court other than a court located within the State of Delaware (a “Foreign Action”) in the name of any stockholder, such stockholder shall be deemed to have consented to (i) the personal jurisdiction of the state and federal courts located within the State of Delaware in connection with any action brought in any such court to enforce the preceding sentence and (ii) having service of process made upon such stockholder in any such action by service upon such stockholder’s counsel in the Foreign Action as agent for such stockholder. Unless this Corporation consents in writing to the selection of an alternative forum, the federal district courts of the United States of America shall be, to the fullest extent permitted by law, the sole and exclusive forum for any action asserting a claim arising under the Securities Act of 1933.
-21-
Exhibit 3.2
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
COYA THERAPEUTICS, INC.
Coya Therapeutics, Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), hereby certifies as follows:
1.The name of this corporation is Coya Therapeutics, Inc. The date of the filing of its original certificate of incorporation with the Secretary of State of the State of Delaware was November 23, 2020.
2.This Amended and Restated Certificate of Incorporation, which restates, integrates and further amends the certificate of incorporation of this corporation as heretofore amended and restated, has been duly adopted by the corporation in accordance with Sections 242 and 245 of the DGCL and has been adopted by the requisite vote of the stockholders of the corporation, acting by written consent in lieu of a meeting in accordance with Section 228 of the DGCL.
3.The certificate of incorporation of this corporation is hereby amended and restated in its entirety to read as follows:
ARTICLE I
The name of the corporation is “Coya Therapeutics, Inc.” (hereinafter called the “Corporation”).
ARTICLE II
The address of the Corporation’s registered office in the State of Delaware is 251 Little Falls Drive, Wilmington, New Castel County, DE USA 19808. The name of its registered agent at such address is Corporation Service 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 General Corporation Law of the State of Delaware or any applicable successor act thereto, as the same may be amended from time to time (the “DGCL”).
ARTICLE IV
(A) Classes of Stock. The total number of shares of all classes of capital stock that the Corporation is authorized to issue is one hundred and ten million (110,000,000) shares which shall be divided into two classes of stock to be designated “Common Stock” and “Preferred Stock”. The total number of shares of Common Stock that the Corporation is authorized to issue is one hundred million (100,000,000) shares, par value $0.0001 per share. The total number of
shares of Preferred Stock that the Corporation is authorized to issue is ten million (10,000,000) shares, par value $0.0001 per share. Subject to the rights of the holders of any series of Preferred Stock, the number of authorized shares of any of the Common Stock or Preferred Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority in voting power of the stock of the Corporation entitled to vote thereon irrespective of the provisions of Section 242(b)(2) of the DGCL, and no vote of the holders of any of the Common Stock or Preferred Stock voting separately as a class shall be required therefor.
(B) Common Stock. The powers, preferences and relative participating, optional or other special rights, and the qualifications, limitations and restrictions thereof, of the Common Stock are as follows:
1.Ranking. The voting powers and dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock of any series as may be designated by the Board of Directors of the Corporation (the “Board”) upon any issuance of the Preferred Stock of any series.
2.Voting. Except as otherwise provided by law or by the resolution or resolutions providing for the issue of any series of Preferred Stock, the holders of outstanding shares of Common Stock shall have the exclusive right to vote for the election and removal of directors and for all other purposes. Notwithstanding any other provision of this Amended and Restated Certificate of Incorporation (as the same may be amended and/or restated from time to time, including the terms of any Preferred Stock Designation (as defined below), this “Certificate of Incorporation”) to the contrary, the holders of Common Stock shall not be entitled to vote on any amendment to this Certificate of Incorporation (including any Preferred Stock Designation) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon pursuant to this Certificate of Incorporation (including any Preferred Stock Designation) or the DGCL.
3.Dividends. Subject to the rights of the holders of Preferred Stock, holders of shares of Common Stock shall be entitled to receive such dividends and distributions and other distributions in cash, stock or property of the Corporation when, as and if declared thereon by the Board from time to time out of assets or funds of the Corporation legally available therefor.
4.Liquidation. Subject to the rights of the holders of Preferred Stock, shares of Common Stock shall be entitled to receive the assets and funds of the Corporation available for distribution in the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary. A liquidation, dissolution or winding up of the affairs of the Corporation, as such terms are used in this Section B(4), shall not be deemed to be occasioned by or to include any consolidation or merger of the Corporation with or into any other person or a sale, lease, exchange or conveyance of all or a part of its assets.
2
(C) Preferred Stock.
Shares of Preferred Stock may be issued from time to time in one or more series. The Board is hereby authorized to provide by resolution or resolutions from time to time for the issuance, out of the unissued shares of Preferred Stock, of one or more series of Preferred Stock, without stockholder approval, by filing a certificate pursuant to the applicable law of the State of Delaware (the “Preferred Stock Designation”), setting forth such resolution and, with respect to each such series, establishing the number of shares to be included in such series, and fixing the voting powers, full or limited, or no voting power of the shares of such series, and the designation, preferences and relative, participating, optional or other special rights, if any, of the shares of each such series and any qualifications, limitations or restrictions thereof. The powers, designation, preferences and relative, participating, optional and other special rights of each series of Preferred Stock, and the qualifications, limitations and restrictions thereof, if any, may differ from those of any and all other series at any time outstanding. The authority of the Board with respect to each series of Preferred Stock shall include, but not be limited to, the determination of the following:
(a)the designation of the series, which may be by distinguishing number, letter or title;
(b)the number of shares of the series, which number the Board may thereafter (except where otherwise provided in the Preferred Stock Designation) increase or decrease (but not below the number of shares thereof then outstanding);
(c)the amounts or rates at which dividends will be payable on, and the preferences, if any, of shares of the series in respect of dividends, and whether such dividends, if any, shall be cumulative or noncumulative;
(d)the dates on which dividends, if any, shall be payable;
(e)the redemption rights and price or prices, if any, for shares of the series;
(f)the terms and amount of any sinking fund, if any, provided for the purchase or redemption of shares of the series;
(g)the amounts payable on, and the preferences, if any, of shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Corporation;
(h)whether the shares of the series shall be convertible into or exchangeable for, shares of any other class or series, or any other security, of the Corporation or any other corporation, and, if so, the specification of such other class or series or such other security, the conversion or exchange price or prices or rate or rates, any adjustments thereof, the date or dates at which such shares shall be convertible or exchangeable and all other terms and conditions upon which such conversion or exchange may be made;
3
(i)restrictions on the issuance of shares of the same series or any other class or series;
(j)the voting powers, if any, of the holders of shares of the series generally or upon specified events; and
(k)any other powers, preferences and relative, participating, optional or other special rights of each series of Preferred Stock, and any qualifications, limitations or restrictions thereof, all as may be determined from time to time by the Board and stated in the resolution or resolutions providing for the issuance of such Preferred Stock.
Without limiting the generality of the foregoing, the resolutions providing for issuance of any series of Preferred Stock may provide that such series shall be superior or rank equally or be junior to any other series of Preferred Stock to the extent permitted by law.
ARTICLE V
This Article V is inserted for the management of the business and for the conduct of the affairs of the Corporation.
(A) General Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board, except as otherwise provided by this Certificate of Incorporation or the DGCL.
(B) Number of Directors; Election of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of the directors of the Corporation shall be fixed from time to time solely by resolution of the Board.
(C) Classes of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the Board shall be divided into three classes, designated Class I, Class II and Class III. Each class shall consist, as nearly as may be possible, of one third of the total number of directors constituting the entire Board. The Board is authorized to assign members of the Board already in office to Class I, Class II or Class III at the time such classification becomes effective.
(D) Terms of Office. Subject to the rights of holders of any series of Preferred Stock to elect directors, each director shall serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected; provided that each director initially assigned to Class I shall serve for a term expiring at the Corporation’s first annual meeting of stockholders held following the time at which the initial classification of the Board becomes effective; each director initially assigned to Class II shall serve for a term expiring at the Corporation’s second annual meeting of stockholders held following the time at which the initial classification of the Board becomes effective; and each director initially assigned to Class III shall serve for a term expiring at the Corporation’s third annual meeting of stockholders held following the time at which the initial classification of the
4
Board becomes effective; provided further, that the term of each director shall continue until the election and qualification of his or her successor and be subject to his or her earlier death, disqualification, resignation or removal.
(E) Vacancies. Subject to the rights of holders of any series of Preferred Stock, any newly created directorship that results from an increase in the number of directors or any vacancy on the Board that results from the death, disability, resignation, disqualification or removal of any director or from any other cause shall be filled solely by the affirmative vote of a majority of the total number of directors then in office, even if less than a quorum, or by a sole remaining director and shall not be filled by the stockholders. Any director elected in accordance with the preceding sentence shall, in the case of a newly created directorship, hold office for the full term of the class in which the newly created directorship was created or, in the case of a vacancy, hold office for the remaining term of his or her predecessor and in each case until his or her successor shall be elected and qualified, subject to his or her earlier death, disqualification, resignation or removal.
(F) Removal. Subject to the rights of the holders of any series of Preferred Stock, any director or the entire Board may be removed from office at any time, but only for cause.
(G) Committees. Pursuant to the Amended and Restated Bylaws of the Corporation (as the same may be amended and/or restated from time to time, the “Bylaws”), the Board may establish one or more committees to which may be delegated any or all of the powers and duties of the Board to the full extent permitted by law.
(H) Stockholder Nominations and Introduction of Business. Advance notice of stockholder nominations for election of directors and other business to be brought by stockholders before a meeting of stockholders shall be given in the manner provided by the Bylaws.
(I) Preferred Stock Directors. During any period when the holders of any series of Preferred Stock have the right to elect additional directors as provided for or fixed pursuant to the provisions of Article IV hereof or any Preferred Stock Designation, then upon commencement and for the duration of the period during which such right continues: (i) the then otherwise total number of authorized directors of the Corporation shall automatically be increased by such specified number of directors, and the holders of such Preferred Stock shall be entitled to elect the additional directors so provided for or fixed pursuant to said provisions, and (ii) each such additional director shall serve until such director’s successor shall have been duly elected and qualified, or until such director’s right to hold such office terminates pursuant to said provisions, whichever occurs earlier, subject to his earlier death, disqualification, resignation or removal. Except as otherwise provided for or fixed pursuant to the provisions of Article IV hereof or any Preferred Stock Designation, whenever the holders of any series of Preferred Stock having such right to elect additional directors are divested of such right pursuant to the provisions of such stock, the terms of office of all such additional directors elected by the holders of such stock, or elected to fill any vacancies resulting from the death, resignation, disqualification or removal of such additional directors, shall forthwith terminate, the person or persons serving as such additional directors shall automatically cease to be qualified to serve as a
5
director and shall automatically cease to be a director and the total authorized number of directors of the Corporation shall be reduced accordingly.
ARTICLE VI
Unless and except to the extent that the Bylaws shall so require, the election of directors of the Corporation need not be by written ballot.
ARTICLE VII
To the fullest extent permitted by the DGCL as the same exists or as may hereafter be amended, a director or officer 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 or officer. No repeal or modification of this Article VII shall apply to or have any adverse effect on any right or protection of, or any limitation of the liability of, a director or officer of the Corporation existing at the time of such repeal or modification with respect to acts or omissions occurring prior to such repeal or modification.
ARTICLE VIII
The Corporation may indemnify, and advance expenses to, to the fullest extent permitted by law, any person who was or is a party to or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative by reason of the fact that the person is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise.
ARTICLE IX
Subject to the terms of any series of Preferred Stock, any action required or permitted to be taken by the stockholders of the Corporation must be effected at an annual or special meeting of the stockholders and may not be effected by consent in lieu of a meeting of stockholders.
ARTICLE X
Special meetings of stockholders for any purpose or purposes may be called at any time by the Board, the Chairman of the Board or the Chief Executive Officer of the Corporation, and may not be called by another other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.
ARTICLE XI
The Corporation reserves the right at any time from time to time to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, and any other provisions authorized by the DGCL may be added or inserted, in the manner now or hereafter prescribed by
6
law; and all rights, preferences and privileges of whatsoever nature conferred upon stockholders, directors, officers or any other persons whomsoever by and pursuant to this Certificate of Incorporation in its present form or as hereafter amended are granted subject to the right reserved in this Article XI. Notwithstanding any other provision of this Certificate of Incorporation or any provision of law that might otherwise permit a lesser vote or no vote, but in addition to any affirmative vote of the holders of any series of Preferred Stock required by law, by this Certificate of Incorporation or by any Preferred Stock Designation, the affirmative vote of the holders of at least sixty-six and two-thirds percent (66 2/3%) in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon shall be required to amend, alter, change or repeal, or adopt any provision inconsistent with, any of Article V, Article VII, Article VIII, Article IX, Article X, Article XII, Article XIII, and this sentence of this Certificate of Incorporation, or in each case, the definition of any capitalized terms used therein or any successor provision (including, without limitation, any such article or section as renumbered as a result of any amendment, alteration, change, repeal or adoption of any other provision of this Certificate of Incorporation). Any amendment, repeal or modification of any of Article VII, Article VIII and this sentence shall not adversely affect any right or protection of any person existing thereunder with respect to any act or omission occurring prior to such repeal or modification.
ARTICLE XII
In furtherance and not in limitation of the powers conferred upon it by law, the Board is expressly authorized and empowered to adopt, amend and repeal the Bylaws. Notwithstanding any other provision of this Certificate of Incorporation or any provision of law that might otherwise permit a lesser vote, but in addition to any affirmative vote of the holders of any series of Preferred Stock required by law, by this Certificate of Incorporation or by any Preferred Stock Designation, the Bylaws may also be amended, altered or repealed and new Bylaws may be adopted by the stockholders of the Corporation by the affirmative vote of the holders of at least sixty-six and two-thirds percent (66 2/3%) in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon.
ARTICLE XIII
Unless the Corporation consents in writing to the selection of an alternative forum, (A) (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 current or former director, officer, other employee 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, this Certificate of Incorporation or the Bylaws or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware or (iv) any action asserting a claim governed by the internal affairs doctrine of the law of the State of Delaware shall, to the fullest extent permitted by law, be exclusively brought in the Court of Chancery of the State of Delaware or, if such court does not have subject matter jurisdiction thereof, the federal district court of the State of Delaware; and (B) the federal district courts of the United States 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. Notwithstanding the foregoing, this Article XIII shall not apply to claims
7
seeking to enforce any liability or duty created by the Securities Exchange Act of 1934, as amended. To the fullest extent permitted by law, 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 consented to the provisions of this Article XIII.
[Remainder of Page Intentionally Left Blank]
8
IN WITNESS WHEREOF, the Corporation has caused this Amended and Restated Certificate of Incorporation to be executed by the undersigned duly authorized officer of the Corporation this __ day of _______________, 202_.
COYA THERAPEUTICS, INC. |
||
|
|
|
By: |
|
|
|
|
Name: |
|
|
Title: |
Exhibit 3.3
CERTIFICATE OF ADOPTION
OF
BYLAWS
OF
COYA THERAPEUTICS, INC.
November 23, 2020
The undersigned hereby certifies that he is the duly elected, qualified and acting Secretary of Coya Therapeutics, Inc., a Delaware corporation (the “Company”), and that the Bylaws attached hereto as Exhibit A were adopted as the Bylaws of the Company by the Board of Directors of the Company by Written Consent dated November 23, 2020, and said Bylaws are presently in effect.
[Remainder of page intentionally blank.]
IN WITNESS WHEREOF, the undersigned has executed this Certificate of Adoption of Bylaws as of the date set forth above.
Howard Berman
Secretary
-2-
EXHIBIT A
Bylaws
BYLAWS
OF
COYA THERAPEUTICS, INC.
(A Delaware Corporation)
Adopted November 23, 2020
TABLE OF CONTENTS
|
|
Page |
|
|
|
|
|
ARTICLE 1 |
OFFICES |
1 |
|
|
1.1 |
Registered Office |
1 |
|
1.2 |
Other Offices |
1 |
ARTICLE 2 |
CORPORATE SEAL |
1 |
|
ARTICLE 3 |
STOCKHOLDERS MEETINGS |
1 |
|
|
3.1 |
Place of Meetings |
1 |
|
3.2 |
Annual Meeting |
1 |
|
3.3 |
Special Meetings |
2 |
|
3.4 |
Notice of Meetings |
2 |
|
3.5 |
Quorum |
2 |
|
3.6 |
Adjournment and Notice of Adjourned Meetings |
3 |
|
3.7 |
Voting Rights |
3 |
|
3.8 |
List of Stockholders |
3 |
|
3.9 |
Joint Owners of Stock |
4 |
|
3.10 |
Action Without Meeting |
4 |
|
3.11 |
Organization |
5 |
ARTICLE 4 |
DIRECTORS |
5 |
|
|
4.1 |
Number and Term of Office |
5 |
|
4.2 |
Powers |
5 |
|
4.3 |
Term of Directors |
6 |
|
4.4 |
Vacancies |
6 |
|
4.5 |
Resignation |
6 |
|
4.6 |
Removal |
6 |
|
4.7 |
Meetings |
6 |
|
4.8 |
4.8 Quorum and Voting |
7 |
|
4.9 |
Action Without Meeting |
7 |
|
4.10 |
Fees and Compensation |
8 |
|
4.11 |
Committees |
8 |
|
4.12 |
Organization |
9 |
ARTICLE 5 |
OFFICERS |
9 |
|
|
5.1 |
Officers Designated |
9 |
|
5.2 |
Tenure and Duties of Officers |
9 |
|
5.3 |
Delegation of Authority |
11 |
|
5.4 |
Resignations |
11 |
|
5.5 |
Removal |
11 |
ARTICLE 6 |
EXECUTION OF CORPORATE INSTRUMENTS AND VOTING OF SECURITIES OWNED BY THE COMPANY |
11 |
|
|
6.1 |
Execution of Corporate Instruments |
11 |
|
6.2 |
Voting of Securities Owned by the Company |
11 |
ARTICLE 7 |
SHARES OF STOCK |
11 |
|
|
7.1 |
Form and Execution of Stock Certificates |
11 |
|
7.2 |
Lost, Stolen or Destroyed Certificates |
12 |
i
|
7.3 |
Transfers |
12 |
|
7.4 |
Fixing Record Dates |
13 |
|
7.5 |
Registered Stockholders |
14 |
ARTICLE 8 |
OTHER SECURITIES OF THE COMPANY |
14 |
|
ARTICLE 9 |
DIVIDENDS |
14 |
|
|
9.1 |
Declaration of Dividends |
14 |
|
9.2 |
Dividend Reserve |
14 |
ARTICLE 10 |
FISCAL YEAR |
15 |
|
ARTICLE 11 |
INDEMNIFICATION |
15 |
|
|
11.1 |
Directors and Officers |
15 |
|
11.2 |
Officers, Employees and Other Agents |
15 |
|
11.3 |
Mandatory Indemnification |
16 |
|
11.4 |
Expenses |
16 |
|
11.5 |
Enforcement |
16 |
|
11.6 |
Non-Exclusivity of Rights |
17 |
|
11.7 |
Survival of Rights |
17 |
|
11.8 |
Insurance |
17 |
|
11.9 |
Amendments |
17 |
|
11.10 |
Saving Clause |
17 |
|
11.11 |
Certain Definitions |
18 |
ARTICLE 12 |
NOTICES |
18 |
|
|
12.1 |
Notice to Stockholders |
18 |
|
12.2 |
Notice to Directors |
19 |
|
12.3 |
Affidavit of Mailing |
19 |
|
12.4 |
Methods of Notice |
19 |
|
12.5 |
Notice to Person with Whom Communication Is Unlawful |
19 |
ARTICLE 13 |
AMENDMENTS |
19 |
|
|
|
|
|
-ii-
BYLAWS
OF
COYA THERAPEUTICS, INC.
(A Delaware Corporation)
Adopted November 23, 2020
1.1Registered Office. The registered office of Coya Therapeutics, Inc. (the “Company”) in the State of Delaware shall be in the City of Wilmington, County of New Castle, State of Delaware.
1.2Other Offices. The Company shall also have and maintain an office or principal place of business at such place as may be fixed by its Board of Directors of the Company (the “Board”) and may also have offices at such other places, both within and without the State of Delaware, as the Board may from time to time determine or the business of the Company may require.
The Board may adopt a corporate seal. The corporate seal shall consist of a die bearing the name of the Company and the inscription, “Corporate Seal-Delaware.” Said seal may be used by causing it or a facsimile thereof to be impressed or affixed or reproduced or otherwise.
ARTICLE 3
STOCKHOLDERS’ MEETINGS
3.1Place of Meetings. Meetings of the stockholders of the Company may be held at such place, either within or without the State of Delaware, as may be determined from time to time by the Board. The Board may, in its sole discretion, determine that the meeting shall not be held at any place, but may instead be held solely by means of remote communication as provided under the General Corporation Law of the State of Delaware (the “DGCL”).
3.2Annual Meeting. An annual meeting of the stockholders of the Company, for the purpose of election of directors and for such other business as may lawfully come before it, may be held at such place, on such date and such time, as the Board shall fix. Nominations of persons for election to the Board and proposal of business to be considered by the stockholders may be made at an annual meeting of stockholders (i) pursuant to the Company’s notice of meeting of stockholders, or (ii) by or at the direction of the Board.
3.3Special Meetings. Special meetings of the stockholders of the Company may be called, for any purpose or purposes, by (i) the Chairman of the Board, if any, (ii) the President, the Chief Executive Officer or the Chief Operating Officer, (iii) the Board pursuant to a resolution adopted by a majority of the total number of directors then in office, and shall be held at such place, on such date, and at such time as the Board shall fix; or (iv) by the President, the Chief Executive Officer or the Chief Operating Officer at the request in writing of stockholders owning not less than fifty percent (50%) of the capital stock of the Company issued and outstanding and entitled to vote, provided, however, that no such meeting may be called to consider any matter which is substantially the same as a matter voted on in the prior twelve (12) month period.
3.4Notice of Meetings. Except as otherwise provided by the DGCL, notice, given in writing or by electronic transmission, of each meeting of stockholders shall be given not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at such meeting, such notice to specify the place, if any, date and hour of the 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 any such meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called. If mailed, notice is given when deposited in the United States mail, postage prepaid, directed to the stockholder at such stockholder’s address as it appears on the records of the Company. Notice of the time, place, if any, and purpose of any meeting of stockholders may be waived in writing, signed by the person entitled to notice thereof, or waived by electronic transmission by such person, either before or after such meeting, and will be waived by any such person by his or her attendance thereat in person, by remote communication, if applicable, or by proxy, except when such 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. Any such person so waiving notice of such meeting shall be bound by the proceedings of any such meeting in all respects as if due notice thereof had been given. Neither the business to be transacted at, nor the purpose of, any annual or special meeting of the stockholders, directors or members of a committee of directors need be specified in any written waiver of notice or any waiver by electronic transmission. Any notice by electronic transmission shall be subject to Section 232 of the DGCL.
3.5Quorum. At all meetings of stockholders, except where otherwise provided by the DGCL, the Certificate of Incorporation of the Company, as amended and restated from time to time (the “Certificate of Incorporation”), or by these Bylaws, the presence, in person, by remote communication, if applicable, or by proxy duly authorized and executed, of the holders of a majority of the outstanding shares of stock entitled to vote shall constitute a quorum for the transaction of any business. In the absence of a quorum, any meeting of stockholders may be adjourned, from time to time, either by the person who is the chair of the meeting or by the vote of the holders of a majority of the shares present or represented thereat, but no other business shall be transacted at such meeting until a quorum shall be present. The stockholders present at a duly called or convened meeting, at which a quorum is present, may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a quorum. Except as otherwise provided by the DGCL, the Certificate of Incorporation or these Bylaws, in all matters other than the election of directors, the affirmative vote of a majority of shares present in person, by remote communication, if applicable, or represented by duly authorized and executed proxy at the meeting and entitled to vote on the subject matter shall be the act of the stockholders. Except as otherwise provided by the DGCL, the Certificate of Incorporation or these Bylaws,
-2-
directors shall be elected by a plurality of the votes of the shares present in person, by remote communication, if applicable, or represented by duly authorized and executed proxy at the meeting and entitled to vote on the election of directors. Where a separate vote by a class or classes or series is required, except where otherwise provided by the DGCL, the Certificate of Incorporation or these Bylaws, a majority of the outstanding shares of such class or classes or series, present in person, by remote communication, if applicable, or represented by duly authorized and executed proxy, shall constitute a quorum entitled to take action with respect to that vote on the matter, and the affirmative vote of the majority (plurality, in the case of the election of directors) of shares of such class or classes or series present in person, by remote communication, if applicable, or represented by duly authorized and executed proxy at the meeting shall be the act of such class or classes or series.
3.6Adjournment and Notice of Adjourned Meetings. Any meeting of stockholders, whether annual or special, may be adjourned from time to time either by the person who is the chair of the meeting or by the vote of a majority of the shares present in person, by remote communication, if applicable, or represented by duly authorized and executed proxy. When a meeting is adjourned to another time or place, if any, notice need not be given of the adjourned meeting if the time and place, if any, thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the Company may transact any business which might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.
3.7Voting Rights. For the purpose of determining those stockholders entitled to vote at any meeting of the stockholders, except as otherwise provided by law, only persons in whose names shares stand on the stock ledger of the Company on the record date, as determined by the process described in Section 7.4 of these Bylaws, shall be entitled to vote at any meeting of stockholders. Each stockholder entitled to vote at a meeting of stockholders or to express consent or dissent to corporate action in writing without a meeting shall have the right to do so either in person, by remote communication, if applicable, or may authorize an agent or agents to act for such stockholder by proxy granted in accordance with the DGCL. An agent so appointed need not be a stockholder. No proxy shall be voted or acted upon after three (3) years from its date, unless the proxy provides for a longer period.
3.8List of Stockholders. The Secretary of the Company shall prepare and make, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at said meeting, arranged in alphabetical order, showing the address of each stockholder and the number of shares registered in the name of each stockholder. Nothing contained in these Bylaws shall require the Company to include electronic mail addresses or other electronic contact information on such list. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, for a period of at least ten (10) days prior to the meeting: (i) on a reasonably accessible electronic network, provided that, the information required to gain access to such list is provided in the notice of the meeting, or (ii) during ordinary business hours, at the principal place of business of the Company. In the event that the Company determines to make the list available on an electronic network, the Company may take reasonable steps to ensure that such information is available only to stockholders of the Company. The list shall be open to examination of any stockholder during the time of the meeting as provided by the DGCL.
-3-
3.9Joint Owners of Stock. If shares or other securities having voting power stand of record in the names of two (2) or more persons, whether as fiduciaries, members of a partnership, joint tenants, tenants in common, tenants by the entirety or otherwise, or if two (2) or more persons have the same fiduciary relationship respecting the same shares, unless the Secretary of the Company is given written notice to the contrary and is furnished with a copy of the instrument or order appointing them or creating the relationship wherein it is so provided, their acts with respect to voting shall have the following effect: (a) if only one (1) votes, such person’s act binds all; (b) if more than one (1) vote, the act of the majority so voting binds all; (c) if more than one (1) vote, but the vote is evenly split on any particular matter, each faction may vote the securities in question proportionally, or any person voting the shares, or a beneficiary, if any, may apply to the Delaware Court of Chancery for relief as provided in Section 217(b) of the DGCL. If the instrument so filed with the Secretary shows that any such tenancy is held in unequal interests, a majority or even split for the purpose of this Bylaw shall be a majority or even split in interest.
3.10.1Unless otherwise provided in the Certificate of Incorporation, any action required by the DGCL to be taken at any annual or special meeting of the stockholders, or any action that may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing or by telegram, cablegram, email or other electronic transmission (hereinafter “electronic transmission”), setting forth the action so taken, shall be 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 and shall be delivered to the Company by delivery to its registered office in the State of Delaware, its principal place of business or an officer or agent of the Company having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Company’s registered office shall be by hand or by certified or registered mail, return receipt requested.
3.10.2Every written consent or electronic transmission under this Bylaw shall bear the date of signature of each stockholder who signs the consent, and no written consent or electronic transmission shall be effective to take the corporate action referred to therein unless, within sixty (60) days of the earliest dated consent delivered to the Company in the manner herein required, written consents or electronic transmissions signed by a sufficient number of stockholders to take action are delivered to the Company by delivery to its registered office in the State of Delaware, its principal place of business or an officer or agent of the Company having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Company’s registered office shall be by hand or by certified or registered mail, return receipt requested.
3.10.3Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing or by electronic transmission and who, if the action had been taken at a meeting, would have been entitled to notice of the meeting if the record date for such meeting had been the date that written consents or electronic transmissions signed by a sufficient number of stockholders to take action were delivered to the Company as provided in Section 228(c) of the DGCL.
-4-
3.10.4An electronic transmission consenting to an action to be taken and transmitted by a stockholder or proxyholder, or by a person or persons authorized to act for a stockholder or proxyholder, shall be deemed to be written, signed and dated for the purposes of this Bylaw, provided that any such electronic transmission sets forth or is delivered with information from which the Company can determine (i) that the electronic transmission was transmitted by the stockholder or proxyholder or by a person or persons authorized to act for the stockholder or proxyholder and (ii) the date on which such stockholder, proxyholder or authorized person or persons transmitted such electronic transmission. The date on which such electronic transmission is transmitted shall be deemed to be the date on which such consent was signed. No consent given by electronic transmission shall be deemed to have been delivered until such consent is reproduced in paper form and until such paper form shall be delivered to the Company by delivery to its registered office in the State of Delaware, its principal place of business or an officer or agent of the Company having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Company’s registered office shall be made by hand or by certified or registered mail, return receipt requested. Notwithstanding the foregoing limitations on delivery, consents given by electronic transmission may be otherwise delivered to the principal place of business of the Company or to an officer or agent of the Company having custody of the book in which proceedings of meetings of stockholders are recorded if, to the extent and in the manner provided by resolution of the Board.
3.10.5Any copy, facsimile or other reliable reproduction of a consent in writing may be substituted or used in lieu of the original writing for any and all purposes for which the original writing could be used, provided that such copy, facsimile or other reproduction shall be a complete reproduction of the entire original writing.
3.11Organization. At every meeting of stockholders, the Chairman of the Board, or if the Chairman of the Board is not appointed by the Board or is absent, the President, the Chief Executive Officer or the Chief Operating Officer or if the President, the Chief Executive Officer or the Chief Operating Officer is absent, a chairman of the meeting chosen by a majority of the stockholders entitled to vote, present in person, by remote communication, if applicable or represented by duly authorized and executed proxy, shall preside over the meeting and act as chairman. The Secretary, or, in his or her absence, any designee of the Secretary, shall act as secretary of the meeting.
4.1Number and Term of Office. The authorized number of directors of the Company shall be fixed from time to time by resolution of the Board. Directors need not be stockholders unless so required by the Certificate of Incorporation. If for any cause, the directors shall not have been elected at an annual meeting or by written consent as provided in the DGCL, they may be elected as soon thereafter as convenient.
4.2Powers. The powers of the Company shall be exercised, its business conducted and its property controlled by the Board, except as may be otherwise provided by the DGCL or by the Certificate of Incorporation.
-5-
4.3Term of Directors. Directors shall be elected at each annual meeting of stockholders or by written consent as provided in the DGCL for a term ending on the next annual meeting of stockholders or until such director’s successor is elected and qualified or until such director’s earlier death, resignation, disqualification, removal or other causes resulting in a vacancy or vacancies on the Board. Each director shall serve until such director’s successor is duly elected and qualified or until such director’s death, resignation or removal. No decrease in the number of directors constituting the Board shall shorten the term of any incumbent director.
4.4Vacancies. Unless otherwise provided in the Certificate of Incorporation, any vacancies on the directors resulting from death, resignation, disqualification, removal or other causes and any newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a single class shall, unless the Board determines by resolution that any such vacancies or newly created directorships shall be filled by the stockholders, be filled only by the affirmative vote of a majority of the directors then in office, although less than a quorum of the directors, or by a sole remaining director. Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall have been elected and qualified. A vacancy in the directors shall be deemed to exist under this Bylaw in the case of the death, resignation, disqualification, removal or other causes resulting in such vacancy.
4.5Resignation. Any director may resign at any time upon notice given in writing or by electronic transmission to the Secretary of the Company, such resignation to specify whether it will be effective at a particular time, upon receipt by the Secretary or at the pleasure of the Board. If no such specification is made, it shall be deemed effective at the pleasure of the Board. Unless otherwise provided in the Certificate of Incorporation, when one (1) or more directors shall resign from the Board, effective at a future date, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each director so chosen shall hold office for the unexpired portion of the term of the director whose place shall be vacated and until such successor shall have been duly elected and qualified.
4.6Removal. Subject to any limitations imposed by applicable law, the entire Board or any director may be removed at any time with or without cause by the affirmative vote of the holders of a majority of the voting power of all then-outstanding shares of capital stock of the Company entitled to vote generally at an election of directors.
4.7.1Regular Meetings. Unless otherwise restricted by the Certificate of Incorporation, regular meetings of the Board may be held at any time or date and at any place within or without the State of Delaware designated by the Board and publicized among all directors, either orally or in writing, by telephone, including a voice-messaging system or other system or technology designed to record and communicate messages, facsimile, telegraph or telex, or by electronic mail or other electronic means. No further notice shall be required for a regular meeting of the Board.
-6-
4.7.2Special Meetings. Unless otherwise restricted by the Certificate of Incorporation, special meetings of the Board may be held at any time and place within or without the State of Delaware whenever called by the Chairman of the Board, if any, the President, the Chief Executive Officer, the Chief Operating Officer or the Secretary.
4.7.3Meetings by Electronic Communications Equipment. Any member of the Board, or of any committee designated by the Board in accordance with Section 4.11 of these Bylaws, may participate in a meeting of such Board or committee by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting by such means shall constitute presence in person at such meeting.
4.7.4Notice of Special Meetings. Notice of the time and place of all special meetings of the Board shall be made either orally or in writing, by telephone, including a voice- messaging system or other system or technology designed to record and communicate messages, facsimile, telegraph or telex, or by electronic mail or other electronic means at least twelve (12) hours before the date and time of the special meeting. If such notice is sent by United States mail, it shall be sent by first class mail, postage prepaid at least two (2) days before the date of the special meeting. Notice of any meeting may be waived in writing or by electronic transmission at any time before or after the special meeting and will be waived by any director by attendance thereat in person, by conference telephone or other remote communication, if applicable, except when the director attends such special 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.
4.7.5Waiver of Notice. The transaction of any business at any meeting of the Board, or any committee designated by the Board in accordance with Section 4.11 of these Bylaws, however called or noticed, or wherever held, shall be as valid as though the meeting was duly held after proper call and notice, if a quorum be present, and if, either before or after the meeting, each of the directors not present who did not receive any call or notice shall sign a written waiver of notice or shall waive notice by electronic transmission. All such waivers shall be filed with the corporate records or made a part of the minutes of the meeting of the Board.
4.8.1Unless the Certificate of Incorporation requires a greater number, a quorum of the Board shall consist of a majority of the directors then in office; provided, however, at any meeting, whether a quorum be present or otherwise, a majority of the directors present may adjourn from time to time until the date and time fixed for the next regular meeting of the Board without any notice other than by announcement at the meeting.
4.8.2At each meeting of the Board at which a quorum is present, all questions and business shall be determined by the affirmative vote of a majority of the directors present, unless a different vote be required by the DGCL or the Certificate of Incorporation.
4.9Action Without Meeting. Unless otherwise restricted by the Certificate of Incorporation, any action required or permitted to be taken at any meeting of the Board or of any committee thereof may be taken without a meeting, if all members of the Board or committee, as
-7-
the case may be, consent thereto in writing, or by electronic transmission (including email) and such writing or writings or electronic transmission or transmissions are filed with the minutes of proceedings of the Board or committee. 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.
4.10Fees and Compensation. Directors shall be entitled to compensation for their services as may be approved by the Board by resolution of the Board, including, if so approved, a fixed sum and expenses of attendance, if any, at each regular or special meeting of the Board and at any meeting of a committee of the Board. Nothing herein contained shall be construed to preclude any director from serving the Company in any other capacity as an officer, agent, employee, or otherwise and receiving compensation therefor.
4.11.1Appointment. The Board may, from time to time, appoint such committees as may be permitted by the DGCL. Such committees appointed by the Board shall consist of one (1) or more members of the Board and shall have such powers and perform such duties as may be permitted by the DGCL or prescribed by the resolution or resolutions of the Board creating such committees, but in no event shall any such committee have the powers or authority in reference to (i) approving or adopting, or recommending to the stockholders, any action or matter expressly required by the DGCL to be submitted to stockholders for approval or (ii) adopting, amending or repealing any Bylaw of the Company.
4.11.2Term. The Board, subject to the foregoing provisions of this Bylaw, may at any time increase or decrease the number of members of a committee or terminate the existence of a committee. The membership of a committee member shall terminate on the date of such committee member’s death, voluntary resignation or removal from the committee or from the Board. The Board may at any time for any reason remove any individual committee member, and the Board may fill any committee vacancy created by death, resignation, removal or increase in the number of members of the committee. The Board may designate one (1) or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee, and, in addition, in the absence or disqualification of any member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of any such absent or disqualified member.
4.11.3Meetings. Unless the Board shall otherwise provide, regular meetings of any committee appointed pursuant to this Bylaw may be held at any time and place within or without the State of Delaware as determined by the Board, or by any such committee, and when notice thereof has been given to each member of such committee in the manner provided in these Bylaws for the giving of notice to the members of the Board, no further notice of such regular meetings need be given thereafter. Special meetings of any such committee may be held at any place which has been determined from time to time by such committee, and may be called by any director who is a member of such committee, upon notice to the members of such committee of the time and place of such special meeting given in the manner provided in these Bylaws for the
-8-
giving of notice to members of the Board of the time and place of special meetings of the Board. Notice of any special meeting of any committee may be waived in writing or by electronic transmission at any time before or after the special meeting and will be waived by any director by attendance thereat in person, by conference telephone or other remote communication, if applicable, except when the director attends such special 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. Unless otherwise provided by the Board in the resolution or resolutions authorizing the creation of the committee, a majority of the number of members of any such committee then serving, shall constitute a quorum for the transaction of business of the committee, and the act of a majority of those present at any committee meeting at which a quorum is present shall be the act of such committee.
4.12Organization. At every meeting of the directors, the President, the Chief Executive Officer or the Chief Operating Officer or if the President, the Chief Executive Officer or the Chief Operating Officer is absent, a chairman of the meeting chosen by a majority of the directors present, shall preside over the meeting and act as the chairman. The Secretary, or in his or her absence, any designee of the Secretary, shall act as secretary of the meeting.
5.1.1General. The officers of the Company shall include, if and when designated by the Board, the President or the Chief Executive Officer, the Treasurer, the Secretary and any other officer duly appointed by the Board, all of whom shall be elected at the annual organizational meeting of the Board. The Board may also appoint a President or the Chief Executive Officer, one (1) or more Vice Presidents, a Chief Operating Officer, an Assistant Secretary, a Controller, and such other officers and agents with such powers and duties as it shall deem necessary or appropriate. The Board may assign such additional titles to one or more of the officers as it shall deem appropriate. Any one person may hold any number of offices of the Company at any one time unless specifically prohibited therefrom by the Certificate of Incorporation or the DGCL. The salaries and other compensation of the officers of the Company shall be fixed by or in the manner designated by the Board. Any officers serving may appoint such subordinate officers as they deem necessary or desirable.
5.2Tenure and Duties of Officers. All officers of the Company shall hold office at the pleasure of the Board until their successors shall have been duly elected and qualified or until such officers’ earlier death, resignation or removal. Any officer elected or appointed by the Board may be removed at any time by the Board. If the office of any officer becomes vacant for any reason, the vacancy may be filled by the Board. The officers of the Company shall have such powers and duties as may be prescribed by the Board.
5.2.1Chairman of the Board. The Chairman of the Board, if chosen by the Board in accordance with these Bylaws and when present, shall preside at all meetings of the stockholders and the Board. The Chairman of the Board shall perform other duties commonly
-9-
incident to the office and shall also perform such other duties and have such other powers as the Board shall designate from time to time.
5.2.2President, the Chief Executive Officer or the Chief Operating Officer. The President, the Chief Executive Officer or the Chief Operating Officer shall preside at all meetings of the stockholders and at all meetings of the Board, unless the Chairman of the Board has been appointed and is present. The President, the Chief Executive Officer or the Chief Operating Officer shall perform other duties commonly incident to those offices and shall also perform such other duties and have such other powers as the Board shall designate from time to time.
5.2.3Vice President. The Vice President, if there be such an officer, shall, subject to the direction of the President or the Chief Executive Officer, if one is appointed, and the control of the Board, have general supervision, direction, and control of the operations of the Company. In the absence of the President or the Chief Executive Officer, the Vice President, if any, designated by the Board, shall perform all the duties of the President or the Chief Executive Officer, as applicable, and when so acting shall have all the powers of, and be subject to all the restrictions upon, the President or the Chief Executive Officer. The Vice President shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board shall designate from time to time.
5.2.4Secretary. The Secretary shall attend all meetings of the stockholders and of the Board and shall record all acts and proceedings thereof in the minute book of the Company. The Secretary shall give notice in conformity with these Bylaws of all meetings of the stockholders and of all meetings of the Board and any committee thereof requiring notice. The Secretary shall perform all other duties provided for in these Bylaws and other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board shall designate from time to time. The President, the Chief Executive Officer or the Chief Operating Officer may direct any officer to assume and perform the duties of the Secretary in the absence or disability of the Secretary, and each such officer shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board, the President, the Chief Executive Officer or the Chief Operating Officer shall designate from time to time.
5.2.5Treasurer. The Treasurer shall keep or cause to be kept the books of account of the Company in a thorough and proper manner and shall render statements of the financial affairs of the Company in such form and as often as required by the Board, the President, the Chief Executive Officer or the Chief Operating Officer. The Treasurer, subject to the order of the Board, shall have the custody of all funds and securities of the Company. The Treasurer shall perform other duties commonly incident to his or her office and shall also perform such other duties and have such other powers as the Board, the President, the Chief Executive Officer or the Chief Operating Officer shall designate from time to time. The President, the Chief Executive Officer or the Chief Operating Officer may direct any officer to assume and perform the duties of the Treasurer in the absence of the Treasurer, and each such officer shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board, the President, the Chief Executive Officer or the Chief Operating Officer shall designate from time to time.
-10-
5.3Delegation of Authority. The Board may from time to time delegate the powers or duties of any officer to any other officer or agent, notwithstanding any provision hereof.
5.4Resignations. Any officer may resign at any time by giving notice in writing or by electronic transmission notice to the Board, the President, the Chief Executive Officer, the Chief Operating Officer or to the Secretary. Any such resignation shall be effective when received by the person or persons to whom such notice is given, unless a later time is specified therein, in which event the resignation shall become effective at such later time. Unless otherwise specified in such notice, the acceptance of any such resignation shall not be necessary to make it effective. Any resignation shall be without prejudice to the rights, if any, of the Company under any contract with the resigning officer.
5.5Removal. Any officer may be removed from office at any time, either with or without cause, by the affirmative vote of a majority of the Board in office at the time, or by the unanimous written consent of the Board in office at the time, or by any committee or superior officer upon whom such power of removal may have been conferred by the Board.
ARTICLE 6
EXECUTION OF CORPORATE INSTRUMENTS AND VOTING OF SECURITIES OWNED BY THE COMPANY
6.1Execution of Corporate Instruments. The Board may, in its discretion, determine the method and designate the signatory officer or officers, or other person or persons, to execute on behalf of the Company any corporate instrument, certificate or document, or to sign on behalf of the Company the corporate name without limitation, or to enter into contracts and agreements on behalf of the Company, except where otherwise provided by law or these Bylaws, and such execution or signature shall be binding upon the Company. All checks and drafts drawn on banks or other depositaries on funds to the credit of the Company or in special accounts of the Company shall be signed by such person or persons as the Board shall authorize so to do. Unless expressly authorized or ratified by the Board in a resolution of the Board or within the agency power of an officer or director authorized or ratified by the Board, no officer, director, agent, employee or any other person shall have any power or authority to bind the Company by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.
6.2Voting of Securities Owned by the Company. All stock and other securities of other corporations owned or held by the Company for itself, or for other persons in any capacity, shall be voted, and all proxies with respect thereto shall be executed, by the person authorized so to do by resolution of the Board, or, in the absence of such authorization, by the President, the Chief Executive Officer or the Chief Operating Officer.
7.1Form and Execution of Stock Certificates. The shares of the Company shall be represented by certificates, provided that the Board may provide by resolution or resolutions that
-11-
some or all of any or all classes or series of its stock shall be uncertificated shares. Any resolution of the Board providing for uncertificated shares shall not apply to shares represented by a certificate until such certificate is surrendered to the Company. Certificates for the shares of stock of the Company shall be in such form as is consistent with the Certificate of Incorporation and the DGCL. Every holder of stock represented by certificates shall be entitled to have a stock certificate signed by, or in the name of the Company by the Chairman of the Board of Directors, the President, the Chief Executive Officer or the Chief Operating Officer and the Secretary, representing the number of shares registered in certificate form. Any or all of the signatures on the certificate may be facsimiles. In case any officer, transfer agent, or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may be issued by the Company with the same effect as if such person were such officer, transfer agent, or registrar at the date of issue. Each certificate shall state upon the face or back thereof, in full or in summary, all of the powers, designations, preferences, and rights, and the limitations or restrictions of the shares authorized to be issued or shall, except as otherwise required by law, set forth on the face or back a statement that the Company will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative, participating, optional, or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights. Within a reasonable time after the issuance or transfer of uncertificated stock, the Company shall send to the registered owner thereof a written notice containing the information required to be set forth or stated on certificates pursuant to Sections 151, 156, 202(a) or 218(a) of the DGCL or a statement that the Company will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
7.2Lost, Stolen or Destroyed Certificates. A new certificate or certificates of the Company’s stock may be issued in place of any certificate or certificates theretofore issued by the Company alleged to have been lost, stolen, or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate or certificates of stock to be lost, stolen, or destroyed. The Company may require, as a condition precedent to the issuance of a new certificate or certificates, the owner of such lost, stolen, or destroyed certificate or certificates, or the owner’s legal representative, to agree to indemnify the Company in such manner as it shall require or to give the Company a bond in such form and amount as it may direct as indemnity against any claim that may be made against the Company on account of the certificate or certificates alleged to have been lost, stolen, or destroyed or the issuance of new certificate or certificates.
7.3Transfers. Upon compliance with provisions restricting the transfer or registration of transfer of shares of stock, if any, transfers or registration of transfer of shares of stock of the Company shall be made only on the stock ledger of the Company by the registered holder thereof, or by such person’s attorney thereunto authorized by power of attorney duly executed and filed with the Secretary of the Company or with a transfer agent or a registrar, if any, and the payment of all taxes due thereon. Upon receipt of proper transfer instructions from the registered owner of uncertificated shares, (i) such uncertificated shares shall be canceled, (ii) issuance of new equivalent uncertificated shares shall be made to the person entitled thereto, and (iii) the transaction shall be recorded upon the books of the Company. The Company shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes
-12-
of stock of the Company to restrict the transfer of shares of stock of the Company of any one or more classes owned by such stockholders in any manner not prohibited by the DGCL.
7.4.1In order that the Company may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, the Board may fix, in advance, a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board, and which record date shall, subject to the DGCL, not be more than sixty (60) nor less than ten (10) days before the date of such meeting. If no record date is fixed by the Board, 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. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board may fix a new record date for the adjourned meeting.
7.4.2In order that the Company may determine the stockholders entitled to consent to corporate action in writing without a meeting, the Board 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, and which date shall not be more than ten (10) days after the date upon which the resolution fixing the record date is adopted by the Board. Any stockholder of record seeking to have the stockholders authorize or take corporate action by written consent shall, by written notice to the Secretary of the Company, request the Board to fix a record date. The Board shall promptly, but in any event within ten (10) days after the date on which such a request is received, adopt a resolution fixing the record date. If no record date has been fixed by the Board within ten (10) days of the date on which such a request is received, the record date for determining stockholders entitled to consent to corporate action in writing without a meeting, when no prior action by the Board is required by the DGCL, shall be the first date on which a signed written consent setting forth the action taken or proposed to be taken is delivered to the Company by delivery to its registered office in the State of Delaware, its principal place of business or an officer or agent of the Company having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Company’s registered office in Delaware shall be by hand or by certified or registered mail, return receipt requested. If no record date has been fixed by the Board and prior action by the Board is required by the DGCL, the record date for determining stockholders entitled to consent to corporate action in writing without a meeting shall be at the close of business on the day on which the Board adopts the resolution taking such prior action.
7.4.3In order that the Company may determine the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights or the stockholders 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 may fix, in advance, a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted, and which record date shall be not more than sixty (60) days prior to such action. If no record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto.
-13-
7.5Registered Stockholders. The Company shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares of the Company’s stock entitled to receive dividends, and to vote as such owner, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person whether or not it shall have express or other notice thereof, except as otherwise provided by the DGCL.
ARTICLE 8
OTHER SECURITIES OF THE COMPANY
All bonds, debentures, notes and other corporate securities of the Company, other than stock certificates (covered in Article 7), may be signed by the President, the Chief Executive Officer or the Chief Operating Officer, or such other person as may be authorized by the Board, and the corporate seal impressed thereon or a facsimile of such seal imprinted thereon and attested by the signature of the Secretary or the Treasurer; provided, however, that where any such bond, debenture, note or other corporate security shall be authenticated by the manual signature, or where permissible, facsimile signature, of a trustee under an indenture pursuant to which such bond, debenture, note or other corporate security shall be issued, the signatures of the persons signing and attesting the corporate seal on such bond, debenture, note or other corporate security may be the imprinted facsimile of the signatures of such persons. Interest coupons appertaining to any such bond, debenture, note or other corporate security, authenticated by a trustee as aforesaid, shall be signed by the Secretary or the Treasurer or such other person as may be authorized by the Board, or bear imprinted thereon the facsimile signature of such person. In case any officer who shall have signed or attested any bond, debenture, note or other corporate security, or whose facsimile signature shall appear thereon or on any such interest coupon, shall have ceased to be such officer before the bond, debenture, note or other corporate security so signed or attested shall have been delivered, such bond, debenture, note or other corporate security nevertheless may be adopted by the Company and issued and delivered as though the person who signed the same or whose facsimile signature shall have been used thereon had not ceased to be such officer of the Company.
9.1Declaration of Dividends. Dividends upon the capital stock of the Company, subject to the restrictions contained in the Certificate of Incorporation and the DGCL, if any, may be declared by the Board pursuant to law at any regular or special meeting. Dividends may be paid in cash, in property, or in shares of the capital stock, subject to the provisions of the Certificate of Incorporation and applicable law.
9.2Dividend Reserve. Before payment of any dividend, there may be set apart out of any funds of the Company available for dividends such sum or sums as the Board from time to time, in their absolute discretion, think proper as a reserve or reserves to meet contingencies, or for equalizing dividends, or for repairing or maintaining any property of the Company, or for such other purpose as the Board shall think conducive to the interests of the Company, and the Board may modify or abolish any such reserve.
-14-
The fiscal year of the Company shall be fixed by resolution of the Board.
11.1Directors and Officers. The Company shall indemnify any director or officer of the Company, and may indemnify any other person, who was or is a party or is threatened to be made a party to any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Company) by reason of the fact that he or she is or was a director, officer, employee, or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee, or agent of another Company, partnership, joint venture, trust, or other enterprise, against expenses (including attorneys’ fees), judgments, fines, and amounts paid in settlement actually and reasonably incurred by him or her in connection with such action, suit, or proceeding if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any action, suit, or proceeding by judgment, order, settlement, or conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.
The Company shall indemnify any director or officer, and may indemnify any other person, who was or is a party or is threatened to be made a party to any threatened, pending, or completed action or suit by or in the right of the Company to procure a judgment in its favor by reason of the fact that he or she is or was a director, officer, employee, or agent of the Company, or is or was serving at the request of the Company as a director, officer, employee, or agent of another Company, partnership, joint venture, trust, or other enterprise against expenses (including attorneys’ fees) actually and reasonably incurred by him or her in connection with the defense or settlement of such action or suit if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Company and except that no indemnification shall be made in respect of any claim, issue, or matter as to which such person shall have been adjudged to be liable to the Company unless and only to the extent that the Delaware Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses as the Delaware Court of Chancery or such other court shall deem proper.
11.2Officers, Employees and Other Agents. The Company shall have power to indemnify its officers, employees and other agents as set forth in the DGCL or any other applicable law. The Board of Directors shall have the power to delegate the determination of whether
-15-
indemnification shall be given to any such person or to such officers or other persons as the Board of Directors shall determine.
11.3Mandatory Indemnification. To the extent that a present or former director or officer of the Corporation has been successful on the merits or otherwise in defense of any action, suit or proceeding referred to in Section 11.1, or in defense of any claim, issue or matter therein, such person shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection therewith.
11.4Expenses. The Company shall advance to any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was a director or officer, of the Company, or is or was serving at the request of the Company as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, prior to the final disposition of the proceeding, promptly following request therefor, all expenses incurred by any director or officer in connection with such proceeding, provided, however, that, if the DGCL requires, an advancement of expenses incurred by a director or officer in his or her capacity as a director or officer (and not in any other capacity in which service was or is rendered by such indemnitee, including, without limitation, service to an employee benefit plan) shall be made only upon delivery to the Company of an undertaking, by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal that such indemnitee is not entitled to be indemnified for such expenses under this Article 11 or otherwise.
Notwithstanding the foregoing, unless otherwise determined pursuant to paragraph (e) of this Article 11, no advance shall be made by the Company to an officer of the Company (except by reason of the fact that such officer is or was a director of the Company, in which event this paragraph shall not apply) in any action, suit or proceeding, whether civil, criminal, administrative or investigative, if a determination is reasonably and promptly made (i) by a majority vote of a quorum consisting of directors who were not parties to the proceeding, even if not a quorum, or (ii) by a committee of such directors designated by a majority of such directors, even though less than a quorum, or (iii) if there are no such directors, or such directors so direct, by independent legal counsel in a written opinion, that the facts known to the decision-making party at the time such determination is made demonstrate clearly and convincingly that such person acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the Company.
11.5Enforcement. Without the necessity of entering into an express contract, all rights to indemnification and advances to directors and officers under this Article 11 shall be deemed to be contractual rights and be effective to the same extent and as if provided for in a contract between the Company and the director or officer. Any right to indemnification or advances granted by this Article 11 to a director or officer shall be enforceable by or on behalf of the person holding such right in any court of competent jurisdiction if (i) the claim for indemnification or advances is denied, in whole or in part, or (ii) no disposition of such claim is made within ninety (90) days of request therefor. The claimant in such enforcement action, if successful in whole or in part, shall be entitled to be paid also the expense of prosecuting the claim. In connection with any claim for indemnification, the Company shall be entitled to raise as a defense to any such action that the
-16-
claimant has not met the standards of conduct that make it permissible under the DGCL or any other applicable law for the Company to indemnify the claimant for the amount claimed. In connection with any claim by an officer of the Company (except in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that such officer is or was a director of the Company) for advances, the Company shall be entitled to raise a defense as to any such action clear and convincing evidence that such person acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the Company, or with respect to any criminal action or proceeding that such person acted without reasonable cause to believe that his conduct was lawful. Neither the failure of the Company (including its Board of Directors, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he has met the applicable standard of conduct set forth in the DGCL or any other applicable law, nor an actual determination by the Company (including its Board of Directors, independent legal counsel or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that claimant has not met the applicable standard of conduct.
11.6Non-Exclusivity of Rights. The rights conferred on any person by this Article 11 shall not be exclusive of any other right which such person may have or hereafter acquire under any applicable statute, provision of the Certificate of Incorporation, Bylaws, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in his official capacity and as to action in another capacity while holding office. The Company is specifically authorized to enter into individual contracts with any or all of its directors, officers, employees or agents respecting indemnification and advances, to the fullest extent not prohibited by the DGCL or any other applicable law.
11.7Survival of Rights. The rights conferred on any person by this Article 11 shall continue as to a person who has ceased to be a director, officer, employee or other agent and shall inure to the benefit of the heirs, executors and administrators of such a person.
11.8Insurance. To the fullest extent permitted by the DGCL, or any other applicable law, the Company, upon approval by the Board of Directors, may purchase insurance on behalf of any person required or permitted to be indemnified pursuant to this Article 11.
11.9Amendments. Any repeal or modification of this Article 11 shall only be prospective and shall not affect the rights under this Article 11 in effect at the time of the alleged occurrence of any action or omission to act that is the cause of any proceeding against any agent of the Company.
11.10Saving Clause. If this Article 11 or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Company shall nevertheless indemnify each director and officer to the full extent not prohibited by any applicable portion of this Article 11 that shall not have been invalidated, or by any other applicable law. If this Section 11.10 shall be invalid due to the application of the indemnification provisions of another jurisdiction, then the Company shall indemnify each director and officer to the full extent under applicable law.
-17-
11.11Certain Definitions. For the purposes of this Article 11, the following definitions shall apply:
11.11.1The term “proceeding” shall be broadly construed and shall include, without limitation, the investigation, preparation, prosecution, defense, settlement, arbitration and appeal of, and the giving of testimony in, any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative.
11.11.2The term “expenses” shall be broadly construed and shall include, without limitation, court costs, attorneys’ fees, witness fees, fines, amounts paid in settlement or judgment and any other costs and expenses of any nature or kind incurred in connection with any proceeding.
11.11.3The term the “Company” shall include, in addition to the Company, the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, and employees or agents, so that any person who is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this Article 11 with respect to the resulting or surviving corporation as he would have with respect to such constituent corporation if its separate existence had continued.
11.11.4References to a “director,” “officer,” “employee,” or “agent” of the Company shall include, without limitation, situations where such person is serving at the request of the Company as, respectively, a director, officer, employee, trustee or agent of another corporation, partnership, joint venture, trust or other enterprise.
11.11.5References to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request of the Company” shall include any service as a director, officer, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, employee, or agent with respect to an employee benefit plan, its participants, or beneficiaries; and a person who acted in good faith and in a manner he reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Company” as referred to in this Article 11.
12.1Notice to Stockholders. Written notice to stockholders of stockholder meetings shall be given as provided in Section 3.4 herein. Without limiting the manner by which notice may otherwise be given effectively to stockholders under any agreement or contract with such stockholder, and except as otherwise required by law, written notice to stockholders for purposes other than stockholder meetings may be sent by United States mail or nationally recognized
-18-
overnight courier, or by facsimile, telegraph or telex, or by electronic mail or other electronic means.
12.2Notice to Directors. Any notice required to be given to any director may be given by any method stated in Section 12.1, or, as applicable, as provided for in Section 4.7.4 of these Bylaws. If such notice is delivered pursuant to these Bylaws, it shall be sent to such address as such director shall have filed in writing with the Secretary, or, in the absence of such filing, to the last known post office address of such director.
12.3Affidavit of Mailing. An affidavit of mailing, executed by a duly authorized and competent employee of the Company or its transfer agent appointed with respect to the class of stock affected or other agent, specifying the name and address or the names and addresses of the stockholder or stockholders, or director or directors, to whom any such notice or notices was or were given, and the time and method of giving the same, shall in the absence of fraud, be prima facie evidence of the facts therein contained.
12.4Methods of Notice. It shall not be necessary that the same method of giving notice be employed in respect of all recipients of notice, but one permissible method may be employed in respect of any one or more, and any other permissible method or methods may be employed in respect of any other or others.
12.5Notice to Person with Whom Communication Is Unlawful. Whenever notice is required to be given, under any provision of the DGCL, the Certificate of Incorporation or the Bylaws of the Company, to any person with whom communication is unlawful, the giving of such notice to such person shall not be required and there shall be no duty to apply to any governmental authority or agency for a license or permit to give such notice to such person. Any action or meeting that shall be taken or held without notice to any such person with whom communication is unlawful shall have the same force and effect as if such notice had been duly given. In the event that the action taken by the Company is such as to require the filing of a certificate under any provision of the DGCL, the certificate shall state, if such is the fact and if notice is required, that notice was given to all persons entitled to receive notice except such persons with whom communication is unlawful.
The Board is expressly empowered to adopt, amend or repeal any Bylaw of the Company. The stockholders shall also have power to adopt, amend or repeal any Bylaw of the Company; provided, however, that, in addition to any vote of the holders of any class or series of stock of the Company required by the DGCL or by the Certificate of Incorporation, the affirmative vote of the holders of at least a majority of the voting power of all of the then- outstanding shares of the capital stock of the Company entitled to vote generally in the election of directors, voting together as a single class or series, shall be required to adopt, amend or repeal any provision of the Bylaws of the Company.
-19-
Exhibit 3.4
AMENDED AND RESTATED BYLAWS
OF
Coya Therapeutics, Inc.
1.1Place of Meetings. All meetings of stockholders shall be held at such place, if any, as may be designated from time to time by the Board of Directors (the “Board”) of Coya Therapeutics, Inc. (the “Corporation”), the Chairman of the Board or the Chief Executive Officer or, if not so designated, at the principal office of the Corporation. The Board may, in its sole discretion, determine that a meeting shall not be held at any place, but may instead be held solely by means of remote communication in accordance with Section 211(a)(2) of the General Corporation Law of the State of Delaware (the “DGCL”).
1.2Annual Meeting. The annual meeting of stockholders for the election of directors to succeed those whose terms expire and for the transaction of such other business as may properly be brought before the meeting shall be held on a date and at a time designated by the Board, the Chairman of the Board or the Chief Executive Officer. The Company may postpone, recess, reschedule or cancel any previously scheduled annual meeting of stockholders.
1.3Special Meetings. Special meetings of stockholders for any purpose or purposes may be called solely in the manner set forth in the Certificate of Incorporation. The Company may postpone, recess, reschedule or cancel any previously scheduled special meeting of stockholders. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.
1.4Notice of Meetings. Except as otherwise provided by law, notice of each meeting of stockholders, whether annual or special, shall be given not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at such meeting as of the record date for determining the stockholders entitled to notice of the meeting. The notices of all meetings shall state the place, if any, date and time of the meeting, the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, and the record date for determining the stockholders entitled to vote at the meeting (if such date is different from the record date for stockholders entitled to notice of the meeting). The notice of a special meeting shall state, in addition, the purpose or purposes for which the meeting is called.
1.5Voting List. The Corporation shall prepare, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting (provided, however, if the record date for determining the stockholders entitled to vote is less than ten (10) days before the date of the meeting, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date), 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 any purpose germane to the meeting, for a period of at least ten (10) days prior to the meeting: (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (b) during ordinary business hours, at the principal place of business of the Corporation. Except as otherwise provided by law, the stock ledger shall presumptively determine the identity of the stockholders entitled to vote at the meeting and the number of shares held by each of them.
1.6Quorum. Except as otherwise provided by law, the Certificate of Incorporation or these Bylaws, the holders of one-third of the voting power of the shares of the capital stock of the Corporation issued and outstanding and entitled to vote at the meeting, present in person, present by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy, shall constitute a quorum for the transaction of business; provided, however, that where a separate vote by a class or classes or series of capital stock is required by law or the Certificate of Incorporation, the holders of a majority in voting power of the shares of such class or classes or series of the capital stock of the Corporation issued and outstanding and entitled to vote on such matter, present in person, present by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy, shall constitute a quorum entitled to take action with respect to the vote on such matter. A quorum, once established at a meeting, shall not be broken by the withdrawal of enough votes to leave less than a quorum.
1.7Adjournments. Any meeting of stockholders, annual or special, may be adjourned from time to time to any other time and to any other place at which a meeting of stockholders may be held under these Bylaws by the Board, the chairman of the meeting or, if directed to be voted on by the chairman of the meeting, by the stockholders present or represented at the meeting and entitled to vote thereon, although less than a quorum. If the adjournment is for more than thirty (30) days, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. If after the adjournment a new record date for determination of stockholders entitled to vote is fixed for the adjourned meeting, the Board shall fix as the record date for determining stockholders entitled to notice of such adjourned meeting the same or an earlier date as that fixed for determination of stockholders entitled to vote at the adjourned meeting, and shall give notice of the adjourned meeting to each stockholder of record entitled to vote at the adjourned meeting as of the record date so fixed for notice of such adjourned meeting. At the adjourned meeting, the Corporation may transact any business which might have been transacted at the original meeting.
1.8Proxies. Each stockholder of record entitled to vote at a meeting of stockholders may vote in person (including by means of remote communications, if any, by which stockholders may be deemed to be present in person and vote at such meeting) or may authorize another person or persons to vote for such stockholder by a proxy executed or transmitted in a manner permitted by applicable law. No such proxy shall be voted upon after three years from its date, unless the proxy expressly provides for a longer period. A proxy shall be irrevocable 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 which is not irrevocable by attending the meeting and voting in person or by delivering to the Secretary of the Corporation a revocation of the proxy or a new proxy bearing a later date.
1.9Action at Meeting. When a quorum is present at any meeting, any matter other than the election of directors to be voted upon by the stockholders at such meeting shall be decided by the a majority of the votes cast affirmatively or negatively on such matter by the holders of all of the outstanding shares of capital stock present or represented at the meeting and entitled to vote thereon (or if any class or series of stock is entitled to vote as a separate class or series, then in the case of each such class or series, by a majority of the votes cast affirmatively or negatively on such matter by the holders of all of the outstanding shares of capital stock of
2
that class or series present or represented at the meeting and entitled to vote thereon), except when a different vote is required by express provision of applicable law, regulation applicable to the Corporation or its securities, the rules or regulations of any stock exchange applicable to the Corporation, the Certificate of Incorporation or these Bylaws, in which case such express provisions shall govern. Voting at meetings of stockholders need not be by written ballot. At all meetings of stockholders for the election of directors at which a quorum is present a plurality of the votes cast shall be sufficient to elect directors.
1.10Notice of Stockholder Business and Nominations.
(A)Annual Meetings of Stockholders. (1) Nominations of persons for election to the Board and the proposal of other business to be considered by the stockholders may be made at an annual meeting of stockholders only (a) solely with respect to the proposal of business (and not with respect to nominations of persons for election to the Board of Directors), pursuant to the Corporation's notice of meeting (or any supplement thereto), (b) by or at the direction of the Board or any committee thereof or (c) by any stockholder of the Corporation who was a stockholder of record of the Corporation at the time the notice provided for in this Section 1.10 is delivered to the Secretary of the Corporation, who is entitled to vote at the meeting upon such election of directors or upon such other business, as the case may be, and who complies with the notice procedures set forth in this Section 1.10.
(2)For any nominations or other business to be properly brought before an annual meeting by a stockholder pursuant to clause (c) of paragraph (A)(1) of this Section 1.10, the stockholder must have given timely notice thereof in writing to the Secretary of the Corporation (and must timely provide any updates or supplements to such notice at such times and in such forms provided by this Section 1.10) and any such proposed business (other than the nominations of persons for election to the Board) must constitute a proper matter for stockholder action. To be timely, a stockholder's notice shall be delivered to the Secretary at the principal executive offices of the Corporation not later than the ninetieth (90th) day, nor earlier than the close of business on the one hundred twentieth (120th) day, prior to the first anniversary of the preceding year's annual meeting (provided, however, that in the event that the date of the annual meeting is more than thirty (30) days before or more than seventy (70) days after such anniversary date, notice by the stockholder must be so delivered not earlier than the close of business on the one hundred twentieth (120th) day prior to such annual meeting and not later than the close of business on the later of the ninetieth (90th) day prior to such annual meeting or the tenth (10th) day following the day on which public announcement of the date of such meeting is first made by the Corporation). For purposes of the first annual meeting following the initial public offering of the Common Stock of the Corporation, the date of the first anniversary of the preceding year’s annual meeting shall be deemed to be June 15, 2022 for purposes of this Section 1.10. In no event shall the public announcement of an adjournment, postponement or recess of an annual meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice as described above. The number of nominees a stockholder may nominate for election at the annual meeting (or in the case of one or more stockholders giving the notice on behalf of a beneficial owner, the number of nominees such stockholders may collectively nominate for election at the annual meeting on behalf of such beneficial owner) shall not exceed the number of directors to be elected at such annual meeting. To be in proper form for purposes of this Section 1.10, such stockholder's notice shall set forth: (a) as to each person
3
whom the stockholder proposes to nominate for election as a director (i) the name, age, business and residence address, and principal occupation or employment of the nominee, (ii) all other information relating to such nominee 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 and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the rules and regulations promulgated thereunder, (iii) a reasonably detailed description of any compensatory, payment or other financial agreement, arrangement or understanding that such nominee has with any other person or entity other than the Corporation including the amount of any payment or payments received or receivable thereunder, in each case in connection with candidacy or service as a director of the Corporation, (iv) such person's written consent to being named in the Corporation’s proxy statement and associated proxy card and to serving as a director if elected, (v) all information with respect to such nominee that would be required to be set forth in a stockholder’s notice pursuant to this Section 1.10 if such nominee were the stockholder giving notice hereunder, (vi) a questionnaire completed and signed by such person (in the form to be provided by the Secretary of the Corporation upon written request of any stockholder of record within ten (10) days of such request) with respect to the background and qualification of such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made and (vii) and a written representation and agreement (in the form to be provided by the Secretary of the Corporation upon written request of any stockholder of record within ten (10) days of such request) that such proposed nominee (A) is not and will not become a party to any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such proposed nominee, if elected as a director of the Corporation, will act or vote on any issue or question that has not been disclosed to the Corporation or that could limit or interfere with such proposed nominee’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 to the Corporation, and (C) would be in compliance, if elected as a director of the Corporation, and will comply with, all applicable publicly disclosed corporate governance, code of conduct and ethics, conflict of interest, confidentiality, corporate opportunities, trading and any other policies and guidelines of the Corporation applicable to directors; (b) as to any other business that the stockholder proposes to bring before the meeting, (i) a brief description of the business desired to be brought before the meeting, (ii) the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the Bylaws of the Corporation, the language of the proposed amendment), (iii) the reasons for conducting such business at the meeting, (iv) any direct or indirect material interest in such business of such stockholder and the beneficial owner, if any, on whose behalf the proposal is made and any other person or persons with whom such stockholder or beneficial owner, if any, has any agreement, arrangement or understanding in connection with such proposal and (v) such other information relating to any proposed item of business as the Corporation may reasonably require to determine whether such proposed item of business is a proper matter for stockholder action; and (c) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination or proposal is made (i) the name and address of such stockholder, as they appear on the Corporation's books, and of such beneficial owner, (ii) the class or series and number of shares of capital stock of the Corporation which are,
4
directly or indirectly, owned beneficially (within the meaning of Rule 13d-3 under the Exchange Act) or of record by such stockholder and such beneficial owner (provided, that such stockholder and the beneficial owner, if any, on whose behalf the nomination or proposal is made shall in all events be deemed to beneficially own any shares of any class or series and number of shares of capital stock of the Corporation as to which such stockholder or beneficial owner, if any, has a right to acquire beneficial ownership at any time in the future), (iii) a description of any agreement, arrangement or understanding with respect to the nomination or proposal between or among such stockholder and/or such beneficial owner, any of their respective affiliates or associates, and any others acting in concert with any of the foregoing, including, in the case of a nomination, the nominee (each of the foregoing, a “Stockholder Associated Person”), (including the names of each such Stockholder Associated Person), (iv) a description of any agreement, arrangement or understanding (including any derivative or short positions, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into as of the date of the stockholder's notice by, or on behalf of, such stockholder and such beneficial owners, whether or not such instrument or right shall be subject to settlement in underlying shares of capital stock of the Corporation, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such stockholder or such beneficial owner, with respect to securities of the Corporation, (v) a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting upon such business or nomination, as the case may be, and intends to appear in person or by proxy at the meeting to propose such business or nomination, (vi) a representation whether such stockholder or any Stockholder Associated Person intends or is part of a group which intends (a) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve or adopt the proposal or elect the nominee, (b) otherwise to solicit proxies or votes from stockholders in support of such proposal or nomination or (c) to solicit proxies in support of any proposed nominee in accordance with Rule 14a-19 promulgated under the Exchange Act, and (vii) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for, as applicable, the proposal and/or for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Exchange Act and the rules and regulations promulgated thereunder. The foregoing notice requirements of this paragraph (A) of this Section 1.10 shall be deemed satisfied by a stockholder with respect to business other than a nomination if the stockholder has notified the Corporation of his, her or its intention to present a proposal at an annual meeting in compliance with applicable rules and regulations promulgated under the Exchange Act and such stockholder's proposal has been included in a proxy statement that has been prepared by the Corporation to solicit proxies for such annual meeting. The Corporation may require any proposed nominee or stockholder seeking to nominate a director candidate or bring other business before an annual meeting to furnish such other information as the Corporation may reasonably request, including, without limitation, for the purpose of determining the eligibility of such proposed nominee to serve as a director of the Corporation or the independence of such proposed nominee. If requested by the Corporation, the information required by this Section 1.10 shall be supplemented by such stockholder of record in writing to the Secretary of the Corporation at the principal executive offices of the Corporation not later than ten (10) days after any record date for the meeting to disclose such information as of such record date; provided,
5
that no such update or supplement shall cure or affect the accuracy (or inaccuracy) of any representations made by any stockholder or Stockholder Associated Person or the validity (or invalidity) of any nomination or proposal that failed to comply with this Section 1.10 or is rendered invalid as a result of any inaccuracy therein.
(3)Notwithstanding anything in the second sentence of paragraph (A)(2) of this Section 1.10 to the contrary, in the event that the number of directors to be elected to the Board at the annual meeting is increased effective after the time period for which nominations would otherwise be due under paragraph (A)(2) of this Section 1.10 and there is no public announcement by the Corporation naming the nominees for the additional directorships at least one hundred (100) days prior to the first anniversary of the preceding year's annual meeting, a stockholder's notice required by this Section 1.10 shall also be considered timely, but only with respect to nominees for the additional directorships, if it shall be delivered to the Secretary at the principal executive offices 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.
(B)Special Meetings of Stockholders. Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the Corporation's notice of meeting. Nominations of persons for election to the Board may be made at a special meeting of stockholders at which directors are to be elected pursuant to the Corporation's notice of meeting (1) by or at the direction of the Board or any committee thereof or (2) provided that the Board has determined that directors shall be elected at such meeting, by any stockholder of the Corporation who is a stockholder of record at the time the notice provided for in this Section 1.10 is delivered to the Secretary of the Corporation, who is entitled to vote at the meeting and upon such election and who complies with the notice procedures set forth in this Section 1.10. The number of nominees a stockholder may nominate for election at the special meeting at which directors are to be elected (or in the case of one or more stockholders giving the notice on behalf of a beneficial owner, the number of nominees such stockholders may collectively nominate for election at such special meeting on behalf of such beneficial owner) shall not exceed the number of directors to be elected at such special meeting. In the event the Corporation calls a special meeting of stockholders for the purpose of electing one or more directors to the Board, any such stockholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the Corporation's notice of meeting, if the stockholder's notice required by paragraph (A)(2) of this Section 1.10 shall be delivered to the Secretary at the principal executive offices of the Corporation not earlier than the close of business on the one hundred twentieth (120th) day prior to such special meeting and not later than the close of business on the later of the ninetieth (90th) day prior to such special meeting or the tenth (10th) day following the day on which the public announcement is first made of the date of the special meeting and of the nominees proposed by the Board to be elected at such meeting. In no event shall the public announcement of an adjournment, postponement or recess of a special meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice as described above.
(C)General. (1) Except as otherwise expressly provided in any applicable rule or regulation promulgated under the Exchange Act, only such persons who are nominated in accordance with the procedures set forth in this Section 1.10 shall be eligible to be elected at an
6
annual or special meeting of stockholders of the Corporation to serve as directors and only such business shall be conducted at a meeting of stockholders as shall have been brought before the meeting in accordance with the procedures set forth in this Section 1.10. Except as otherwise provided by law, the chairman of any meeting of stockholders (and, in advance of any meeting of stockholders, the Board) shall have the power and duty (a) to determine whether a nomination or any business proposed to be brought before the meeting was made or proposed, as the case may be, in accordance with the procedures set forth in this Section 1.10 (including whether the stockholder or beneficial owner, if any, on whose behalf the nomination or proposal is made, solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies or votes in support of such stockholder's nominee or proposal in compliance with such stockholder's representation as required by clause (A)(2)(c)(vi) of this Section 1.10) and (b) if any proposed nomination or business was not made or proposed in compliance with this Section 1.10, to declare that such nomination shall be disregarded or that such proposed business shall not be transacted. Notwithstanding the foregoing provisions of this Section 1.10, unless otherwise required by law, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual or special meeting of stockholders of the Corporation to present a nomination or proposed business (including, without limitation, any nominee that is not part of the Corporation’s slate of nominees or any proposed business included in the Corporation’s proxy statement, notice of meeting or other proxy materials or any supplement thereto pursuant to Rule 14-19 or 14a-8 promulgated under the Exchange Act), such nomination shall be disregarded and such proposed business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 1.10, to be considered a qualified representative of the stockholder, a person must be a duly authorized officer, manager or partner of such stockholder or must be authorized by a writing 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 writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders. Notwithstanding anything to the contrary in these Bylaws, unless otherwise required by law, if any stockholder or Stockholder Associated Person (i) provides notice pursuant to Rule 14a-19(b) promulgated under the Exchange Act with respect to any proposed nominee and (ii) subsequently fails to comply with the requirements of Rule 14a-19(a)(2) or Rule 14a-19(a)(3) promulgated under the Exchange Act (or fails to timely provide reasonable evidence sufficient to satisfy the Corporation that such stockholder has met the requirements of Rule 14a-19(a)(3) promulgated under the Exchange Act in accordance with the following sentence), then the nomination of each such proposed nominee shall be disregarded, notwithstanding that proxies or votes in respect of the election of such proposed nominees may have been received by the Corporation (which proxies and votes shall be disregarded). Upon request by the Corporation, if any stockholder or Stockholder Associated Person provides notice pursuant to Rule 14a-19(b) promulgated under the Exchange Act, such stockholder shall deliver to the Corporation, no later than five (5) business days prior to the applicable meeting, reasonable evidence that it or such Stockholder Associated Person has met the requirements of Rule 14a-19(a)(3) promulgated under the Exchange Act.
(2)For purposes of this Section 1.10, “public announcement” shall include disclosure in a press release reported by the Dow Jones News Service, Associated Press or other national news service or in a document publicly filed by the Corporation with the Securities and
7
Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act and the rules and regulations promulgated thereunder.
(3)Notwithstanding the foregoing provisions of this Section 1.10, a stockholder shall also comply with all applicable requirements of the Exchange Act and the rules and regulations promulgated thereunder with respect to the matters set forth in this Section 1.10; provided however, that any references in these Bylaws to the Exchange Act or the rules and regulations promulgated thereunder are not intended to and shall not limit any requirements applicable to nominations or proposals as to any other business to be considered pursuant to this Section 1.10 (including paragraphs (A)(1)(c) and (B) hereof), and compliance with paragraphs (A)(1)(c) and (B) of this Section 1.10 shall be the exclusive means for a stockholder to make nominations or submit other business (other than, as provided in the penultimate sentence of (A)(2), business other than nominations brought properly under and in compliance with Rule 14a-8 of the Exchange Act, as may be amended from time to time). Nothing in this Section 1.10 shall be deemed to affect any rights (a) of stockholders to request inclusion of proposals (other than nominations) in the Corporation's proxy statement pursuant to applicable rules and regulations promulgated under the Exchange Act or (b) of the holders of any series of Preferred Stock to elect directors pursuant to any applicable provisions of the Certificate of Incorporation.
1.11Conduct of Meetings; Inspectors of Election.
(A)Meetings of stockholders shall be presided over by the Chairman of the Board, if any, or in the Chairman's absence by the Vice Chairman of the Board, if any, or in the Vice Chairman's absence by the Chief Executive Officer, or in the Chief Executive Officer's absence, by the President, or in the President's absence by a Vice President, or in the absence of all of the foregoing persons by a chairman designated by the Board. The Secretary shall act as secretary of the meeting, but in the Secretary's absence the chairman of the meeting may appoint any person to act as secretary of the meeting.
(B)The Board may adopt by resolution such rules, regulations and procedures for the conduct of any meeting of stockholders of the Corporation as it shall deem appropriate including, without limitation, such guidelines and procedures as it may deem appropriate regarding the participation by means of remote communication of stockholders and proxyholders not physically present at a meeting. Except to the extent inconsistent with such rules, regulations and procedures as adopted by the Board, the chairman of any meeting of stockholders shall have the right and authority to convene and (for any or no reason) to recess and/or adjourn the meeting, to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board or prescribed by the chairman of the meeting, may include, without limitation, the following: (i) the establishment of an agenda or order of business for the meeting; (ii) rules and procedures for maintaining order at the meeting and the safety of those present; (iii) 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 shall be determined; (iv) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (v) limitations on the time allotted to questions or comments by participants. Unless and to the extent determined by the Board or the chairman of the
8
meeting, meetings of stockholders shall not be required to be held in accordance with the rules of parliamentary procedure.
(C)The chairman of the meeting shall announce at the meeting when the polls for each matter to be voted upon at the meeting will be opened and closed. After the polls close, no ballots, proxies or votes or any revocations or changes thereto may be accepted.
(D)The Corporation may, and if required by law, shall, in advance of any meeting of stockholders, appoint one or more inspectors of election to act at the meeting and make a written report thereof. One or more other persons may be designated 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 chairman of the meeting shall appoint one or more inspectors to act at the meeting. Unless otherwise required by law, inspectors may be officers, employees, agents or representatives of the Corporation. Each inspector, before entering upon the discharge of such inspector’s duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of such inspector’s ability. The inspector shall have the duties prescribed by law and, when the vote is completed, shall certify their determination of the result of the vote taken and of such other facts as may be required by law. Every vote taken by ballots shall be counted by a duly appointed inspector or duly appointed inspectors.
2.1General Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board, who may exercise all of the powers of the Corporation except as otherwise provided by law or the Certificate of Incorporation.
2.2Number, Election; Term and Qualification. The total number of directors constituting the Board shall be as fixed in, or in the manner provided by, the Certificate of Incorporation. Election of directors need not be by written ballot. The term of office of each director shall be as specified in the Certificate of Incorporation. Directors need not be stockholders of the Corporation.
2.3Chairman of the Board; Vice Chairman of the Board. The Board may appoint from its members a Chairman of the Board and a Vice Chairman of the Board, neither of whom need be an employee or officer of the Corporation. If the Board appoints a Chairman of the Board, such Chairman shall perform such duties and possess such powers as are assigned by the Board and, if the Chairman of the Board is also designated as the Corporation's Chief Executive Officer, shall have the powers and duties of the Chief Executive Officer prescribed in Section 3.7 of these Bylaws. If the Board appoints a Vice Chairman of the Board, such Vice Chairman shall perform such duties and possess such powers as are assigned by the Board. Unless otherwise provided by the Board, the Chairman of the Board or, in the Chairman's absence, the Vice Chairman of the Board, if any, shall preside at all meetings of the Board.
2.4Quorum. The greater of (a) a majority of the directors at any time in office and (b) one-third of the whole Board shall constitute a quorum of the Board. If at any meeting of the Board there shall be less than a quorum, a majority of the directors present may adjourn the
9
meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.
2.5Action at Meeting. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the Board, unless a greater number is required by law, the Certificate of Incorporation or these Bylaws.
2.6Removal. Subject to the rights of holders of any series of Preferred Stock, directors of the Corporation may be removed only as expressly provided in the Certificate of Incorporation.
2.7Newly Created Directorships; Vacancies. Any newly created directorship that results from an increase in the number of directors or any vacancy on the Board that results from the death, disability, resignation, disqualification or removal of any director or from any other cause shall be filled in accordance with the Certificate of Incorporation.
2.8Resignation. Any director may resign by delivering a resignation in writing or by electronic transmission to the Corporation at its principal office or to the Chairman of the Board, the Chief Executive Officer, the President or the Secretary. Such resignation shall be effective upon delivery unless it is specified to be effective at some later time or upon the happening of some later event.
2.9Regular Meetings. Regular meetings of the Board may be held without notice at such time and place as shall be determined from time to time by the Board; provided that any director who is absent when such a determination is made shall be given notice of the determination. A regular meeting of the Board may be held without notice immediately after and at the same place as the annual meeting of stockholders.
2.10Special Meetings. Special meetings of the Board may be called by the Chairman of the Board, the Chief Executive Officer, the affirmative vote of a majority of the directors then in office, or by one director in the event that there is only a single director in office.
2.11Notice of Special Meetings. Notice of the date, place and time of any special meeting of the Board shall be given to each director (a) in person or by telephone at least twenty-four (24) hours in advance of the meeting, (b) by sending written notice by reputable overnight courier, telecopy, electronic mail, facsimile or other means of electronic transmission, or delivering written notice by hand, to such director's last known business, home or means of electronic transmission address at least twenty-four (24) hours in advance of the meeting, or (c) by sending written notice by first-class mail to such director's last known business or home address at least seventy-two (72) hours in advance of the meeting. Such notice may be given by the Secretary or by the Chairman of the Board, the Chief Executive Officer or one of the directors calling the meeting. A notice or waiver of notice of a meeting of the Board need not specify the purposes of the meeting.
2.12Meetings by Conference Communications Equipment. Directors may participate in meetings of the Board or any committee thereof by means of conference telephone or other
10
communications equipment by means of which all persons participating in the meeting can hear each other, and participation by such means shall constitute presence in person at such meeting.
2.13Action by Consent. Any action required or permitted to be taken at any meeting of the Board or of any committee thereof may be taken without a meeting, if all members of the Board or committee, as the case may be, consent to the action in writing or by electronic transmission. After an action is taken, the consent or consents relating thereto shall be filed with the minutes of proceedings of the Board, or the committee thereof, in the same paper or electronic form as the minutes are maintained.
2.14Committees. The Board may designate one or more committees, each committee to consist of one or more of the directors of the Corporation with such lawfully delegable powers and duties as the Board thereby confers, to serve at the pleasure of the Board. The Board 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 a committee, the member or members of the committee present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board and subject to the provisions of law, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of the Corporation and may authorize the seal of the Corporation to be affixed to all papers which may require it. Each such committee shall keep minutes and make such reports as the Board may from time to time request. Except as otherwise provided in the Certificate of Incorporation, these Bylaws, or the resolution of the Board designating the committee, a committee may create one or more subcommittees, each subcommittee to consist of one or more members of the committee, and delegate to a subcommittee any or all of the powers and authority of the committee.
3.1Titles. The officers of the Corporation may consist of a Chief Executive Officer, a President, a Chief Financial Officer, a Treasurer and a Secretary and such other officers with such other titles as the Board shall from time to time determine. The Board may appoint such other officers, including one or more Vice Presidents and one or more Assistant Treasurers or Assistant Secretaries, as it may deem appropriate from time to time. The only individuals who shall be considered the officers of the Corporation shall be those individuals who have been appointed or elected as an officer of the Corporation by the Board.
3.2Election. The officers of the Corporation shall be elected by the Board.
3.3Qualification. No officer need be a stockholder. Any two or more offices may be held by the same person.
3.4Tenure. Except as otherwise provided by law, by the Certificate of Incorporation or by these Bylaws, each officer shall hold office until such officer's successor is duly elected
11
and qualified, unless a different term is specified in the resolution electing or appointing such officer, or until such officer's earlier death, resignation, disqualification or removal.
3.5Resignation and Removal. Any officer may resign by delivering a resignation in writing or by electronic transmission to the Corporation at its principal office or to the Board, the Chief Executive Officer, the President or the Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some later time or upon the happening of some later event. Any officer may be removed at any time, with or without cause, by the affirmative vote of a majority of the directors then in office. Except as the Board may otherwise determine, no officer who resigns or is removed shall have any right to any compensation as an officer for any period following such officer's resignation or removal, or any right to damages on account of such removal, whether such officer's compensation be by the month or by the year or otherwise, unless such compensation is expressly provided for in a duly authorized agreement with the Corporation.
3.6Vacancies. The Board may fill any vacancy occurring in any office for any reason and may, in its discretion, leave unfilled, for such period as it may determine, any offices. Each such successor shall hold office for the unexpired term of such officer's predecessor and until a successor is duly elected and qualified, or until such officer's earlier death, resignation, disqualification or removal.
3.7President; Chief Executive Officer. Unless the Board has designated another person as the Corporation's Chief Executive Officer, the President shall be the Chief Executive Officer of the Corporation. The Chief Executive Officer shall have general charge and supervision of the business of the Corporation subject to the direction of the Board, and shall perform all duties and have all powers that are commonly incident to the office of chief executive or that are delegated to such officer by the Board. The President shall perform such other duties and shall have such other powers as the Board or the Chief Executive Officer (if the President is not the Chief Executive Officer) may from time to time prescribe. In the event of the absence, inability or refusal to act of the Chief Executive Officer or the President (if the President is not the Chief Executive Officer), the Vice President (or if there shall be more than one, the Vice Presidents in the order determined by the Board) shall perform the duties of the Chief Executive Officer and when so performing such duties shall have all the powers of and be subject to all the restrictions upon the Chief Executive Officer.
3.8Vice Presidents/Other Officers. Each Vice President and any other officer designated by the Board shall perform such duties and possess such powers as the Board or the Chief Executive Officer may from time to time prescribe. The Board may assign to any Vice President the title of Executive Vice President or Senior Vice President, and may assign to any Vice President or other officer any other title selected by the Board.
3.9Secretary and Assistant Secretaries. The Secretary shall perform such duties and shall have such powers as the Board or the Chief Executive Officer may from time to time prescribe. In addition, the Secretary shall perform such duties and have such powers as are incident to the office of the secretary, including without limitation the duty and power to give notices of all meetings of stockholders and special meetings of the Board, to attend all meetings of stockholders and the Board and keep a record of the proceedings, to maintain a stock ledger
12
and prepare lists of stockholders and their addresses as required, to be custodian of corporate records and the corporate seal and to affix and attest to the same on documents.
Any Assistant Secretary shall perform such duties and possess such powers as the Board, the Chief Executive Officer or the Secretary may from time to time prescribe. In the event of the absence, inability or refusal to act of the Secretary, the Assistant Secretary (or if there shall be more than one, the Assistant Secretaries in the order determined by the Board) shall perform the duties and exercise the powers of the Secretary.
The chairman of any meeting of the Board or of stockholders may designate a temporary secretary to keep a record of any meeting.
3.10Treasurer and Assistant Treasurers. The Treasurer shall perform such duties and shall have such powers as may from time to time be assigned by the Board or the Chief Executive Officer. In addition, the Treasurer shall perform such duties and have such powers as are incident to the office of treasurer, including without limitation the duty and power to keep and be responsible for all funds and securities of the Corporation, to deposit funds of the Corporation in depositories selected in accordance with these Bylaws, to disburse such funds as ordered by the Board, to make proper accounts of such funds, and to render as required by the Board statements of all such transactions and of the financial condition of the Corporation.
The Assistant Treasurers shall perform such duties and possess such powers as the Board, the Chief Executive Officer or the Treasurer may from time to time prescribe. In the event of the absence, inability or refusal to act of the Treasurer, the Assistant Treasurer (or if there shall be more than one, the Assistant Treasurers in the order determined by the Board) shall perform the duties and exercise the powers of the Treasurer.
3.11Delegation of Authority. The Board may from time to time delegate the powers or duties of any officer to any other officer or agent, notwithstanding any provision hereof.
4.1Stock Certificates; Uncertificated Shares. The shares of the Corporation shall be represented by certificates, provided that the Board may provide by resolution or resolutions that some or all of any or all classes or series of the Corporation's stock shall be uncertificated shares. Every holder of stock of the Corporation represented by certificates shall be entitled to have a certificate, in such form as may be prescribed by law and by the Board, representing the number of shares held by such holder registered in certificate form. Each such certificate shall be signed in a manner that complies with Section 158 of the DGCL and each of the Chief Executive Officer, the President, a Vice President, the Secretary, an Assistant Secretary, the Treasurer or an Assistant Treasurer are duly authorized to sign such certificates by, or in the name of, the Corporation, unless otherwise expressly provided in the resolution of the Board electing such officer.
Each certificate for shares of stock which are subject to any restriction on transfer pursuant to the Certificate of Incorporation, these Bylaws, applicable securities laws or any agreement among any number of stockholders or among such holders and the Corporation shall
13
have conspicuously noted on the face or back of the certificate either the full text of the restriction or a statement of the existence of such restriction.
If the Corporation shall be authorized to issue more than one class of stock or more than one series of any class, the powers, designations, preferences and relative participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of each certificate representing shares of such class or series of stock, provided that in lieu of the foregoing requirements there may be set forth on the face or back of each certificate representing shares of such class or series of stock a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
Within a reasonable time after the issuance or transfer of uncertificated shares, the registered owner thereof shall be given a notice, in writing or by electronic transmission, containing the information required to be set forth or stated on certificates pursuant to Sections 151, 156, 202(a) or 218(a) of the DGCL or, with respect to Section 151 of DGCL, a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
4.2Transfers. Shares of stock of the Corporation shall be transferable in the manner prescribed by law, the Certificate of Incorporation and in these Bylaws. Transfers of shares of stock of the Corporation shall be made only on the books of the Corporation or by transfer agents designated to transfer shares of stock of the Corporation. Subject to applicable law, shares of stock represented by certificates shall be transferred only on the books of the Corporation by the surrender to the Corporation or its transfer agent of the certificate representing such shares properly endorsed or accompanied by a written assignment or power of attorney properly executed, and with such proof of authority or the authenticity of signature as the Corporation or its transfer agent may reasonably require. Except as may be otherwise required by law, by the Certificate of Incorporation 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 to such stock, 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.
4.3Lost, Stolen or Destroyed Certificates. The Corporation may issue a new certificate or uncertificated shares in place of any previously issued certificate alleged to have been lost, stolen or destroyed, upon such terms and conditions as the Corporation may prescribe, including the presentation of reasonable evidence of such loss, theft or destruction and the giving of such indemnity and posting of such bond sufficient to indemnify the Corporation 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 or uncertificated shares.
14
4.4Record Date. In order that the Corporation may determine the stockholders entitled to notice of any meeting of stockholders or any adjournment thereof, the Board 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, and which record date shall, unless otherwise required by law, not be more than sixty (60) nor less than ten (10) days before the date of such meeting. If the Board so fixes a date, such date shall also be the record date for determining the stockholders entitled to vote at such meeting unless the Board determines, at the time it fixes such record date, that a later date on or before the date of the meeting shall be the date for making such determination. If no record date is fixed by the Board, 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. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board may fix a new record date for determination of stockholders entitled to vote at the adjourned meeting, and in such case shall also fix as the record date for stockholders entitled to notice of such adjourned meeting the same or an earlier date as that fixed for determination of stockholders entitled to vote in accordance herewith at the adjourned meeting.
In order that the Corporation may determine the stockholders 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 may fix a record date, which shall not be more than sixty (60) days prior to such action. If no such record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto.
4.5Regulations. The issue and registration of shares of stock of the Corporation shall be governed by such other regulations as the Board may establish.
5.1Fiscal Year. Except as from time to time otherwise designated by the Board, the fiscal year of the Corporation shall begin on the first day of January of each year and end on the last day of December in each year.
5.2Corporate Seal. The corporate seal shall be in such form as shall be approved by the Board.
5.3Waiver of Notice. Whenever notice is required to be given by law, by the Certificate of Incorporation or by these Bylaws, a written waiver signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before, at or after the time of the event for which notice is to be given, shall be deemed equivalent to notice required to be given to such person. Neither the business nor the purpose of any meeting need be specified in any such waiver. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of
15
objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened.
5.4Voting of Securities. Except as the Board may otherwise designate, the Chief Executive Officer, the President, the Chief Financial Officer or the Treasurer may waive notice, vote, consent, or appoint any person or persons to waive notice, vote or consent, on behalf of the Corporation, and act as, or appoint any person or persons to act as, proxy or attorney-in-fact for the Corporation (with or without power of substitution and re-substitution), with respect to the securities of any other entity which may be held by this Corporation.
5.5Evidence of Authority. A certificate by the Secretary, or an Assistant Secretary, or a temporary Secretary, as to any action taken by the stockholders, directors, a committee or any officer or representative of the Corporation shall as to all persons who rely on the certificate in good faith be conclusive evidence of such action.
5.6Certificate of Incorporation. All references in these Bylaws to the Certificate of Incorporation shall be deemed to refer to the Certificate of Incorporation of the Corporation, as amended and/or restated and in effect from time to time.
5.7Severability. Any determination that any provision of these Bylaws is for any reason inapplicable, illegal or ineffective shall not affect or invalidate any other provision of these Bylaws.
5.8Pronouns. All pronouns used in these Bylaws shall be deemed to refer to the masculine, feminine or neuter, singular or plural, as the identity of the person or persons may require.
5.9Manner of Notice. Without limiting the manner by which notice otherwise may be given effectively to stockholders, any notice to stockholders given by the Corporation under any provision of the DGCL, the Certificate of Incorporation or these Bylaws may be given in writing directed to the stockholder’s mailing address (or by electronic transmission directed to the stockholder’s electronic mail address, as applicable) as it appears on the records of the Corporation. Notice shall be given (i) if mailed, when deposited in the United States mail, (ii) if delivered by courier service, the earlier of when the notice is received or left at the stockholder’s address, or (iii) if given by electronic mail, when directed at to such stockholder’s electronic mail address (unless the stockholder has notified the Corporation in writing or by electronic transmission of an objection to receiving notice by electronic mail or such notice is prohibited by the DGCL to be given by electronic transmission). A notice by electronic mail must include a prominent legend that the communication is an important notice regarding the Corporation. A notice by electronic mail shall be deemed to include any files attached thereto and any information hyperlinked to a website if such electronic mail includes the contact information of an officer or agent of the Corporation who is available to assist with accessing such files or information. Any notice to stockholders under any provision of the DGCL, the Certificate of Incorporation or these Bylaws provided by electronic transmission (other than any such notice given by electronic mail) may only be given in a form consented to by such stockholder, and any such notice by electronic transmission shall be deemed to be given as provided by the DGCL.
16
5.10Electronic Transmission. For purposes of these Bylaws, “electronic transmission” means any form of communication, not directly involving the physical transmission of paper, including the use of, or participation in, one or more electronic networks or databases (including one or more distributed electronic networks or databases), that creates a record that may be retained, retrieved, and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
These Bylaws may be altered, amended or repealed, in whole or in part, or new Bylaws may be adopted by the Board or by the stockholders as expressly provided in the Certificate of Incorporation.
ARTICLE VII
INDEMNIFICATION AND ADVANCEMENT
7.1Power to Indemnify in Actions, Suits or Proceedings other than Those by or in the Right of the Corporation. Subject to Section 7.3, the Corporation shall indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that such person is or was a director or officer of the Corporation, or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another Corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, against 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 if 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 action or proceeding, had no reasonable cause to believe such person's conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that such person's conduct was unlawful.
7.2Power to Indemnify in Actions, Suits or Proceedings by or in the Right of the Corporation. Subject to Section 7.3, the Corporation shall indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that such person is or was a director or officer of the Corporation, or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another Corporation, partnership, joint venture, trust, employee benefit plan or other enterprise against expenses (including attorneys' fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best
17
interests of the Corporation; except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the Corporation unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.
7.3Authorization of Indemnification. Any indemnification under this Article VII (unless ordered by a court) shall be made by the Corporation only as authorized in the specific case upon a determination that indemnification of the director or officer is proper in the circumstances because such person has met the applicable standard of conduct set forth in Section 7.1 or Section 7.2, as the case may be. Such determination shall be made, with respect to a person who is a director or officer at the time of such determination, (i) by a majority vote of the directors who are not parties to such action, suit or proceeding, even though less than a quorum, or (ii) by a committee of such directors designated by a majority vote of such directors, even though less than a quorum, or (iii) if there are no such directors, or if such directors so direct, by independent legal counsel in a written opinion or (iv) by the stockholders. Such determination shall be made, with respect to former directors and officers, by any person or persons having the authority to act on the matter on behalf of the Corporation. To the extent, however, that a present or former director or officer of the Corporation has been successful on the merits or otherwise in defense of any action, suit or proceeding set forth in Section 7.1 or Section 7.2 or in defense of any claim, issue or matter therein, such person shall be indemnified against expenses (including attorneys' fees) actually and reasonably incurred by such person in connection therewith, without the necessity of authorization in the specific case.
7.4Good Faith Defined. For purposes of any determination under Section 7.3, a person shall be deemed to have 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, or, with respect to any criminal action or proceeding, to have had no reasonable cause to believe such person's conduct was unlawful, if such person's action is based on good faith reliance on the records or books of account of the Corporation or another enterprise, or on information supplied to such person by the officers of the Corporation or another enterprise in the course of their duties, or on the advice of legal counsel for the Corporation or another enterprise or on information or records given or reports made to the Corporation or another enterprise by an independent certified public accountant or by an appraiser or other expert selected with reasonable care by the Corporation or another enterprise. The term “another enterprise” as used in this Section 7.4 shall mean any other corporation or any partnership, joint venture, trust, employee benefit plan or other enterprise of which such person is or was serving at the request of the Corporation as a director, officer, employee or agent. The provisions of this Section 7.4 shall not be deemed to be exclusive or to limit in any way the circumstances in which a person may be deemed to have met the applicable standard of conduct set forth in Section 7.1 or 7.2, as the case may be.
7.5Right of Claimant to Bring Suit. Notwithstanding any contrary determination in the specific case under Section 7.3, and notwithstanding the absence of any determination thereunder, if a claim under Sections 7.1 or 7.2 of the Article VII is not paid in full by the Corporation within (i) ninety (90) days after a written claim for indemnification has been
18
received by the Corporation following the final disposition of the underlying action, suit or proceeding, or (ii) thirty (30) days after a written claim for an advancement of expenses has been received by the Corporation, the claimant may at any time thereafter (but not before) bring suit against the Corporation in the Court of Chancery in the State of Delaware to recover the unpaid amount of the claim, together with interest thereon, or to obtain advancement of expenses, as applicable. It shall be a defense to any such action brought to enforce a right to indemnification (but not in an action brought to enforce a right to an advancement of expenses) that the claimant has not met the standards of conduct which make it permissible under the DGCL (or other applicable law) for the Corporation to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the Corporation. Neither a contrary determination in the specific case under Section 7.3 nor the absence of any determination thereunder shall be a defense to such application or create a presumption that the claimant has not met any applicable standard of conduct. If successful, in whole or in part, the claimant shall also be entitled to be paid the expense of prosecuting such claim, including reasonable attorneys' fees incurred in connection therewith, to the fullest extent permitted by applicable law.
7.6Expenses Payable in Advance. Expenses, including without limitation attorneys' fees, incurred by a current or former director or officer in defending any civil, criminal, administrative or investigative action, suit or proceeding shall be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such current or former director or officer to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the Corporation as authorized in this Article VII.
7.7Nonexclusivity of Indemnification and Advancement of Expenses. The rights to indemnification and advancement of expenses provided by or granted pursuant to this Article VII shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under the Certificate of Incorporation, any agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person's official capacity and as to action in another capacity while holding such office, it being the policy of the Corporation that, subject to Section 7.11, indemnification of the persons specified in Sections 7.1 and 7.2 shall be made to the fullest extent permitted by law. The provisions of this Article VII shall not be deemed to preclude the indemnification of any person who is not specified in Section 7.1 or 7.2 but whom the Corporation has the power or obligation to indemnify under the provisions of the DGCL, or otherwise.
7.8Insurance. The Corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person's status as such, whether or not the Corporation would have the power or the obligation to indemnify such person against such liability under the provisions of this Article VII.
7.9Certain Definitions. For purposes of this Article VII, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent corporation
19
(including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, employees or agents so that any person who is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, shall stand in the same position under the provisions of this Article VII with respect to the resulting or surviving corporation as such person would have with respect to such constituent corporation if its separate existence had continued. For purposes of this Article VII, references to “fines” shall include any excise taxes assessed on a person with respect of any employee benefit plan; and references to “serving at the request of the Corporation” shall include any service as a director, officer, employee or agent of the Corporation which imposes duties on, or involves services by, such director, officer, employee or agent with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner such person reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Corporation” as referred to in this Article VII.
7.10Survival of Indemnification and Advancement of Expenses. The indemnification and advancement of expenses provided by, or granted pursuant to, this Article VII shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and administrators of such a person.
7.11Limitation on Indemnification. Notwithstanding anything contained in this Article VII to the contrary, except for proceedings to enforce rights to indemnification (which shall be governed by Section 7.5), the Corporation shall not be obligated to indemnify any director, officer, employee or agent in connection with an action, suit proceeding (or part thereof) initiated by such person unless such action, suit or proceeding (or part thereof) was authorized by the Board.
7.12Contract Rights. The obligations of the Corporation under this Article VII to indemnify, and advance expenses to, a person who is or was a director or officer of the Corporation shall be considered a contract between the Corporation and such person, and no modification or repeal of any provision of this Article VII shall affect, to the detriment of such person, such obligations of the Corporation in connection with a claim based on any act or failure to act occurring before such modification or repeal.
20
Exhibit 4.1
ZQ|CERT#|COY|CLS|RGSTRY|ACCT#|TRANSTYPE|RUN#|TRANS# COMMON STOCK COMMON STOCK PAR VALUE $0.0001 Coya Therapeutics Shares *000000 Certificate Number ZQ00000000 Certificate Number ZQ00000000 COYA THERAPEUTICS, INC INCORPORATED UNDER THE LAWS OF THE STATE OF DELAWARE THIS CERTIFIES THAT Mr sample & MRS sample & MR. Sample & Mrs Sample SEE REVERSE FOR CERTAIN DEFINITIONS CUSIP XXXXXX XX X is the owner of ZERO HUNDRED THOUSAND Zero Hundred and zero THIS CERTIFICATE IS TRANSFERABLE IN CITIES DESIGNATED BY THE TRANSFER AGENT, AVAILABLE ONLINE AT www.computershare.com FULLY-PAID AND NON-ASSESSABLE SHARES OF COMMON STOCK OF Coya Therapeutics, Inc. (hereinafter called the “Company”), transferable on the books of the Company in person or by duly authorized attorney, upon surrender of this Certificate properly endorsed. This Certificate and the shares represented hereby, are issued and shall be held subject to all of the provisions of the Certificate of Incorporation, as amended, and the By-Laws, as amended, of the Company (copies of which are on file with the Company and with the Transfer Agent), to all of which each holder, by acceptance hereof, assents. This Certificate is not valid unless countersigned and registered by the Transfer Agent and Registrar Witness the facsimile seal of the Company and the facsimile signatures of its duly authorized officers. FACSIMILE SIGNATURE TO COME DATED DD-MMM-YYYY COUNTERSIGNED AND REGISTERED: COMPUTERSHARE TRUST COMPANY, N.A. TRANSFER AGENT AND REGISTRAR, C OYA THERAPEUTICS, IN C. CORPORATE seal 11/23/2020 DELAWARE FACSIMILE SIGNATURE TO COME By AUTHORIZED SIGNATURE .Coya therapeutics PO Box 43004, Providence RI 02940-3004 DESIGNATION (IF ANY) MR A SAMPLE ADD 4 ADD 3 ADD 2 ADD 1 CUSIP/IDENTIFIER Holder ID Insurance Value Number of Shares DTC Total Transaction 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 Certificate Numbers XXXXXX XX X XXXXXXXXXX 1,000,000.00 12345678 123456789012345 Num/No. Denom. Tota 123456 123456 1234567
COYA THERAPEUTICS, INC. THE COMPANY WILL FURNISH WITHOUT CHARGE TO EACH SHAREHOLDER WHO SO REQUESTS, A SUMMARY OF THE POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE, PARTICIPATING, OPTIONAL OR OTHER SPECIAL RIGHTS OF EACH CLASS OF STOCK OF THE COMPANY AND THE QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SUCH PREFERENCES AND RIGHTS, AND THE VARIATIONS IN RIGHTS, PREFERENCES AND LIMITATIONS DETERMINED FOR EACH SERIES, WHICH ARE FIXED BY THE CERTIFICATE OF INCORPORATION OF THE COMPANY, AS AMENDED, AND THE RESOLUTIONS OF THE BOARD OF DIRECTORS OF THE COMPANY, AND THE AUTHORITY OF THE BOARD OF DIRECTORS TO DETERMINE VARIATIONS FOR FUTURE SERIES. SUCH REQUEST MAY BE MADE TO THE OFFICE OF THE SECRETARY OF THE COMPANY OR TO THE TRANSFER AGENT. THE BOARD OF DIRECTORS MAY REQUIRE THE OWNER OF A LOST OR DESTROYED STOCK CERTIFICATE, OR HIS LEGAL REPRESENTATIVES, TO GIVE THE COMPANY A BOND TO INDEMNIFY IT AND ITS TRANSFER AGENTS AND REGISTRARS AGAINST ANY CLAIM THAT MAY BE MADE AGAINST THEM ON ACCOUNT OF THE ALLEGED LOSS OR DESTRUCTION OF ANY SUCH CERTIFICATE. The following abbreviations, when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according to applicable laws or regulations: TEN COM - as tenants in common UNIF GIFT MIN ACT Custodian TEN ENT - as tenants by the entireties (Cust) (Minor) under Uniform Gifts to Minors Act (State) JT TEN - as joint tenants with right of survivorship UNIF TRF MIN ACT and not as tenants in common UNIF TRF MIN AC Custodian (until age. (Cust) Additional abbreviations may also be used though not in the above list. (Minor) under Uniform Transfers to Minors Ac State) For value received, hereby sell, assign and transfer unto PLEASE INSERT SOCIAL SECURITY OR OTHER IDENTIFYING NUMBER OF ASSIGNEE (PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING POSTAL ZIP CODE, OF ASSIGNEE) Shares of the common stock represented by the within Certificate, and do hereby irrevocably constitute and appoint Attorney to transfer the said stock on the books of the within-named Company with full power of substitution in the premises. Dated: 20 Signature Signature(s) Guaranteed: Medallion Guarantee Stamp THE SIGNATURE(S) SHOULD BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (Banks, Stockbrokers, Savings and Loan Associations and Credit Unions) WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM, PURSUANT TO S.E.C. RULE 17Ad-15. Signature: Notice: The signature to this assignment must correspond with the name as written upon the face of the certificate, in every particular, without alteration or enlargement, or any change whateve
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
FIRST AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT
THIS FIRST AMENDED AND RESTATED INVESTORS’ RIGHTS AGREEMENT (this “Agreement”), is made as of March 4, 2022, by and among Coya Therapeutics, Inc., a Delaware corporation (the “Company”), each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor.”
WHEREAS, the Company and the Investors entered into an Investors’ Rights Agreement dated December 22, 2020 (the “Prior Agreement”), granting certain rights as provided therein; and
WHEREAS, the Company is contemplating conducting a private placement exempt from the registration requirements of the Securities Act, pursuant to which it would offer and sell unsecured convertible promissory notes up to a maximum aggregate principal amount of $20,000,000 (the “Convertible Note Financing” and such promissory notes, the “Convertible Notes”);
WHEREAS, the Company and the Investors wish to provide further inducement to prospective investors to invest in the Convertible Note Financing; and
WHEREAS, in accordance with and pursuant to Section 5.6 of the Prior Agreement, (i) the Company;(ii) the holders of at least a majority of the Registrable Securities then outstanding); and (iii) the holders of at least a majority of the Registrable Securities then outstanding and held by the Major Investors, have agreed to amend, modify, restate, supersede and replace the Prior Agreement in its entirety, as hereinafter set forth, and therefore, all parties to the Prior Agreement (whether or not signing this Agreement) shall become bound by this Agreement.
NOW, THEREFORE, the parties hereto further agree to amend and restate the Prior Agreement in ites entirety as follows:
1.Definitions. For purposes of this Agreement:
1.1“409A Valuation” means the Company’s most recent valuation report prepared to comply with Internal Revenue Code Section 409A.
1.2“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 adviser of, or shares the same management company or investment adviser with, such Person.
1.3“Board of Directors” means the board of directors of the Company.
1.4“Certificate of Incorporation” means the Company’s Amended and Restated Certificate of Incorporation, as amended and/or restated from time to time.
1.5“Common Stock” means shares of the Company’s common stock, par value $0.0001 per share.
1.6“Competitor” means a Person engaged, directly or indirectly (including through any partnership, limited liability company, corporation, joint venture or similar arrangement (whether now existing or formed hereafter)), in providing products or services the Company provides to its member or partners, but shall not include any financial investment firm or collective investment vehicle that, together with its Affiliates, holds less than five (5)% of the outstanding equity of any Competitor and does not, nor do any of its Affiliates, have a right to designate any members of the board of directors of any Competitor.
1.7“Company Valuation” shall mean the valuation of the entire Company as reflected in its most recent 409A Valuation.
1.8“Conversion Price” shall mean the lesser of (i) the price per share resulting from dividing $60,000,000 by the Fully Diluted Capitalization (the “Conversion Cap”); or (ii) 80% of the price per share resulting from dividing the Company Valuation by the Fully Diluted Capitalization (the “Discount Price”). For purposes of determining the Conversion Price, the both the Fully Diluted Capitalization and Company Valuation shall be calculated as of the date of determination.
1.9 “Convertible Note Financing” has the meaning set forth in the Recitals.
1.10“Convertible Note Share Equivalents” means, with respect to each Convertible Note, the number resulting from dividing (i) the outstanding Note Obligations with respect to such Convertible Note; by (ii) the Conversion Price, in each case rounded down to the nearest integer.
1.11“Convertible Notes” has the meaning set forth in the Recitals.
1.12“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.
1.13“Derivative Securities” means any securities or rights convertible into, or exercisable or exchangeable for (in each case, directly or indirectly), Common Stock, including options and warrants.
1.14“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
-2-
1.15“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.
1.16“FOIA Party” means a Person that, in the reasonable determination of the Board of Directors, may be subject to, and thereby required to disclose non-public information furnished by or relating to the Company under, the Freedom of Information Act, 5 U.S.C. 552 (“FOIA”), any state public records access law, any state or other jurisdiction’s laws similar in intent or effect to FOIA, or any other similar statutory or regulatory requirement.
1.17“Founders” means each of Howard Berman, Bertex, LLC, Jani Tuomi, Andrea Goldstein, The Methodist Hospital and Allele Capital.
1.18“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.
1.19“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.
1.20“Fully Diluted Capitalization” means the aggregate issued and outstanding shares of the Common Stock of the Company, assuming conversion or exercise of all outstanding options, warrants and convertible securities, but, excluding (i) the Convertible Notes, any securities issuable upon conversion of the Notes, and (ii) any shares reserved for grant, but unissued, under any equity incentive plan or similar plan of the Company.
1.21“GAAP” means generally accepted accounting principles in the United States as in effect from time to time.
1.22“Holder” means any holder of Registrable Securities who is a party to this Agreement.
1.23“Immediate Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, 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.
1.24“Initiating Holders” means, collectively, Holders who properly initiate a registration request under this Agreement.
1.25“IPO” means the Company’s first underwritten public offering of its Common Stock under the Securities Act.
1.26“Major Investor” means any Investor that, individually or together with such Investor’s Affiliates, holds at least 375,036 shares of Registrable Securities (as adjusted for any
-3-
stock split, stock dividend, combination, or other recapitalization or reclassification effected after the date hereof) and/or Convertible Note Share Equivalents.
1.27“New Securities” means, collectively, 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.
1.28“Note Obligations” means, as of the date of measurement and with respect to each Convertible Note, the Company's obligation to pay the aggregate sum of (i) the outstanding unpaid principal amount of under such Convertible Note; (ii) all accrued and unpaid interest thereon; and (iii) any other amounts payable thereunder with respect to such Convertible Note.
1.29“Original Coya Stockholders” means Kumar Singh, David Marston, Shawn Milemore Titcomb Revocable Trust, Shawn Titcomb, Menachem Kranz, Thomas Masterson and Charles Matthew Hughes.
1.30“Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.
1.31“Preferred Director” means any director of the Company that the holders of record of the Preferred Stock are entitled to elect, exclusively and as a separate class, pursuant to the Certificate of Incorporation.
1.32“Preferred Stock” means shares of the Series A Preferred Stock, and any class or series of preferred stock that is authorized after the date of this Agreement.
1.33“Prior Agreement” has the meaning set forth in the Recitals.
1.34“Registrable Securities” means, without duplication, (i) the Common Stock held by the Founders, the Original Coya Stockholders and Tribal, including that underlying warrants or other securities convertible into or exercisable for Common Stock; provided that such Commmon Stock shall not be deemed Registrable Securities for purposes of Section 2.1; (ii) the Common Stock issuable or issued upon conversion, whether directly or indirectly, of the Preferred Stock or Convertible Notes; (iii) 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 Holders after December 22, 2020; and (iv) any Common Stock issued as (or issuable upon the conversion or exercise of any warrant, right, or other 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 clause (ii) above; excluding in all cases, however, any Registrable Securities sold by a Person in a transaction in which the applicable rights under this Agreement are not assigned pursuant to Subsection 5.1, and excluding for purposes of Section 2 any shares for which registration rights have terminated pursuant to Subsection 2.12 of this Agreement.
1.35“Registrable Securities then outstanding” means the number of shares determined by adding (without duplication) (i) the number of shares of outstanding Common Stock that are Registrable Securities, (ii) the number of shares of Common Stock that are Registrable Securities that are issuable (directly or indirectly) pursuant to then exercisable and/or convertible securities, and (iii) the number of shares of Common Stock that are Registrable Securities that are issued or issuable (directly or indirectly) upon conversion of the Preferred Stock and/or Convertible Note Share Equivalents.
-4-
1.36“Restricted Securities” means the securities of the Company required to be notated with the legend set forth in Subsection 2.11(b) hereof.
1.37“SEC” means the Securities and Exchange Commission.
1.38“SEC Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.
1.39“SEC Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.
1.40 “Series A Preferred Stock” means shares of the Company’s Series A Preferred stock, par value $0.0001 per share.
1.41“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
1.42“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 any Holder, except for the fees and disbursements of the Selling Holder Counsel borne and paid by the Company as provided in Subsection 2.6.
1.43“Tribal” means Tribal Capital Markets, LLC.
2.Registration Rights. The Company covenants and agrees as follows:
(a)Form S-1 Demand. If at any time after the date that is the earlier of (A) one hundred eighty (180) days after the effective date of the registration statement for a Qualified IPO (as such term is defined in the Certificate of Incorporation) and (B) three years following the date of the intiail sale of Preferred Stock, the Company receives a request from Holders of at least fifty percent (50%) of the Registrable Securities then outstanding that the Company file a Form S-1 registration statement with respect to the outstanding Registrable Securities of such Holders having an anticipated aggregate offering price, net of Selling Expenses, of more than $5,000,000 then outstanding, then the Company shall (x) within ten (10) days after the date such request is given, give notice thereof (the “Demand Notice”) to all Holders other than the Initiating Holders; and (y) as soon as practicable, and in any event within sixty (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 Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given, and in each case, subject to the limitations of Subsections 2.1(c) and 2.3.
(b)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 Holders of at least thirty percent (30%) of the Registrable Securities then outstanding that the Company file a Form S-3 registration statement with respect to outstanding Registrable Securities of such Holders having an anticipated aggregate offering price, net of Selling Expenses, of at least $3,000,000, then the Company shall (i) within ten (10) days after the date such request is given, give a Demand Notice to all Holders other than the Initiating Holders; and (ii) as soon as practicable, and in any event within forty-five (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
-5-
requested to be included in such registration by any other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given, and in each case, subject to the limitations of Subsections 2.1(c) and 2.3.
(c)Notwithstanding the foregoing obligations, if the Company furnishes to Holders requesting a registration pursuant to this Subsection 2.1 a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of 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, because such action would (i) materially interfere with a significant acquisition, corporate reorganization, or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, 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 one hundred twenty (120) days after the request of the Initiating Holders is given; provided, however that the Company may not invoke this right more than twice in any twelve (12) month period.
(d)The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(a) (i) during the period that is sixty (60) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is one hundred eighty (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 registrations pursuant to Subsection 2.1(a); 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 Subsection 2.1(b). The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(b) (i) during the period that is thirty (30) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is ninety (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 Subsection 2.1(b). A registration shall not be counted as “effected” for purposes of this Subsection 2.1(d) 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 Subsection 2.6, in which case such withdrawn registration statement shall be counted as “effected” for purposes of this Subsection 2.1(d); provided, that if such withdrawal is during a period the Company has deferred taking action pursuant to Subsection 2.1(c), then the Initiating Holders may withdraw their request for registration and such registration will not be counted as “effected” for purposes of this Subsection 2.1(d).
2.2Company Registration. If the Company proposes to register (including, for this purpose, a registration effected by the Company for stockholders other than the Holders) 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), the Company shall, at such time, promptly give each Holder notice of such registration. Upon the request of each Holder given within twenty (20) days after such notice is given by the Company, the Company shall, subject to the provisions of Subsection 2.3, use best efforts to cause to be registered all of the Registrable Securities that each such Holder 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 Subsection 2.2 before the effective date of such registration, whether or not any Holder has elected to include Registrable Securities in
-6-
such registration. The expenses (other than Selling Expenses) of such withdrawn registration shall be borne by the Company in accordance with Subsection 2.6.
(a)If, pursuant to Subsection 2.1, 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 Subsection 2.1, 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 a majority in interest of the Initiating Holders. In such event, the right of any Holder to include such Holder’s Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in Subsection 2.4(e)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting. Notwithstanding any other provision of this Subsection 2.3, if the 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 Holders 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 Holders of Registrable Securities, including the Initiating Holders, in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Holder or in such other proportion as shall mutually be agreed to by all such selling Holders; provided, however, that the number of Registrable Securities held by the Holders to be included in such underwriting 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 Holder to the nearest one hundred (100) shares.
(b)In connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Subsection 2.2, the Company shall not be required to include any of the Holders’ Registrable Securities in such underwriting unless the Holders accept 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 the selling Holders in proportion (as nearly as practicable to) the number of Registrable Securities owned by each selling Holder or in such other proportions as shall mutually be agreed to by all such selling Holders. 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 Holder to the nearest one hundred (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 thirty percent (30%) of the total number of securities included in such offering, unless such offering is the Qualified IPO, in which case the selling Holders 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 Subsection 2.3(b) concerning apportionment, for any selling Holder that is a partnership, limited liability
-7-
company, or corporation, the partners, members, retired partners, retired members, stockholders, and Affiliates of such Holder, 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 Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate number of Registrable Securities owned by all Persons included in such “selling Holder,” as defined in this sentence.
2.4Obligations of the Company. Whenever required under this Section 2 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:
(a)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 Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for a period of up to one hundred twenty (120) days or, if earlier, until the distribution contemplated in the registration statement has been completed; provided, however, that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Holder 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 one hundred twenty (120) day period shall be extended for up to sixty (60) days, if necessary, to keep the registration statement effective until all such Registrable Securities are sold;
(b)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;
(c)furnish to the selling Holders such numbers of copies of a prospectus, including a preliminary prospectus, as required by the Securities Act, and such other documents as the Holders may reasonably request in order to facilitate their disposition of their Registrable Securities;
(d)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 the selling Holders; 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;
(e)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;
(f)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;
-8-
(g)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;
(h)promptly make available for inspection by the selling Holders, any 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 the selling Holders, 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;
(i)notify each selling Holder, 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
(j)after such registration statement becomes effective, notify each selling Holder 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.
2.5Furnish Information. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 2 with respect to the Registrable Securities of any selling Holder that such Holder 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 Holder’s Registrable Securities.
2.6Expenses of Registration. All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to Section 2, 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 $10,000, of one counsel for the selling Holders (“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 Subsection 2.1 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all selling Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn registration), unless the Holders of a majority of the Registrable Securities agree to forfeit their right to one registration pursuant to Subsections 2.1(a) or 2.1(b), as the case may be; provided further that if, at the time of such withdrawal, the Holders shall have learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Holders at the time of their request and have withdrawn the request with reasonable promptness after learning of such information then the Holders shall not be required to pay any of such expenses and shall not forfeit their right to one registration pursuant to Subsections 2.1(a) or 2.1(b). All Selling Expenses relating to Registrable Securities registered pursuant to this Section 2 (other than fees and disbursements of counsel to any Holder, other than the Selling Holder Counsel, which shall be borne by the Holder engaging such
-9-
counsel) shall be borne and paid by the Holders pro rata on the basis of the number of Registrable Securities registered on their behalf.
2.7Delay of Registration. No Holder 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 2.
2.8Indemnification. If any Registrable Securities are included in a registration statement under this Section 2:
(a)To the extent permitted by law, the Company will indemnify and hold harmless each selling Holder, and the partners, members, officers, directors, and stockholders of each such Holder; legal counsel and accountants for each such Holder; any underwriter (as defined in the Securities Act) for each such Holder; and each Person, if any, who controls such Holder or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to each such Holder, 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 Subsection 2.8(a) 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 any such Holder, underwriter, controlling Person, or other aforementioned Person expressly for use in connection with such registration.
(b)To the extent permitted by law, each selling Holder, 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 Holder selling securities in such registration statement, and any controlling Person of any such underwriter or other Holder, 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 Holder expressly for use in connection with such registration; and each such selling Holder 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 Subsection 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld; and provided further that in no event shall the aggregate amounts payable by any Holder by way of indemnity or contribution under Subsections 2.8(b) and 2.8(d) exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of fraud or willful misconduct by such Holder.
(c)Promptly after receipt by an indemnified party under this Subsection 2.8 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 Subsection 2.8, 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;
-10-
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 Subsection 2.8, 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 Subsection 2.8.
(d)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 Subsection 2.8 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 Subsection 2.8 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 Subsection 2.8, 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 Holder 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 Holder’s liability pursuant to this Subsection 2.8(d), when combined with the amounts paid or payable by such Holder pursuant to Subsection 2.8(b), exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of willful misconduct or fraud by such Holder.
(e)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.
(f)Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations of the Company and Holders under this Subsection 2.8 shall survive the completion of any offering of Registrable Securities in a registration under this Section 2, and otherwise shall survive the termination of this Agreement.
2.9Reports Under Exchange Act. With a view to making available to the Holders the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form S‑3, the Company shall:
-11-
(a)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;
(b)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
(c)furnish to any Holder, so long as the Holder owns 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 ninety (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); and (ii) such other information as may be reasonably requested in availing any Holder 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).
2.10“Market Stand‑off” Agreement. Each Holder hereby agrees that it 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 for its own behalf 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, a Qualified IPO or a Qualifying Reverse Merger (as each such term is defined in the Certificate of Incorporation) and ending on the date specified by the Company and the managing underwriter (such period not to exceed (x) one hundred eighty (180) days, or (y) 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 FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4) (or any successor provisions or amendments thereto) and provided that the Company does not qualify as an “Emerging Growth Company” (as defined therein) such that the Company is subject to such restrictions), (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 (whether such shares or any such securities are then owned by the Holder or are thereafter acquired) 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 Subsection 2.10 shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement and shall be applicable to the Holders 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 one percent (1%) 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 Subsection 2.10 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Holder further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Subsection 2.10 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
-12-
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; provided that, to the extent that the underwriters will not agree to include such pro rata release requirement in such agreements executed in connection with such public offering (after the Company has used commercially reasonable efforts to include such provision), then this sentence shall be of no further force and effect, but the remainder of this Subsection 2.11 shall continue in full force and effect.
(a)The Preferred Stock, Convertible Notes 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 Holder will cause any proposed purchaser, pledgee, or transferee of the Preferred Stock, Converible Notes and the Registrable Securities held by such Holder to agree to take and hold such securities subject to the provisions and upon the conditions specified in this Agreement.
(b)Each certificate, instrument, or book entry representing (i) the Preferred Stock, (ii) the Convertible Notes, (iii) the Registrable Securities, and (iv) any other securities issued in respect of the securities referenced in clauses (i) through (iii), upon any stock split, stock dividend, recapitalization, merger, consolidation, or similar event, shall (unless otherwise permitted by the provisions of Subsection 2.12(c)) 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.
The Holders consent 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 Subsection 2.11.
(c)The holder of such Restricted Securities, by acceptance of ownership thereof, agrees to comply in all respects with the provisions of this Section 2. 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, 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
-13-
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 the Holder to the Company. The Company will not require such a 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 each transferee agrees in writing to be subject to the terms of this Subsection 2.11. 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 Subsection 2.12(b), 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.
2.12Termination of Registration Rights. The right of any Holder to request registration or inclusion of Registrable Securities in any registration pursuant to Subsections 2.1 or 2.2 shall terminate upon the earlier to occur of:
(a)the first anniversary of the Qualified IPO or Qualifying Merger (as such terms are defined in the Certificate of Incorporation); and
(b)such time after consummation of the IPO as Rule 144 or another similar exemption under the Securities Act is available for the sale of all of such Holder’s shares without limitation during a three-month period without registration.
3.Rights to Future Stock Issuances.
3.1Right of First Offer. Subject to the terms and conditions of this Subsection 3.1 (including, without limitation, Section 3.1(d)) and applicable securities laws, if the Company proposes to offer or sell any New Securities, the Company shall first offer such New Securities to each Major Investor. A Major 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, (ii) its Affiliates and (iii) its beneficial interest holders, such as limited partners, members or any other Person having “beneficial ownership,” as such term is defined in Rule 13d-3 promulgated under the Exchange Act, of such Major Investor (“Investor Beneficial Owners”); provided that each such party and Affiliate (x) is not a Competitor or FOIA Party, unless such person’s purchase of New Securities is otherwise consented to by the Board, and (y) agrees to enter into this Agreement and each of the Voting Agreement and Right of First Refusal and Co-Sale Agreement (as such terms are defined in the Purchase Agreement and in each case as may be amended from time to time), as an investor under each such agreement (provided that any Competitor or FOIA Party shall not be entitled to any rights as a Major Investor under this Subsection 3.1).
(a)The Company shall give notice (the “Offer Notice”) to each Major Investor, 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.
(b)By notification to the Company within twenty (20) days after the Offer Notice is given, each Major Investor may elect to purchase or otherwise acquire, at the price and on the terms specified in the Offer Notice, up to that number of such New Securities required in order for (i) the proportion that the Common Stock then held by such Major Investor immediately prior to the issuance of
-14-
such New Securities (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 Major Investor and, for purposes of this Section 3, treating each Convertible Notes Share Equivalent as a share of Common Stock on a 1:1 basis) bears to the total Common Stock of the Company then outstanding immediately prior to the issuance of such New Securities (assuming full conversion and/or exercise, as applicable, of all Preferred Stock and any other Derivative Securities then outstanding and including any shares reserved for issuance under any equity incentive plan or similar plan adopted by the Company but not including any increase to the number of such reserved shares in connection with the issuance of such New Securities) to be equal to (ii) the proportion that the Common Stock held by such Major Investor immediately following the issuance of such New Securities (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 Major Investor) bears to the total Common Stock of the Company outstanding immediately following the issuance of such New Securities (assuming full conversion and/or exercise, as applicable, of all Preferred Stock and any other Derivative Securities then outstanding and including any shares reserved for issuance under any equity incentive plan or similar plan adopted by the Company and including any increase to the number of such reserved shares in connection with the issuance of such New Securities). At the expiration of such twenty (20) day period, the Company shall promptly notify each Major Investor that elects to purchase or acquire all the shares available to it (each, a “Fully Exercising Investor”) of any other Major Investor’s failure to do likewise. During the ten (10) day period commencing after the Company has given such notice, each Fully Exercising Investor may, by giving notice to the Company, elect to purchase or acquire, in addition to the number of shares specified above, up to that portion of the New Securities for which Major Investors were entitled to subscribe but that were not subscribed for by the Major Investors which is equal to the proportion that the Common Stock issued and held, or issuable (directly or indirectly) upon conversion and/or exercise, as applicable, of Preferred Stock and any other Derivative Securities then held, by such Fully Exercising Investor bears to the Common Stock issued and held, or issuable (directly or indirectly) upon conversion and/or exercise, as applicable, of the Preferred Stock and any other Derivative Securities then held, by all Fully Exercising Investors who wish to purchase such unsubscribed shares. The closing of any sale pursuant to this Subsection 3.1(b) shall occur within the later of one hundred and twenty (120) days of the date that the Offer Notice is given and the date of initial sale of New Securities pursuant to Subsection 3.1(c).
(c)If all New Securities referred to in the Offer Notice are not elected to be purchased or acquired as provided in Subsection 3.1(b), the Company may, during the ninety (90) day period following the expiration of the periods provided in Subsection 3.1(b), offer and sell the remaining unsubscribed portion of such New Securities to any Person or Persons at a price not less than, and upon terms no more favorable to the offeree than, those specified in the Offer Notice. If the Company does not enter into an agreement for the sale of the New Securities within such period, or if such agreement is not consummated within thirty (30) days of the execution thereof, the right provided hereunder shall be deemed to be revived and such New Securities shall not be offered unless first reoffered to the Major Investors in accordance with this Subsection 3.1.
(d)The right of first offer in this Subsection 3.1 shall not be applicable to (i) Exempted Securities (as defined in the Certificate of Incorporation); and (ii) shares of Common Stock issued in the IPO.
3.2Termination. The covenants set forth in Subsection 3.1 shall terminate and be of no further force or effect (i) immediately before the consummation of a Qualified IPO or Qualifying Merger (as such terms are defined in the Certificate of Incorporation), (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, or (iii) upon the closing of a Deemed Liquidation Event (as such term is defined in the Certificate of Incorporation), whichever event occurs first.
-15-
4.1Insurance. The Company shall obtain, within sixty (60) days of the date hereof, from financially sound and reputable insurers, Directors and Officers liability insurance in an amount and on terms and conditions satisfactory to the Board of Directors, and will use commercially reasonable efforts to cause such insurance policy to be maintained until such time as the Board of Directors determines that such insurance should be discontinued. The policy shall not be cancelable by the Company without prior approval by the Board of Directors.
4.2Employee Agreements. The Company will cause each Person now or hereafter employed by it or by any subsidiary (or engaged by the Company or any subsidiary as a consultant/independent contractor) with access to confidential information and/or trade secrets to enter into a nondisclosure and proprietary rights assignment agreement. In addition, the Company shall not amend, modify, terminate, waive, or otherwise alter, in whole or in part, any of the above-referenced agreements or any restricted stock agreement between the Company and any employee, without the consent of the Board of Directors.
4.3Board of Directors Matters. The Company will use its best efforts to deliver to each member of the Board of Directors all presentations, reports and other materials to be presented to the Board of Directors at any meeting of or other action to be taken by the Board of Directors at least one (1) day before the Board of Directors meeting or action to which they relate; provided, however, that the failure by the Company to comply with the terms of this Subsection 4.3 shall not in any way invalidate, render void, or otherwise compromise in any way any decision or action by the Board of Directors taken without receipt (or timely receipt) of such presentations, reports or other materials or information.
4.4Matters Requiring Allele Director Approval. So long as Allele Capital Partners, LLC has the right to designate a director (the “Allele Director”), the Company hereby covenants and agrees that it shall not, without the approval of the Allele Director:
(a)make, or permit any subsidiary to make, any loan or advance to any Person, including, without limitation, any employee or director of the Company or any subsidiary, except advances and similar expenditures in the ordinary course of business, under the terms of any employee stock or option plan approved by the Board of Directors, or to officers or directors pursuant to indemnification agreements;
(b) make, or permit any subsidiary to make, any loan or advance to, or own any stock or other securities of, any subsidiary or other corporation, partnership, or other entity unless it is wholly owned by the Company;
(c)guarantee, directly or indirectly, or permit any subsidiary to guarantee, directly or indirectly, any indebtedness except for trade accounts of the Company or any subsidiary arising in the ordinary course of business; or
(d)incur any aggregate indebtedness in excess of $2,000,000 that is not already included in the Company’s budget as approved by the Board of Directors, other than trade credit incurred in the ordinary course of business.
4.5Successor Indemnification. If the Company or any of its successors or assignees consolidates with or merges into any other Person and is not the continuing or surviving corporation or entity of such consolidation or merger, then to the extent necessary, proper provision
-16-
shall be made so that the successors and assignees of the Company assume the obligations of the Company with respect to indemnification of members of the Board of Directors as in effect immediately before such transaction, whether such obligations are contained in the Company’s Bylaws, the Certificate of Incorporation, or elsewhere, as the case may be.
4.6Indemnification Matters. The Company hereby acknowledges that the Allele (subject to certain conditions and restrictions) is entitled to nominate the Allele Director to serve on the Board of Directors and that such Allele Director may have certain rights to indemnification, advancement of expenses and/or insurance provided by Allele and certain of its Affiliates (collectively, the “Allele Indemnitors”). The Company hereby agrees (a) that it is the indemnitor of first resort (i.e., its obligations to the Allele Director are primary and any obligation of the Allele Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by such Allele Director are secondary), (b) that it shall be required to advance the full amount of expenses incurred by such Allele Director and shall be liable for the full amount of all expenses, judgments, penalties, fines and amounts paid in settlement by or on behalf of any such Allele Director to the extent legally permitted and as required by the Company’s Certificate of Incorporation or Bylaws of the Company (or any agreement between the Company and such Allele Director), without regard to any rights such Allele Director may have against the Allele Indemnitors, and, (c) that it irrevocably waives, relinquishes and releases the Allele Indemnitors from any and all claims against the Allele Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof. The Company further agrees that no advancement or payment by the Allele Indemnitors on behalf of any such Allele Director with respect to any claim for which such Allele Director has sought indemnification from the Company shall affect the foregoing and the Allele Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of such Allele Director against the Company. The Allele Director and the Allele Indemnitors are intended third‑party beneficiaries of this Subsection 4.6 and shall have the right, power and authority to enforce the provisions of this Subsection 4.6 as though they were a party to this Agreement.
4.7Termination of Covenants. The covenants set forth in this Section 4, except for Subsection 4.6, shall terminate and be of no further force or effect (i) immediately before the consummation of the Qualified IPO or Qualifying Merger (as such terms are defined in the Certificate of Incorporation), (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, or (iii) upon a Deemed Liquidation Event, as such term is defined in the Certificate of Incorporation, whichever event occurs first.
5.1Successors and Assigns. The rights under this Agreement may be assigned (but only with all related obligations) by a Holder to a transferee of Registrable Securities that (i) is an Affiliate of a Holder; (ii) is a Holder’s Immediate Family Member or trust for the benefit of an individual Holder or one or more of such Holder’s Immediate Family Members; or (iii) after such transfer, holds at least 375,036 shares of Registrable Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations, and other recapitalizations); provided, however, that (x) the Company is, within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee and the Registrable Securities with respect to which such rights are being transferred; and (y) such transferee agrees in a written instrument delivered to the Company to be bound by and subject to the terms and conditions of this Agreement, including the provisions of Subsection 2.10. For the purposes of determining the number of shares of Registrable Securities held by a transferee, the holdings of a transferee (1) that is an Affiliate or stockholder of a Holder; (2) who is a Holder’s Immediate Family Member; or (3) that is a trust for the benefit of
-17-
an individual Holder or such Holder’s Immediate Family Member shall be aggregated together and with those of the transferring Holder; provided further that all transferees who would not qualify individually for assignment of rights shall, as a condition to the applicable transfer, establish a single attorney-in-fact for the purpose of exercising any rights, receiving notices, or taking any action under this Agreement. The terms and conditions of this Agreement inure to the benefit of and are binding upon the respective successors and permitted assignees 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 permitted assignees any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided herein.
5.2Governing Law. This Agreement shall be governed by the internal law 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.
5.3Counterparts. 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 facsimile, 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.
5.4Titles and Subtitles. The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing or interpreting this Agreement.
(a)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 (i) personal delivery to the party to be notified; (ii) when sent, if sent by electronic mail or facsimile during the recipient’s normal business hours, and if not sent during normal business hours, then on the recipient’s next business day; (iii) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (iv) one (1) business day after the business day of deposit with a nationally recognized overnight courier, freight prepaid, specifying next-day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their addresses as set forth on Schedule A or Schedule B (as applicable) hereto, or to the principal office of the Company and to the attention of the Chief Executive Officer, in the case of the Company, or to such email address, facsimile number, or address as subsequently modified by written notice given in accordance with this Subsection 5.5. If notice is given to the Company, a copy (which shall not constitute notice) shall also be sent to Jones Day c/o Taylor Stevens, 4655 Executive Drive, Suite 1500, San Diego, CA 92121.
(b)Consent to Electronic Notice. Each Investor consents to the delivery of 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 or the facsimile number set forth below such Investor’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. To the extent that any notice given by means of electronic transmission is returned or undeliverable for any reason, the foregoing consent shall be deemed to have been revoked until a new or corrected electronic mail address has been provided, and such attempted Electronic Notice shall be ineffective and deemed to not have been given. Each Investor 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.
-18-
5.6Amendments and Waivers. Any term of this Agreement may be amended, modified or terminated 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,the holders of at least a majority of the Registrable Securities then outstanding and the holders of at least a majority of the aggregate principal amount of the Convertible Notes then outstanding; provided that the Company may in its sole discretion waive compliance with Subsection 2.11(c) (and the Company’s failure to object promptly in writing after notification of a proposed assignment allegedly in violation of Subsection 2.11(c) shall be deemed to be a waiver); and provided further 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, (a) 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, if such amendment, modification, termination or waiver would on its face adversely affect the rights of such Investor under this Agreement in a manner disproportionate to any adverse effect such amendment, modification, termination or waiver would have on the rights of the other Investors under this Agreement (it being agreed that a waiver of the provisions of Section 3 with respect to a particular transaction shall be deemed to apply to all Investors proportionately 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 (b) Section 3 and any other section of this Agreement applicable to the Major Investors (including this clause (b) of this Subsection 5.6 may not be amended, modified, terminated or waived without the written consent of the holders of at least a majority of the Registrable Securities then outstanding and held by the Major Investors. Notwithstanding the foregoing, Schedule A hereto may be amended by the Company from time to time to add transferees of any Registrable Securities in compliance with the terms of this Agreement without the consent of the other parties. 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 Subsection 5.6 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 or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.
5.7Severability. In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to the maximum extent permitted by law.
5.8Aggregation of Stock. All shares of Registrable Securities held or acquired by Affiliates shall be aggregated together for the purpose of determining the availability of any rights under this Agreement and such Affiliated persons may apportion such rights as among themselves in any manner they deem appropriate.
5.9Entire Agreement. This Agreement (including any Schedules and Exhibits hereto) constitutes the full and entire understanding and agreement among 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 is expressly canceled.
5.10Dispute Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the Delaware Court of Chancery and to the jurisdiction of the United States District Court for the District of Delaware for the purpose of any suit, action or
-19-
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 Delaware Court of Chancery 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. The prevailing party shall be entitled to reasonable attorney’s fees, costs, and necessary disbursements in addition to any other relief to which such party may be entitled.
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.
5.11Delays 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 nonbreaching or nondefaulting party, nor shall it be construed to be a waiver of or acquiescence to any such breach or default, or to 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. All remedies, whether under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.
5.12Additional Parties. Notwithstanding anything to the contrary contained herein, (i) Bertex, LLC; (ii) each investor in the Convertible Note Financing, and (iii) each person who purchase shares of Preferred Stock from the Company after the date hereof shall become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement and thereafter shall be deemed an “Holder” for all purposes hereunder.
[Remainder of Page Intentionally Left Blank]
-20-
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.
|
|
COMPANY: |
|
|
|
|
|
|
|
|
|
|
|
Coya Therapeutics, Inc. |
|
|
|
|
|
|
|
By: |
/s/ Howard Berman |
|
|
Name: |
Howard Berman |
|
|
Title: |
Chief Executive Officer |
|
|
Email: hberman@coyatherapeutics.com |
Signature Page to First Amended and Restated Investors’ Rights Agreement
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.
|
|
INVESTORS: |
|
|
|
|
|
|
|
By: |
|
|
|
|
|
|
|
Name: |
|
|
|
|
|
|
|
Title: |
|
Signature Page to First Amended and Restated Investors’ Rights Agreement
[***]
Sch. A-1
Exhibit 10.2
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (“Agreement”) is made as of _____, 2022 by and between Coya Therapeutics, Inc., a Delaware corporation (the “Company”), and _____ (“Indemnitee”). This Agreement supersedes and replaces any and all previous Agreements between the Company and Indemnitee covering the subject matter of this Agreement.
RECITALS
WHEREAS, the Board of Directors of the Company (the “Board”) believes that highly competent persons have become more reluctant to serve publicly-held corporations as directors and officers or in other capacities unless they are provided with adequate protection through insurance or adequate indemnification against inordinate risks of claims and actions against them arising out of their service to and activities on behalf of the corporation;
WHEREAS, the Board has determined that, in order to attract and retain qualified individuals, the Company will attempt to maintain on an ongoing basis, at its sole expense, liability insurance to protect persons serving the Company and its subsidiaries from certain liabilities. Although the furnishing of such insurance has been a customary and widespread practice among United States-based corporations and other business enterprises, the Company believes that, given current market conditions and trends, such insurance may be available to it in the future only at higher premiums and with more exclusions. At the same time, directors, officers, and other persons in service to corporations or business enterprises are being increasingly subjected to expensive and time-consuming litigation relating to, among other things, matters that traditionally would have been brought only against the Company or business enterprise itself. The Bylaws (the “Bylaws”) and Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) of the Company each require indemnification of the officers and directors of the Company. Indemnitee may also be entitled to indemnification pursuant to the General Corporation Law of the State of Delaware (the “DGCL”). The Bylaws, Certificate of Incorporation, and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the board of directors, officers and other persons with respect to indemnification;
WHEREAS, the uncertainties relating to such insurance and to indemnification may increase the difficulty of attracting and retaining such persons;
WHEREAS, the Board has determined that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Company and its stockholders and that the Company should act to assure such persons that there will be increased certainty of such protection in the future;
WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons to the fullest
extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified;
WHEREAS, this Agreement is a supplement to and in furtherance of the Bylaws, the Certificate of Incorporation, and any resolutions adopted pursuant thereto, as well as any rights of Indemnitees under any directors’ and officers’ liability insurance policy, and this Agreement shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder; and
WHEREAS, Indemnitee does not regard the protection available under the Bylaws, the Certificate of Incorporation, and insurance as adequate in the present circumstances, and may not be willing to serve or continue to serve as an officer or director without adequate protection, and the Company desires Indemnitee to serve or continue to serve in such capacity. Indemnitee is willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that Indemnitee be so indemnified.
NOW, THEREFORE, in consideration of the premises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:
Section 1.Services to the Company. Indemnitee agrees to serve as a director or officer of the Company, at the request of the Company, as a director or officer of another corporation, partnership, joint venture, trust or other enterprise. Indemnitee may at any time and for any reason resign from such position (subject to any other contractual obligation or any obligation imposed by operation of law), in which event the Company shall have no obligation under this Agreement to continue Indemnitee in such position. This Agreement shall not be deemed an employment contract between the Company (or any of its subsidiaries or any Enterprise) and Indemnitee. Indemnitee specifically acknowledges that Indemnitee’s employment with the Company (or any of its subsidiaries or any Enterprise), if any, is at will, and the Indemnitee may be discharged at any time for any reason, with or without cause, except as may be otherwise provided in any written employment contract between Indemnitee and the Company (or any of its subsidiaries or any Enterprise), other applicable formal severance policies duly adopted by the Board, or, with respect to service as a director or officer of the Company, by the Certificate of Incorporation, the Bylaws, and the DGCL. The foregoing notwithstanding, this Agreement shall continue in force after Indemnitee has ceased to serve as an officer or director of the Company, at the request of the Company, as a director or officer of another corporation, partnership, joint venture, trust or other enterprise, as provided in Section 16 hereof.
Section 2.Definitions. As used in this Agreement:
(a)References to “agent” shall mean any person who is or was a director, officer, or employee of the Company or a subsidiary of the Company or other person authorized by the Company to act for the Company, to include such person serving in such capacity as a director, officer, employee, fiduciary or other official of another corporation, partnership, limited
-2-
liability company, joint venture, trust or other enterprise at the request of, for the convenience of, or to represent the interests of the Company or a subsidiary of the Company.
(b)A “Change in Control” shall be deemed to occur upon the earliest to occur after the date of this Agreement of any of the following events:
i.Acquisition of Stock by Third Party. Any Person (as defined below) is or becomes the Beneficial Owner (as defined below), directly or indirectly, of securities of the Company representing thirty five percent (35%) or more of the combined voting power of the Company’s then outstanding securities unless the change in relative Beneficial Ownership of the Company’s securities by any Person results solely from a reduction in the aggregate number of outstanding shares of securities entitled to vote generally in the election of directors;
ii.Change in Board of Directors. During any period of two (2) consecutive years (not including any period prior to the execution of this Agreement), individuals who at the beginning of such period constitute the Board, and any new director (other than a director designated by a person who has entered into an agreement with the Company to effect a transaction described in Sections 2(b)(i), 2(b)(iii) or 2(b)(iv)) whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved, cease for any reason to constitute at least a majority of the members of the Board;
iii.Corporate Transactions. The effective date of a merger or consolidation of the Company with any other entity, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the Surviving Entity) more than 50% of the combined voting power of the voting securities of the Surviving Entity outstanding immediately after such merger or consolidation and with the power to elect at least a majority of the board of directors or other governing body of such Surviving Entity;
iv.Liquidation. The approval by the stockholders of the Company of a complete liquidation of the Company or an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets; and
v.Other Events. There occurs any other event of a nature that would be required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or a response to any similar item on any similar schedule or form) promulgated under the Exchange Act (as defined below), whether or not the Company is then subject to such reporting requirement.
For purposes of this Section 2(b), the following terms shall have the following meanings:
-3-
(A)“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended from time to time.
(B)“Person” shall have the meaning as set forth in Sections 13(d) and 14(d) of the Exchange Act; provided, however, that Person shall exclude (i) the Company, (ii) any trustee or other fiduciary holding securities under an employee benefit plan of the Company, and (iii) any entity owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company.
(C)“Beneficial Owner” shall have the meaning given to such term in Rule 13d-3 under the Exchange Act; provided, however, that Beneficial Owner shall exclude any Person otherwise becoming a Beneficial Owner by reason of the stockholders of the Company approving a merger of the Company with another entity.
(d)“Surviving Entity” shall mean the surviving entity in a merger or consolidation or any entity that controls, directly or indirectly, such surviving entity.
(c)“Corporate Status” describes the status of a person who is or was a director, trustee, partner, managing member, officer, employee, agent or fiduciary of the Company or of any other corporation, limited liability company, partnership or joint venture, trust or other enterprise which such person is or was serving at the request of the Company.
(d)“Disinterested Director” shall mean a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee.
(e)“Enterprise” shall mean the Company and any other corporation, limited liability company, partnership, joint venture, trust or other enterprise of which Indemnitee is or was serving at the request of the Company as a director, officer, trustee, partner, managing member, employee, agent or fiduciary.
(f)“Expenses” shall include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees and other costs of experts and other professionals, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, any federal, state, local or foreign taxes imposed on Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement, ERISA excise taxes and penalties, and all other disbursements, obligations or expenses of the types customarily incurred in connection with, or as a result of, prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be a deponent or witness in, or otherwise participating in, a Proceeding. Expenses also shall include (i) Expenses incurred in connection with any appeal
-4-
resulting from any Proceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersedeas bond, or other appeal bond or its equivalent, (ii) Expenses incurred in connection with recovery under any directors’ and officers’ liability insurance policies maintained by the Company, regardless of whether Indemnitee is ultimately determined to be entitled to such indemnification, advancement or Expenses or insurance recovery, as the case may be, and (iii) for purposes of Section 14(d) only, Expenses incurred by Indemnitee in connection with the interpretation, enforcement or defense of Indemnitee’s rights under this Agreement, the Certificate of Incorporation, the Bylaws or under any directors’ and officers’ liability insurance policies maintained by the Company, by litigation or otherwise. The parties agree that for the purposes of any advancement of Expenses for which Indemnitee has made written demand to the Company in accordance with this Agreement, all Expenses included in such demand that are certified by affidavit of Indemnitee’s counsel as being reasonable in the good faith judgment of such counsel shall be presumed conclusively to be reasonable. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of judgments or fines against Indemnitee.
(g)“Independent Counsel” shall mean a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five years has been, retained to represent: (i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning the Indemnitee under this Agreement, or of other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the reasonable fees and expenses of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
(h)The term “Proceeding” shall include any threatened, pending or completed action, suit, claim, counterclaim, cross claim, arbitration, mediation, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether brought in the right of the Company or otherwise and whether of a civil, criminal, administrative, legislative, regulatory or investigative (formal or informal) nature, including any appeal therefrom, in which Indemnitee was, is or will be involved as a party, potential party, non-party witness or otherwise by reason of Indemnitee’s Corporate Status, by reason of any action taken by Indemnitee (or a failure to take action by Indemnitee) or of any action (or failure to act) on Indemnitee’s part while acting pursuant to Indemnitee’s Corporate Status, in each case whether or not serving in such capacity at the time any liability or Expense is incurred for which indemnification, reimbursement, or advancement of Expenses can be provided under this Agreement. If the Indemnitee believes in good faith that a given situation may lead to or culminate in the institution of a Proceeding, this shall be considered a Proceeding under this paragraph.
-5-
(i)Reference to “other enterprise” shall include employee benefit plans; references to “fines” shall include any excise tax assessed with respect to any employee benefit plan; references to “serving at the request of the Company” shall include any service as a director, officer, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, employee or agent with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner Indemnitee reasonably believed to be in the best interests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Company” as referred to in this Agreement.
Section 3.Indemnity in Third-Party Proceedings. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 3 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding, other than a Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified to the fullest extent permitted by applicable law against all Expenses, judgments, fines and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses, judgments, fines and amounts paid in settlement) actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company and, in the case of a criminal Proceeding had no reasonable cause to believe that Indemnitee’s conduct was unlawful. The parties hereto intend that this Agreement shall provide to the fullest extent permitted by law for indemnification in excess of that expressly permitted by statute, including, without limitation, any indemnification provided by the Certificate of Incorporation, the Bylaws, vote of the Company’s stockholders or disinterested directors or applicable law.
Section 4.Indemnity in Proceedings by or in the Right of the Company. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 4 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 4, Indemnitee shall be indemnified to the fullest extent permitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company. No indemnification for Expenses shall be made under this Section 4 in respect of any claim, issue or matter as to which Indemnitee shall have been finally adjudged by a court to be liable to the Company, unless and only to the extent that the Delaware Court (as hereinafter defined) or any court in which the Proceeding was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnification.
Section 5.Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provisions of this Agreement, to the fullest extent permitted by applicable law and to the extent that Indemnitee is a party to (or a participant in)
-6-
and is successful, on the merits or otherwise, in any Proceeding or in defense of any claim, issue or matter therein, in whole or in part, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by or on behalf of Indemnitee in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with or related to each successfully resolved claim, issue or matter to the fullest extent permitted by law. For purposes of this Section and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
Section 6.Indemnification For Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the fullest extent permitted by applicable law and to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a witness, is or was made (or asked) to respond to discovery requests in any Proceeding, or otherwise asked to participate in any Proceeding to which Indemnitee is not a party, Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith.
Section 7.Partial Indemnification. If Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of Expenses, but not, however, for the total amount thereof, the Company shall nevertheless indemnify Indemnitee for the portion thereof to which Indemnitee is entitled.
Section 8.Additional Indemnification.
(a)Notwithstanding any limitation in Sections 3, 4, or 5, the Company shall indemnify Indemnitee to the fullest extent permitted by applicable law if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding (including a Proceeding by or in the right of the Company to procure a judgment in its favor) by reason of Indemnitee’s Corporate Status.
(b)For purposes of Section 8(a), the meaning of the phrase “to the fullest extent permitted by applicable law” shall include, but not be limited to:
i.to the fullest extent permitted by the provision of the DGCL that authorizes or contemplates additional indemnification by agreement, or the corresponding provision of any amendment to or replacement of the DGCL, and
ii.to the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its officers and directors.
-7-
Section 9.Exclusions. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnification payment in connection with any claim involving Indemnitee:
(a)for which payment has actually been made to or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess beyond the amount paid under any insurance policy or other indemnity provision; or
(b)for (i) an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of Section 16(b) of the Exchange Act (as defined in Section 2(b) hereof) or similar provisions of state statutory law or common law, (ii) any reimbursement of the Company by the Indemnitee of any bonus or other incentive-based or equity-based compensation or of any profits realized by the Indemnitee from the sale of securities of the Company, as required in each case under the Exchange Act (including any such reimbursements that arise from an accounting restatement of the Company pursuant to Section 304 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), or the payment to the Company of profits arising from the purchase and sale by Indemnitee of securities in violation of Section 306 of the Sarbanes-Oxley Act) or (iii) any reimbursement of the Company by Indemnitee of any compensation pursuant to any compensation recoupment or clawback policy adopted by the Board or the compensation committee of the Board, including but not limited to any such policy adopted to comply with stock exchange listing requirements implementing Section 10D of the Exchange Act; or
(c)except as provided in Section 14(d) of this Agreement, in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Proceeding (or any part of any Proceeding) prior to its initiation, (ii) such payment arises in connection with any mandatory counterclaim or cross claim brought or raised by Indemnitee in any Proceeding (or any part of any Proceeding), or (iii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law.
Section 10.Advances of Expenses. Notwithstanding any provision of this Agreement to the contrary (other than Section 14(d)), the Company shall advance, to the extent not prohibited by law, the Expenses incurred by or on behalf of Indemnitee in connection with any Proceeding (or any part of any Proceeding) not initiated by Indemnitee or any Proceeding initiated by Indemnitee with the prior approval of the Board as provided in Section 9(c), and such advancement shall be made within thirty (30) days after the receipt by the Company of a statement or statements requesting such advances from time to time, whether prior to or after final disposition of any Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the Expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. In accordance with Section 14(d), advances shall include any and all reasonable Expenses incurred pursuing an action to enforce this right of advancement, including Expenses
-8-
incurred preparing and forwarding statements to the Company to support the advances claimed. The Indemnitee shall qualify for advances upon the execution and delivery to the Company of this Agreement, which shall constitute an undertaking providing that the Indemnitee undertakes to repay the amounts advanced (without interest) by the Company pursuant to this Section 10, if and only to the extent that it is ultimately determined that Indemnitee is not entitled to be indemnified by the Company. No other form of undertaking shall be required other than the execution of this Agreement. This Section 10 shall not apply to any claim made by Indemnitee for which indemnity is excluded pursuant to Section 9.
Section 11.Procedure for Notification and Defense of Claim.
(a)Indemnitee shall notify the Company in writing of any matter with respect to which Indemnitee intends to seek indemnification or advancement of Expenses hereunder as soon as reasonably practicable following the receipt by Indemnitee of written notice thereof. The written notification to the Company shall include a description of the nature of the Proceeding and the facts underlying the Proceeding. To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification following the final disposition of such Proceeding. The omission by Indemnitee to notify the Company hereunder will not relieve the Company from any liability which it may have to Indemnitee hereunder or otherwise than under this Agreement, and any delay in so notifying the Company shall not constitute a waiver by Indemnitee of any rights under this Agreement. The Secretary of the Company shall, promptly upon receipt of such a request for indemnification, advise the Board in writing that Indemnitee has requested indemnification.
(b)The Company will be entitled to participate in the Proceeding at its own expense.
(c)The Company shall not settle any Proceeding (in whole or in part) if such settlement would impose any Expense, judgment, liability, fine, penalty or limitation on Indemnitee in respect of which Indemnitee is not entitled to be indemnified hereunder without Indemnitee’s prior written consent, which shall not be unreasonably withheld.
Section 12.Procedure Upon Application for Indemnification.
(a)Upon written request by Indemnitee for indemnification pursuant to Section 11(a), a determination, if required by applicable law, with respect to Indemnitee’s entitlement thereto shall be made in the specific case: (i) if a Change in Control shall have occurred, by Independent Counsel in a written opinion to the Board, a copy of which shall be delivered to Indemnitee; or (ii) if a Change in Control shall not have occurred, (A) by a majority vote of the Disinterested Directors, even though less than a quorum of the Board, (B) by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though less than a quorum of the Board, (C) if there are no such Disinterested Directors or, if such Disinterested Directors so direct, by Independent Counsel in a written
-9-
opinion to the Board, a copy of which shall be delivered to Indemnitee or (D) if so directed by the Board, by the stockholders of the Company; and, if it is so determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made within ten (10) days after such determination. Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. Any costs or Expenses (including attorneys’ fees and disbursements) incurred by or on behalf of Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom. The Company promptly will advise Indemnitee in writing with respect to any determination that Indemnitee is or is not entitled to indemnification, including a description of any reason or basis for which indemnification has been denied.
(b)In the event the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 12(a) hereof, the Independent Counsel shall be selected as provided in this Section 12(b). If a Change in Control shall not have occurred, the Independent Counsel shall be selected by the Board, and the Company shall give written notice to Indemnitee advising Indemnitee of the identity of the Independent Counsel so selected. If a Change in Control shall have occurred, the Independent Counsel shall be selected by Indemnitee (unless Indemnitee shall request that such selection be made by the Board, in which event the preceding sentence shall apply), and Indemnitee shall give written notice to the Company advising it of the identity of the Independent Counsel so selected. In either event, Indemnitee or the Company, as the case may be, may, within ten (10) days after such written notice of selection shall have been given, deliver to the Company or to Indemnitee, as the case may be, a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 2 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If such written objection is so made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or the Delaware Court has determined that such objection is without merit. If, within twenty (20) days after the later of submission by Indemnitee of a written request for indemnification pursuant to Section 11(a) hereof and the final disposition of the Proceeding, no Independent Counsel shall have been selected and not objected to, either the Company or Indemnitee may petition the Delaware Court for resolution of any objection which shall have been made by the Company or Indemnitee to the other’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by such court or by such other person as such court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under Section 12(a) hereof. Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 14(a) of this Agreement, Independent Counsel shall be discharged and
-10-
relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).
(c)If the Company disputes a portion of the amounts for which indemnification is requested, the undisputed portion shall be paid and only the disputed portion withheld pending resolution of any such dispute.
Section 13.Presumptions and Effect of Certain Proceedings.
(a)In making a determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination shall, to the fullest extent not prohibited by law, presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee has submitted a request for indemnification in accordance with Section 11(a) of this Agreement, and the Company shall, to the fullest extent not prohibited by law, have the burden of proof to overcome that presumption in connection with the making by any person, persons or entity of any determination contrary to that presumption. Neither the failure of the Company (including by its directors or Independent Counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including by its directors or Independent Counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
(b)Subject to Section 14(e), if the person, persons or entity empowered or selected under Section 12 of this Agreement to determine whether Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of the request therefor, the requisite determination of entitlement to indemnification shall, to the fullest extent not prohibited by law, be deemed to have been made and Indemnitee shall be entitled to such indemnification, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making the determination with respect to entitlement to indemnification in good faith requires such additional time for the obtaining or evaluating of documentation and/or information relating thereto; and provided, further, that the foregoing provisions of this Section 13(b) shall not apply (i) if the determination of entitlement to indemnification is to be made by the stockholders pursuant to Section 12(a) of this Agreement and if (A) within fifteen (15) days after receipt by the Company of the request for such determination the Board has resolved to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (B) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat, or (ii)
-11-
if the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 12(a) of this Agreement.
(c)The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful.
(d)For purposes of any determination of good faith, Indemnitee shall be deemed to have acted in good faith if Indemnitee’s action is based on the records or books of account of the Enterprise, including financial statements, or on information supplied to Indemnitee by the directors or officers of the Enterprise in the course of their duties, or on the advice of legal counsel for the Enterprise or on information or records given or reports made to the Enterprise by an independent certified public accountant or by an appraiser, financial advisor or other expert selected with reasonable care by or on behalf of the Enterprise. The provisions of this Section 13(d) shall not be deemed to be exclusive or to limit in any way the other circumstances in which the Indemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement.
(e)The knowledge and/or actions, or failure to act, of any director, officer, trustee, partner, managing member, fiduciary, agent or employee of the Enterprise shall not be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.
Section 14.Remedies of Indemnitee.
(a)Subject to Section 14(e), in the event that (i) a determination is made pursuant to Section 12 of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 10 of this Agreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 12(a) of this Agreement within ninety (90) days after receipt by the Company of the request for indemnification, (iv) payment of indemnification is not made pursuant to Section 5, 6 or 7 or the second to last sentence of Section 12(a) of this Agreement within ten (10) days after receipt by the Company of a written request therefor, (v) payment of indemnification pursuant to Section 3, 4 or 8 of this Agreement is not made within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification, or (vi) the Company or any other person takes or threatens to take any action to declare this Agreement void or unenforceable, or institutes any litigation or other action or Proceeding designed to deny, or to recover from, the Indemnitee the benefits provided or intended to be provided to the Indemnitee hereunder, Indemnitee shall be entitled to an adjudication by a court of Indemnitee’s entitlement to such indemnification or advancement of Expenses. Alternatively, Indemnitee, at Indemnitee’s option, may seek an award in arbitration to be conducted by a single arbitrator
-12-
pursuant to the Commercial Arbitration Rules of the American Arbitration Association. Indemnitee shall commence such proceeding seeking an adjudication or an award in arbitration within 180 days following the date on which Indemnitee first has the right to commence such proceeding pursuant to this Section 14(a). The Company shall not oppose Indemnitee’s right to seek any such adjudication or award in arbitration.
(b)In the event that a determination shall have been made pursuant to Section 12(a) of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to this Section 14 shall be conducted in all respects as a de novo trial, or arbitration, on the merits and Indemnitee shall not be prejudiced by reason of that adverse determination. In any judicial proceeding or arbitration commenced pursuant to this Section 14 the Company shall have the burden of proving Indemnitee is not entitled to indemnification or advancement of Expenses, as the case may be.
(c)If a determination shall have been made pursuant to Section 12(a) of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding or arbitration commenced pursuant to this Section 14, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law.
(d)The Company shall, to the fullest extent not prohibited by law, be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Section 14 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company is bound by all the provisions of this Agreement. It is the intent of the Company that, to the fullest extent permitted by law, the Indemnitee not be required to incur legal fees or other Expenses associated with the interpretation, enforcement or defense of Indemnitee’s rights under this Agreement by litigation or otherwise because the cost and expense thereof would substantially detract from the benefits intended to be extended to the Indemnitee hereunder. The Company shall, to the fullest extent permitted by law, indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within ten (10) days after receipt by the Company of a written request therefor) advance, to the extent not prohibited by law, such Expenses to Indemnitee, which are incurred by or on behalf of Indemnitee in connection with any action brought by Indemnitee for indemnification or advancement of Expenses from the Company under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company if, in the case of indemnification, Indemnitee is wholly successful on the underlying claims; if Indemnitee is not wholly successful on the underlying claims, then such indemnification shall be only to the extent Indemnitee is successful on such underlying claims or otherwise as permitted by law, whichever is greater.
(e)Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement of Indemnitee to indemnification under this Agreement shall be required to be made prior to the final disposition of the Proceeding.
-13-
Section 15.Non-exclusivity; Survival of Rights; Insurance; Subrogation.
(a)The rights of indemnification and to receive advancement of Expenses as provided by this Agreement (i) shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Certificate of Incorporation, the Bylaws, any agreement, a vote of stockholders or a resolution of directors, or otherwise and (ii) shall be interpreted independently of, and without reference to, any other such rights to which Indemnitee may at any time be entitled. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by Indemnitee in Indemnitee’s Corporate Status prior to such amendment, alteration or repeal. To the extent that a change in Delaware law, whether by statute or judicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Bylaws, the Certificate of Incorporation, and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.
(b)To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, employees, or agents of the Enterprise, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any such director, officer, employee or agent under such policy or policies. If, at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of such claim or of the commencement of a Proceeding, as the case may be, to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.
(c)In the event of any payment made by the Company under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
(d)The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise.
(e)The Company’s obligation to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, trustee,
-14-
partner, managing member, fiduciary, employee or agent of any other corporation, limited liability company, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of Expenses from such other corporation, limited liability company, partnership, joint venture, trust or other enterprise.
Section 16.Duration of Agreement. This Agreement shall continue until and terminate upon the later of: (a) ten (10) years after the date that Indemnitee shall have ceased to serve as a director or officer of the Company or (b) one (1) year after the final termination of any Proceeding then pending in respect of which Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding (including any appeal thereof) commenced by Indemnitee pursuant to Section 14 of this Agreement relating thereto. The indemnification and advancement of expenses rights provided by or granted pursuant to this Agreement shall be binding upon and be enforceable by the parties hereto and their respective successors and assigns (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company), shall continue as to an Indemnitee who has ceased to be a director, officer, employee or agent of the Company or of any other Enterprise, and shall inure to the benefit of Indemnitee and Indemnitee’s spouse, assigns, heirs, devisees, executors and administrators and other legal representatives. The Company shall require and shall cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company to, by written agreement, expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.
Section 17.Severability. Nothing in this Agreement is intended to require or shall be construed as requiring the Company to do or fail to do any act in violation of applicable law. If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Agreement (including without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (b) such provision or provisions shall be deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (c) to the fullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested thereby.
Section 18.Enforcement.
(a)The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligations imposed on it hereby in order to induce Indemnitee to serve as a director or officer of the Company, and the Company acknowledges that Indemnitee is
-15-
relying upon this Agreement in serving or continuing to serve as a director or officer of the Company.
(b)This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof; provided, however, that this Agreement is a supplement to and in furtherance of the Certificate of Incorporation, the Bylaws, any directors’ and officers’ insurance maintained by the Company and applicable law, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder.
Section 19.Modification and Waiver. No supplement, modification or amendment of this Agreement shall be binding unless executed in writing by the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement nor shall any waiver constitute a continuing waiver.
Section 20.Notice by Indemnitee. Indemnitee agrees promptly to notify the Company in writing upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification or advancement of Expenses covered hereunder. The failure of Indemnitee to so notify the Company shall not relieve the Company of any obligation which it may have to the Indemnitee under this Agreement or otherwise.
Section 21.Notices. All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed to have been duly given if (a) delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed, (b) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed, (c) mailed by reputable overnight courier and receipted for by the party to whom said notice or other communication shall have been directed or (d) sent by facsimile transmission, with receipt of oral confirmation that such transmission has been received:
(a)If to Indemnitee, at the address indicated on the signature page of this Agreement, or such other address as Indemnitee shall provide to the Company.
(b)If to the Company to
Coya Therapeutics, Inc.
5850 San Felipe St Suite 500
Houston TX 77057
Attention: Chairman of the Board
or to any other address as may have been furnished to Indemnitee by the Company.
Section 22.Contribution. To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason
-16-
whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transaction(s).
Section 23.Applicable Law and Consent to Jurisdiction. This Agreement and the legal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. Except with respect to any arbitration commenced by Indemnitee pursuant to Section 14(a) of this Agreement, the Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Court of Chancery of the State of Delaware (the “Delaware Court”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent such party is not otherwise subject to service of process in the State of Delaware, irrevocably Corporation Services Company as its agent in the State of Delaware as such party’s agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legal force and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper or inconvenient forum.
Section 24.Identical Counterparts. This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.
Section 25.Miscellaneous. Use of the masculine pronoun shall be deemed to include usage of the feminine pronoun where appropriate. The headings of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.
-17-
IN WITNESS WHEREOF, the parties have caused this Agreement to be signed as of the day and year first above written.
COYA THERAPEUTICS, INC. |
|
INDEMNITEE |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By: |
|
|
|
|
||
Name: |
|
|
|
Name: |
|
|
Office: |
|
|
|
Address: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-18-
EXECUTIVE EMPLOYMENT AGREEMENT
This Executive Employment Agreement (“Agreement”), dated December 15, 2020 (“Effective Date”), is between Coya Therapeutics, Inc. (the “Company”) and Howard Berman (“Executive”).
1.Position, Responsibilities, and term
a.Position. Executive is employed by the Company to render services to the Company in the position of Chief Executive Officer. Executive shall perform such duties and responsibilities as are normally related to such position in accordance with the standards of the industry and any additional duties now or hereafter assigned to Executive by the Company’s Board of Directors (“Board”) (“Services”). Executive shall abide by the rules, regulations, and practices as adopted or modified from time to time in the Company’s sole discretion. Executive will devote Executive’s full time efforts to the provision of Services under this Agreement. If the Executive is transferred to another position within the Company by the Board during the Term, Executive will continue to receive the compensation and benefits set forth in Section 2.
b.Other Activities. Except upon the prior written consent of the Company, Executive will not, during the term of this Agreement: (i) acquire any interest of any type in any other business which is in competition with the Company, provided, however, that the foregoing shall not be deemed to prohibit the Executive from acquiring solely as an investment up to one percent (1%) of the outstanding equity interests of any publicly-held company.
c.No Conflict. Executive represents and warrants that Executive’s execution of this Agreement and performance of Services under this Agreement will not violate any obligations Executive may have to any other employer, person or entity, including any obligations to keep in confidence proprietary information, knowledge, or data acquired by Executive in confidence or in trust prior to becoming an employee of the Company.
d.Term of Employment. The initial term of this Agreement shall be for a period of (i) two (2) years after the Effective Date of this Agreement (“Initial Term”); or (ii) the date upon which Executive’s employment is terminated in accordance with Section 3. This Agreement shall be automatically renewed for additional one (1) year terms (each an “Extension Term”) upon the expiration of the Initial Term and each Extension Term, unless either party gives the other party a written notice of termination not less than thirty (30) days prior to the date of expiration of the Initial Term or any Extension Term (together, the Initial Term and all Extension Terms are referred to herein as the “Term”). Where the Agreement is terminated upon notice and the expiration of the Initial Term or an Extension Term, the Company shall pay to Executive all compensation to which Executive is entitled up through the effective date of termination according to its normal payroll practices, and the Company shall not have any further obligations under this Agreement.
2.Compensation and Benefits
a.Base Salary. In consideration of the Services to be rendered under this Agreement, the Company shall pay Executive a gross salary at the rate of $300,000 per year, less applicable
withholdings (“Base Salary”). The Base Salary shall be paid in accordance with the Company’s normal payroll practices. Executive’s Base Salary will be reviewed from time to time in accordance with the established procedures of the Company for adjusting salaries for similarly situated employees and may be adjusted in the sole discretion of the Company. Following an offering of equity or debt securities of the Company with gross proceeds to the Company of no less than $20 million and a pre-offering valuation of at least $50 million during the Term, Executive’s Base Salary shall be increased to $450,000 per year.
b.Annual Bonus. In further consideration of the Services to be rendered under this Agreement, Executive shall be eligible to receive an annual bonus of up to 20 % of Base Salary, less applicable withholdings, based on achievement of goals and objectives established by the Company (“Annual Bonus”). Any Annual Bonus earned by Executive will be paid within two-and-one-half months of the end of the year in which it was earned. Executive must remain employed with the Company through the end of the calendar year at issue in order to be eligible to receive the Annual Bonus.
c.Signing Bonus. In further consideration of the Services to be rendered under this Agreement, the Company shall pay Executive a signing bonus of $25,000, less applicable withholdings, within one week of the Effective Date.
d.Employment Benefits Plans. In further consideration of the Services to be rendered under this Agreement, Executive will be entitled to participate in pension, profit sharing and other retirement plans, incentive compensation plans, group health, hospitalization and disability or other insurance plans, and other employee welfare benefit plans generally made available to other similarly-situated employees of the Company, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company’s sole discretion.
e.Vacation. Executive shall be eligible to receive paid vacation consistent with the policies and procedures adopted by the Company, if any, in its sole discretion.
f.Expenses. The Company will pay or reimburse Executive for all normal and reasonable travel and entertainment expenses incurred by Executive in connection with Executive’s responsibilities to the Company upon submission of proper vouchers and documentation in accordance with the Company’s expense reimbursement policy.
g.Car Allowance. The Company will provide Executive with a car allowance of $500 per month, less applicable withholdings.
3.At-Will Employment
The employment of Executive shall be “at-will” at all times. The Company or Executive may terminate Executive’s employment with the Company at any time, without any advance notice, for any reason or no reason at all, notwithstanding anything to the contrary contained in or arising from any statements, policies or practices of the Company relating to the employment, discipline or termination of its employees. Following the termination of Executive’s employment, the Company shall pay to Executive all compensation to which Executive is entitled up through
the date of termination. Thereafter, all obligations of the Company under this Agreement shall cease other than those set forth in Section 4.
4.Company Termination Obligations
a.Termination by Company for Cause. Where the Company terminates Executive’s employment for Cause, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3. For purposes of this Agreement, “Cause” shall mean: (i) Executive engages in misconduct, including but not limited to misappropriation of trade secrets, fraud, or embezzlement; (ii) Executive commits a crime involving dishonesty, breach of trust, or physical harm to any person; (iii) Executive breaches this Agreement; (iv) Executive refuses to implement or follow a lawful policy or directive of the Company; (v) Executive engages in misfeasance or malfeasance demonstrated by Executive’s failure to perform Executive’s job duties diligently and/or professionally; or (vi) Executive violates a Company policy or procedure which causes harm to the Company, including violation of the Company’s policy concerning sexual harassment, discrimination or retaliation.
b.Termination by Company without Cause. Where the Company terminates Executive’s employment without Cause, and Executive’s employment is not terminated due to death or Disability (as defined below), Executive will be eligible to receive continued payment of Base Salary for twelve (12) months according to the Company’s normal payroll practices, less applicable withholdings and any remuneration paid to Executive during each applicable Company payroll period because of Executive’s employment or self-employment during such period. Executive’s eligibility to receive the severance set forth in this Section 4(b) is conditioned on Executive having first signed the Company’s form severance and general release agreement in the form provided by the Company and the release becoming irrevocable by its terms within fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service, as such term is defined in Section 4(g)). All other obligations of the Company under this Agreement shall cease.
c.Termination Due to Disability. Executive’s employment shall terminate automatically if Executive becomes Disabled. Executive shall be deemed Disabled if Executive is unable for medical reasons to perform Executive’s essential job duties for either ninety (90) consecutive calendar days or one hundred twenty (120) business days in a twelve (12) month period and, within thirty (30) days after a notice of termination is given to Executive, Executive has not returned to work. If Executive’s employment is terminated by the Company due to Executive’s Disability, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
d.Termination Due to Death. Executive’s employment shall terminate automatically upon Executive’s death. If Executive’s employment is terminated due to Executive’s death, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
e.Executive’s Resignation. Executive may resign Executive’s employment at any time during the Term of this Agreement pursuant to Section 3, and thereafter, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
-2-
f.Timing of Payments. In the event that Executive becomes entitled to receive continued payment of Base Salary pursuant to Section 4(b), Executive shall not be entitled to receive any such payments until the Company’s first payroll date that is coincident with or next following the date that is fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service) and any payments that otherwise would have been paid to Executive during such period shall be paid to Executive with the first installment paid to Executive following the end of such period. Any pro-rated Annual Bonus that becomes payable to Executive pursuant to Section 4(b) shall be paid to Executive in a lump sum payment on the date that Executive receives the first installment payment of continued Base Salary as provided in the preceding sentence.
g.Section 409A; Delayed Payments. To the extent applicable, the provisions in this Section 4 are intended to comply with Section 409A of the Internal Revenue Code of 1986, as amended, and guidance promulgated thereunder (“409A”) and this Agreement shall be administered and construed in a manner consistent with this intent. In the event that any compensation that becomes payable to Executive pursuant to this Section 4 qualifies as a deferral of compensation within the meaning of and subject to 409A, then, notwithstanding anything to the contrary in this Agreement (i) such compensation shall be paid to Executive only in the event of Executive’s “separation from service” with the Company within the meaning of 409A (“Separation from Service”) and (ii) payment of that compensation shall be delayed if Executive is a “specified employee,” as defined in 409A(a)(2)(B)(i), and such delayed payment is required by 409A. Such delay shall last six (6) months from the date of Executive’s Separation from Service. On the Company’s first payroll date that occurs after the end of such six-month period, the Company shall make a catch-up payment to Executive equal to the total amount of such payments that would have been made during the six-month period but for this Section 4(g). To the extent applicable, each and every payment to be made pursuant to Section 4(b) shall be treated as a separate payment and not as one of a series of payments treated as a single payment for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii).
5.Executive Termination Obligations
a.Return of Property. Executive agrees that all property (including without limitation all equipment, tangible proprietary information, documents, records, notes, contracts and computer-generated materials) furnished to or created or prepared by Executive incident to Executive’s employment belongs to the Company and shall be promptly returned to the Company upon termination of Executive’s employment.
b.Resignation and Cooperation. Upon termination of Executive’s employment, Executive shall be deemed to have resigned from all offices and directorships then held with the Company. Following any termination of employment, Executive shall cooperate with the Company in the winding up of pending work on behalf of the Company and the orderly transfer of work to other employees. Executive shall also cooperate with the Company in the defense of any action brought by any third party against the Company that relates to Executive’s employment by the Company.
-3-
c.Continuing Obligations. Executive understands and agrees that Executive’s obligations under Sections 6 and 7 herein (including Exhibits A and B) shall survive the termination of Executive’s employment for any reason and the termination of this Agreement.
6.Inventions and Proprietary Information
Executive agrees to sign and be bound by the terms of the Proprietary Information and Inventions Agreement, which is attached as Exhibit A (“Proprietary Information Agreement”).
7.Arbitration
Executive agrees to sign and be bound by the terms of the Mutual Arbitration Agreement, which is attached as Exhibit B (“Mutual Arbitration Agreement”).
8.Amendments; Waivers; Remedies
This Agreement may not be amended or waived except by a writing signed by Executive and by the Company’s Board. Failure to exercise any right under this Agreement shall not constitute a waiver of such right. Any waiver of any breach of this Agreement shall not operate as a waiver of any subsequent breaches. All rights or remedies specified for a party herein shall be cumulative and in addition to all other rights and remedies of the party hereunder or under applicable law.
9.Assignment; Binding Effect
a.Assignment. The performance of Executive is personal hereunder, and Executive agrees that Executive shall have no right to assign and shall not assign or purport to assign any rights or obligations under this Agreement. This Agreement may be assigned or transferred by the Company; and nothing in this Agreement shall prevent the consolidation, merger or sale of the Company or a sale of any or all or substantially all of its assets.
b.Binding Effect. Subject to the foregoing restriction on assignment by Executive, this Agreement shall inure to the benefit of and be binding upon each of the parties; the affiliates, officers, directors, agents, successors and assigns of the Company; and the heirs, devisees, spouses, legal representatives and successors of Executive.
10.Notices
All notices or other communications required or permitted hereunder shall be made in writing and shall be deemed to have been duly given if delivered: (a) by hand; (b) by a nationally recognized overnight courier service; or (c) by United States first class registered or certified mail, return receipt requested, to the principal address of the other party.
11.Severability
If any provision of this Agreement shall be held by a court or arbitrator to be invalid, unenforceable, or void, such provision shall be enforced to the fullest extent permitted by law, and the remainder of this Agreement shall remain in full force and effect. In the event that the time period or scope of any provision is declared by a court or arbitrator of competent jurisdiction to
-4-
exceed the maximum time period or scope that such court or arbitrator deems enforceable, then such court or arbitrator shall reduce the time period or scope to the maximum time period or scope permitted by law.
12.Taxes
All amounts paid under this Agreement shall be paid less all applicable state and federal tax withholdings and any other withholdings required by any applicable jurisdiction.
13.Governing Law
This Agreement shall be governed by and construed in accordance with the laws of the State of Texas.
14.Interpretation
This Agreement shall be construed as a whole, according to its fair meaning, and not in favor of or against any party. Sections and section headings contained in this Agreement are for reference purposes only, and shall not affect in any manner the meaning or interpretation of this Agreement. Whenever the context requires, references to the singular shall include the plural and the plural the singular.
15.Obligations Survive Termination of Employment
Executive agrees that any and all of Executive’s obligations under this Agreement, including but not limited to Exhibits A and B, shall survive the termination of employment and the termination of this Agreement.
16.Counterparts
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original of this Agreement, but all of which together shall constitute one and the same instrument.
17.Authority
Each party represents and warrants that such party has the right, power and authority to enter into and execute this Agreement and to perform and discharge all of the obligations hereunder; and that this Agreement constitutes the valid and legally binding agreement and obligation of such party and is enforceable in accordance with its terms.
18.Entire Agreement
This Agreement is intended to be the final, complete, and exclusive statement of the terms of Executive’s employment by the Company and may not be contradicted by evidence of any prior or contemporaneous statements or agreements, except for agreements specifically referenced herein (including the Award Agreement, Proprietary Information Agreement, and Mutual Arbitration Agreement. To the extent that the practices, policies or procedures of the Company,
-5-
now or in the future, apply to Executive and are inconsistent with the terms of this Agreement, the provisions of this Agreement shall control. Any subsequent change in Executive’s duties, position, or compensation will not affect the validity or scope of this Agreement.
19.Executive Acknowledgement
EXECUTIVE ACKNOWLEDGES EXECUTIVE HAS HAD THE OPPORTUNITY TO CONSULT LEGAL COUNSEL CONCERNING THIS AGREEMENT, THAT EXECUTIVE HAS READ AND UNDERSTANDS THE AGREEMENT, THAT EXECUTIVE IS FULLY AWARE OF ITS LEGAL EFFECT, AND THAT EXECUTIVE HAS ENTERED INTO IT FREELY BASED ON EXECUTIVE’S OWN JUDGMENT AND NOT ON ANY REPRESENTATIONS OR PROMISES OTHER THAN THOSE CONTAINED IN THIS AGREEMENT.
In Witness Whereof, the parties have duly executed this Agreement as of the date first written above.
|
COYA THERAPEUTICS, INC. |
||||
|
|
|
|
|
|
By: |
|
/s/ David S. Snyder* |
|
/s/ Howard Berman |
|
|
|
|
|
|
|
Its: |
|
CFO/COO |
|
Howard Berman |
|
|
|
|
|
|
|
Dated: |
|
11/10/22 |
|
Dated: |
12/15/2020 |
*Signed by David S. Snyder, Chief Financial and Chief Operating Officer of Coya Therapeutics, Inc. on November 10, 2022 to be effective as of December 15, 2020.
-6-
EXHIBIT A
PROPRIETARY INFORMATION AGREEMENT
-7-
MUTUAL ARBITRATION AGREEMENT
-8-
Exhibit 10. 4
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
Employment Agreement Addendum
This employment contract addendum “Addendum” is made on April 1, 2022, (04/01/22) by and between:
Employer: Coya Therapeutics, with a mailing address of 5850 San Felipe, suite 500 Houston, TX 77057. And
Employee: Howard Berman, with a mailing address of [***]
This addendum shall be added to the original employment agreement, dated December 15th, 2020 (12/15/20).
The aforementioned employment contract is hereby supplemented as follows:
As of April 01, 2022, this employment agreement will be updated to reflect the following:
|
• |
Base Salary: 450,000 per annum |
|
• |
Bonus: 35% on a performance basis |
We, the Employer and Employee, agree to the aforementioned additions to the employment contract. Any changes made here are legally binding upon signature of both parties. These changes are pursuant to the vote made by the Board regarding Howard’s executive compensation review.
/s/ David Snyder |
|
5/23/2022 |
David Snyder |
|
Date Signed |
|
|
|
|
|
|
/s/ Howard Berman |
|
5/16/2022 |
Howard Berman |
|
Date Signed |
Exhibit 10.5
EXECUTIVE EMPLOYMENT AGREEMENT
This Executive Employment Agreement (“Agreement”), dated March 14, 2022 (“Effective Date”), is between Coya Therapeutics, Inc. (the “Company”) and David Snyder (“Executive”).
1.Position, Responsibilities, and term
a.Position. Executive is employed by the Company to render services to the Company in the position of Chief Financial Officer / Chief Operating Officer. Executive shall perform such duties and responsibilities as are normally related to such position in accordance with the standards of the industry and any additional duties now or hereafter assigned to Executive by the Company’s Board of Directors (“Board”) (“Services”). Executive shall abide by the rules, regulations, and practices as adopted or modified from time to time in the Company’s sole discretion. Executive will devote Executive’s full time efforts to the provision of Services under this Agreement. If the Executive is transferred to another position within the Company by the Board during the Term, Executive will continue to receive the compensation and benefits set forth in Section 2.
b.Other Activities. Except upon the prior written consent of the Company, Executive will not, during the term of this Agreement: (i) be employed elsewhere; (ii) engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might interfere with Executive’s duties and responsibilities hereunder or create a conflict of interest with the Company; or (iii) acquire any interest of any type in any other business which is in competition with the Company, provided, however, that the foregoing shall not be deemed to prohibit the Executive from acquiring solely as an investment up to one percent (1%) of the outstanding equity interests of any publicly-held company.
c.No Conflict. Executive represents and warrants that Executive’s execution of this Agreement and performance of Services under this Agreement will not violate any obligations Executive may have to any other employer, person or entity, including any obligations to keep in confidence proprietary information, knowledge, or data acquired by Executive in confidence or in trust prior to becoming an employee of the Company.
d.Term of Employment. The initial term of this Agreement shall be for a period of (i) two (2) years after the Effective Date of this Agreement (“Initial Term”); or (ii) the date upon which Executive’s employment is terminated in accordance with Section 3. This Agreement shall be automatically renewed for additional one (1) year terms (each an “Extension Term”) upon the expiration of the Initial Term and each Extension Term, unless either party gives the other party a written notice of termination not less than thirty (30) days prior to the date of expiration of the Initial Term or any Extension Term (together, the Initial Term and all Extension Terms are referred to herein as the “Term”). Where the Agreement is terminated upon notice and the expiration of the Initial Term or an Extension Term, the Company shall pay to Executive all compensation to which Executive is entitled
up through the effective date of termination according to its normal payroll practices, and the Company shall not have any further obligations under this Agreement.
2.Compensation and Benefits
a.Base Salary. In consideration of the Services to be rendered under this Agreement, the Company shall pay Executive a gross salary at the rate of $350,000 per year (“Base Salary”), less applicable withholdings . The Base Salary shall be paid in accordance with the Company’s normal payroll practices. Executive’s Base Salary will be reviewed from time to time in accordance with the established procedures of the Company for adjusting salaries for similarly situated employees and may be adjusted in the sole discretion of the Company.
b.Annual Bonus. In further consideration of the Services to be rendered under this Agreement, Executive shall be eligible to receive an annual bonus of up to 35 % of Base Salary, less applicable withholdings, based on achievement of goals and objectives established by the Company (“Annual Bonus”). Any Annual Bonus earned by Executive will be paid within two-and-one-half months of the end of the year in which it was earned. Executive must remain employed with the Company through the end of the calendar year at issue in order to be eligible to receive the Annual Bonus.
c.Employment Benefits Plans. In further consideration of the Services to be rendered under this Agreement, Executive will be entitled to participate in pension, profit sharing and other retirement plans, incentive compensation plans, group health, hospitalization and disability or other insurance plans, and other employee welfare benefit plans generally made available to other similarly-situated employees of the Company, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company’s sole discretion.
d.Vacation. Executive shall be eligible to receive paid vacation consistent with the policies and procedures adopted by the Company, if any, in its sole discretion.
e.Equity Plan. Option Equity plan (1% at contract and 1% after next options pool refresh, to be issued at that time with new issuance), vesting over 3 years with a 1 year cliff and standard clauses.
f.Expenses. The Company will pay or reimburse Executive for all normal and reasonable travel and entertainment expenses incurred by Executive in connection with Executive’s responsibilities to the Company upon submission of proper vouchers and documentation in accordance with the Company’s expense reimbursement policy.
3.At-Will Employment
The employment of Executive shall be “at-will” at all times. The Company or Executive may terminate Executive’s employment with the Company at any time, without any advance notice, for any reason or no reason at all, notwithstanding anything to the contrary contained in or arising from any statements, policies or practices of the Company relating to the employment, discipline or termination of its employees. Fallowing the
termination of Executive’s employment, the Company shall pay to Executive all compensation to which Executive is entitled up through the date of termination. Thereafter, all obligations of the Company under this Agreement shall cease other than those set forth in Section 4.
4.Company Termination Obligations
a.Termination by Company for Cause. Where the Company terminates Executive’s employment for Cause, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3. For purposes of this Agreement, “Cause” shall mean: (i) Executive engages in misconduct, including but not limited to misappropriation of trade secrets, fraud, or embezzlement; (ii) Executive commits a crime involving dishonesty, breach of trust, or physical harm to any person; (iii) Executive breaches this Agreement; (iv) Executive refuses to implement or follow a lawful policy or directive of the Company; (v) Executive engages in misfeasance or malfeasance demonstrated by Executive’s failure to perform Executive’s job duties diligently and/or professionally; or (vi) Executive violates a Company policy or procedure which causes harm to the Company, including violation of the Company’s policy concerning sexual harassment, discrimination or retaliation.
b.Termination by Company without Cause. Where the Company terminates Executive’s employment without Cause, and Executive’s employment is not terminated due to death or Disability (as defined below), Executive will be eligible to receive continued payment of Base Salary for nine (9) months according to the Company’s normal payroll practices, less applicable withholdings and any remuneration paid to Executive during each applicable Company payroll period because of Executive’s employment or self-employment during such period. Executive’s eligibility to receive the severance set forth in this Section 4(b) is conditioned on Executive having first signed the Company’s form severance and general release agreement in the form provided by the Company and the release becoming irrevocable by its terms within fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service, as such term is defined in Section 4(g)). All other obligations of the Company under this Agreement shall cease.
c.Termination Due to Disability. Executive’s employment shall terminate automatically if Executive becomes Disabled.• Executive shall be deemed Disabled if Executive is unable for medical reasons to perform Executive’s essential job duties for either ninety (90) consecutive calendar days or one hundred twenty (120) business days in a twelve (12) month period and, within thirty (30) days after a notice of termination is given to Executive, Executive has not returned to work. If Executive’s employment is terminated by the Company due to Executive’s Disability, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
d.Termination Due to Death. Executive’s employment shall terminate automatically upon Executive’s death. If Executive’s employment is terminated due to Executive’s death, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
-2-
e.Executive’s Resignation. Executive may resign Executive’s employment at any time during the Term of this Agreement pursuant to Section 3, and thereafter, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
f.Timing of Payments. In the event that Executive becomes entitled to receive continued payment of Base Salary pursuant to Section 4(b), Executive shall not be entitled to receive any such payments until the Company’s first payroll date that is coincident with or next following the date that is fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service) and any payments that otherwise would have been paid to Executive during such period shall be paid to Executive with the first installment paid to Executive following the end of such period. Any pro-rated Annual Bonus that becomes payable to Executive pursuant to Section 4(b) shall be paid to Executive in a lump sum payment on the date that Executive receives the first installment payment of continued Base Salary as provided in the preceding sentence.
g.Section 409A; Delayed Payments. To the extent applicable, the provisions in this Section 4 are intended to comply with Section 409A of the Internal Revenue Code of 1986, as amended, and guidance promulgated thereunder (“409A”) and this Agreement shall be administered and construed in a manner consistent with this intent. In the event that any compensation that becomes payable to Executive pursuant to this Section 4 qualifies as a deferral of compensation within the meaning of and subject to 409A, then, notwithstanding anything to the contrary in this Agreement (i) such compensation shall be paid to Executive only in the event of Executive’s “separation from service” with the Company within the meaning of 409A (“Separation from Service”) and (ii) payment of that compensation shall be delayed if Executive is a “specified employee,” as defined in 409A(a)(2)(B)(i), and such delayed payment is required by 409A. Such delay shall last six (6) months from the date of Executive’s Separation from Service. On the Company’s first payroll date that occurs after the end of such six-month period, the Company shall make a catch-up payment to Executive equal to the total amount of such payments that would have been made during the six-month period but for this Section 4(g). To the extent applicable, each and every payment to be made pursuant to Section 4(b) shall be treated as a separate payment and not as one of a series of payments treated as a single payment for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii).
5.Executive Termination Obligations
a.Return of Property. Executive agrees that all property (including without limitation all equipment, tangible proprietary information, documents, records, notes, contracts and computer-generated materials) furnished to or created or prepared by Executive incident to Executive’s employment belongs to the Company and shall be promptly returned to the Company upon termination of Executive’s employment.
b.Resignation and Cooperation. Upon termination of Executive’s employment, Executive shall be deemed to have resigned from all offices and directorships then held with the Company. Following any termination of employment, Executive shall
-3-
cooperate with the Company in the winding up of pending work on behalf of the Company and the orderly transfer of work to other employees. Executive shall also cooperate with the Company in the defense of any action brought by any third party against the Company that relates to Executive’s employment by the Company.
c.Continuing Obligations. Executive understands and agrees that Executive’s obligations under Sections 6 and 7 herein (including Exhibits A and B) shall survive the termination of Executive’s employment for any reason and the termination of this Agreement.
6.Inventions and Proprietary Information
Executive agrees to sign and be bound by the terms of the Proprietary Information and Inventions Agreement, which is attached as Exhibit A (“ Proprietary Information Agreement”).
7.Arbitration
Executive agrees to sign and be bound by the terms of the Mutual Arbitration Agreement, which is attached as Exhibit B (“Mutual Arbitration Agreement”).
8.Amendments; Waivers; Remedies
This Agreement may not be amended or waived except by a writing signed by Executive and by the Company’s Board. Failure to exercise any right under this Agreement shall not constitute a waiver of such right. Any waiver of any breach of this Agreement shall not operate as a waiver of any subsequent breaches. All rights or remedies specified for a party herein shall be cumulative and in addition to all other rights and remedies of the party hereunder or under applicable law.
9.Assignment; Binding Effect
a.Assignment. The performance of Executive is personal hereunder, and Executive agrees that Executive shall have no right to assign and shall not assign or purport to assign any rights or obligations under this Agreement. This Agreement may be assigned or transferred by the Company; and nothing in this Agreement shall prevent the consolidation, merger or sale of the Company or a sale of any or all or substantially all of its assets.
b.Binding Effect. Subject to the foregoing restriction on assignment by Executive, this Agreement shall inure to the benefit of and be binding upon each of the parties; the affiliates, officers, directors, agents, successors and assigns of the Company; and the heirs, devisees, spouses, legal representatives and successors of Executive.
10.Notices
All notices or other communications required or permitted hereunder shall be made in writing and shall be deemed to have been duly given if delivered: (a) by hand; (b) by a
-4-
nationally recognized overnight courier service; or (c) by United States first class registered or certified mail, return receipt requested, to the principal address of the other party.
11.Severability
If any provision of this Agreement shall be held by a court or arbitrator to be invalid, unenforceable, or void, such provision shall be enforced to the fullest extent permitted by law, and the remainder of this Agreement shall remain in full force and effect. In the event that the time period or scope of any provision is declared by a court or arbitrator of competent jurisdiction to exceed the maximum time period or scope that such court or arbitrator deems enforceable, then such court or arbitrator shall reduce the time period or scope to the maximum time period or scope permitted by law.
12.Taxes
All amounts paid under this Agreement shall be paid less all applicable state and federal tax withholdings and any other withholdings required by any applicable jurisdiction.
13.Governing Law
This Agreement shall be governed by and construed in accordance with the laws of the State of Texas.
14.Interpretation
This Agreement shall be construed as a whole, according to its fair meaning, and not in favor of or against any party. Sections and section headings contained in this Agreement are for reference purposes only, and shall not affect in any manner the meaning or interpretation of this Agreement. Whenever the context requires, references to the singular shall include the plural and the plural the singular.
15.Obligations Survive Termination of Employment
Executive agrees that any and all of Executive’s obligations under this Agreement, including but not limited to Exhibits A and B, shall survive the termination of employment and the termination of this Agreement.
16.Counterparts
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original of this Agreement, but all of which together shall constitute one and the same instrument.
17.Authority
Each party represents and warrants that such party has the right, power and authority to enter into and execute this Agreement and to perform and discharge all of the obligations
-5-
hereunder; and that this Agreement constitutes the valid and legally binding agreement and obligation of such party and is enforceable in accordance with its terms.
18.Entire Agreement
This Agreement is intended to be the final, complete, and exclusive statement of the terms of Executive’s employment by the Company and may not be contradicted by evidence of any prior or contemporaneous statements or agreements, except for agreements specifically referenced herein (including the Award Agreement, Proprietary Information Agreement, and Mutual Arbitration Agreement. To the extent that the practices, policies or procedures of the Company, now or in the future, apply to Executive and are inconsistent with the terms of this Agreement, the provisions of this Agreement shall control. Any subsequent change in Executive’s duties, position, or compensation will not affect the validity or scope of this Agreement.
19.Executive Acknowledgement
EXECUTIVE ACKNOWLEDGES EXECUTIVE HAS HAD THE OPPORTUNITY TO CONSULT LEGAL COUNSEL CONCERNING THIS AGREEMENT, THAT EXECUTIVE HAS READ AND UNDERSTANDS THE AGREEMENT, THAT EXECUTIVE IS FULLY AWARE OF ITS LEGAL EFFECT, AND THAT EXECUTIVE HAS ENTERED INTO IT FREELY BASED ON EXECUTIVE’S OWN JUDGMENT AND NOT ON ANY REPRESENTATIONS OR PROMISES OTHER THAN THOSE CONTAINED IN THIS AGREEMENT.
IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the date first written above.
COYA THERAPEUTICS, INC. |
|
EMPLOYEE |
|||
|
|
|
|||
|
|
|
|||
By: |
/s/ Howard Berman |
|
/s/ David Snyder |
||
|
|
|
|||
Howard Berman, CEO |
|
David Snyder |
|||
|
|
|
|||
Dated: |
2/11/22 |
|
Dated: |
2/11/2022 |
-6-
EXHIBIT A
PROPRIETARY INFORMATION AGREEMENT
-7-
EXHIBITB
MUTUAL ARBITRATION AGREEMENT
-8-
Exhibit 10.6
EXECUTIVE EMPLOYMENT AGREEMENT
This Executive Employment Agreement (“Agreement”), dated November 1, 2021 (“Effective Date”), is between Coya Therapeutics, Inc. (the “Company”) and Adrian Hepner (“Executive”).
1.Position, Responsibilities, and term
a.Position. Executive is employed by the Company to render services to the Company in the position of Chief Medical Officer / President. Executive shall perform such duties and responsibilities as are normally related to such position in accordance with the standards of the industry and any additional duties now or hereafter assigned to Executive by the Company’s Board of Directors (“Board”) (“Services”). Executive shall abide by the rules, regulations, and practices as adopted or modified from time to time in the Company’s sole discretion. Executive will devote Executive’s full time efforts to the provision of Services under this Agreement. If the Executive is transferred to another position within the Company by the Board during the Term, Executive will continue to receive the compensation and benefits set forth in Section 2.
b.Other Activities. Except upon the prior written consent of the Company, Executive will not, during the term of this Agreement: (i) be employed elsewhere; (ii) engage, directly or indirectly, in any other business activity (whether or not pursued for pecuniary advantage) that might interfere with Executive’s duties and responsibilities hereunder or create a conflict of interest with the Company; or (iii) acquire any interest of any type in any other business which is in competition with the Company, provided, however, that the foregoing shall not be deemed to prohibit the Executive from acquiring solely as an investment up to one percent (1%) of the outstanding equity interests of any publicly-held company.
c.No Conflict. Executive represents and warrants that Executive’s execution of this Agreement and performance of Services under this Agreement will not violate any obligations Executive may have to any other employer, person or entity, including any obligations to keep in confidence proprietary information, knowledge, or data acquired by Executive in confidence or in trust prior to becoming an employee of the Company.
d.Term of Employment. The initial term of this Agreement shall be for a period of (i) two (2) years after the Effective Date of this Agreement (“Initial Term”); or (ii) the date upon which Executive’s employment is terminated in accordance with Section 3. This Agreement shall be automatically renewed for additional one (1) year terms (each an “Extension Term”) upon the expiration of the Initial Term and each Extension Term, unless either party gives the other party a written notice of termination not less than thirty (30) days prior to the date of expiration of the Initial Term or any Extension Term (together, the Initial Term and all Extension Terms are referred to herein as the “Term”). Where the Agreement is terminated upon notice and the expiration of the Initial Term or an Extension Term, the Company shall pay to Executive all compensation to which Executive is entitled up through the effective date of termination according to its normal payroll practices, and the Company shall not have any further obligations under this Agreement.
2.Compensation and Benefits
a.Base Salary. In consideration of the Services to be rendered under this Agreement, the Company shall pay Executive a gross salary at the rate of $425,000 per year (“Base Salary”), less applicable withholdings . The Base Salary shall be paid in accordance with the Company’s normal payroll practices. Executive’s Base Salary will be reviewed from time to time in accordance with the established procedures of the Company for adjusting salaries for similarly situated employees and may be adjusted in the sole discretion of the Company.
b.Annual Bonus. In further consideration of the Services to be rendered under this Agreement, Executive shall be eligible to receive an annual bonus of up to 35 % of Base Salary, less applicable withholdings, based on achievement of goals and objectives established by the Company (“Annual Bonus”). Any Annual Bonus earned by Executive will be paid within two-and-one-half months of the end of the year in which it was earned. Executive must remain employed with the Company through the end of the calendar year at issue in order to be eligible to receive the Annual Bonus.
c.Employment Benefits Plans. In further consideration of the Services to be rendered under this Agreement, Executive will be entitled to participate in pension, profit sharing and other retirement plans, incentive compensation plans, group health, hospitalization and disability or other insurance plans, and other employee welfare benefit plans generally made available to other similarly-situated employees of the Company, in accordance with the benefit plans established by the Company, and as may be amended from time to time in the Company’s sole discretion.
d.Vacation. Executive shall be eligible to receive paid vacation consistent with the policies and procedures adopted by the Company, if any, in its sole discretion.
e.Equity Plan. Option Equity plan (2% at contract, vesting over 3 years with a 1 year cliff and standard clauses.)
f.Expenses. The Company will pay or reimburse Executive for all normal and reasonable travel and entertainment expenses incurred by Executive in connection with Executive’s responsibilities to the Company upon submission of proper vouchers and documentation in accordance with the Company’s expense reimbursement policy.
3.At-Will Employment
The employment of Executive shall be “at-will” at all times. The Company or Executive may terminate Executive’s employment with the Company at any time, without any advance notice, for any reason or no reason at all, notwithstanding anything to the contrary contained in or arising from any statements, policies or practices of the Company relating to the employment, discipline or termination of its employees. Following the termination of Executive’s employment, the Company shall pay to Executive all compensation to which Executive is entitled up through the date of termination. Thereafter, all obligations of the Company under this Agreement shall cease other than those set forth in Section 4.
-2-
4.Company Termination Obligations
a.Termination by Company for Cause. Where the Company terminates Executive’s employment for Cause, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3. For purposes of this Agreement, “Cause” shall mean: (i) Executive engages in misconduct, including but not limited to misappropriation of trade secrets, fraud, or embezzlement; (ii) Executive commits a crime involving dishonesty, breach of trust, or physical harm to any person; (iii) Executive breaches this Agreement; (iv) Executive refuses to implement or follow a lawful policy or directive of the Company; (v) Executive engages in misfeasance or malfeasance demonstrated by Executive’s failure to perform Executive’s job duties diligently and/or professionally; or (vi) Executive violates a Company policy or procedure which causes harm to the Company, including violation of the Company’s policy concerning sexual harassment, discrimination or retaliation.
b.Termination by Company without Cause. Where the Company terminates Executive’s employment without Cause, and Executive’s employment is not terminated due to death or Disability (as defined below), Executive will be eligible to receive continued payment of Base Salary for nine (9) months according to the Company’s normal payroll practices, less applicable withholdings and any remuneration paid to Executive during each applicable Company payroll period because of Executive’s employment or self-employment during such period. Executive’s eligibility to receive the severance set forth in this Section 4(b) is conditioned on Executive having first signed the Company’s form severance and general release agreement in the form provided by the Company and the release becoming irrevocable by its terms within fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service, as such term is defined in Section 4(g)). All other obligations of the Company under this Agreement shall cease.
c.Termination Due to Disability. Executive’s employment shall terminate automatically if Executive becomes Disabled. Executive shall be deemed Disabled if Executive is unable for medical reasons to perform Executive’s essential job duties for either ninety (90) consecutive calendar days or one hundred twenty (120) business days in a twelve (12) month period and, within thirty (30) days after a notice of termination is given to Executive, Executive has not returned to work. If Executive’s employment is terminated by the Company due to Executive’s Disability, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
d.Termination Due to Death. Executive’s employment shall terminate automatically upon Executive’s death. If Executive’s employment is terminated due to Executive’s death, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
e.Executive’s Resignation. Executive may resign Executive’s employment at any time during the Term of this Agreement pursuant to Section 3, and thereafter, all obligations of the Company under this Agreement shall cease, other than those set forth in Section 3.
f.Timing of Payments. In the event that Executive becomes entitled to receive continued payment of Base Salary pursuant to Section 4(b), Executive shall not be entitled to
-3-
receive any such payments until the Company’s first payroll date that is coincident with or next following the date that is fifty five (55) calendar days following the date of Executive’s termination of employment (or, if applicable, the date of Executive’s Separation from Service) and any payments that otherwise would have been paid to Executive during such period shall be paid to Executive with the first installment paid to Executive following the end of such period. Any pro-rated Annual Bonus that becomes payable to Executive pursuant to Section 4(b) shall be paid to Executive in a lump sum payment on the date that Executive receives the first installment payment of continued Base Salary as provided in the preceding sentence.
g.Section 409A; Delayed Payments. To the extent applicable, the provisions in this Section 4 are intended to comply with Section 409A of the Internal Revenue Code of 1986, as amended, and guidance promulgated thereunder (“409A”) and this Agreement shall be administered and construed in a manner consistent with this intent. In the event that any compensation that becomes payable to Executive pursuant to this Section 4 qualifies as a deferral of compensation within the meaning of and subject to 409A, then, notwithstanding anything to the contrary in this Agreement (i) such compensation shall be paid to Executive only in the event of Executive’s “separation from service” with the Company within the meaning of 409A (“Separation from Service”) and (ii) payment of that compensation shall be delayed if Executive is a “specified employee,” as defined in 409A(a)(2)(B)(i), and such delayed payment is required by 409A. Such delay shall last six (6) months from the date of Executive’s Separation from Service. On the Company’s first payroll date that occurs after the end of such six-month period, the Company shall make a catch-up payment to Executive equal to the total amount of such payments that would have been made during the six-month period but for this Section 4(g). To the extent applicable, each and every payment to be made pursuant to Section 4(b) shall be treated as a separate payment and not as one of a series of payments treated as a single payment for purposes of Treasury Regulation Section 1.409A-2(b)(2)(iii).
5.Executive Termination Obligations
a.Return of Property. Executive agrees that all property (including without limitation all equipment, tangible proprietary information, documents, records, notes, contracts and computer-generated materials) furnished to or created or prepared by Executive incident to Executive’s employment belongs to the Company and shall be promptly returned to the Company upon termination of Executive’s employment.
b.Resignation and Cooperation. Upon termination of Executive’s employment, Executive shall be deemed to have resigned from all offices and directorships then held with the Company. Following any termination of employment, Executive shall cooperate with the Company in the winding up of pending work on behalf of the Company and the orderly transfer of work to other employees. Executive shall also cooperate with the Company in the defense of any action brought by any third party against the Company that relates to Executive’s employment by the Company.
c.Continuing Obligations. Executive understands and agrees that Executive’s obligations under Sections 6 and 7 herein (including Exhibits A and B) shall survive the termination of Executive’s employment for any reason and the termination of this Agreement.
-4-
6.Inventions and Proprietary Information
Executive agrees to sign and be bound by the terms of the Proprietary Information and Inventions Agreement, which is attached as Exhibit A (“Proprietary Information Agreement”).
7.Arbitration
Executive agrees to sign and be bound by the terms of the Mutual Arbitration Agreement, which is attached as Exhibit B (“Mutual Arbitration Agreement”).
8.Amendments; Waivers; Remedies
This Agreement may not be amended or waived except by a writing signed by Executive and by the Company’s Board. Failure to exercise any right under this Agreement shall not constitute a waiver of such right. Any waiver of any breach of this Agreement shall not operate as a waiver of any subsequent breaches. All rights or remedies specified for a party herein shall be cumulative and in addition to all other rights and remedies of the party hereunder or under applicable law.
9.Assignment; Binding Effect
a.Assignment. The performance of Executive is personal hereunder, and Executive agrees that Executive shall have no right to assign and shall not assign or purport to assign any rights or obligations under this Agreement. This Agreement may be assigned or transferred by the Company; and nothing in this Agreement shall prevent the consolidation, merger or sale of the Company or a sale of any or all or substantially all of its assets.
b.Binding Effect. Subject to the foregoing restriction on assignment by Executive, this Agreement shall inure to the benefit of and be binding upon each of the parties; the affiliates, officers, directors, agents, successors and assigns of the Company; and the heirs, devisees, spouses, legal representatives and successors of Executive.
10.Notices
All notices or other communications required or permitted hereunder shall be made in writing and shall be deemed to have been duly given if delivered: (a) by hand; (b) by a nationally recognized overnight courier service; or (c) by United States first class registered or certified mail, return receipt requested, to the principal address of the other party.
11.Severability
If any provision of this Agreement shall be held by a court or arbitrator to be invalid, unenforceable, or void, such provision shall be enforced to the fullest extent permitted by law, and the remainder of this Agreement shall remain in full force and effect. In the event that the time period or scope of any provision is declared by a court or arbitrator of competent jurisdiction to exceed the maximum time period or scope that such court or arbitrator deems enforceable, then such court or arbitrator shall reduce the time period or scope to the maximum time period or scope permitted by law.
-5-
12.Taxes
All amounts paid under this Agreement shall be paid less all applicable state and federal tax withholdings and any other withholdings required by any applicable jurisdiction.
13.Governing Law
This Agreement shall be governed by and construed in accordance with the laws of the State of Texas.
14.Interpretation
This Agreement shall be construed as a whole, according to its fair meaning, and not in favor of or against any party. Sections and section headings contained in this Agreement are for reference purposes only, and shall not affect in any manner the meaning or interpretation of this Agreement. Whenever the context requires, references to the singular shall include the plural and the plural the singular.
15.Obligations Survive Termination of Employment
Executive agrees that any and all of Executive’s obligations under this Agreement, including but not limited to Exhibits A and B, shall survive the termination of employment and the termination of this Agreement.
16.Counterparts
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original of this Agreement, but all of which together shall constitute one and the same instrument.
17.Authority
Each party represents and warrants that such party has the right, power and authority to enter into and execute this Agreement and to perform and discharge all of the obligations hereunder; and that this Agreement constitutes the valid and legally binding agreement and obligation of such party and is enforceable in accordance with its terms.
18.Entire Agreement
This Agreement is intended to be the final, complete, and exclusive statement of the terms of Executive’s employment by the Company and may not be contradicted by evidence of any prior or contemporaneous statements or agreements, except for agreements specifically referenced herein (including the Award Agreement, Proprietary Information Agreement, and Mutual Arbitration Agreement. To the extent that the practices, policies or procedures of the Company, now or in the future, apply to Executive and are inconsistent with the terms of this Agreement, the provisions of this Agreement shall control. Any subsequent change in Executive’s duties, position, or compensation will not affect the validity or scope of this Agreement.
-6-
19.Executive Acknowledgement
EXECUTIVE ACKNOWLEDGES EXECUTIVE HAS HAD THE OPPORTUNITY TO CONSULT LEGAL COUNSEL CONCERNING THIS AGREEMENT, THAT EXECUTIVE HAS READ AND UNDERSTANDS THE AGREEMENT, THAT EXECUTIVE IS FULLY AWARE OF ITS LEGAL EFFECT, AND THAT EXECUTIVE HAS ENTERED INTO IT FREELY BASED ON EXECUTIVE’S OWN JUDGMENT AND NOT ON ANY REPRESENTATIONS OR PROMISES OTHER THAN THOSE CONTAINED IN THIS AGREEMENT.
In Witness Whereof, the parties have duly executed this Agreement as of the date first written above.
COYA THERAPEUTICS, INC. |
|
EMPLOYEE |
||
|
|
|
||
|
|
|
|
|
By: |
/s/ Howard Berman |
|
/s/ Adrian Hepner |
|
|
|
|
||
Howard Berman, CEO |
|
Adrian Hepner |
||
|
|
|
||
Dated: |
8/15/2022 |
|
Dated: |
8/12/2022 |
|
|
|
|
|
-7-
EXHIBIT A
PROPRIETARY INFORMATION AGREEMENT
-8-
MUTUAL ARBITRATION AGREEMENT
-9-
EXHIBIT 10.7
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
CONFIDENTIAL
AMENDED AND RESTATED PATENT AND KNOW HOW LICENSE AGREEMENT
METHODIST AGREEMENT # [***]
THIS AMENDED AND RESTATED PATENT AND KNOW HOW LICENSE AGREEMENT (this
“Agreement”) is made effective as of October 6, 2020 (the “Effective Date”) by and between The Methodist Hospital, a Texas non-profit corporation (“METHODIST”), and Coya Therapeutics, Inc. (“LICENSEE”), a Delaware corporation (as successor in interest to Nicoya Health, Inc.).
W I T N E S S E T H
WHEREAS, METHODIST owns, or has the right to license, certain Patent Rights and Know- How (defined below); and
WHEREAS, the predecessor of LICENSEE (Nicoya Health, Inc.) obtained a license from METHODIST to practice certain Patent Rights and Know-How pursuant to that Patent and Know How License Agreement effective as of the Effective Date and on December 22, 2020 that predecessor was merged with and into LICENSEE with LICENSEE as the surviving company and such predecessor assigning all of its rights and obligations under this Agreement to LICENSEE pursuant to a Consent and Waiver among the Parties;
WHEREAS, METHODIST and LICENSEE amended this Agreement on October 29, 2021 in that First Amendment to Patent and Know How License Agreement, and the Parties desire to further amend and restate such agreement upon the terms stated herein effective as of the Effective Date; and
WHEREAS, METHODIST desires to have such Patent Rights and Know-How further developed in the Licensed Field and used for the benefit of LICENSEE, METHODIST and the general public;
NOW, THEREFORE, for and in consideration of the premises, the mutual covenants herein and other good and valuable consideration, the receipt and adequacy of which are acknowledged and confessed, the parties hereto agree as follows:
1
CONFIDENTIAL
As used in this Agreement, capitalized terms used in this agreement have the meaning ascribed to them above, in the Attachments to this Agreement, or in the Articles that follow:
|
(a) |
any person or business entity more than 50% owned, directly or indirectly, by such party, or |
|
(b) |
any person or business entity that owns, directly or indirectly, more than 50% of such party, or |
|
(c) |
any person or business entity that is more than 50% owned by a business entity that owns at least 50% of such party. |
1.2“Confidential Information” means any proprietary information or material disclosed by one party (“discloser”) to the other party (“recipient”) hereunder that is related to the subject matter of this Agreement (including Licensed Patent Rights and Licensed Know-How) and that is identified as confidential or proprietary when disclosed or reasonably would be considered confidential information if exchanged by third parties under similar circumstances. The parties shall use reasonable efforts to mark Confidential Information provided in tangible form as “Confidential” or “Proprietary” (or the substantial equivalent thereof), or if not disclosed in tangible form, summarized in writing within thirty (30) days thereafter. Confidential Information provided hereunder shall not be denied the protections afforded by this Agreement solely on the basis that the Confidential Information was not marked in accordance with the obligations herein. Confidential Information excludes information that the recipient can establish:
|
(b) |
later became part of the public domain through no act or omission of the recipient, its employees, agents, successor and assigns; |
|
(c) |
was lawfully disclosed to the recipient by a third party having the right to disclose it without any obligation of confidentiality to the discloser; |
|
(e) |
was independently developed by the recipient, as evidenced by written documentation created or existing at or promptly after the time of development. |
1.3"Exclusive" means exclusive to LICENSEE to the exclusion of all others, including METHODIST, its Affiliates, and all third parties, except for the Retained Rights.
1.4“Fair Market Value” means (a) the cash consideration the seller charges in an arm’s length Sale to a buyer who is not an Affiliate of the same or substantially the same Licensed Product or Licensed Service under the same or substantially similar quantity and terms, time and place or (b) if no such comparable Sales exist, then a reasonable portion of the price of the bundle/combination taking into account the relative value of the Licensed Product or Licensed Service and as compared
2
CONFIDENTIAL
to each of the other elements of the bundle/combination.
1.5“Indication” means a disease or condition and all of its associated signs, symptoms, stages or progression (including precursor conditions) with respect to the entire population with the disease or condition (and not merely a subpopulation or a stratified group of patients within the population).
1.6“Know-how” means technical and other information, trade secrets, processes, procedures, compositions, devices, methods, formulas, patterns, compilations, programs, products, protocols, techniques, software, designs, inventions, discoveries, drawings, databases or data, whether or not patentable, and regardless of the form in which any of the foregoing was created or thereafter reproduced or stored.
1.7“Late Fee” means interest accrued at the lesser of non-compounding 1.5% per month (18% annual) or the maximum rate permitted and considered non-usurious under law.
1.8“Licensed Field” means the diagnosis, prevention or treatment of amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, or other disease or condition in humans, the preparation or manufacture of products (including cells and exosomes) for the foregoing, and services related to any of the foregoing.
1.9“Licensed Know-how” means METHODIST’s rights in (a) the Know-how that (i) exists as of the Effective Date and is described on Attachment A (“Existing Technology”) or (ii) is created, made or otherwise first exists after the Effective Date and corresponds to the practice, improvement or advancement of the Existing Technology or any invention or discovery covered by Licensed Patent Rights; and (b) all trade secret rights, copyrights and other intellectual or industrial technology rights in the Know How described in the foregoing clause (a) that are owned by METHODIST or any of its Affiliates or licensed to METHODIST or any of its Affiliates with the right to sublicense to LICENSEE as contemplated in Section 3.1, except for Licensed Patent Rights. “Exclusive Licensed Know-how” means that Licensed Know-how that is necessary for the practice, improvement or advancement of the Existing Technology or any invention or discovery covered by Licensed Patent Rights.
1.10“Licensed Patent Rights” means all rights in (a) the application(s) for Patent listed on Attachment A or that otherwise have been filed as of the Effective Date related to the Existing Technology (“Existing Patent Applications”), (b) all applications for Patent filed by or on behalf of METHODIST on any other invention or discovery within the Licensed Know-how that is necessary for the practice, improvement or advancement of the Existing Technology or any invention or discovery covered by Existing Patent Applications, (c) all pre-grant forms of the foregoing applications, including converted provisionals, divisionals, and continuations (in whole or in part), (d) all Patents issuing from any of the foregoing, (e) all post-grant forms of or related to the foregoing, including reissues, reexaminations, oppositions, and extensions, and (f) counterparts or equivalents to any of the foregoing anywhere in the world; in each case that are owned by METHODIST or any of its Affiliates or licensed to METHODIST or any of its Affiliates with the right to sublicense as of the Effective Date or at any time during the Term. Any claim of an unexpired Licensed Patent Right is presumed to be valid unless it has been held to be invalid by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken. The Licensed Patent Rights further include those Patent Rights listed on Attachment G, as it may be updated from time to time.
3
CONFIDENTIAL
1.11“Licensed Product” means any tangible apparatus, material, equipment, machine, cells, exosomes or other product that is comprised of, contains, is derived from or was made using a process that incorporates Licensed Know-how or the manufacture, use, sale, offer for sale or import of which is covered by Licensed Patent Rights.
1.12“Licensed Service” means any service, method, procedure or other process (including software and other computer instructions) that is provided or performed using any of the Licensed Know-how or the use of which is covered by any of the Licensed Patent Rights, including the isolation, generation, reproduction, preparation, manufacturing and supply of cells, exosomes or other products.
1.13“Licensed Territory” means, with respect to the Licensed Patent Rights, wherever existing, and with respect to the Licensed Know-how, worldwide.
1.14“Patent Costs” means all out of pocket costs incurred by METHODIST in connection with the preparation, filing, prosecution, and maintenance of the Licensed Patent Rights in each jurisdiction, including interference or derivation proceedings, post grant review, reexaminations, and other reviews, appeals and patent related procedures.
1.15“Patents” means all (a) patents, industrial and utility models, industrial designs, petty patents, design patents, patents of importation, patents of addition, certificates of invention, and other indicia of ownership of an invention or discovery that is issued or granted by any Governmental Entity, (b) applications for any of the foregoing, including provisional, utility, design, priority, divisional, and continuation (in whole or in part) applications, and all other pre- grant forms of any of the foregoing, (c) extensions, reissues, re-examinations, renewals, or other post-grant forms of any of the foregoing; and (d) equivalents or counterparts of any of the foregoing.
1.16“Regulatory Authority” means the Food and Drug Administration of the United States of America (or a successor agency) or any comparable agency in a country outside the United States of America that is authorized to regulate the licensure, approval, manufacture, or sale of pharmaceuticals, biologics, dietary supplements, medical foods, nutraceuticals, food additives, cosmetics, diagnostics, medical devices, or medical processes and any applicable Institutional Review Board or Ethics Committee.
|
(c) |
the right to publish any information included in the Licensed Patent Rights or Licensed Know-how, subject to Article 8; |
4
CONFIDENTIAL
|
|
(d) |
the rights necessary to fulfill the obligations of METHODIST to LICENSEE under this Agreement, including continuing and completing the Ongoing Phase 2a Trial. |
1.18“Sale”, “Sold” or “Sell” means the transfer or disposition of a Licensed Product or provision of a Licensed Service for consideration.
1.19“Sales Revenue” means the gross sales price and/or the monetary equivalent of any other consideration actually received by LICENSEE and its Affiliates in the Sale of a Licensed Product or Licensed Service, less any of the following items that are itemized on the relevant invoice or which LICENSEE can demonstrate have been actually paid or credited with respect to that Sale:
|
(b) |
sales, excise, use, value added or other taxes, tariffs, export license fees and duties paid to a governmental entity; |
Neither sales commissions nor the costs of collection are deductible from the gross sales price when calculating Sales Revenue.
Notwithstanding the foregoing, (a) if LICENSEE or its Affiliates bundle or combine a Licensed Product or a Licensed Service with any other good(s) or service(s) that is/are not a Licensed Product or Licensed Service, whether in the form of a kit consisting of two products, a product containing multiple active ingredients, either independently or co-formulated, or a combination of a product plus a service, in each case wherein part of the bundle or combination is a Licensed Product or Licensed Service and other part is not, then the term “Sales Revenue” with respect to such Licensed Product or the Licensed Service will mean the Fair Market Value; (b) Sales Revenues will be accrued for Licensed Services only if the Licensed Service do not result in Licensed Products that are Sold; and (c) no Sales Revenues will accrue upon Sales between or among LICENSEE or any of its Affiliates or Sublicensees, but instead in such cases Sales Revenues will accrue on the first Sale to any person or entity that is not LICENSEE or any of its Affiliates or Sublicensees. For clarity, Sales Revenues do not include any Sublicensing Revenues.
1.20“Sublicensee” means any person or entity to which LICENSEE grants, directly or indirectly, a sublicense under any of the rights granted to LICENSEE in Section 3.1.
1.21“Sublicensing Revenues” has the meaning set forth on Attachment C.
5
CONFIDENTIAL
2.Representations and Warranties; Disclaimers and Limitation on Damages.
|
(a) |
LICENSEE UNDERSTANDS AND ACKNOWLEDGES THAT, BY THIS AGREEMENT, EXCEPT AS EXPRESSLY STATED IN SECTIONS 2.8 AND 2.9, METHODIST DISCLAIMS ALL WARRANTIES AND MAKES NO REPRESENTATION (A) AS TO THE OPERABILITY OR FITNESS FOR ANY USE, SAFETY, EFFICACY, ABILITY TO OBTAIN REGULATORY APPROVAL, PATENTABILITY, OR BREADTH OF THE LICENSED PATENT RIGHTS OR LICENSED KNOW-HOW, (B) AS TO WHETHER THERE ARE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY METHODIST IN THE LICENSED FIELD, (C) THAT THE LICENSED PRODUCTS OR THE LICENSED SERVICES DO NOT INFRINGE ANY OTHER PATENTS NOW HELD OR THAT WILL BE HELD BY OTHERS OR BY METHODIST, AND (D) THAT ALL OF THE CLAIMS OF ANY PATENT INCLUDED IN THE LICENSED PATENT RIGHTS ARE VALID. |
|
(c) |
METHODIST UNDERSTANDS AND ACKNOWLEDGES THAT, BY THIS AGREEMENT, LICENSEE DISCLAIMS ALL WARRANTIES AND MAKES NO REPRESENTATION (A) AS TO THE OPERABILITY OR FITNESS FOR ANY USE, SAFETY, EFFICACY, ABILITY TO OBTAIN REGULATORY APPROVAL, PATENTABILITY, OR BREADTH OF THE LICENSED PATENT RIGHTS OR LICENSED KNOW-HOW, (B) AS TO WHETHER THERE ARE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSEE IN THE LICENSED FIELD, (C) THAT THE LICENSED PRODUCTS OR THE LICENSED SERVICES DO NOT INFRINGE ANY OTHER PATENTS NOW HELD OR THAT WILL BE HELD BY OTHERS OR BY METHODIST, AND |
|
(D) |
THAT ALL OF THE CLAIMS OF ANY PATENT INCLUDED IN THE LICENSED PATENT RIGHTS ARE VALID. |
2.2Due Diligence. LICENSEE, by execution hereof, represents, warrants and agrees that (a) it has not been induced in any way by METHODIST or any of its employees or agents to enter into this Agreement, except for the representations and warranties of METHODIST, the rights and licenses granted by METHODIST to LICENSEE, and the covenants and obligations of METHODIST to LICENSEE expressly stated in this Agreement; (b) it has conducted sufficient due diligence with respect to all items and issues pertaining to this Article 2 and all other matters pertaining to this Agreement; and (c) LICENSEE has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and agrees to accept all risks inherent herein subject to the terms and conditions of this Agreement.
6
CONFIDENTIAL
2.3LICENSEE Acknowledgments. LICENSEE acknowledges that (a) other than through this Agreement, LICENSEE has no rights to, or ownership interest in, the Licensed Patent Rights or Licensed Know-how, and (b) METHODIST has no obligation to file any patent application or maintain any patent in any jurisdiction or to commence any legal action against third persons infringing the Licensed Patent Rights.
2.4Compliance with Law. Each party shall comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this Agreement, including the transfer of products and technical data.
2.5Export Restrictions. It is understood that each party and its Affiliates are subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other items (including the Arms Export Control Act, as amended, the Export Administration Regulations and U.S. economic sanctions), and that their obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license or other authorization from the appropriate agency of the United States government and/or written assurances by the recipient that it shall not export data or commodities to certain foreign countries without prior approval of such agency (including, as controlled under U.S. law, release of technology, source code, and technological data to non-U.S. persons). Without limiting the generality of Section 2.1, neither party makes any representations and each party disclaims any warranty regarding whether a license shall be required or that, if required, it shall be issued with respect to any of the Licensed Know-how or Confidential Information exchanged under this Agreement.
2.6LIMITATION ON DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER SUCH PARTY KNOWS OR
SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES, PROVIDED THAT THE FOREGOING SHALL NOT LIMIT A CLAIM BY EITHER PARTY FOR BREACH OF CONFIDENTIALITY, USE OF THE LICENSED PATENT RIGHTS OR LICENSED KNOW-HOW OUTSIDE OF THE LICENSE GRANTED UNDER THIS AGREEMENT OR INDEMNIFICATION UNDER ARTICLE 7.
2.8Mutual Representations and Warranties. Each party represents and warrants to the other party as follows:
|
(b) |
no consent, approval, authorization or filing of any certificate, notice application, report or other document with any governmental entity is required on the part of |
7
CONFIDENTIAL
|
such party in connection with the valid execution and delivery of this Agreement or the performance by such party of any of its obligations hereunder. |
2.9METHODIST Further Representations and Warranties. METHODIST further represents and warrants to LICENSEE that, as of the Effective Date:
|
(a) |
The Licensed Patent Rights listed on Attachment A constitute [***] the Patents owned (solely or jointly) by METHODIST [***]. |
|
(c) |
To Methodist knowledge, the regulatory documents listed in Attachment E are true and accurate copies of the actual regulatory submissions. |
|
(d) |
To the best of the knowledge of METHODIST after reasonable inquiry, none of the [***] Existing Patent Applications are subject to any of the governmental rights described in Section 3.2. |
|
(e) |
All of the [***] Existing Patent Applications are solely owned by METHODIST and no other person or entity has any license or security interest therein. |
3.1Grants. Subject to the terms of this Agreement and the Retained Rights, METHODIST hereby grants to LICENSEE a license, including the right to sublicense, under (a) the Licensed Patent Rights to make, have made, use, Sell, offer to Sell, and import Licensed Products and Licensed Services, solely for applications within the Licensed Field and in the Licensed Territory; (b) all rights in the Licensed Know-how in connection with the research, development, Regulatory Approval, manufacturing, distribution, Sale, marketing or other exploitation of Licensed Products and Licensed Services, solely for applications within the Licensed Field and in the Licensed Territory. The foregoing licenses are Exclusive for the Licensed Patent Rights, Exclusive for the Exclusive Licensed Know-how, and non-exclusive for the other Licensed Know- how. METHODIST further grants to LICENSEE an exclusive right of reference with respect to the Existing IND (as defined on Attachment A) and all related data and documentation generated in connection with the Existing IND.
3.2Government Rights. If any of the Licensed Patent Rights were developed in the course of research sponsored by a governmental authority or agency (federal, state or local), this Agreement is explicitly made subject to the government’s rights under any agreement and any applicable law or regulation related to such research. METHODIST reserves on behalf of the appropriate
8
CONFIDENTIAL
governmental entity a license with respect to the Patent Rights to the extent required under any such agreement, applicable law or regulation, including 35 USC 200 et seq. and 37 CFR 401. IF THERE IS A CONFLICT BETWEEN A GOVERNMENT AGREEMENT, APPLICABLE LAW OR REGULATION AND THIS AGREEMENT, THE TERMS OF ANY GOVERNMENT AGREEMENT, APPLICABLE LAW OR REGULATION SHALL PREVAIL. If any of the Licensed Patent Rights were developed in course of U.S. federal government sponsored research, each Licensed Product and Licensed Service to be sold in the United States must be manufactured substantially in the United States unless LICENSEE obtains a written waiver in advance from the government.
3.3Reservation of Rights. This Agreement does not confer any license or rights by implication, estoppel or otherwise in any patents, know-how or other technology or intellectual property that is not explicitly granted to LICENSEE in Section 3.1. Each party expressly retains all rights not explicitly granted to the other party. Except as expressly and specifically provided under this Agreement, the parties agree that neither party is granted any implied rights to or under any of the other party’s current or future patents, trade secrets, copyrights, moral rights, trade or service marks, trade dress, or any other intellectual property rights. WITHOUT LIMITING THE FOREGOING, EXCEPT AS PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAY USE THE NAME, LOGOS OR OTHER MARKS (INCLUDING TRADEMARKS, SERVICE MARKS AND TRADE NAMES) OF THE OTHER PARTY, ITS AFFILIATES, OR ANY OF THEIR DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS WITHOUT EXPRESS WRITTEN CONSENT FOR EACH USE.
3.4Sublicenses. LICENSEE may grant sublicenses under the rights granted to LICENSEE under Section 3.1 (each, a “Sublicense”) consistent with the requirements of this Section without the consent of METHODIST and otherwise only with the consent of METHODIST, not to be unreasonably withheld, conditioned or delayed. LICENSEE is responsible for the operations of its Sublicensee(s) relevant to this Agreement as if the operations were carried out by LICENSEE, including, whether or not paid to LICENSEE by a Sublicensee, (a) the milestone payments for milestone events identified in Part II of Attachment B, achieved by Sublicensees and (b) payment of royalties on Sublicensing Revenues by the Sublicensee(s). Each Sublicense granted without consent of METHODIST must:
|
(b) |
Be of no greater scope than scope of the rights granted to LICENSEE in Section 3.1 and be subject to the Retained Rights and the limitations in Sections 3.2 and 3.3 and 3.6; |
|
(c) |
Require the Sublicensee to notify LICENSEE if Sublicensee achieves any milestone events identified in Part II of Attachment B and to issue reports to LICENSEE on Sales of Licensed Products or Licensed Services sufficient to permit LICENSEE to report on and pay the amount of royalties due thereon to METHODIST in a timely manner, including the ability to share such reports with METHODIST as provided in Section 4.5; |
|
(d) |
Require the Sublicensee to pay to LICENSEE twice the amount of each royalty due from Sublicensee to LICENSEE if the Sublicensee takes any of the actions described in Section 4.3; |
|
(e) |
Require Sublicensee to maintain the confidentiality of the Confidential Information of METHODIST consistent with the obligations of LICENSEE under Article 8; |
|
(f) |
Require Sublicensee to indemnify, defend and hold harmless METHODIST as if the Sublicensee were LICENSEE under Article 7.1; |
|
(g) |
Include audit rights by LICENSEE at least as extensive as those set forth in Section 4.4, which METHODIST may require LICENSEE to invoke to cause an audit of Sublicensee; |
9
CONFIDENTIAL
|
(h) |
Permit LICENSEE to provide to METHODIST copies of the transaction documents contemplated in Section 4.7; |
|
(i) |
Prohibit the Sublicensee from assigning any of the rights sublicensed to Sublicensee without consent of LICENSEE, except to Affiliates of Sublicensee; and |
|
(j) |
Name METHODIST as a third-party beneficiary of the rights described in foregoing clauses (c) through (i) with the right to enforce such provisions directly against the Sublicensee. |
3.5Diligence Requirement. The license granted in Section 3.1 is further subject to the requirement of LICENSEE to use commercially reasonable efforts to continue to develop and seek, obtain and maintain Regulatory Approval for at least one Licensed Product or Licensed Service, and after obtaining such Regulatory Approval, to promote, market, and Sell such Licensed Product or Licensed Service within the Licensed Territory in compliance with applicable laws and regulations. LICENSEE will use commercially reasonable efforts to achieve the development milestones set forth in the “Part I: Target Development Milestones” section of Attachment B within the time frames specified for the milestone. If LICENSEE fails to timely achieve any such milestone, METHODIST will notify LICENSEE of that failure and discuss the reasons therefor. If (a) LICENSEE continues to be unable to achieve the milestone within ninety (90) days following notice from METHODIST, (b) the Parties have not otherwise mutually agreed to extend the time frames or otherwise modify such development milestone, and (c) such failure is not due to due to the actions or inactions of any Regulatory Authority when LICENSEE has not breached its obligations under this Section 3.5 or to the breach by METHODIST of this Agreement, then METHODIST shall have the right, at its option by notice to LICENSEE, to terminate this Agreement or convert the license granted under Section 3.1 to a non-exclusive license and restrict the Licensed Territory to the countries in which LICENSEE has made Sales within the previous six months.
3.6Transfer Restrictions. LICENSEE will not transfer or otherwise dispose of any of the Licensed Products or provide any of the Licensed Services (including for donation or promotion) for use outside of the Licensed Field or outside of the Licensed Territory without the advance, written consent of METHODIST. METHODIST will not transfer the Existing IND to any person or entity that is not a not-for-profit hospital or university without the advance, written consent of LICENSEE.
3.7Marking. LICENSEE will mark, and cause each Affiliate and Sublicensee to mark, all Licensed Products with patent numbers to the extent that such marking is required to enable the Patent Rights to be enforced against infringements thereon in any country where the Licensed Products are Sold. LICENSEE may, but is not obligated to, mark Licensed Products with patent numbers otherwise in accordance with applicable laws and regulations.
3.8Technology Transfer. If from time to time LICENSEE believes that any documentation or data constituting Licensed Know-how exists but has not yet been provided, then LICENSEE may request disclosure thereof in reasonable level of specificity and METHODIST will use commercially reasonable efforts to promptly provide to LICENSEE a complete and accurate electronic copy of such documentation and data in the possession or control of METHODIST. Promptly after completion of the Ongoing Phase 2a Trial (as defined on Attachment A), METHODIST will or will cause to be delivered to LICENSEE a copy of all documentation and data generated for or from the Ongoing Phase 2a Trial.
3.9Right of Reference Authorization. METHODIST will provide a letter of authorization or other documentation prepared by LICENSEE reasonably requested by LICENSEE to exercise the right of reference granted to LICENSEE under Section 3.1.
10
CONFIDENTIAL
4.1Royalties and Fees. In consideration of rights granted by METHODIST to LICENSEE under this Agreement, LICENSEE will pay or issue to METHODIST each the following:
11
CONFIDENTIAL
|
calendar year. |
|
(e) |
payments for achievement of certain milestone events by LICENSEE or its Affiliates or Sublicensees described in the “Part II: Milestone Payments” section of Attachment B. |
4.2Patent Costs and Patent Costs Reserve. METHODIST may invoice LICENSEE for Patent Costs incurred after the Effective Date as incurred, but not more frequently than monthly. During any such time in which LICENSEE is controlling the prosecution or maintenance for any of the Licensed Patent Rights, LICENSEE will only be required to reimburse METHODIST for those Patent Costs incurred by METHODIST prior to the Effective Date. LICENSEE will reimburse METHODIST for all Patent Costs properly invoiced within thirty (30) days of receipt of invoice. On the Effective Date, LICENSEE will pay to METHODIST [***] to be held in escrow by METHODIST for LICENSEE for reimbursement of Patent Costs that were incurred but not yet billed to METHODIST prior to the Effective Date (such money, the “Patent Costs Reserve”). LICENSEE will increase the amount to be held by METHODIST as Patent Costs Reserve to [***] at the end of three (3) months after the Effective Date and to [***] at the end of six (6) months after the Effective Date and maintain such amount thereafter until mutually agreed by the Parties it is no longer necessary. If METHODIST properly applies any of the Patent Costs Reserve towards such unreimbursed payments, then within thirty (30) days after notice thereof by METHODIST, LICENSEE must pay to METHODIST an amount to be credited to the Patent Costs Reserve so that it is restored to its minimum balance.
4.3Challenge Premium. Notwithstanding the above, if LICENSEE, any of its Affiliates or Sublicensees or any person or entity acting on behalf or in the interest of any of the foregoing brings an action seeking to invalidate a Licensed Patent Right, Section 4.1(d) shall be automatically amended so that the applicable royalty rate is double the highest applicable royalty rate set forth in Attachment C without application of any reductions or credits otherwise provided herein or in any subsequent Agreement of the parties that is subject to this Agreement.
4.4Books and Records; Audits. During the term of this Agreement and for three (3) years thereafter, LICENSEE agrees to keep complete and accurate records of its and its Affiliates’ Sales Revenue and Sublicensing Revenues and reports received from Sublicensees in sufficient detail to enable the royalties payable hereunder to be determined. LICENSEE agrees to permit METHODIST or its representatives, at METHODIST’s expense, to examine such records once per year, upon reasonable advance notice, and during regular business hours for the purpose of and to the extent necessary to verify any royalty report required under this Agreement. Such examination may, at METHODIST’s sole discretion, consist of a self-audit conducted by LICENSEE to verify that the royalty amounts paid are correct and certified in writing by an officer of LICENSEE. If the amounts due to METHODIST are determined to have been underpaid by five percent (5%) or greater for the period being audited, LICENSEE will pay the actual out-of-pocket costs reasonably incurred for the examination and the Late Fee applicable to the underpayment as if such amounts had been timely reported as due and payable.
4.5Quarterly Reports. Within forty-five (45) days after March 31, June 30, September 30, and December 31, beginning immediately after the calendar quarter in which Sales Revenues or Sublicensing Revenues are first accrued, LICENSEE shall deliver to METHODIST a true and accurate written report, even if no payments are due METHODIST, giving the particulars of the business related to the Patent Rights that was conducted by LICENSEE and its Sublicensee(s), during the
12
CONFIDENTIAL
preceding three (3) calendar months under this Agreement as are pertinent to calculating payments hereunder. This report will include at least:
|
(a) |
The total Sales by LICENSEE or any of its Affiliates separately listed into United States and foreign Sales; |
Simultaneously with the delivery of each report, LICENSEE shall pay to METHODIST the amount, if any, due for the period of each report for Sales Revenues and for Sublicensing Revenues received from each Sublicensee for the subject quarter.
4.6Periodic Reports. On or before each anniversary of the Effective Date until the first Sales Revenues or Sublicensing Revenues occur, LICENSEE shall prepare, and deliver to METHODIST, a written report summarizing LICENSEE’s (and its Affiliates’ and any Sublicensees’) (a) efforts and accomplishments during the preceding year and (b) plans for the upcoming year, in each case, to develop and seek, obtain and maintain Regulatory Approval for Licensed Products or Licensed Services, and after obtaining such Regulatory Approval, to promote, market, and Sell Licensed Products or Licensed Services, as appropriate to LICENSEE’s stage of development. LICENSEE will provide to METHODIST a copy of any documentation that is submitted or received as part of a Regulatory Authority’s processes of scientific and regulatory review to evaluate the safety and effectiveness of or for permission for clinical experimentation in humans of device Licensed Product or Licensed Services as may be reasonably requested by METHODIST from time to time and to the extent not prohibited by any applicable law. Upon request of METHODIST, but no more frequently than once per calendar year, LICENSEE shall provide to METHODIST the information necessary for METHODIST to complete required reports to governmental agencies and granting agencies regarding utilization of funded inventions within the Licensed Know-how or that are the subject of the Licensed Patent Rights.
4.7LICENSEE Responsibility for Sublicensees. LICENSEE shall provide a copy of all agreements that are part of a transaction or series of transactions that involve the grant of a sublicense. Such copy may be redacted for sensitive information that is requested to be redacted by the Sublicensee and that is unrelated to the grant of sublicense or the basis for Sublicensing Revenues, including identities or other personal information of employees of Sublicensee and its Affiliates or other information subject to privacy regulation or the research or development targets of therapy, diagnosis or prevention not yet the subject of publicly available documents. LICENSEE shall deliver to METHODIST a copy of each Sublicensee’s statements of amounts payable to LICENSEE that constitute Sublicensing Revenues. LICENSEE is responsible for paying all royalties, sublicense fees and other sums payable with respect to the activities of its Affiliates and Sublicensees, and LICENSEE will bear all credit risks associated with its Affiliates and Sublicensees.
4.8No Refunds, Offsets or Co-Ownership Reductions. All payments under this Article 4 shall be non-refundable and non-creditable unless otherwise expressly stated in this Agreement. No
13
CONFIDENTIAL
payments due or royalty rates owed under this Agreement will be reduced as a result of co- ownership of Patent Rights by METHODIST and another party, including, but not limited to, LICENSEE.
4.9Taxes. All amounts payable herein by LICENSEE shall be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind, except those required by applicable law. METHODIST is a tax-exempt organization under the laws of the State of Texas and of the United States and shall be solely responsible for any taxes that may hereafter be levied upon the payments to METHODIST.
4.10Currency. When a Licensed Product or Licensed Service is Sold for monies other than United States dollars, the earned royalties first will be determined in the foreign currency in the country in which such Licensed Product or Licensed Service was Sold, and then converted into equivalent United States funds. The conversion method and rate will be that used by the seller for currency conversions as consistently applied by the seller in accordance with applicable accounting standards.
4.11Late Fees. All royalty payments which are not paid by LICENSEE by the thirty-first (31st) day after each quarterly payment date shall bear interest at the Late Fee rate. Such interest payments shall be calculated from the quarterly due dates until the payment is received by METHODIST.
4.12Payment Method. All payments shall reference the contract number of this Agreement (set out at the top of the first page). All checks shall be sent to the following address:
The Methodist Hospital
Office of Technology Transfer
6670 Bertner Ave, M.S. R12-111
Houston, Texas 77030
If LICENSEE desires to make payment by a wire transfer, LICENSEE shall contact METHODIST to obtain the required wire transfer information and shall reference the contract number of this Agreement in the wire transfer information.
5.1Term. The term of this Agreement is from the Effective Date until no intellectual property right in the Licensed Patent Rights or Licensed Know-how remains, unless terminated sooner pursuant to Section 5.2, 5.3 or 5.4 below.
5.1Automatic Termination. Subject to any rights that survive termination, this Agreement will earlier terminate in its entirety automatically if LICENSEE becomes bankrupt or insolvent and/or if the business of LICENSEE is placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of LICENSEE or otherwise.
14
CONFIDENTIAL
|
(e) |
If LICENSEE is in material breach of this Agreement, then METHODIST may notify LICENSEE of METHODIST’s intent to terminate this Agreement if such breach is not cured. If (i) LICENSEE does not cure the breach and (ii) neither party disputes in good faith the alleged breach by initiation of dispute resolution, both within [***] after METHODIST has provided the foregoing notice, then METHODIST may terminate this Agreement immediately by a second notice to LICENSEE. If a party does initiate dispute resolution in good faith within such time and the final, binding results of such dispute resolution are that LICENSEE is in material breach of the Agreement, then METHODIST may terminate this Agreement immediately by notice to Licensee. |
5.3Termination by LICENSEE. Licensee may terminate this Agreement by written notice to METHODIST for any or no reason.
15
CONFIDENTIAL
5.4Effects of Termination. If this Agreement is terminated:
|
(a) |
nothing herein will be construed to release either party of any obligation matured prior to the effective date of the termination; and |
|
(e) |
the provisions of Article 1, Sections 2.1, 2.6, 3.2, 3.3, 4.4, this 5.4, and Articles 7, 8 and 9 will remain in effect and survive termination as applicable; and |
6.1Patent Management. LICENSEE will have the first right and responsibility for preparing, filing, prosecuting and maintaining all Licensed Patent Rights, including defending them against all challenges to their validity or patentability as further described below and subject to Section
6.2.After the Effective Date and before the amendment and restatement of this Agreement, LICENSEE and METHODIST entered into a Patent Prosecution Agreement that was attached to this Agreement on the Effective Date as Attachment F.
16
CONFIDENTIAL
|
(b) |
LICENSEE will notify METHODIST before taking any substantive actions in prosecuting the claims of any pending applications within the Licensed Patent Rights, and LICENSEE will have final approval on how to proceed with any such claims; provided, however, that LICENSEE may not abandon any such patent without the approval of METHODIST. |
|
(d) |
LICENSEE will reimburse METHODIST for METHODIST’s reasonable, actual out-of- pocket costs incurred in complying with requests of LICENSEE and its designated patent attorneys/agents. |
|
(h) |
As between the parties, all costs and expenses of activities conducted by or at the direction of LICENSEE, including payment of all costs and expenses of its patent |
17
CONFIDENTIAL
|
attorneys and agents and governmental filing fees, are the sole responsibility of LICENSEE. |
6.2Communication on Patent Matters. Each party will promptly inform the other as to all matters that come to its attention that may affect the preparation, filing, prosecution or maintenance of the Licensed Patent Rights and permit each other to provide comments and suggestions with respect to the preparation, filing, prosecution and maintenance of Licensed Patent Rights, which comments and suggestions will be considered by the other party.
6.3Notice of Infringement. If a third party sues or threatens to sue LICENSEE or any of its Affiliates for the continued Sale of any Licensed Product or Licensed Service, LICENSEE agrees to notify METHODIST promptly of same in writing.
|
(a) |
LICENSEE, at its expense, has the first right to enforce any Licensed Patent Right or Licensed Know-how against infringement, misappropriation or other violation thereof by third parties, including by bringing a suit or threatening to bring a suit. LICENSEE is entitled to retain all monetary recovery from such enforcement except that LICENSEE must (i) reimburse METHODIST for any actual, out-of-pocket costs reasonably incurred by METHODIST in connection with such enforcement and (ii) pay to METHODIST [***] of the net amounts of such monetary recovery actually received by LICENSEE as a result of such enforcement (including from settlement or court awards) after deduction of all of LICENSEE’s and METHODIST’s actual, out of pocket costs incurred in connection with such enforcement. If the result of such enforcement is the creation of a Sublicensee, then LICENSEE would owe royalties for such Net Sales occurring under the applicable sublicense agreement consistent with the terms of this Agreement applicable to Sublicensees. |
6.5Cooperation in Infringement Actions. In any infringement suit or dispute involving enforcement of any of the Licensed Patent Rights or Licensed Know-How, the parties agree to cooperate fully with each other, including by joining as a party to litigation if necessary to effect standing to sue. At the request and expense of the party bringing suit, the other party will permit
18
CONFIDENTIAL
access to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours, in each case in accordance with that party’s reasonable restrictions applicable to site visits.
6.6Joint Enforcement of Infringement. LICENSEE may request that METHODIST join the enforcement of Licensed Patents Rights against an infringer by sharing in the costs to do so as they are incurred. If METHODIST agrees, then LICENSEE and METHODIST shall share in the actual, out-of-pocket costs reasonably incurred by LICENSEE and METHODIST in connection with such enforcement by both parties paying their agree share promptly as incurred, and after deducting such costs, any remaining recovery shall be divided between LICENSEE and METHODIST at the same percentage that the costs were shared.
7.1Indemnification by LICENSEE. LICENSEE agrees to defend, hold harmless and indemnify METHODIST and its Affiliates, and each of their directors, officers, employees, and agents from and against any claims, demands, or causes of action whatsoever brought by any third party against any of the foregoing, and all associated damages, awards, penalties, fines, costs and expenses, including reasonable attorney’s fees, including those arising on account of any injury or death of persons or damage to property, in each case to the extent caused by, or arising out of, or resulting from the exercise, practice or breach of any of the provisions of this Agreement by LICENSEE, its Affiliates, its Sublicensees or any of their respective directors, officers, employees or agents and not a matter for which METHODIST is obligated to indemnify under Section 7.2.
7.2Indemnification by METHODIST. METHODIST agrees to defend, hold harmless and indemnify LICENSEE and its Affiliates, and each of their directors, officers, employees and agents from and against any claims, demands or causes of action brought by any third party against any of the foregoing, and all associated damages, awards, penalties, fines, costs and expenses, including reasonable attorney’s fees, including those arising on account of injury or death of persons or damage to property, in each case to the extent caused by, or arising out of, or resulting from the exercise, practice or breach of any of the provisions of this Agreement by METHODIST, its Affiliates or any of their respective directors, officers, employees or agents and not a matter for which LICENSEE is obligated to indemnify under Section 7.1.
7.3Insurance. Beginning at the time when any Licensed Product or Licensed Service is being distributed or Sold (including clinical research for the purpose of obtaining regulatory approvals) by LICENSEE, an Affiliate or a Sublicensee, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than [***] per incident and [***] annual aggregate and naming METHODIST as an additional insured. Such commercial general liability insurance shall provide (a) product liability coverage; (b) broad form contractual liability coverage for LICENSEE's indemnification under this Agreement; and (c) coverage for litigation costs. The minimum amounts of insurance coverage required shall not be construed to create a limit of LICENSEE's liability with respect to its indemnification under this Agreement. LICENSEE shall provide METHODIST with written evidence of such insurance upon METHODIST's request. LICENSEE shall provide METHODIST with written notice promptly after the cancellation, non-renewal or material change in such insurance. LICENSEE shall maintain such commercial general liability insurance
19
CONFIDENTIAL
beyond the expiration or termination of this Agreement during (i) the period that any Licensed Product/Service developed pursuant to this Agreement is being commercially distributed or Sold by LICENSEE or by a Sublicensee or their agent; and (ii) the one year period immediately after such period.
8.1Confidentiality. METHODIST and LICENSEE each agree that, as a recipient, all Confidential Information of the discloser (a) is to be received in strict confidence, (b) is to be used only for the purposes of this Agreement, and (c) is not to be disclosed by the recipient to any third party without the prior written consent of the other party, except as expressly permitted under this Agreement. The Licensed Know-how and any unpublished Licensed Patent Right is the Confidential Information of both parties and subject to the limitations and permissions regarding its disclosure as a recipient in Sections 8.1 – 8.3 (but the obligation under Section 5.5(f) does not apply to METHODIST with respect to such Confidential Information). The terms of this Agreement, but not its mere existence, constitute the Confidential Information of each of the parties for which each of the parties is deemed a recipient. Each party’s obligation under this Section 8.1 shall be fulfilled by using at least the same degree of care with the other party’s Confidential Information as it uses to protect its own confidential information of like nature. This obligation shall exist while this Agreement is in force and for a period of three (3) years thereafter.
8.2Required Disclosures. If any portion of the Confidential Information of discloser is required to be disclosed pursuant to governmental law, regulation or judicial proceeding, the recipient shall promptly provide notice of such requirement to the discloser and cooperate with that discloser’s efforts in seeking a protective order or other assurance that confidential treatment will be accorded to the Confidential Information that is required to be disclosed. In the event that such protective order or other remedy is not obtained, or that the discloser waives compliance with the provisions hereof, the recipient required to furnish the Confidential Information and its employees and agents agree to use reasonable efforts to furnish only that portion of the discloser’s Confidential Information that is legally required to be furnished.
|
(b) |
to patent offices of governmental entities to file, prosecute, maintain, defend or enforce any Licensed Patent Rights in accordance with the terms of this Agreement; |
|
(c) |
in connection with the seeking, obtaining or maintaining Regulatory Approvals for Licensed Products or Licensed Services in accordance with the terms of this Agreement; |
20
CONFIDENTIAL
|
9.1Entire Agreement. This Agreement constitutes the entire and only agreement between the parties for Licensed Patent Rights and Licensed Know-how and all other prior negotiations, representations, agreements, and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by a written document signed by both parties.
9.2Notices. Any notice required by this Agreement shall be given by prepaid, first class, certified mail, return receipt requested, addressed to:
In the case of METHODIST to: |
|
||
|
The Methodist Hospital |
|
|
|
Office of General Counsel |
|
|
|
6565 Fannin St., Ste. D-200 |
|
|
|
Houston, Texas 77030 |
|
|
|
|
|
|
|
with copy to: |
|
|
|
|
|
|
|
The Methodist Hospital |
|
|
|
Office of Technology Transfer |
|
|
|
6670 Bertner Ave., M.S. R12-111 |
|
|
|
Houston, Texas 77030 |
|
|
|
|
|
|
or in the case of LICENSEE to: |
|
||
|
|
||
|
Coya Therapeutics, Inc. |
|
|
|
12645 Memorial Drive, Suite F1 #305 |
|
|
|
Houston, Texas 77024 |
|
|
|
Attention: President |
|
|
|
|
|
|
|
with copy to: |
|
|
|
|
|
|
|
Jones Day |
|
|
|
4655 Executive Drive, Suite 1500 San Diego, CA 92121-3134 |
|
|
|
Attention: Thomas A Briggs and Michael A Oblon |
|
or other addresses as may be given from time to time under the terms of this notice provision.
21
CONFIDENTIAL
9.3Governing Law. This Agreement will be construed and enforced in accordance with the laws of the United States of America and of the State of Texas without reference to its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods (“CISG”) shall not be applicable to this Agreement or the transactions contemplated by this Agreement, and the parties expressly exclude application of the CISG.
9.4Attorneys’ Fees. The prevailing Party in any dispute resolution process initiated by either Party in connection with this Agreement, including litigation or other dispute resolution processes to resolve a dispute as to whether a Party has the right to terminate for material breach of the other Party, will be entitled to recovery of all its actual out-of-pocket costs and expenses, including attorneys’ fees, reasonably incurred in connection with such litigation or other dispute resolution process to the maximum extent permitted by applicable law.
9.5Construction of Agreement. The Parties have negotiated this Agreement and the language in this Agreement will not be construed for or against either Party. The headings used herein are for reference and convenience only and will not enter into the interpretation of this Agreement. The terms “herein”, “hereby”, “hereof”, “hereunder”, “hereto” and similar expressions mean or refer to this Agreement as a whole, and not to any particular provision or section of this Agreement. In construing this Agreement and where context requires, references to the singular will include the plural and references to the plural will include the singular, and words denoting any gender shall include all genders. Unless the context clearly indicates the contrary, the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or”. The words “include”, “includes” and “including” will be deemed to be followed by the phrase “without limitation”, and will not be interpreted to limit the provision to which it relates. A statute or statutory instrument or any of their provisions is to be construed as a reference to that statute or statutory instrument or such provision as the same may have been or may from time to time hereafter be amended or re-enacted.
9.6No Waiver. The failure or delay of a party to enforce or to exercise, at any time for any period of time, any provision hereof or any right or remedy hereunder shall not be construed as a waiver of such provision or right or remedy or of the right of such party to enforce or exercise the same, provided, however, that such right or remedy is not time-barred or otherwise precluded by law or by a writing expressly waiving such right or remedy and signed by that party and by the party seeking to assert such right or remedy. The written waiver by either party of a breach of any term or provision of this Agreement by the other party shall not be construed as a waiver of any subsequent breach.
9.7Independent Contractor; No Agency. LICENSEE and METHODIST agree that their relationship established by this Agreement is that of licensor and licensee, and that this Agreement does not, is not intended to, and shall not be construed to establish a partnership or joint venture, nor shall this Agreement create or establish an employment, agency or any other relationship. Neither party has any right, power or authority to, nor shall it represent itself as having any authority to, assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other party or any of its Affiliates, nor to act as an agent for such other party or any of its Affiliates for any purpose.
9.8Assignment. Except as provided herein, this Agreement may not be assigned in whole or in part by LICENSEE without the prior written consent or deemed consent of METHODIST, which will not be unreasonably withheld, conditioned or delayed, and payment of the Assignment Fee, when applicable. If LICENSEE desires to effect an assignment without consent, LICENSEE must provide to METHODIST information before the assignment showing that the intended assignee (a) is reasonably expected at such time to be capable of performing LICENSEE’s obligations under this Agreement and has the financial resources adequate to do so or the ability to obtain them and (b) will assume all of the obligations and liabilities under this Agreement arising after the assignment (the information provided about the assignee, collectively, the “Assignment Package”). If the Assignment Package does not meet such criteria and METHODIST either consents to that assignment or does not deliver a written notice to LICENSEE of its reasonable objections thereto within fifteen (15) days of receiving the Assignment Package, the consent to the assignment will be deemed provided. Whether or not such consent is required to be provided, within thirty (30) days after the assignment, the assignee (as the new LICENSEE) must pay to METHODIST an assignment fee (“Assignment Fee”) in the amount of [***].
22
CONFIDENTIAL
9.9Severability. If any term, clause or provision hereof is held invalid or unenforceable by a court of competent jurisdiction, such invalidity shall not affect the validity or operation of any other term, clause or provision and such invalid term, clause or provision shall be deemed to be severed from the Agreement. If any provision of this Agreement is held to be void or contrary to law, such provision shall be construed as nearly as possible to reflect the intention of the parties, with the other provisions remaining in full force and effect.
9.10Compliance Plan Participation. LICENSEE agrees to participate in any reasonable contract and claims audits by METHODIST and to cooperate and assist during any reasonable internal compliance review, investigation, monitoring protocol and/or audit, without regard to whether the review, investigation, or audit occurs before or after termination of the Agreement. In addition, LICENSEE shall notify METHODIST of any violation of any applicable law, regulation, or third party payer requirement by METHODIST immediately after LICENSEE, its employees, or agents become aware of it. Such notification should be given to the METHODIST executive overseeing this Agreement, but may also be given through either of the following methods: (a) anonymously through The Methodist Hospital’s Hotline service [***]; or (b) to The Methodist Hospital’s Business Practices Officer.
9.11Deficit Reduction Act; False Claims. The Deficit Reduction Act of 2005 requires us to inform all employees, contractors and their agents of the following: METHODIST and its Affiliates receive reimbursement for many of its services from the Medicare and Medicaid programs. Under the federal False Claims Act and Texas laws, any person who knowingly submits, or causes someone else to submit illegal claims for payment of government funds is subject to government fines and penalties. Reports of suspected illegal claim activity should be made through any of the methods mentioned in Section 9.10, but may also be made to the Department of Health and Human Services Office of Inspector General or the Texas Health and Human Services Commission’s Office of Inspector General. Those who report questionable practices are protected from retaliation for reports made in good faith by Methodist policy and by federal and state laws.
9.12Representation of Non-Exclusion. Each party represents and warrants to the other party that, as of the Effective Date of this Agreement, it is not excluded from any federal or state health care program, nor has it been debarred or sanctioned by the US Food and Drug Agency. If either
23
CONFIDENTIAL
party becomes so excluded, sanctioned, or debarred, it will notify the other party immediately.
9.13Digital Signatures. The parties agree that a digital signature may be used for any and all purposes for which the original signature may have been used.
[Signature page follows]
24
CONFIDENTIAL
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives to be effective as of the Effective Date.
THE METHODIST HOSPITAL |
|
COYA THERAPEUTICS, INC. |
|||
By: |
/s/ Ramon M. Cantu |
|
By: |
/s/ Howard Berman |
|
Name: |
Ramon M. Cantu |
|
Name: |
Howard Berman |
|
Title: |
EVP & Chief Legal Officer |
|
Title: |
Chief Executive Officer |
|
|
|
|
|||
HM Legal Approved as to Form: |
/s/ Lee Schwartz |
||||
|
25
CONFIDENTIAL
ATTACHMENT A
KNOW-HOW and PATENT RIGHTS AS OF THE EFFECTIVE DATE
[***]
26
CONFIDENTIAL
ATTACHMENT B
TARGET DEVELOPMENT MILESTONES AND MILESTONE PAYMENTS
PART I: TARGET DEVELOPMENT MILESTONES OF LICENSEE (FOR PURPOSES OF SECTION 3.5)
a. |
[***] |
b. |
[***] |
c. |
Within twelve (12) months of the Effective Date, create a plan to develop a manufacturing process for a Licensed Product or a Licensed Services with adequate product quality and adequate controls for the then-current stage of clinical evaluation. |
d. |
After creating such plan, establish manufacturing capabilities for a Licensed Product or Licensed Services, whether internally or through a third party, when such capability is needed. |
e. |
If METHODIST completes the primary endpoint(s) of the Ongoing Phase 2a Trial and conducts a successful End-of-Phase 2 (EOP2) meeting with the FDA for such trial, initiate a phase 2b or phase 3 clinical trial under an IND filed for a Licensed Product or a Licensed Service within twenty-four (24) months of the Effective Date or as soon as reasonably possible after successful achievement of such activities by METHODIST, whichever is later. |
f. |
Within forty-eight (48) months of the Effective Date, complete the primary endpoint(s) of either a phase 2(b) or phase 3 clinical trial for a Licensed Product or Licensed Service. |
PART II: MILESTONE PAYMENTS (FOR PURPOSES OF 4.1(e))
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***]
27
CONFIDENTIAL
ATTACHMENT C
RUNNING ROYALTIES
[***]
28
CONFIDENTIAL
ATTACHMENT D
SHARE ISSUANCE AGREEMENT
This Share Issuance Agreement (“Agreement”) is made effective as of the date of last signature below by and between Nicoya Health, Inc., a Delaware corporation (the “Company”), and The Methodist Hospital, a Texas non-profit corporation (“Methodist”). The Company and Methodist hereby agree as follows:
1.Shares. Pursuant to that certain Patent and Know How License Agreement (the “License Agreement”) of even date herewith between the Company and Methodist, the Company is issuing 750,000 shares of its $0.0001 par value common stock (“Common Stock”) to Methodist (the “Shares”).
2.Status of Issuance; Closing.
(a)The issuance of the Shares is being made without registration under the Securities Act of 1933, as amended (“Securities Act”) in reliance upon the exemptions from registration provided for in Sections 4(a)(2) and/or 4(a)(5) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder and in reliance on applicable exemptions from registration afforded certain private placements under state securities laws.
(b)The issuance of the Shares shall take place remotely via the exchange of documents and signatures, at 10 a.m., on September , 2020, or at such other time and place as the Company and Methodist mutually agree upon, orally or in writing (which time and place are designated as the “Closing”).
3.Methodist Representations and Warranties. Methodist hereby acknowledges, represents, warrants and agrees as follows:
(a)Accredited Investor. Methodist is an “accredited investor” within the meaning of Rule 501(a) of Regulation D promulgated by the Securities and Exchange Commission (the “SEC”), as presently in effect, the meaning of which is understood by Methodist. In that regard, Methodist represents that Methodist is an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended (the “Code”), with total assets in excess of $5,000,000.
(b)Information About the Company.
(i)Methodist has had an opportunity to obtain all information it has requested from the Company relating to the business and affairs of the Company.
(ii)Methodist has been given reasonable opportunity to meet with officers of the Company for the purpose of asking reasonable questions of such officers concerning the business of the Company and all such questions have been answered to Methodist’s full satisfaction. Methodist has also been given an opportunity to obtain any additional relevant information to the extent reasonably available to the Company. Methodist has received all information regarding the Company that Methodist has reasonably requested. Methodist
29
CONFIDENTIAL
understands that there is no assurance as to the future performance of the Company or the value of the Shares. The foregoing, however, does not limit or modify the representations and warranties of the Company in Section 4 of this Agreement or the right of Methodist to rely thereon.
(iii)Methodist acknowledges that any estimates, forward-looking statements or projections provided to Methodist were prepared in good faith by the officers of the Company, but the attainment of any such estimates, forward-looking statements or projections cannot be guaranteed by the Company or its officers and should not be relied upon.
(c)Restrictions on Transfer.
(i)Securities Law Restrictions. Methodist understands that (a) the Shares have not been registered under the Securities Act or the securities laws of certain states in reliance on specific exemptions from registration; (b) no securities administrator of any state or the SEC or any other federal agency has recommended or endorsed the issuance of the Shares or made any finding or determination relating to the fairness of Methodist’s acceptance of the Shares; (c) the Company is relying on Methodist’s representations and warranties in Section 3(b) for the purpose of determining whether the issuance of the Shares meets the requirements of the exemptions afforded by the Securities Act and certain state securities laws. Methodist acknowledges that the Shares will be subject to restrictions on transferability and may not be resold, assigned or otherwise disposed of unless they are subsequently registered under the Securities Act and under applicable securities laws of certain states or an exemption from such registration is available. Methodist further acknowledges that Methodist shall be subject to additional transfer restrictions with respect to the Shares as described in this Section 3(c).
(ii)Lock-up Restrictions. Methodist understands that the Shares may not be sold, transferred, assigned, pledged, hypothecated, mortgaged, or otherwise disposed of or made subject to any lien or security interest, during the Restricted Period (as defined below) without the consent of the Company in its sole discretion. The “Restricted Period” shall be defined as the period commencing on the date hereof and continuing until 180 days of the Initial Trading Date; provided, however, if such business day is a Friday, then the Restricted Period shall expire on the next business day; provided further, that the Company may elect to release Methodist from this lock-up at any time or from time to time for any reason or no reason with respect to any or all of the Shares. No such release shall be deemed to obligate the Company to grant any future releases to Methodist. In addition, Methodist agrees to execute any lock-up agreement required by the lead underwriter in connection with the Company’s Initial Public Offering (as defined below) that the Company may conduct while Methodist holds any of the Shares; provided, that any such agreement is consistent with the form of lock-up agreements generally required by underwriters to be signed by the Company’s officers, directors and stockholders. For purposes hereof, the “Initial Trading Date” shall mean the first date upon which shares of the Company’s capital stock trade on (a) a national securities exchange or through any quotation service that requires as a condition for trading that the Company report under the Securities Act or the Exchange Act or (b) the
OTCQB or OTCQX (collectively, a “Qualified Trading Market”); and the “Initial Public Offering” or “IPO” shall mean the commencement of a public trading market for any class of securities of the Company on a Qualified Trading Market.
30
CONFIDENTIAL
(iii)Legends of Certificate. Methodist understands that each certificate evidencing the Shares will bear the legends substantively similar to that set forth below:
“THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE AND MAY NOT BE SOLD, PLEDGED, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION OR OFFERING STATEMENT WITH RESPECT THERETO UNDER THE SECURITIES ACT AND COMPLIANCE WITH ANY APPLICABLE STATE SECURITIES LAW, OR UNLESS THE COMPANY RECEIVES AN OPINION OF COUNSEL, SATISFACTORY TO THE COMPANY, THAT SUCH REGISTRATION IS NOT REQUIRED.
THE COMPANY’S SHARE ISSUANCE AGREEMENT WITH THE HOLDER SETS FORTH CERTAIN RESTRICTIONS ON THE HOLDER’S ABILITY TO TRANSFER SUCH SECURITIES. A COPY OF SUCH SHARE ISSUANCE AGREEMENT IS AVAILABLE FOR INSPECTION AT THE COMPANY’S OFFICE.”
(d)No Market for the Securities. Methodist is accepting the Shares for its own account for investment and not with a view to, or for sale in connection with, any subsequent distribution thereof, nor with any present intention of selling or otherwise disposing of all or any part of the Shares. Methodist understands that there is currently no market for any securities of the Company, including any shares of the Company’s Common Stock, and there may not be any market for the Common Stock or any other securities of the Company in the future. Methodist agrees that it may have to hold the Shares for an indefinite period of time because neither the Company’s Common Stock nor any of the Company’s other securities have been registered under the Securities Act and may never be registered and cannot be resold, pledged, assigned, or otherwise disposed of unless the securities are subsequently registered under the Securities Act and under applicable securities laws of certain states or an exemption from such registration is available. Methodist understands that the Company is under no obligation to register any of the Shares, or to assist Methodist in complying with any exemption from such registration under the Securities Act or any state securities laws.
(e)Entity Authority. The person signing this Agreement on behalf of Methodist has been duly authorized by Methodist to do so.
(f)Principal Place of Business; Residency. Methodist represents and warrants to the Company that its principal place of business and executive offices is located at the address set forth on the Information Sheet attached to this Agreement.
31
CONFIDENTIAL
4.Company Representations and Warranties. The Company hereby represents and warrants to Methodist as follows:
(a)Organization. The Company is a corporation duly organized and validly existing and in good standing under the laws of the State of Delaware and has the requisite power and authority to own its properties and to carry on its business as presently 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 on the business, assets (including intangible assets), liabilities, financial condition, property, prospects or results of operations of the Company (a “Material Adverse Effect”).
(b)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.
(c)Authority. The Company has all necessary corporate power and authority to enter into this Agreement and to issue the Shares; the execution and delivery and performance by the Company of this Agreement and the consummation of the transaction contemplated hereby, have been duly authorized by all necessary corporate action on the part of the Company; this Agreement constitutes the valid and binding obligation of the Company enforceable in accordance with its terms, except as the same may be limited by (i) applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer or similar laws of general application now or hereafter in effect affecting the rights and remedies of creditors and by general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity); and (ii) the applicability of the federal and state securities laws as to the enforceability of the indemnification provisions of this Agreement.
(d)Capitalization. The authorized capital of the Company consists, immediately prior to the Initial Closing, of 20,000,000 shares of Common Stock, 10,000,000 shares of which are issued and outstanding immediately prior to the Closing. The Company does not have any authorized series of Preferred Stock. 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.
(e)Valid Issuance of Shares. The Shares, when issued 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 explicitly set forth herein, applicable state and federal securities laws and liens or encumbrances created by or imposed by Methodist. Assuming the accuracy of the representations of Methodist in Section 3 of this Agreement, the Shares will be issued in compliance with all applicable federal and state securities laws.
(f)Governmental Consents and Filings. Assuming the accuracy of the representations made by Methodist in Section 3 of this Agreement, no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state
32
CONFIDENTIAL
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 filings pursuant to applicable securities laws, which have been made or will be made in a timely manner.
(g)Litigation. There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or to the Company’s knowledge, currently threatened (i) against the Company or any officer, director or Founder (as such term is defined below) of the Company arising out of their employment or board relationship with the Company or (ii) to the Company’s knowledge, 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 Founder 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 Founders, 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.
(h)Compliance with Other Instruments. The Company is not in violation or default (i) of any provisions of its Certificate of Incorporation (the “Charter”) or Bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) under any note, indenture or mortgage, or (iv) under any lease, agreement, contract or purchase order to which it is a party or by which it is bound, or (v) of any provision of federal or state statute, rule or regulation applicable to the Company, the violation of which would have a Material Adverse Effect. The execution, delivery and performance of this Agreement and the consummation of the transactions contemplated by this Agreement 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.
|
(i) |
Certain Transactions. |
(i)Other than (i) standard employee benefits generally made available to all employees, standard employee offer letters and proprietary invention assignment agreements, (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, in each instance previously provided to Methodist, there are no agreements, understandings or proposed transactions between the Company and any of its officers, directors, consultants or Founders, or any affiliate thereof.
(ii)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
33
CONFIDENTIAL
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 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 contract with the Company.
(j)Corporate Documents. The Charter and Bylaws of the Company as of the date of this Agreement are in the form provided to Methodist. The copy of the minute books of the Company provided to Methodist 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.
(k)Disclosure. The Company has made available to Methodist all the information that Methodist has requested for deciding whether to acquire the Shares, including certain of the Company’s projections describing its proposed business plan (the “Business Plan”). No representation or warranty of the Company contained in this Agreement and no certificate furnished or to be furnished to Methodist at the Closing contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements contained herein or therein not misleading in light of the circumstances under which they were made. The Business Plan was prepared in good faith; however, the Company does not warrant that it will achieve any results projected in the Business Plan.
5.Transferability. Unless otherwise determined by the Company, during any period in which the Company does not have a class of its securities registered under Section 12 of the Exchange Act and is not required to file reports under Section 15(d) of the Exchange Act, the Shares shall not be transferable by Methodist other than to an Affiliate; provided, however, in each case, that such transferees agree to be bound by the terms of this Agreement as if they were Methodist, the transfer is documented in a form and substance reasonably acceptable to the Company and the transferees execute accredited investor questionnaires to the reasonable satisfaction of the Company. For purposes of this Agreement, “Affiliate” means any entity, individual, firm, or corporation, directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with Methodist.
6.Repurchase Right.
(a)In the event of the termination of the License Agreement by the Company pursuant to Section 5.3 thereof for a Specified Reason (defined below) within two (2) years following the License Agreement Effective Date (as defined therein), the Company shall, upon the date of such termination, have an irrevocable, exclusive option (the “Repurchase Right”) for a period of two months from the Outside Date (defined below) to repurchase all or any portion of the Shares at a per share price equal to $0.0001 (as adjusted for any stock splits, stock dividends and the like). For purposes of
34
CONFIDENTIAL
this Agreement, “Specified Reason” means Methodist is in an material breach of the License Agreement that would allow the Company to terminate the License Agreement in accordance with its terms and the Company is not in material breach of the License Agreement, unless before the end of the thirty (30) day period following written notice from the Company to Methodist of such material breach (the “Outside Date”), Methodist has cured the breach and so notifies the Company, stating the manner of the cure.
(b)Unless the Company notifies Methodist within two months from the Outside Date that it does not intend to exercise its Repurchase Right with respect to some or all of the Shares, the Repurchase Right shall be deemed automatically exercised by the Company as of the end of such two-month period following such Outside Date, provided that the Company may notify Methodist that it is exercising its Repurchase Right as of a date prior to the end of such two-month period. Unless Methodist is otherwise notified by the Company pursuant to the preceding sentence that the Company does not intend to exercise its Repurchase Right as to some or all of the Shares to which it applies at the time of termination, execution of this Agreement by Methodist constitutes written notice to Methodist of the Company’s intention to exercise its Repurchase Right with respect to all Shares to which such Repurchase Right applies. The Company shall satisfy its payment obligation to Methodist with respect to exercise of the Repurchase Right by delivering a check to Methodist in the amount of the purchase price for the Shares being repurchased. As a result of any repurchase of Shares pursuant to this Section 6, the Company shall become the legal and beneficial owner of the Shares being repurchased and shall have all rights and interest therein or related thereto, and the Company shall have the right to transfer to its own name the number of Shares being repurchased by the Company, without further action by Methodist.
7.Information Rights.
(a)Delivery of Financial Statements. The Company shall deliver to Methodist:
(i)as soon as practicable, but in any event within one hundred twenty (120) days after the end of each fiscal year of the Company (i) an unaudited balance sheet as of the end of such year, (ii) unaudited statements of income and of cash flows for such year, and (iii) an unaudited statement of stockholders’ equity as of the end of such year, all prepared in accordance with GAAP (except that such financial statements may not contain all notes thereto that may be required in accordance with GAAP);
(ii)as soon as practicable, but in any event within forty-five (45) days after the end of each quarter of each fiscal year of the Company, unaudited statements of income and cash flows for such fiscal quarter, and an unaudited balance sheet as of the end of such fiscal quarter, all prepared in accordance with GAAP (except that such financial statements may (i) be subject to normal year-end audit adjustments; and (ii) not contain all notes thereto that may be required in accordance with GAAP); and
(iii)such other information relating to the financial condition, business, prospects, or corporate affairs of the Company as Methodist may from time to time reasonably request; provided, however, that the Company shall not be obligated under this Section 7(a) to provide information (i) that the Company reasonably determines in good faith to be a trade secret or confidential information (unless covered by an enforceable confidentiality agreement, in a form acceptable to the Company); or (ii) the disclosure of which would adversely affect the attorney-client privilege between
35
CONFIDENTIAL
the Company and its counsel.
If, for any period, the Company has any subsidiary whose accounts are consolidated with those of the Company, then in respect of such period the financial statements delivered pursuant to the foregoing sections shall be the consolidated and consolidating financial statements of the Company and all such consolidated subsidiaries.
Notwithstanding anything else in this Section 7(a) to the contrary, the Company may cease providing the information set forth in this Section 3.1 during the period starting with the date thirty (30) days before the Company’s good-faith estimate of the date of filing of a registration statement if it reasonably concludes it must do so to comply with the SEC rules applicable to such registration statement and related offering; provided that the Company’s covenants under this Section 7(a) shall be reinstated at such time as the Company is no longer actively employing its commercially reasonable efforts to cause such registration statement to become effective.
(b)Inspection. The Company shall permit Methodist, at Methodist’s expense, 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 Methodist; provided, however, that the Company shall not be obligated pursuant to this Section 7(b) 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.
(c)Termination of Information and Inspection Rights. The covenants set forth in Section 7(a) and 7(b) shall terminate and be of no further force or effect (i) immediately before the consummation of the IPO or (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), whichever event occurs first.
(d)Notice of Certain Transactions. The Company shall notify Methodist within ten (10) days of becoming aware of any transaction or relationship described in Section 4(i) “Certain Transactions” involving payments in excess of one million dollars ($1,000,000), other than grants of capital stock pursuant to a stock incentive plan duly approved by the Company’s board of directors (the “Board”), if such material transaction or relationship would have been in breach of the representations in Section 4(i) had it arisen on or prior to the date of this Agreement.
(e)Confidentiality. Methodist agrees that it will keep confidential and will not disclose, divulge, or use for any purpose (other than to monitor or make decisions with respect to its investment in the Company) any confidential information obtained from the Company pursuant to the terms of this Agreement (including notice of the Company’s intention to file a registration statement), unless such confidential information (a) is known or becomes known to the public in general (other than as a result of a breach of this Section 7(e) by Methodist), (b) is or has been independently developed or conceived by Methodist without use of the Company’s confidential information, or (c) is or has been made known or disclosed to Methodist by a third party without a breach of any obligation of confidentiality such third party may have to the Company; provided, however, that Methodist may disclose confidential information (i) to its attorneys, accountants, consultants, and other professionals to the extent reasonably necessary to obtain their services in connection with monitoring its investment in the Company; (ii) to any prospective purchaser of any Shares from Methodist, if such prospective purchaser agrees to be bound by the provisions of this Section 7(e); (iii)
36
CONFIDENTIAL
to any Affiliate, partner, member, stockholder, or wholly owned subsidiary of Methodist in the ordinary course of business, provided that Methodist informs such Person that such information is confidential and directs such Person to maintain the confidentiality of such information; or (iv) as may otherwise be required by law, regulation, rule, court order or subpoena.
8.Tag Along Right. The Company shall ensure that if at any time either Howard Berman or Jani Tuomi (each a “Founder”) enters into an agreement to sell all or any portion of such Founder’s Common Stock to any person or entity other than a transfer made without consideration for bona fide estate planning purposes, Methodist shall have the right to transfer to the proposed transferee a number of the Shares equal to (a) the number of shares of Common Stock proposed to be transferred by such Founder multiplied by (b) the percentage of issued and outstanding Common Stock of the Company then owned by Methodist, at the same price per share and on the same terms and conditions as are applicable to the proposed transfer by the Founder (the “Tag-Along Right”). Prior to any sale of a Founder’s Common Stock subject to these provisions, the Founder shall notify Methodist and the Company in writing (the “Seller’s Notice”) of the proposed sale, which notice shall set forth: (i) the number of shares of Common Stock proposed to be transferred by such Founder, (ii) the name and address of the proposed transferee, and (iii) the proposed consideration and terms and conditions of payment offered by such proposed transferee. Methodist may exercise its Tag-Along Right by delivering a written notice (the “Tag‐Along Notice”) to the Founder within fifteen (15) days of the date the Founder delivered or caused to be delivered the Seller’s Notice. The Tag‐Along Notice shall state the number of shares of Common Stock that Methodist proposes to include in the proposed sale. If Methodist delivers a Tag‐Along Notice, Methodist shall be obligated to sell the number of shares of Common Stock specified in the Tag‐Along Notice upon the same terms and conditions as those under which the Founder is selling its shares of Common Stock, conditioned upon and contemporaneously with, the Founder’s sale of its shares of Common Stock in the proposed transfer. If any proposed sale by a Founder is not consummated within forty-five (45) days after receipt of the Seller’s Notice by Methodist, the Founder proposing the sale may not sell any Company securities unless he first complies in full with each provision of this Section 8. The exercise or election not to exercise any right by Methodist hereunder shall not adversely affect its right to participate in any other sales of Company securities subject to this Section 8.
9.Drag Along.
(a)If holders owning a majority of the outstanding equity securities of the Company (on an as‐converted basis) (the “Approving Stockholders”) approve a transaction that would result in the acquisition of equity securities of the Company by a party that is not an Approving Stockholder or an affiliate thereof, by means of any transaction or series of related transactions (including, without limitation, any merger, consolidation, sale, assignment, transfer, distribution or issuance of stock with respect to the Company) and pursuant to such transaction the holders of the equity securities of the Company immediately prior to such transaction will not hold, directly or indirectly, at least a majority of the voting power of the surviving or continuing entity (a “Drag‐Along Transaction”), then, upon thirty (30) days’ written notice to Methodist (the “Drag‐Along Notice”), which notice shall include substantially all of the details of the proposed transaction, including the proposed time and place of closing and the consideration to be received by selling stockholders in such transaction, and provided the terms of such transaction as they apply to Methodist are the same terms as they apply to the other holders of Common Stock, Methodist shall raise no objection to such Drag‐Along Transaction and be obligated to, and shall sell, transfer and deliver, or cause to be sold, transferred and delivered, to such party, all of its shares of Common Stock then held by Methodist in the same transaction at the closing thereof (and will deliver such shares of Common Stock free and clear of all liens, claims, or encumbrances).
(b)Methodist shall not be required to comply with Section 9(a) above in connection with a Drag-Along Transaction unless:
37
CONFIDENTIAL
(i)Methodist is not required to make any representations or warranties, or to provide indemnification, in connection with any Drag‐Along Transaction, other than to that: (A) Methodist holds all right, title and interest in and to the shares of Common Stock Methodist purports to hold, free and clear of all liens and encumbrances, (B) the obligations of Methodist in connection with the transaction have been duly authorized, if applicable, and (C) the documents to be entered into by Methodist have been duly executed by Methodist and delivered to the acquirer and are enforceable (subject to customary limitations) against Methodist in accordance with their respective terms;
(ii)Methodist is not required to agree to any restrictive covenant in connection with the Drag‐Along Transaction (including, without limitation, any covenant not to compete or covenant not to solicit customers, employees or suppliers of any party to the Drag‐Along Transaction) or any release of claims other than a release in customary form of claims arising solely in Methodist’s capacity as a stockholder of the Company;
(iii)Methodist and its Affiliates are not required to amend, extend or terminate any contractual or other relationship with the Company, the acquirer or their respective affiliates, except that Methodist may be required to agree to terminate the investment-related documents between or among Methodist, the Company and/or other stockholders of the Company;
(iv)Methodist is not liable for the breach of any representation, warranty or covenant made by any other person in connection with the Drag‐Along Transaction, other than the Company; and
(v)liability shall be limited to Methodist’s applicable share (determined based on the respective proceeds payable to each stockholder in connection with such Drag‐ Along Transaction in accordance with the provisions of the Charter) of a negotiated aggregate indemnification amount that applies equally to all stockholders but that in no event exceeds the amount of consideration otherwise payable to Methodist in connection with such Drag‐ Along Transaction.
(c)Termination of Drag Along. The covenants set forth in Section 9 shall terminate and be of no further force or effect (i) immediately before the consummation of the IPO or (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, whichever event occurs first.
10.Right of Participation. If the Company proposes to sell equity securities of the Company (“Financing Transaction Securities”) in a bona fide financing transaction following the date of this Agreement in which the Company receives gross proceeds of at least One Million Dollars ($1,000,000) (a “Financing Transaction”), then Methodist and/or its Affiliates and/or assignees (provided such assignees are reasonably acceptable to the Company and execute accredited investor questionnaires to the reasonable satisfaction of the Company) will have the right to purchase a number of Financing Transaction Securities equal to (a) the number of Financing Transaction Securities proposed to be offered in the Financing Transaction multiplied by (b) the percentage of issued and outstanding equity interests of the Company then owned by Methodist on the same terms and conditions as are offered to the other purchasers in the Financing Transaction. Financing Transactions
38
CONFIDENTIAL
shall not include transactions involving the issuance of securities of the Company: (a) as a dividend or distribution on the existing securities of the Company; (b) in order to effect a subdivision or combination of existing securities of the Company; (c) in connection with any reorganization, recapitalization, consolidation or merger involving the Company; (d) to employees or directors of, or consultants or advisors to, the Company or any of its subsidiaries pursuant to a plan, agreement or arrangement approved by the Board; (e) upon the exercise of equity incentive shares of the Company or upon the conversion or exchange of convertible securities of the Company, in each case provided such issuance is pursuant to the terms of such equity incentive shares or convertible securities; (f) to banks, equipment lessors or other financial institutions, or to real property lessors, pursuant to a debt financing, equipment leasing or real property leasing transaction approved by the Board; (g) to suppliers or third party service providers, other than Related Parties, in connection with the provision of goods or services pursuant to transactions approved by the Board; (h) as acquisition consideration pursuant to the acquisition of another entity, other than a Related Party, by the Company by merger, purchase of substantially all of the assets or other reorganization or to a joint venture agreement, provided that such issuances are approved by the Board; or (i) in connection with sponsored research, collaboration, technology license, development, OEM, marketing or other similar agreements or strategic partnerships approved by the Board and in each case other than with Related Parties. “Related Party” means a Founder, member of the Board, any of their immediate family members or any affiliate of the foregoing. The Company shall provide Methodist thirty (30) days advance written notice of a proposed Financing Transaction, which notice shall include reasonable detail regarding such milestones of the Financing Transaction. Then, the rights granted in this Section 10 shall terminate upon the closing of the first Financing Transaction following the date of this Agreement; provided, the Company may, in its sole discretion, permit Methodist and/or its Affiliates and/or assignees (provided such assignees are reasonably acceptable to the Company and execute accredited investor questionnaires to the reasonable satisfaction of the Company) to participate in future Financial Transactions taking place after the first Financial Transaction following the date of this Agreement. Methodist may assign all or any portion of its rights under this paragraph, including without limitation the right of assignment, to an Affiliate and/or assignees (provided such assignees are reasonably acceptable to the Company and execute accredited investor questionnaires to the reasonable satisfaction of the Company), and such assignee shall have all of the rights of Methodist hereunder mutatis mutandis; provided, Methodist may not assign its rights under this paragraph to a competitor of the Company.
11.Indemnification. Each of the Company and Methodist (the “Indemnifying Party”) hereby agrees to indemnify and hold harmless the other party (the “Indemnified Party”), its officers, directors, stockholders, employees, agents, and attorneys against any and all losses, claims, demands, liabilities, and expenses (including reasonable legal or other expenses incurred by each such person in connection with defending or investigating any such claims or liabilities, whether or not resulting in any liability to such person or whether incurred by the indemnified party in any action or proceeding between the indemnitor and indemnified party or between the indemnified party and any third party) to which any such indemnified party may become subject, insofar as such losses, claims, demands, liabilities and expenses (i) arise out of or are based upon any untrue statement or alleged untrue statement of a material fact made by the Indemnifying Party and contained herein, or (ii) arise out of or are based upon any breach by the Indemnifying Party of any representation, warranty, or agreement made by the Indemnifying Party contained herein.
12.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. The Company agrees to indemnify and hold harmless Methodist 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.
39
CONFIDENTIAL
13.Severability. In the event any parts of this Agreement are found to be void, the remaining provisions of this Agreement are nevertheless binding with the same effect as though the void parts were deleted and such void or unenforceable provision shall be replaced with a valid and enforceable provision that as closely as possible reflects the intent of the parties hereto.
14.Governing Law and Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware without regard to its rules of conflict of laws. The parties hereto hereby irrevocably and unconditionally consent to and submit to the exclusive jurisdiction of the courts of the State of Delaware (the “Delaware Courts”) for any litigation arising out of or relating to this Agreement and the transactions contemplated hereby (and agree not to commence any litigation relating thereto except in such courts), waive any objection to the laying of venue of any such litigation in the Delaware Courts and agree not to plead or claim in any Delaware Court that such litigation brought therein has been brought in any inconvenient forum.
15.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 instrument. The execution of this Agreement may be by actual or facsimile signature.
16.Benefit. This Agreement is binding upon and inures to the benefit of the parties hereto and their respective heirs, executors, personal representatives, successors and assigns.
17.Notices. All notices, offers, acceptance and any other acts under this Agreement (except payment) must be in writing, and are sufficiently given if delivered to the addressees in person, by overnight courier service, or, if mailed, postage prepaid, by certified mail (return receipt requested). All communications to Methodist should be sent to its preferred address on the Information Sheet. All communications to the Company should be sent to the address set forth on Schedule 1. Each party may designate another address by notice to the other party.
18.Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior oral and written agreements between the parties hereto with respect to the subject matter hereof. This Agreement may not be changed, waived, discharged, or terminated orally, but rather, only by a statement in writing signed by the party or parties against which enforcement or the change, waiver, discharge or termination is sought.
19.Section Headings. The section headings herein have been inserted for reference only and will not be deemed to limit or otherwise affect, in any matter, or be deemed to interpret in whole or in part, any of the terms or provisions of this Agreement.
20.Survival or Representations, Warranties and Agreements. The representations, warranties and agreements contained herein will survive the issuance and delivery of the Shares and shall in no way be affected by any investigation or knowledge of the subject matter thereof made by or on behalf of Methodist or the Company.
40
CONFIDENTIAL
[Signature Page and Information Sheet to Follow]
41
CONFIDENTIAL
SIGNATURE PAGE
IN WITNESS WHEREOF, the parties hereto have signed this Agreement to be executed by their duly authorized representatives.
THE METHODIST HOSPITAL |
NICOYA HEALTH, INC. |
|
|
By: /s/ Ramon M. Cantu |
By:/s/ Jani Tuomi |
|
|
Name:Ramon M. Cantu |
Name:Jani Tuomi |
|
|
Title:Executive Vice President |
Title: Cofounder and COO |
|
|
Time:10/6/2020 | 4:36 PM CDT |
Time:10/6/2020 | 11:48 AM CDT |
HMH LEGAL APPROVED AS TO FORM: |
|
|
|
/s/ Lee Schwartz |
|
42
EXHIBIT 10.8
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
CONFIDENTIAL
SPONSORED RESEARCH AGREEMENT
This SPONSORED RESEARCH AGREEMENT (this “Agreement”), effective as of February 3, 2021 (the “Effective Date”), is entered into by and between The Methodist Hospital Research Institute dba Houston Methodist Research Institute (“HMRI”), a Texas nonprofit corporation and an affiliate of The Methodist Hospital, and Coya Therapeutics, Inc. (“COMPANY”), a Delaware corporation, governing the specific research project identified below to be conducted at HMRI.
WHEREAS, HMRI is pursuing scientific research in the area of neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS); and
WHEREAS, the COMPANY is willing to fund such research by HMRI; and
NOW, THEREFORE, in consideration of the premises and the mutual covenants and conditions hereinafter recited, the parties do hereby agree as follows:
|
1. |
Definitions |
For purposes of this Agreement, the following definitions apply:
|
1.1 |
“Affiliate” means with respect to an entity, an entity controlling, controlled by, or under common control with such entity. As used in this definition, the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract, or otherwise. |
|
|
1.2 |
“Budget” means the budget detailed in Exhibit B to this Agreement, as modified by mutual agreement of the parties from time to time. |
|
|
1.3 |
“Confidential Information” shall mean any proprietary information or material disclosed by one party to the other party hereunder that is related to the subject matter of this Agreement and that is identified as confidential or proprietary when disclosed or reasonably would be considered confidential information if exchanged by third parties under similar circumstances. |
|
|
1.4 |
“FDA” shall mean the United States Food and Drug Administration. |
|
1.5 |
“HMRI Invention” means a Subject Invention made exclusively by personnel of |
|
|
|
CONFIDENTIAL
HMRI or its Affiliates in the course of participation by such personnel in the Research. For the purposes of this definition, member of physician practice or like groups, resident physicians, students, or visiting faculty, if any, providing services to HMRI in connection with this Agreement will be considered HMRI’s personnel.
|
1.6 |
“Invention” shall mean any useful discovery, composition of matter, device, process, or method, whether patentable or not. |
|
|
1.7 |
“IP Rights” shall mean any legally-protected proprietary right pertaining to Inventions, including patents and trade secrets. |
|
|
1.8 |
“Joint Invention” means a Subject Invention made jointly by COMPANY personnel and individuals who would constitute HMRI’s personnel under this Agreement. Funding or providing resources for Research, and participation of a board or commission that advises either or both parties in the development or review of a plan relating to Research, shall be insufficient involvement (on their own) to cause a HMRI Invention or COMPANY Invention to be deemed a Joint Invention. |
|
|
1.9 |
“Principal Investigator” means Stanley Appel, M.D. |
|
1.10 |
“Project Funds” shall mean those funds paid by the COMPANY to HMRI for the Research in accordance with this Agreement. |
|
|
1.11 |
“Project Team” shall mean the Principal Investigator and the researchers and research technicians under the Principal Investigator’s direction and control who are supported in whole or in part by the Project Funds. |
|
|
1.12 |
“Research” shall mean research pertaining to the research enhancing the viability and suppressive function of ALS T-reg In-vitro and Ex-Vitro as described more fully in Exhibit A (which is incorporated herein by reference and made part of this Agreement) or such modifications of Exhibit A as may be mutually agreed upon in writing performed under this Agreement by duly authorized representatives of HMRI and the COMPANY. |
|
|
1.13 |
“COMPANY Invention” means a Subject Invention made exclusively by personnel of COMPANY or its Affiliates in the course of participation by such personnel in the Research. |
|
|
1.14 |
“Subject Invention” shall mean any Invention that is conceived and reduced to practice or developed in the performance of the Research. |
|
|
1.15 |
“Term” shall mean the period commencing on the Effective Date of this Agreement and terminating on one (1) year thereafter, or if extended in accordance with its terms, terminating on the date specified in the extension. |
|
CONFIDENTIAL
|
2. |
Research |
|
2.1 |
During the Term, the Project Team shall use its good faith efforts to conduct the Research in accordance with academic research standards. Notwithstanding the foregoing, COMPANY understands that HMRI’s primary mission is education and advancement of knowledge and the Research will be designed to carry out that mission. The manner of performance of the Research shall be determined solely by the Principal Investigator. HMRI does not guarantee specific results. |
|
|
2.2 |
Nothing in this Agreement shall be construed to limit the freedom of HMRI, the Principal Investigator, or the Project Team, whether paid under this Agreement or otherwise, to engage in similar research performed independently under other grants, contracts, awards, or agreements with parties other than COMPANY, or as unsponsored research. COMPANY understands COMPANY shall not gain any rights via this Agreement under such other research. |
|
|
2.3 |
HMRI does not guarantee that any IP Rights will result from the Research, that the scope of any IP Rights arising from the Research will cover COMPANY’s commercial interest, or that any IP Rights may be practiced or will be free of dominance by other patents, including those based on inventions made by other inventors at HMRI. |
|
|
2.4 |
HMRI shall advise the COMPANY of the results of the Research and provide COMPANY with written reports concerning the Research as mutually agreed upon by HMRI and COMPANY. |
|
|
2.5 |
In performance of their respective obligations under this Agreement, each party shall comply with all applicable federal, state, or local laws, regulations, or guidelines governing the conduct of such Research, including, but not limited to, the NIH Grants Policy Statement, U.S. export control laws and regulations, U.S. Food and Drug Administration laws and regulations, and the laws, regulations, guidance, and requirements of the Office of Human Research Protections, and the Office of Laboratory Animal Welfare. |
|
|
2.6 |
If, for any reason, the Principal Investigator ceases to be associated with HMRI, or otherwise becomes unavailable to work on the Research, a qualified replacement researcher at HMRI shall be mutually appointed by HMRI and the COMPANY to be the Principal Investigator, or, at the parties’ option, this Agreement shall be terminated on thirty (30) days written notice from either party to the other. |
|
|
2.7 |
If the Research is considered to be human subject research and subject to 21 CFR 812, the parties agree that the Principal Investigator will be both the sponsor and the principal investigator as set forth therein. HMRI will obtain and hold any investigational new drug application (“IND”) or investigational device exemption |
|
CONFIDENTIAL
(“IDE”) as required by the FDA. COMPANY agrees that it will cooperate with HMRI and Principal Investigator in fulfilling their obligations under the FDA including providing HMRI will relevant information such as information about adverse events.
|
3. |
Payments |
|
3.1 |
The COMPANY shall pay HMRI the Project Funds as outlined in the Budget set forth in Exhibit B. In addition, should the contractual payments to HMRI be subject to any VAT, GST, surcharges or taxes, COMPANY shall be responsible for those additional fees and taxes. If no conflicting terms are set forth in Exhibit B, payment of Project Funds shall be made as follows: |
|
(a) |
HMRI will invoice COMPANY monthly for all costs and expenses incurred in the performance of the Research as outlined in Exhibit B for the immediately preceding month using HMRI’s standard invoice. |
|
|
(b) |
COMPANY’s address for invoices is: |
Coya Therapeutics Attn: Jani Tuomi
5850 San Felipe Street, Suite 500
Houston, Texas 77057
|
(c) |
All payments are due within thirty (30) days from COMPANY’s receipt of HMRI’s invoice. |
|
|
3.2 |
In the event that any payment due hereunder is not made when due, the payment shall accrue interest beginning on the first day of the month following the date when such payment is due, calculated at the annual rate of the sum of 1% plus the prime interest rate quoted by Citibank, N.A., New York, New York, on the date such payment is due, or on the date payment is made, whichever is higher, the interest being compounded on the last day of each calendar month, provided that in no event shall said annual rate exceed the maximum legal interest rate for corporations. Such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of HMRI to any other remedy, legal or equitable, to which HMRI may be entitled because of the delinquency of the payment. |
|
|
3.3 |
Direction of Payments |
Payments under the terms of this Agreement shall be made by check referencing the Principal Investigator and the Research title payable to:
Name on check: |
The Methodist Hospital Research Institute |
Tax ID #: |
[***] |
CONFIDENTIAL
|
3.4 |
The Principal Investigator may transfer funds within the Budget as needed without COMPANY’s approval so long as the scope of work under the Research remains unchanged. |
|
|
3.5 |
If COMPANY requires that personnel of HMRI travel to perform any of the Research or to deliver results, COMPANY shall reimburse HMRI for such personnel(s) travel costs, including transportation, hotel, and conference registration, as applicable. |
|
|
3.6 |
HMRI shall retain title to all equipment, supplies and materials (including, without limitation, biologics, cell lines, animal models) purchased and/or fabricated by it with funds provided by COMPANY under this Agreement. |
|
|
4. |
Non-Disclosure Agreement and Publications |
|
4.1 |
HMRI and COMPANY may wish to disclose Confidential Information to each other in connection with work contemplated by this Agreement. Each party will use reasonable efforts to prevent the disclosure of the other party’s Confidential Information to third parties for a period of three (3) years after the termination of this Agreement. Notwithstanding the above, such obligation of confidentiality shall not apply to information that at the time of disclosure: |
|
|
(a) |
is in the public domain or publicly available or later comes into the public domain or becomes publicly available through no fault of the receiving party; |
|
|
(b) |
is independently developed by the receiving party or was known to the receiving party prior to its disclosure by the disclosing party; |
|
|
(c) |
is disclosed by a third party not under an obligation of non-disclosure; |
|
(d) |
is required by law, regulation or legal process to be disclosed; or |
|
(e) |
written permission for disclosure has been granted to the receiving party by the disclosing party. |
|
The receiving party shall be entitled to retain copies of Confidential Information in a secure location for purposes of monitoring its obligations hereunder, regulatory, back-up, disaster recovery, and archival storage made in accordance with the receiving party’s standard business and retention practices.
4.2The parties reserve the right to publish or otherwise make public the data resulting from the Research. Authorship shall be determined in accordance with commonly accepted practices for scientific publications. Notwithstanding the foregoing, the party so wishing to publish or make public shall submit any manuscript or release
CONFIDENTIAL
to the other party at least thirty (30) days prior to publication or release so that party may review the submission for any of its proprietary information that it may desire to protect. If the recipient identifies proprietary information that it desires to protect, the recipient may require delay of the submission for publication for up an additional sixty (60) days. The recipient may require any of its Confidential Information to be deleted from the submission, provided that the removal of such information does not have the effect of making the publication false, misleading, inaccurate or incomplete.
|
5. |
Ownership and Patents |
|
5.1 |
HMRI may, in the course of performing the Research, use intellectual property developed by HMRI or a third party prior to Effective Date or developed other than through its participation in the Research (“Background IP”). For purposes of clarity, not limitation, the parties understand that Subject Inventions do not include, and nothing in this Agreement expresses or implies any grant of rights to COMPANY of, rights in Background IP. As between the parties to this Agreement: |
|
|
(a) |
Title to any HMRI Invention will reside in HMRI. |
|
(b) |
Title to any COMPANY Invention will reside in COMPANY. |
|
(c) |
Title to Joint Inventions will be jointly owned and each party will have an equal, undivided, and unrestricted ownership interest therein. |
|
5.2 |
Pursuant to the Patent and Know How License Agreement between COMPANY (formerly Nicoya Health, Inc.) and The Methodist Hospital effective as of October 6, 2020, Methodist Agreement [***] (“Existing License Agreement”), intellectual property specified in that agreement is already licensed to COMPANY by The Methodist Hospital. To the extent that any HMRI inventions resulting from work under this Agreement are not Licensed Patent Rights as defined in the Existing License Agreement, HMRI grants to the COMPANY the right of first review with respect to the opportunity to license any such Subject Invention(s), discovered during the performance of the Research, under the following the terms: |
|
|
(a) |
The COMPANY shall comply with the terms of non-disclosure, as set forth in Section 4 of this Agreement. |
|
|
(b) |
COMPANY and its Affiliates will have the first option to negotiate an exclusive license to make, have made, use, offer to sell, and sell under HMRI’s rights in any such HMRI Inventions or those Joint Inventions within the Research scope under terms and conditions to be negotiated in good faith, in each case subject to any federal or state governmental rights therein and to HMRI retaining the rights to make, have made and use such Inventions solely for research, educational and patient care purposes. |
|
|
|
CONFIDENTIAL
COMPANY hereby grants to HMRI the right to make, have made and use any COMPANY Inventions necessary for the performance of the Research and (b) any other COMPANY intellectual property provided by COMPANY to HMRI in connection with the Research.
|
(c) |
COMPANY shall have three (3) months from disclosure of any Subject Invention to notify HMRI that it wants to enter into such a license agreement. The parties shall negotiate in good faith for a period not to exceed six (6) months from COMPANY’s notification or a longer period of time if the parties mutually agree to extend negotiations. If COMPANY and HMRI fail to enter into an agreement, the rights to such Subject Inventions shall be disposed of in accordance with HMRI policies, with no obligation to COMPANY. Until a Subject Invention has been presented as set forth above, HMRI shall not offer rights to that Subject Invention to any third party. In the event COMPANY elects to exercise its option as detailed above, it shall be obligated to pay all patent expenses for the licensed Subject Invention. This shall include but not be limited to the cost of any activities investigating patentability before COMPANY’s exercise of the option. |
|
|
5.3 |
Each party will protect its own Subject Inventions in its own discretion and at its own expense. |
|
|
5.4 |
In the case of Joint Inventions, each party concerned will promptly inform the other party in writing whose employee is involved in such Joint Inventions. The parties will hereinafter agree on an appropriate course of action for filing applications for Joint Inventions, including which party is to be designated with the preparation, filing and prosecution of such applications and in |
|
|
5.5 |
which countries of the world to file such applications. The filing of such applications for Joint Inventions will be subject to mutual agreement between the parties. All costs related to applications for IP Rights resulting from such applications will be shared equally between the parties or any of their Affiliates, except as provided below. One of the parties (the “Administering Party”) will be designated to file or have filed, prosecute and maintain applications for Joint Inventions and any IP Rights resulting therefrom. The other party will at its own cost furnish the filing party with all documents, or other assistance, that may be reasonably necessary for the filing and prosecution of each such application. If, |
|
|
however, one party is not interested in filing an application on a Joint Invention, the other party or any of its Affiliates may file or have filed such application at its own expense and will be the sole owner of any resultant IP Rights, subject to a free, fully paid-up, non- exclusive, license solely for the internal use (without sublicense) by the party who was not interested in filing such application in its name and its Affiliates and subject to any prior commitments and renewals thereof of the party who was not |
|
CONFIDENTIAL
interested in filing such application in its name and its Affiliates. The non-filing party will assign its rights in such Joint Invention to the filing party.
|
5.6 |
If one of the parties to this Agreement (the “Foreign Filing Party”) desires to file an application for a Joint Invention in a country where the other party does not want to file in its own name, the Foreign Filing Party or any of its Affiliates will be entitled to file or have filed in its own name applications in such country and will be the sole owner of any resultant IP Rights. All additional costs related or pursuant to such filing, including prosecution costs, maintenance costs of the application or the maintenance costs for IP Rights granted thereon will be paid by the Foreign Filing Party or any of its Affiliates. Such Joint Inventions are subject to a free, fully paid-up, non-exclusive non-assignable license in the countries concerned in favor of the relinquishing party and its Affiliates solely for the internal use (without sublicense) of the relinquishing party and its Affiliates. |
|
|
5.7 |
If one of the joint owners of a Joint Invention wants to stop the payment of its share of the maintenance fees or other costs in any country, the other owner may take over the payment of such share. The party discontinuing to pay its proportionate share for one or more countries will relinquish to the other party which continues such payments, its title to and interest in such Joint Invention for the countries concerned, subject, however, to the retention of a free, fully paid- up, non-exclusive, non-assignable license under the Joint Invention in the countries concerned in favor of the relinquishing party and its Affiliates solely for internal use (without sublicense) of the relinquishing party and its Affiliates, except that the rights of third parties (other than Affiliates) under already existing licenses and agreements with the relinquishing party will not be prejudiced. In respect of the other countries, its rights will not be affected. |
|
|
5.8 |
If the Administering Party decides either not to pursue or to abandon patent protection for Joint Invention(s), the Administering Party shall provide sixty (60) days prior written notice to the other party. The other party may elect to continue prosecution and/or maintenance of such application(s) or patent(s) at its sole discretion and expense. In addition, the other party may file and/or maintain patent applications at its own expense in any country in which the original Administering Party elects not to file or maintain patent applications. |
|
|
5.9 |
An owner of Joint Invention(s) may bring an action for infringement of a Joint Invention only with the consent of the other owner. However, the other owner may only withhold its consent if such action would be materially prejudicial to its |
|
|
commercial or scientific interests as can be demonstrated to the reasonable satisfaction of the joint owner interested to bring such infringement action. |
|
CONFIDENTIAL
|
6. |
Termination |
|
6.1 |
This Agreement shall remain in effect for the Term, which may be extended by the mutual written consent of the duly authorized representatives of HMRI and the COMPANY. |
|
|
6.2 |
Either party may terminate this Agreement without cause upon ninety (90) days notice to the other party. |
|
|
6.3 |
In the event that either party shall be in default of any of its obligations under this Agreement and shall fail to remedy such default within thirty (30) days after receipt of written notice thereof, the party not in default shall have the option of canceling this Agreement by giving thirty (30) days written notice of termination to the other party. |
|
|
6.4 |
Termination of this Agreement shall not affect the rights and obligations of the parties, which shall have accrued prior to termination, including, without limitation, the confidentiality obligations set forth in Section 4 and the rights and obligations of the parties under the Existing License Agreement (defined in Section |
|
5.2 above).
|
7. |
Indemnification |
|
7.1 |
COMPANY agrees to defend, indemnify and hold harmless HMRI, its parent and Affiliates, and each of their directors, officers, agents, staff, employees, students, and researchers from and against any and all liability, claims, lawsuits, losses, demands, damages, costs, and expenses (including reasonable attorney’s fees and court costs), arising from or relating to (a) any negligent or willful acts or omissions of COMPANY or the design, manufacture, sale or use of any device, drug, or method of COMPANY, including in the event of HMRI’s joint negligence, but only to the extent of COMPANY’s actual proportionate negligence, |
|
(b)COMPANY’s breach of this Agreement, or (c) COMPANY’s failure to comply with any law, regulation or legal action. Notwithstanding the foregoing, COMPANY will not be responsible for any liability, claims, lawsuits, losses, demands, damages, costs, and expenses (including attorney’s fees and court costs) which arise solely from: (i) the negligence or intentional misconduct of HMRI, the Principal Investigator, or the Project Team; and (ii) actions by HMRI, the Principal Investigator, or the Project Team in violation of applicable laws or regulations.
|
7.2 |
HMRI agrees to defend, indemnify and hold harmless COMPANY, its Affiliates, and each of their directors, officers, agents, staff, and employees from and against any and all liability, claims, lawsuits, losses, demands, damages, costs, and expenses (including reasonable attorney’s fees and court costs), arising from |
|
CONFIDENTIAL
or related to: (a) any negligent or willful acts or omissions of HMRI, including in the event of COMPANY’s joint negligence, but only to the extent of HMRI’s actual proportionate negligence, (b) HMRI’s breach of this Agreement, or
(c)HMRI’s failure to comply with any law, regulation or legal action. Notwithstanding the foregoing, HMRI will not be responsible for any liability, claims, lawsuits, losses, demands, damages, costs, and expenses (including attorney’s fees and court costs) which arise solely from: (i) the negligence or intentional misconduct of COMPANY; and (ii) actions by COMPANY in violation of applicable laws or regulations.
|
7.3 |
Any party wishing to be indemnified as provided in Sections 7.1 and 7.2 shall: |
|
(a) |
after receipt of notice of any liability, claims, lawsuits or demands, promptly notify the indemnifying party of said liability, claims, lawsuits or demands and send to the indemnifying party a copy of all papers served on or received by the indemnified party, if any; provided, however, that failure to give such prompt notice shall not relieve the indemnifying party of its obligation to indemnify the party seeking indemnification provided that the delay does not materially prejudice the defense of the claim; |
|
|
(b) |
permit the indemnifying party to retain counsel of its choosing to represent the indemnified party, but the indemnified party may select its own counsel, the fees and all costs of such counsel will be borne by the indemnified party; and |
|
|
(c) |
allow the indemnifying party to retain exclusive control of any liability, claims, lawsuits, losses, demands, damages, costs, and expenses, including the right to make any settlement, except that the indemnifying party will not have the right to make any settlement or take any other action which would be deemed to confess wrongdoing by any of the indemnified parties or which places an affirmative obligation on an indemnified party, without the prior written consent of the indemnified party, such consent to not be unreasonably withheld. |
|
|
7.4 |
This indemnity provision expressly survives termination or expiration of this Agreement. |
|
|
8. |
Use of Facilities |
Nothing in this Agreement shall require the attendance of COMPANY at a facility of HMRI or its affiliates and no research or other work shall be performed at any such facility by COMPANY, its employees, agents or representatives. COMPANY shall require all of its employees, representatives and agents that enter a HMRI or affiliate premises (each, a “Visitor”) to comply with all policies and procedures applicable to contractors at such
CONFIDENTIAL
facility, including execution of HMRI’s confidentiality agreements with respect to information that is not publicly available at such facility, such as patient information and information on research other than the Research. Visitor may be required to provide proof of a history of vaccinations sufficient to meet the guidelines of HMRI’s Department of Employee Health Services, including proof of a negative tuberculosis screening test. If Visitor cannot provide proof of a negative tuberculosis screening test, Visitor must successfully undergo tuberculosis screening through HMRI’s Department of Employee Health Services.
HMRI will have the right to immediately dismiss Visitor from HMRI if HMRI determines that: (i) the presence of Visitor has a detrimental or disruptive effect upon HMRI’s facilities, patients, or personnel; (ii) Visitor is compromising HMRI’s standards of care or performance; (iii) Visitor fails to abide by the terms of this Agreement or any HMRI guidelines, policies, procedures, rules, or regulations, (iv) Visitor fails to satisfy and maintain all legal requirements to work in the United States, and/or (v) HMRI determines that it requires for its own needs any space allocated to Visitor.
|
9. |
Insurance |
During the term of this Agreement, the COMPANY shall maintain in full force and effect a policy or policies with insurers with an A.M. Best's Rating of not less than A-VIII at all times and with limits not less than:
|
(a) |
Commercial general liability insurance with limits of not less than $5,000,000 each occurrence and $5,000,000 annual aggregate; and |
|
|
(b) |
Products Liability insurance with limits of not less than $5,000,000 each occurrence and $5,000,000 annual aggregate. |
|
Such policies shall name HMRI as an Additional Insured. COMPANY will maintain such coverage for the duration of this Agreement and for two years thereafter. Such coverage(s) shall be purchased from a carrier or carriers deemed acceptable to HMRI which shall provide certificates evidencing the coverage(s) maintained and specifying that HMRI will be given no less than sixty (60) days prior written notice of any change in or cancellation of such coverage(s).
|
10. |
Independent Contractors |
COMPANY and HMRI shall at all times be independent parties and nothing contained in this Agreement shall be construed or implied to create an agency, joint venture, or partnership. Neither party shall have the authority to contract or incur expenses on behalf of the other except as may be expressly authorized by collateral agreements. The Principal Investigator and members of the Project Team shall not be deemed to be employees of COMPANY.
CONFIDENTIAL
|
11. |
Use of Institution Name/Public Statements |
Each of the parties agrees that it will not at any time during or following termination of this Agreement use the names, insignia, symbol(s), or logotypes associated with the other party or any variant thereof, or the names of the Principal Investigator or members of the Project Team orally or in any literature, advertising, or other materials without the prior written consent of the other party, except as required by law, regulation or legal action. Notwithstanding the foregoing, the parties shall be permitted to state orally and in writing the fact that the Research is being conducted with the support of COMPANY at HMRI under the direction of the Principal Investigator.
|
12. |
Warranties; Limitation of Liability |
HMRI MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, CONCERNING THE RESULTS OF THE RESEARCH. EXCEPT FOR A PARTY’S LIABILITY ARISING UNDER SECTION 7 (INDEMNIFICATION), NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT, OR CONSEQUENTIAL DAMAGES SUFFERED BY THE OTHER PARTY AS A RESULT OF THE
CONDUCT OF THE RESEARCH. No warranties or representations made by COMPANY to third parties shall purport to bind, nor shall they bind, HMRI, its affiliates, or any their directors, officers, agents, staff, employees, students, and faculty members, or its affiliated hospitals.
|
13. |
Choice of Law |
This Agreement shall be governed by the laws of the state of Texas without giving effect to its choice of law provisions. Venue for any disputes or claims arising under this Agreement shall lie in Harris County, Texas.
|
14. |
Severability |
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.
|
15. |
Waiver |
The failure of any party hereto to insist upon strict performance of any provision of this Agreement or to exercise any right hereunder will not constitute a waiver of that provision or right.
|
16. |
Notices |
Any notice or communication required or permitted to be given or made under this Agreement by one of the parties hereto to the other shall be in writing and shall be
CONFIDENTIAL
deemed to have been sufficiently given or made for all purposes if mailed by certified mail, postage prepaid, addressed to such other party at its respective address as follows:
If to the COMPANY:
(Name of representative, address, and phone number)
Coya Therapeutics Attn: Jani Tuomi
5850 San Felipe Street, Suite 500
Houston, Texas 77057
If to HMRI with respect to all non-technical matters:
The Methodist Hospital Research Institute
[***]
[***]
[***]
If to HMRI with respect to technical questions: Dr. Stanley Appel
[***]
[***]
Tel # [***]
Fax # [***]
email: [***]
|
17. |
Assignment |
This Agreement may not be assigned by either party without the prior written consent of the other party; provided, however, that subject to the approval of HMRI, which may not be unreasonably withheld, COMPANY may assign this Agreement to any purchaser or transferee of all or substantially all of COMPANY’s assets or stock upon prior written notice to HMRI, and HMRI may assign its right to receive payments hereunder.
|
18. |
Entirety |
This Agreement represents the entire agreement of the parties, and it expressly supersedes all previous written and oral communications between the parties, relating to this Research. No amendment, alteration, or modification of this Agreement or any exhibits attached hereto shall be valid unless executed in writing by authorized signatories of both parties.
CONFIDENTIAL
|
19. |
Representation of Non-Exclusion |
COMPANY and HMRI each represent that, as of the Effective Date of this Agreement, neither of them has been debarred or sanctioned by, or excluded from participating in, any governmental, health care or research program or organization, including, but not limited to, Medicare, Medicaid, or FDA regulated research. If at any time during this Agreement either HMRI or COMPANY becomes so excluded, it will promptly notify the other party in writing.
|
20. |
Compliance Plan Participation |
COMPANY agrees to participate in any reasonable contract and claims audits by HMRI’s affiliate, The Methodist Hospital (“TMH”), and to cooperate and assist during any reasonable internal compliance review, investigation, monitoring protocol and/or audit, without regard to whether the review, investigation, or audit occurs before or after termination of the Agreement. In addition, COMPANY shall notify TMH of any violation of any applicable law, regulation, or third party payer requirement by TMH immediately after COMPANY, its employees, or agents become aware of it. Such notification should be given to the TMH executive overseeing this Agreement, but may also be given through either of the following methods: (a) anonymously through TMH’s Hotline service [***]; or (b) to TMH’s Business Practices Officer.
The Deficit Reduction Act of 2005 requires TMH to inform all employees, contractors and their agents of the following: TMH receives reimbursement for many of its services from the Medicare and Medicaid programs. Under the federal False Claims Act and Texas laws, any person who knowingly submits, or causes someone else to submit illegal claims for payment of government funds is subject to government fines and penalties. Reports of suspected illegal claim activity should be made through any of the methods mentioned in the preceding paragraph, but may also be made to the Department of Health and Human Services Office of Inspector General or the Texas Health and Human Services Commission’s Office of Inspector General. Those who report questionable practices are protected from retaliation for reports made in good faith by TMH policy and by federal and state laws.
|
21. |
Export Control. |
Notwithstanding any other provision of this Agreement, the parties understand and agree that they are subject to, and agree to abide by, any and all applicable United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities. The parties' obligations hereunder are contingent on the parties' ability to comply with applicable United States export and embargo laws and regulations. It is the expectation of the parties that the work done pursuant to this Agreement will constitute fundamental research and be exempt from export control licensing requirements under the applicable export control laws and regulations. The
CONFIDENTIAL
parties do not wish to take receipt of export-controlled information except as may be knowingly and expressly agreed to in writing signed by an authorized representative of the parties and for which the parties have made specific arrangements. The parties agree to work together to ensure that, with regard to this Agreement, both are in compliance with any and all applicable U.S. export control laws and regulations, as well as any and all embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset Controls.
|
22. |
Force Majeure. |
Neither COMPANY nor HMRI shall be responsible for delays or errors in its performance under this Agreement occurring by reasons or circumstances beyond its control, including, without limitation, acts of civil or military authority, national emergencies, fire, flood or catastrophe, acts of God, insurrection, war, riots, or failure of transportation, communication, or power supply.
|
23. |
No Third Party Beneficiaries. |
The provisions of this Agreement are for the benefit of the parties and not for any other entity or individual.
[Remainder of Page Intentionally Blank – Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in duplicate counterpart original by their duly authorized representatives to be effective as of the Effective Date.
COMPANY |
|
HMRI |
|||
By: |
/s/ Howard Berman |
|
By: |
/s/ Edward A. Jones |
|
Name: |
Howard Berman |
|
Name: |
Edward A. Jones |
|
Title: |
CEO |
|
Title: |
President and Chief Executive Officer |
|
Date: |
2/3/2021 |
|
Date: |
2/3/2021 |
|
|
|
|
|||
|
|
HM Legal Approved as to Form: |
[***] |
||
|
|||||
|
|
Read & Acknowledged: |
|||
|
|
By: |
/s/ Stanley Appel, MD |
||
|
|
Name: |
Stanley H. Appel, MD |
||
|
|
Title: |
Principal Investigator |
CONFIDENTIAL
EXHIBIT B
BUDGET
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
TOTAL |
$ 1,547,094 |
EXHIBIT 10.9
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
FIRST AMENDMENT TO SPONSORED RESEARCH AGREEMENT
This first amendment (“Amendment 1”) to that certain Sponsored Research Agreement dated February 3, 2021 (“Agreement”), is by and between Coya Therapeutics Inc. (“Company”) and The Methodist Hospital Research Institute dba Houston Methodist Research Institute (“HMRI”). This Amendment 1 is executed as of the dates set forth below but shall be effective February 4, 2022 (“Amendment 1 Effective Date”).
WHEREAS, Company and HMRI are parties to the Agreement pursuant to which HMRI is performing certain research activities; and
WHEREAS, the Agreement expired on February 3, 2022, however the parties have been acting as if the Agreement has been in place as extended;
WHEREAS, the parties desire to amend the Agreement on the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual agreement among the parties hereto, it is agreed as follows:
|
1. |
Amendment. |
1.Definition. Definition 1.14 “Term” is hereby amended to extend the Agreement for an additional year. Accordingly, subsection 1.14 is hereby deleted and replaced in its entirety with the following:
“1.14 “Term” shall mean the period commencing on the Effective Date of this Agreement and terminating three (3) years thereafter, or if extended in accordance with its terms, terminating on the date specified in the extension.”
|
2. |
Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement. |
|
|
3. |
It is understood and agreed that all other provisions of the Agreement shall remain in full force and effect. |
|
1
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in duplicate counterpart original by their duly authorized representatives.
|
HMRI |
||||
By: |
/s/ Howard Berman |
|
By: |
/s/ Edward A. Jones |
|
Name: |
Howard Berman |
|
Name: |
Edward A. Jones |
|
Title: |
CEO |
|
Title: |
President and CEO |
|
Date: |
2/16/22 |
|
Date: |
2/20/2022 |
|
|
|
|
|||
|
|
|
|||
|
|
Read & Acknowledged: |
|||
|
|
By: |
/s/ Stanley Appel |
||
|
|
Name: |
Stanley H. Appel, MD |
||
|
|
|
|
||
|
|
HM Legal Approved as To Form: |
[***] |
2
EXHIBIT 10.10
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
SECOND AMENDMENT TO SPONSORED RESEARCH AGREEMENT
This second amendment (“Amendment 2”) to that certain Sponsored Research Agreement dated February 3, 2021 and last amended on February 4, 2022 (“Agreement”), is by and between Coya Therapeutics Inc. (“Company”) and The Methodist Hospital Research Institute dba Houston Methodist Research Institute (“HMRI”). This Amendment 2 is executed as of the last date of signature below but shall be effective as of February 4, 2022 (“Amendment 2 Effective Date”).
WHEREAS, Company and HMRI are parties to the Agreement pursuant to which HMRI is performing certain research activities;
WHEREAS, Company and HMRI desire to amend the Agreement to: (i) extend the Term for an additional one year period and (ii) add three additional years of funding to the Budget to allow work on the Research to continue for an additional three-year period; and
WHEREAS, the parties desire to amend the Agreement on the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual agreement among the parties hereto, it is agreed as follows:
1.Amendment.
A.Definition. Definition 1.15 “Term” is hereby amended to extend the Agreement for an additional year. Accordingly, subsection 1.15 is hereby deleted and replaced in its entirety with the following:
“1.15 “Term” shall mean the period commencing on the Effective Date of this Agreement and terminating four (4) years thereafter, or if extended in accordance with its terms, terminating on the date specified in the extension.”
B.Exhibit B. Exhibit B included in the Agreement is hereby deleted in its entirety and replaced with Exhibit B-1 appended to this Amendment 2. Each mention in the Agreement of “Exhibit B” will now be deemed to be a reference to Exhibit B-1.
1
|
2. |
Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement. |
|
|
3. |
It is understood and agreed that all other provisions of the Agreement shall remain in full force and effect. |
|
[Signature Page Follows]
2
IN WITNESS WHEREOF, the parties hereto have caused this Amendment 2 to be executed in duplicate counterpart original by their duly authorized representatives.
COMPANY |
|
HMRI |
|||
By: |
/s/ Howard Berman |
|
By: |
/s/ Edward A. Jones |
|
Name: |
Howard Berman |
|
Name: |
Edward A. Jones |
|
Title: |
CEO |
|
Title: |
President and CEO |
|
Date: |
6/28/22 |
|
Date: |
7/3/2022 |
|
|
|||||
|
|
Read & Acknowledged: |
|||
|
|
By: |
/s/ Stanley Appel |
||
|
|
Name: |
Stanley H. Appel, MD |
||
|
|||||
|
|
HM Legal Approved as To Form: |
[***] |
3
EXHIBIT B
Budget for Coya Therapeutics – [***]
|
Funding Year 1 |
Funding Year 2 |
Funding Year 3 |
Funding Year 4 |
|
Description |
2021 |
2022 |
2023 |
2024 |
Total |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
TOTAL |
1,547,094.00 |
1,547,094.00 |
1,547,094.00 |
1,547,094.00 |
[***] |
4
EXHIBIT 10.11
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
MATERIAL TRANSFER AND OPTION AGREEMENT
Carnegie Mellon University – Coya Therapeutics
This Agreement (hereinafter this “Agreement”) is made and entered into this 24th day of June 2022 (“Effective Date”) by and between Carnegie Mellon University (hereinafter “Carnegie Mellon”), a Pennsylvania non-profit corporation having a principal place of business at 5000 Forbes Avenue, Pittsburgh, Pennsylvania 15213 and Coya Therapeutics, Inc., a Delaware corporation having a principal place of business at 5850 San Felipe St. Suite 500; Houston, TX 77057 (“Licensee”).
Whereas, Carnegie Mellon owns certain rights in certain technology and related intellectual property relating to exosome modification materials; and
Whereas, Licensee desires to evaluate the commercial potential of the aforementioned technology and intellectual property for possible licensing from Carnegie Mellon and, to do so, desires to evaluate the materials and information specified in Attachment A (the “Carnegie Mellon Materials”) on and subject to the terms and conditions hereinafter set forth (the “Purpose”);
Whereas, pursuant to a separate Material Transfer Agreement entered into by the parties concurrently with this Agreement, the form of which is attached hereto as Attachment B (“MTA”), Licensee agrees to share with Carnegie Mellon its proprietary exosomes in order for Carnegie Mellon to incorporate its exosome modification materials, in order to create the Carnegie Mellon Materials, to accomplish the Purpose; and
Whereas, Carnegie Mellon is willing to provide to Licensee such Carnegie Mellon Materials and related information (as set forth more fully below) for the Purpose on and subject to the terms and conditions of this Agreement.
Now, therefore, in consideration of the mutual covenants contained herein and intending to be legally bound hereby, the parties agree as follows:
|
1. |
DELIVERY; RIGHT TO INSPECT |
1.1Following Carnegie Mellon’s creation of the Carnegie Mellon Materials, which Carnegie Mellon shall do as soon as reasonably practicable (anticipated to be within approximately two months following the date that Carnegie Mellon receives the Original Material (as that term is defined in the MTA) from Licensee pursuant to the MTA), Carnegie Mellon shall deliver to Licensee the Carnegie Mellon Materials via an appropriate shipping provider (e.g., FedEx) for overnight delivery to Licensee at the following address: Houston Methodist Hospital; Fondren Building; 5th Floor Room F530; 6565 Fannin Street; Houston, TX 7703, to the attention of [***].
1
1.2Licensee accepts the Carnegie Mellon Materials on an “AS IS, AS PROVIDED” basis. The Carnegie Mellon Materials are the product of academic research, ARE EXPERIMENTAL AND MAY HAVE HAZARDOUS PROPERTIES, and Carnegie Mellon does not represent that they are free from errors or are suitable for any particular task.
1.3Carnegie Mellon reserves the right to inspect Licensee’s use of the Carnegie Mellon Materials from time to time upon reasonable prior notice to Licensee and during normal business hours for the purpose of verifying Licensee’s compliance with this Agreement. Licensee agrees to reasonably cooperate with Carnegie Mellon in any such inspections.
1.4A transmittal fee of [***], payable within thirty (30) days of execution of this Agreement, shall be paid by Licensee to Carnegie Mellon, for preparation and distribution costs associated with making the Carnegie Mellon Materials.
|
2. |
USE; OWNERSHIP; PROPRIETARY PROTECTION |
2.1The Carnegie Mellon Materials and associated Confidential Information (as defined below) are furnished to Licensee on a non-exclusive basis solely for the Purpose, at Licensee’s facilities and no other purpose. Licensee shall use the Carnegie Mellon Materials and Confidential Information solely for such purpose, and in compliance with applicable laws, rules and regulations.
2.2Carnegie Mellon hereby grants to Licensee a non-exclusive, non-transferrable, limited right during the term of this Agreement to practice under U.S. Patent Application [***] (the “Patent”) solely for the Purpose.
2.3Licensee may not copy, reverse engineer, or disassemble the Carnegie Mellon Materials or otherwise unlock (as that term is generally used in the industry) the Carnegie Mellon Materials or make any derivatives thereof.
2.4The Carnegie Mellon Materials and information disclosed or provided by Carnegie Mellon relating thereto, including the Patent, contain Confidential Information of Carnegie Mellon. All Confidential Information has been entrusted to Licensee for use only as expressly authorized under this Agreement. Licensee shall devote reasonable efforts, consistent with the practices and procedures under which it protects its own most valuable proprietary information and materials, but no less than a reasonable standard of care, to protect the Carnegie Mellon Materials, the Patent and associated Confidential Information against any unauthorized use or disclosure. Consistent with the foregoing, Licensee shall maintain in confidence and shall not disclose to any third party nor shall Licensee use or exploit in any way for its benefit or for the benefit of any third party, any Confidential Information (including Confidential Information related to the prosecution of the Patent) for a period of three years from the date of such disclosure, unless such information ceases to be Confidential Information prior to the end of such three-year period through no fault of Licensee, or Licensee and Carnegie Mellon enter into a written agreement authorizing same.
2.5For purposes of this Agreement, “Confidential Information” means any information relating to the Carnegie Mellon Materials, including know-how, designs, data, any information relating to the prosecution of the Patent, patent applications and oral communications relating to the Carnegie Mellon Materials disclosed by Carnegie Mellon to Licensee (other than information relating to the
2
Original Materials (as defined in the MTA)). All such information shall be Confidential Information, including information disclosed or provided to Licensee prior to the date of this Agreement, unless such information (i) was already known to Licensee prior to the disclosure or provision thereof by Carnegie Mellon, (ii) has been published or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of Licensee, (iii) is received by Licensee from a third party not under any obligation of confidentiality with respect thereto, or (iv) is independently developed by Licensee without use of or reference to the Confidential Information.
2.6Licensee agrees that the Carnegie Mellon Materials and Confidential Information (including Confidential Information related to the prosecution of the Patent) shall not be used as the basis of a commercial product or service, rewritten in another computer language or otherwise adapted to circumvent the need for obtaining a license from Carnegie Mellon (if one is then available) for the use of the Carnegie Mellon Materials and Confidential Information (including Confidential Information related to the prosecution of the Patent) other than as specified by this Agreement.
2.7Licensee agrees that it will not directly or indirectly transmit, by way of trans-shipment, export, diversion or otherwise, the Carnegie Mellon Materials or any Confidential Information outside of the United States.
2.8This Agreement conveys to Licensee only a limited right to use, fully terminable in accordance with the provisions of this Agreement. Licensee shall not assert any right, title, or interest in or to any technology and/or intellectual property comprised in the Patent, Carnegie Mellon Materials or Confidential Information, except for any intellectual property solely related to the Materials (as such term is defined in the MTA). Title to the Carnegie Mellon Materials (including copyright) and Confidential Information shall remain with Carnegie Mellon. Carnegie Mellon claims and reserves to itself all rights and benefits afforded under U.S. copyright law and all international copyright conventions in the Carnegie Mellon Materials (and any associated Confidential Information).
|
3. |
TERM OF AGREEMENT; TERMINATION |
3.1The term of this Agreement shall commence on the Effective Date and shall continue until the earlier of (i) nine (9) months thereafter, (ii) Licensee’s permanent cessation of use of the Carnegie Mellon Materials and associated Confidential Information, or (iii) thirty (30) days following Licensee’s receipt from Carnegie Mellon of written notice of Licensee’s breach of this Agreement if Licensee fails to cure such breach within the thirty (30) day period.
3.2Upon termination of this Agreement, Licensee shall cease use of the Carnegie Mellon Materials and Confidential Information, dispose of any remaining Carnegie Mellon Materials in compliance with applicable laws, rules and regulations, and destroy any notes or other documents referencing or containing the Carnegie Mellon Materials and/or Confidential Information.
3.3Any rights or obligations under this Agreement that by their nature survive following termination shall survive following termination of this Agreement and continue to remain binding upon the parties.
3
|
4. |
OPTION FOR COMMERCIAL LICENSE |
4.1Carnegie Mellon hereby grants to Licensee the option (“Option”) to negotiate an exclusive license from Carnegie Mellon to manufacture, use, sell, lease or otherwise dispose of products and/or services based on, in whole or in part, the technology and intellectual property comprised in the Carnegie Mellon Materials and to practice under the Patent for exosome and cellular therapeutic applications.
4.2The Option shall exist and be exercisable by Licensee during the period of time commencing with the Effective Date and continuing for nine (9) months following the Effective Date (the “Option Period”), unless sooner terminated pursuant to the terms of this Agreement.
4.3In consideration of the granting of the Option, Licensee shall pay to Carnegie Mellon a fee (“Option Fee”) of [***], payable within thirty (30) days of execution of this Agreement, which Option Fee is fully creditable toward any fees or other consideration payable under any commercial license, if any, for the technology and intellectual property comprised in the Carnegie Mellon Materials and the Patent by Licensee from Carnegie Mellon subsequently obtained as a result of any exercise of the Option.
4.4In addition to the Option Fee, in consideration of the granting of the Option, should Carnegie Mellon incur any out of pocket fees or expenses for the filing, prosecution or maintenance of the Patent or any U.S. patents comprising the Carnegie Mellon Materials during the Option Period, Licensee agrees to reimburse Carnegie Mellon for all such fees and expenses within thirty (30) days of receipt of each notification or bill therefor, regardless of whether Licensee exercises its Option or whether Licensee obtains a license from Carnegie Mellon for the technology and intellectual property comprised in the Carnegie Mellon Materials and the Patent. Carnegie Mellon will provide Licensee with any proposed filings or submissions relating to the filing, prosecution or maintenance of the Patent or any U.S. patents comprising the Carnegie Mellon Materials.
4.5If Licensee elects to exercise the Option, it shall do so by notifying Carnegie Mellon in writing of the same, so that Carnegie Mellon receives such request within the Option Period. Within fifteen (15) days of receipt by Carnegie Mellon of Licensee’s written notice of such exercise, the parties shall thereupon negotiate exclusively and in good faith in an effort to arrive at mutually agreeable, commercially reasonable terms regarding the amount of royalties. If, despite negotiating in good faith, the parties are unable to come to mutually agreeable, commercially reasonable terms for a commercial license within ninety (90) days of receipt by Carnegie Mellon of Licensee’s written notice of such exercise, neither party shall thereafter have any further obligation to negotiate.
5.NO WARRANTIES; LIMITATIONS ON TYPES AND AMOUNTS OF DAMAGES; INDEMNIFICATION
5.1. ANY AND ALL INFORMATION, CARNEGIE MELLON MATERIALS, SERVICES, INTELLECTUAL PROPERTY AND OTHER PROPERTY AND RIGHTS GRANTED AND/OR PROVIDED BY CARNEGIE MELLON PURSUANT TO THIS AGREEMENT, INCLUDING THE CARNEGIE MELLON MATERIALS AND/OR THE CONFIDENTIAL
4
INFORMATION ARE GRANTED AND/OR PROVIDED ON AN "AS IS" BASIS. CARNEGIE MELLON MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, AND ALL SUCH WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSLY DISCLAIMED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, CARNEGIE MELLON DOES NOT MAKE ANY WARRANTY OF ANY KIND RELATING TO EXCLUSIVITY, INFORMATIONAL CONTENT, ERROR-FREE OPERATION, RESULTS TO BE OBTAINED FROM USE, FREEDOM FROM PATENT, TRADEMARK AND COPYRIGHT INFRINGEMENT AND/OR FREEDOM FROM THEFT OF TRADE SECRETS. LICENSEE IS PROHIBITED FROM MAKING ANY EXPRESS OR IMPLIED WARRANTY TO ANY THIRD PARTY ON BEHALF OF CARNEGIE MELLON RELATING TO ANY MATTER, INCLUDING THE APPLICATION OF OR THE RESULTS TO BE OBTAINED FROM THE INFORMATION, CARNEGIE MELLON MATERIALS, SERVICES, INTELLECTUAL PROPERTY OR OTHER PROPERTY OR RIGHTS, INCLUDING THE CARNEGIE MELLON MATERIALS AND/OR THE CONFIDENTIAL INFORMATION GRANTED AND/OR PROVIDED BY CARNEGIE MELLON PURSUANT TO THIS AGREEMENT.
CARNEGIE MELLON SHALL NOT BE LIABLE TO LICENSEE OR ANY THIRD PARTY FOR ANY REASON WHATSOVER ARISING OUT OF OR RELATING TO THIS AGREEMENT (INCLUDING ANY BREACH OF THIS AGREEMENT) FOR LOSS OF PROFITS OR FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF CARNEGIE MELLON HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR HAS OR GAINS KNOWLEDGE OF THE EXISTENCE OF SUCH DAMAGES.
CARNEGIE MELLON’S MAXIMUM LIABILITY FOR ANY REASON WHATSOEVER ARISING OUT OF OR RELATING TO THIS AGREEMENT (INCLUDING ANY BREACH OF THIS AGREEMENT), REGARDLESS OF THE MANNER CLAIMED OR FORM OF ACTION ALLEGED, IS LIMITED TO THE AMOUNTS PAID TO CARNEGIE MELLON BY LICENSEE UNDER THIS AGREEMENT DURING THE ONE YEAR PERIOD IMMEDIATELY PRECEDING THE EVENT OR OTHER CIRCUMSTANCE GIVING RISE TO THE CLAIMED LIABILTY.
5.2 Licensee shall defend, indemnify and hold harmless Carnegie Mellon, its trustees, officers, employees, attorneys and agents from and against any liability, damage, loss or expense (including attorneys’ fees and expenses) incurred by or imposed upon any of Carnegie Mellon and/or its trustees, officers, employees, attorneys and agents in connection with any claim, suit, action or demand arising out of or relating to Licensee’s possession of the Carnegie Mellon Materials (including any use by Licensee of the Carnegie Mellon Materials), any exercise of any right or license granted or provided to Licensee under this Agreement under any theory of liability (including without limitation, actions in the form of tort, warranty, or strict liability, or violation of any law, and regardless of whether such action has any factual basis).
5
|
6. |
NOTICES |
Any notice under any of the provisions of this Agreement shall be deemed given when (i) personally delivered, (ii) sent prepaid by nationally recognized overnight carrier, or (iii) deposited in the mail, postage prepaid, registered or certified first class mail, and in the case of (ii) or (iii), when addressed to the applicable party at the address indicated below, or such other address as such party shall specify for itself by like notice to other party. Each party shall in the case of (ii) or (iii), transmit to the other a facsimile copy or an electronic mail copy of each such notice promptly after sending the same by nationally recognized overnight carrier or depositing the same in the mail, as applicable.
In the case of Carnegie Mellon:
Center for Technology Transfer and Enterprise Creation Carnegie Mellon University 4615 Forbes Avenue, Suite 302 Pittsburgh, PA 15213
Fax: [***] Email: [***] |
In the case of Licensee:
Coya Therapeutics, Inc. 5850 San Felipe St. Suite 500 Houston, TX 77057 [***] Attention: CEO and CFO
|
|
7. |
MISCELLANEOUS |
7.1Neither party may assign or transfer its rights or obligations under this Agreement without the prior written consent of the other party.
7.2This Agreement shall be governed and construed in all respects in accordance with the substantive laws of the Commonwealth of Pennsylvania without regard to conflict of law provisions in that or any other jurisdiction. All claims and/or controversies of every kind and nature arising out of or relating to this Agreement, including any questions concerning its existence, negotiation, validity, meaning, performance, non-performance, breach, continuance or termination shall be settled (a) at Carnegie Mellon’s election, by binding arbitration administered by the American Arbitration Association (“AAA”) in accordance with its Commercial Arbitration Rules and, in such case (i) the arbitration proceedings shall be conducted before a panel of three arbitrators, with each party selecting one disinterested arbitrator from a list submitted by the AAA and the two disinterested arbitrators selecting a third arbitrator from the list, (ii) each party shall bear its own cost of arbitration, (iii) all arbitration hearings shall be conducted in Allegheny County, Pennsylvania, and (iv) the provisions hereof shall be a complete defense to any suit, action or proceeding instituted in any federal, state or local court of before any administrative tribunal with respect to any claim or controversy arising out of or relating to this Agreement and which is arbitrable as provided in this Agreement, provided that either party may seek injunctive relief in a court of law or equity to assert, protect or enforce its rights in any intellectual property and/or Confidential Information as described in this Agreement, or (b) in the event that Carnegie Mellon does not elect binding arbitration as permitted in point (a) above, exclusively in the U.S. District Court for the Western District of Pennsylvania or, if such Court does not have jurisdiction, in any
6
court of general jurisdiction in Allegheny County, Pennsylvania and each party consents to the exclusive jurisdiction of any such courts and waives any objection which such party may have to the laying of venue in any such courts.
7.3All remedies available to a party for one or more breaches by the other party shall be cumulative and may be exercised separately or concurrently without waiver of any other remedies. The failure of either party to act on a breach of this Agreement by the other party shall not be deemed a waiver of said breach or a waiver of future breaches, unless such a waiver is in writing and is signed by the party against whom enforcement is sought.
7.4This Agreement constitutes the entire agreement of the parties hereto and supersedes all prior representations, proposals, discussions, and communications, whether oral or in writing. This Agreement may be modified only by a writing signed by a duly authorized representative of the party against whom enforcement thereof is sought.
Both parties have caused this Agreement to be executed by their duly authorized representatives effective as of the Effective Date.
By: |
/s/ Daryl Weinert |
|
Daryl Weinert, Vice President for Operations and Interim Vice President for Research |
|
|
Coya Therapeutics, Inc.: |
|
By: |
/s/ Howard Berman |
|
Howard Berman, CEO |
7
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.
LICENSE AGREEMENT
By and Between
COYA THERAPEUTICS, INC.
AND
ARSCIENCE BIOTHERAPEUTICS INC.
LICENSE AGREEMENT
This LICENSE AGREEMENT (this “Agreement”) is entered into and made effective as of August 23, 2022 (the “Execution Date”), by and between Coya Therapeutics, Inc., a Delaware corporation, having its principal place of business at 5850 San Felipe St., Suite 500, Houston, TX 77057 (“Coya”), and ARScience Biotherapeutics Inc., a Delaware corporation having its principal place of business at 1400 112th Ave SE, Suite 100, Bellevue, Washington 98004 (“ARScience Bio”). Coya and ARScience Bio shall be referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, ARScience Bio is the owner of or otherwise controls certain rights in proprietary technology and know-how relating to manufacturing and commercialization of hr- IL2 (as defined below) investigational products for human use;
- 1 -
WHEREAS, Coya is a biotechnology company engaged in the research and development of autologous regulatory T-cell therapies, autologous and allogeneic exosome therapies, and biologic therapies;
WHEREAS, pursuant to the terms and conditions set forth herein, Coya desires to obtain, and ARScience Bio desires to grant to Coya, a license under the ARScience Bio Technology for the research, development, manufacturing and commercialization of Products in the Field in the Territory.
NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth in this Article 1 (Definitions) unless context dictates otherwise:
1.1.“Accounting Standards” means, with respect to a Party or its Affiliates or its or their (sub)licensees/Sublicensees, United States generally accepted accounting principles or International Financial Reporting Standards as issued by the International Accounting Standards Board, as applicable, in each case consistently applied.
1.2.“Achieved Milestone Event” has the meaning set forth in Section 5.2 (Development Milestone Payments).
1.3.“Affiliate” means, with respect to a Person, any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such first Person for so long as such Person controls, is controlled by or is under common control with such first Person, regardless of whether such Affiliate is or becomes an Affiliate on or after the Effective Date. A Person shall be deemed to “control” another Person if it (a) owns, directly or indirectly, beneficially or legally, more than 50% of the outstanding voting securities or capital stock of such other Person, or has other comparable ownership interests with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of such other Person.
1.4.“Agreement” has the meaning set forth in the preamble.
1.5.“Agreement IP” means Agreement Know-How and Agreement Patents.
1.6.“Agreement Know-How” means all Know-How conceived, discovered, developed or otherwise made in the course of activities conducted pursuant to this Agreement by or on behalf of a Party (or its Affiliates), whether solely or jointly by or on behalf of the Parties (or their Affiliates).
1.7.“Agreement Patent” means any Patent Right that claims any Agreement Know-
How.
1.8.“ALS” has the meaning set forth in Section 1.91 (Mono Product Field).
1.9.“Annual Net Sales” has the meaning set forth in Section 5.3 (Royalties).
- 2 -
1.10.“ARScience Bio” has the meaning set forth in the preamble.
1.11.“ARScience Bio Indemnitees” has the meaning set forth in Section 9.1(Indemnification by Coya).
1.12.“ARScience Bio Agreement Know-How” has the meaning set forth in Section 6.1.1(b)(i) (Agreement IP).
1.13.“ARScience Bio Agreement Patents” has the meaning set forth in Section 6.1.1(b)(i) (Agreement IP).
1.14.“ARScience Bio Agreement Technology” has the meaning set forth in Section 6.1.1(b)(i) (Agreement IP).
1.15.“ARScience Bio Know-How” means all Know-How that (a) is Controlled by ARScience Bio as of the Effective Date or during the Term, (b) is not generally known, and (c) is necessary or reasonably useful to Develop, Manufacture, have Manufactured, use, Commercialize or otherwise Exploit the Licensed Compound and Products in the Field in the Territory.
1.16.“ARScience Bio Patents” means all Patent Rights Controlled by ARScience Bio as of the Effective Date or during the Term that are necessary or reasonably useful to Develop, Manufacture, have Manufactured, use, Commercialize or otherwise Exploit the Licensed Compound and Products in the Field in the Territory. Without limiting the foregoing, the ARScience Bio Patents as of the Effective Date are set forth in Schedule 1.16 (ARScience Bio Patents); provided that any Patent Right that otherwise meets the definition of ARScience Bio Patents described in the first sentence of this Section 1.16 (ARScience Bio Patents) is considered an ARScience Bio Patent regardless of whether or not it is included in Schedule 1.16 (ARScience Bio Patents).
1.17.“ARScience Bio Technology” means the ARScience Bio Patents and ARScience Bio Know-How.
1.18.“Audit Arbitrator” has the meaning set forth in Section 5.9.2 (Audit Dispute).
1.19.“Biosimilar Competition” means, on a Product-by-Product, country-by-country, and Calendar Year-by-Calendar Year basis, a Biosimilar Product with respect to such Product is being marketed and sold by a Third Party in such Calendar Year in such country.
1.20.“Biosimilar Product” means, with respect to a Product in a country, any product that is a generic, biosimilar, or interchangeable product with respect to such Product sold by a Third Party (provided that such Third Party is not selling such product under a license, authorization, or other grant of rights by Coya and did not purchase or acquire such product in a chain of distribution that included Coya or any of its Affiliates or Sublicensees) and that (a) is subject to a license for administration to humans under Section 351(a) or 351(k) of the PHSA and (i) contains an active ingredient that is the same as the active ingredient of such Product or (ii) is “biosimilar” (as defined in Section 351(i)(2) of the PHSA) or “interchangeable” (as defined in Section 351(i)(3) of the PHSA) to such Product (or otherwise bioequivalent, biosimilar, interchangeable, or the like, in each case, to such Product under analogous laws for gene therapy products), (b) has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation, or (c) has otherwise received Regulatory Approval as a generic, biosimilar, bioequivalent, or interchangeable product from another applicable Regulatory Authority in such country, including by referencing Regulatory Approvals (or data therein) of such Product, or, in each case, (a), (b), or (c), an analogous law, statute, or regulation for gene therapy products.
- 3 -
1.21.“BLA” means a Biologic License Application (within the meaning of 21 C.F.R. 601.2), or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.
1.22.“Breaching Party” has the meaning set forth in Section 10.2.1 (Termination for Cause).
1.23.“Business Day” means a day other than a Saturday or Sunday on which banking institutions in Houston, Texas are open for business.
1.24.“Calendar Quarter” means a period of three consecutive months ending on the last day of March, June, September, or December, respectively, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.
1.25.“Calendar Year” means a period of 12 consecutive months beginning on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.26.“CDA” means that certain Mutual Confidentiality Agreement, by and between Coya and Amcyte Bio, Inc., dated as of February 22, 2022.
1.27.“cGMP” means the current Good Manufacturing Practices as provided for (and as amended from time to time) in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7 (ICH Q7), the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use in Volume 4 of the European Commission’s Rules governing medicinal products in the European Union, and the United States Code of Federal Regulations 21 C.F.R. Parts 210 and 211.
1.28.“Change of Control” means, with respect to a Party, any of the following: (a) the acquisition of beneficial ownership, directly or indirectly, by any Person (other than such Party or an existing Affiliate of such Party) of securities or other voting interest of such Party representing a majority or more of the combined voting power of such Party’s then outstanding securities or other voting interests other than as a result of a bona fide financing, (b) any merger, reorganization, consolidation or business combination involving such Party with a Third Party that results in the holders of beneficial ownership of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of more than 50% of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or business combination, or (c) any sale, lease, exchange, contribution or other transfer (in one transaction or a series of related transactions) of all or substantially all of the assets of such Party to which this Agreement relates, other than a sale or disposition of such assets to an existing Affiliate of such Party.
- 4 -
1.29.“Clinical Study” means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.
1.30.“Combination Product” has the meaning set forth in Section 1.92 (Net Sales).
1.31.“Combination Product Field” means all uses, including any and all uses for the diagnosis, prevention, amelioration, and treatment of any disease or medical condition in humans and animals.
1.32.“Commercialization” and “Commercialize” means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Compound or Product, and, for purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting Medical Affairs Activities and conducting Phase IV Clinical Studies, and interacting with Regulatory Authorities or other Governmental Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.
1.33.“Commercially Reasonable Efforts” means, with respect to the Development or Commercialization of a Product, that level of efforts and resources commonly dedicated by a similarly situated company in the pharmaceutical or biotechnology industry to the development or commercialization, as the case may be, of a product of similar commercial potential at a similar stage in its lifecycle, in each case taking into account, without limitation, with respect to each such Licensed Compound or Product, (i) issues of safety, efficacy and product profile,
(ii) likelihood of receiving Regulatory Approval for the applicable Product, (iii) regulatory structure involved, (iv) Regulatory Authority-approved labeling, (v) competitiveness in the marketplace, (vi) proprietary position and (vii) other scientific, technical and business factors deemed relevant by the applicable Party or its Affiliate or Sublicensee. “Commercially Reasonable Efforts” with respect to any objective relating to the Development or Commercialization of a Licensed Compound or Product by Coya will be determined on a country-by-country basis and activities that are conducted in one country under this Agreement that have an effect on achieving the relevant objective in another country will be considered in determining whether Commercially Reasonable Efforts have been applied in such other countries.
1.34.“Confidential Information” means any information or data provided orally, visually, in writing or other form by or on behalf of one Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including information relating to the terms of this Agreement, the Licensed Compound or any Product (including Regulatory Filings), any Exploitation of the Licensed Compound or any Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates, or the scientific, regulatory or business affairs or other activities of either Party. Notwithstanding the foregoing, (a) the existence and terms of this Agreement shall be deemed to be the Confidential Information of both Parties other than to the extent a press release is agreed by the parties and released pursuant to Section 7.4 (Public Announcements), and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto, and (b) all reports provided by Coya to ARScience Bio under Section 3.1 (Development), Section 3.2 (Commercialization) and Section 5.7 (Reports; Payment of Royalty) shall be deemed to be the Confidential Information of Coya, and Coya shall be deemed to be the disclosing Party and ARScience Bio shall be deemed to be the receiving Party with respect thereto.
- 5 -
1.35.“Control” means, with respect to a Person and any material, Know-How, Patent Right or other intellectual property right, the possession by such Person or any of its Affiliates of the right, whether through ownership or license (other than by a license under this Agreement), to grant the licenses, sublicenses or other rights as provided herein without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding anything to the contrary in this Agreement, if either Party or its Affiliates undergoes a Change of Control, then any Patent Rights, Know-How or other intellectual property rights that are owned or controlled immediately prior to the effective date of such Change of Control by a Third Party that becomes an Affiliate of such acquired Party as a result of such Change of Control shall be deemed not to be Controlled by such Party or its Affiliates for purposes of this Agreement unless (a) prior to the effective date of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Patent Rights, Know-How or other intellectual property rights, (b) any such Patent Rights, Know-How or other intellectual property rights arose from participation by employees, subcontractors or consultants of such Third Party in any activities under this Agreement after such Change of Control or (c) such Patent Rights, Know-How or other intellectual property rights owned or controlled by such Third Party were not used in the performance of activities under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, such acquired Party or any of its Affiliates used any such Patent Rights, Know-How or other intellectual property rights in the performance of its obligations or exercise of its rights under this Agreement, in which case (i.e., any of the foregoing (a) through (c) is met), such Patent Rights, Know-How or other intellectual property rights will be “Controlled” by such Party for purposes of this Agreement.
1.36.“Convicted Individual” or “Convicted Entity” means an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a(a) or 42 U.S.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible.
1.37.“Cover,” “Covering” or “Covers” means, as to a compound or product any Patent Right, that, in the absence of a license granted under, or ownership of, such Patent Right, the making, using, keeping, selling, offering for sale or importation of such compound or product would infringe such Patent Right or, as to a pending claim included in such Patent Right, the making, using, keeping, selling, offering for sale or importation of such compound or product would infringe such Patent Right if such pending claim were to issue in an issued patent without modification.
1.38.“Coya” has the meaning set forth in the preamble.
1.39.“Coya Additional Mono Product Indication” has the meaning set forth in Section 2.7.2 (Coya Interest).
1.40.“Coya Agreement Know-How” has the meaning set forth in Section 6.1.1(b)(ii) (Agreement IP).
1.41.“Coya Agreement Patents” has the meaning set forth in Section 6.1.1(b)(ii) (Agreement IP).
1.42.“Coya Agreement Technology” has the meaning set forth in Section 6.1.1(b)(ii) (Agreement IP).
1.43.“Coya Background IP” means Patent Rights and Know-How Controlled by Coya or its Affiliates (a) as of the Effective Date or (b) during the Term outside the terms of this Agreement after the Effective Date.
1.44.“Coya Indemnitees” has the meaning set forth in Section 9.2 (Indemnification by ARScience Bio).
- 6 -
1.45.“Coya Standard Exchange Rate Methodology” means Coya’s then-current standard exchange rate methodology, which is in accordance with Coya’s Accounting Standards applied in its external reporting for the conversion of foreign currency sales into Dollars or, in the case of Sublicensees, such similar methodology, consistently applied.
1.46.“Debarred Entity” means a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.
1.47.“Debarred Individual” means an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a(a) or from providing services in any capacity to a Person that has an approved or pending drug or biological product application.
1.48.“Deemed Royalty Portion” has the meaning set forth in Section 6.3.4 (Recovery).
1.49.“Development” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Regulatory Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” means to engage in Development. Notwithstanding the foregoing, Development does not include any Commercialization activities.
1.50.“Development Milestone Event” has the meaning set forth in Section 5.2 (Development Milestone Payments).
1.51.“Development Milestone Payment” has the meaning set forth in Section 5.2 (Development Milestone Payments).
1.52.“Development Plan” has the meaning set forth in Section 3.1.2 (Development
Plans).
1.53.“Dispute” has the meaning set forth in Section 11.1.2 (Dispute Resolution).
1.54.“Distributor” means any Person appointed by Coya or any of its Affiliates or its or their Sublicensees to distribute, market and sell a Product with or without packaging rights, in one or more countries in the Territory, in circumstances where such Person purchases its requirements of such Product from Coya or its Affiliates or its or their Sublicensees.
1.55.“Dollars” or “$” means the legal tender of the U.S.
1.56.“Effective Date” has the meaning set forth in Section 2.1 (Option).
1.57.“EMA” means the European Medicines Agency, and any successor entity thereto.
1.58.“Excluded Individual” or “Excluded Entity” means (a) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (b) an individual or entity, as applicable, who has been
- 7 -
excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA).
1.59.“Executive Officers” means the Chief Executive Officer, or his or her designee, in the case of ARScience Bio, and the Chief Executive Officer, or his or her designee, in the case of Coya.
1.60.“Exploit” or “Exploitation” means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribute, promote, market, have sold or otherwise dispose of.
1.61.“Exploitation License” has the meaning set forth in Section 2.2.1 (Exploitation License).
1.62.“Extended Option Exercise Period” has the meaning set forth in Section 2.1 (Option).
1.63.“FDA” means the United States Food and Drug Administration, and any successor entity thereto.
1.64.“FFDCA” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
1.65.“Field” means (a), with respect to a Mono Product, the Mono Product Field and
(b)with respect to a Combination Product, the Combination Product Field.
1.66.“First Commercial Sale” means the first sale of a Product, by or under the authority of Coya, an Affiliate of Coya, or their Sublicensees to a Third Party in a country following Regulatory Approval of such Product in that country or, if no such Regulatory Approval or similar approval is required, the date on which such Product is first commercially launched in such country; provided that “First Commercial Sale” shall not include: (a) any distribution or other sale solely for so-called treatment investigational new drug sales, named patient sales, compassionate or emergency use sales or pre-license sales, in each case provided that such Product is distributed without charge or sold at or below cost or (b) intercompany transfers to Affiliates of Coya.
1.67.“Governmental Authority” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.
1.68.“hrIL-2” means human recombinant interleukin 2.
1.69.“In-License Agreement” means any agreement between ARScience Bio or its Affiliate, on one hand, and a Third Party on the other hand under which Coya is granted a sublicense or other right under this Agreement as provided in Section 2.5 (In-License Agreements).
1.70.“IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
- 8 -
1.71.“IND Acceptance” means, with respect to an IND for a Product: (a) in the U.S., the date that is 30 days following the filing of such IND for such Product, if Coya or its Affiliates or Sublicensees has not received any notice of a clinical hold (including any complete or partial clinical hold) or any other administrative delay from the FDA during such 30 day period; provided that, if Coya or its Affiliate or Sublicensee does receive a notice of such a clinical hold (including any complete or partial clinical hold) or there is such other administrative delay, then the “IND Acceptance” for such Product will be the date on which the FDA lifts such clinical hold or such other administrative delay is otherwise resolved and the FDA first allows such Product to be administered to a human pursuant to such IND, or (b) in other regulatory jurisdictions outside the U.S., the date on which such Product is first permitted by the applicable Regulatory Authority of such jurisdiction to be administered to a human pursuant to such IND in accordance with applicable Law.
1.72.“Indemnified Party” has the meaning set forth in Section 9.3 (Conditions to Indemnification).
1.73.“Indemnifying Party” has the meaning set forth in Section 9.3 (Conditions to Indemnification).
1.74.“Indication” means any indication, disease or condition which can be treated, prevented, cured or the progression of which can be delayed. For clarity, (a) distinctions between indications, diseases or conditions with respect to a Product shall be made by reference to the World Health Organization International Classification of Diseases and Related Health Problems (including any updates or successors thereto) and (b) any indication, disease or condition that requires the Regulatory Approval of a separate BLA in order to include such human indication, disease or condition in the Product’s labeling shall be considered to be a separate Indication for purposes of this Agreement.
1.75.“Infringement” has the meaning set forth in Section 6.3.1 (Notice).
1.76.“Initial Option Exercise Period” has the meaning set forth in Section 2.1 (Option).
1.77.“Intellectual Property” has the meaning set forth in Section 2.6.1 (Section 365(n) of the Bankruptcy Code).
1.78.“Japan PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function.
1.79.“Joint Agreement Know-How” has the meaning set forth in Section 6.1.1(b)(iii) (Agreement IP).
1.80.“Joint Agreement Patents” has the meaning set forth in Section 6.1.1(b)(iii) (Agreement IP).
1.81.“Joint Agreement Technology” has the meaning set forth in Section 6.1.1(b)(iii) (Agreement IP).
1.82.“Know-How” means all knowledge, materials and information of a technical, scientific, business and other nature, including inventions, know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, Regulatory Filings, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control
- 9 -
data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed.
1.83.“Law” means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.
1.84.“Licensed Compound” means Low Dose lyophilized and liquid formulations of hrIL-2.
1.85.“Losses” has the meaning set forth in Section 9.1 (Indemnification by Coya).
1.86.“Low Dose” means 2 MM IU or less.
1.87.“Major EU Market” means each of the following: the United Kingdom, Germany, France, Italy, and Spain.
1.88.“Manufacture” and “Manufacturing” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Licensed Compound, Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control.
1.89.“Medical Affairs Activities” means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to the Licensed Compound or Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Product.
1.90.“Mono Product” means any therapeutic product, medical therapy, preparation or substance, comprising or employing, the Licensed Compound, in any form or formulation, with no other therapeutically active ingredients.
1.91.“Mono Product Field” means Amyotrophic lateral sclerosis (“ALS”), Alzheimer’s disease, mild cognitive impairment, fronto-temporal dementia, Parkinson’s disease/Lewy body dementia or any other Third Party Additional Mono Product Indication or Coya Additional Mono Product Indication that is included in the Mono Product Field pursuant to Section 2.7.3 (Mono Product Field Expansion).
1.93.“New Indication” has the meaning set forth in Section 5.2 (Development Milestone Payments).
1.94.“Non-Breaching Party” has the meaning set forth in Section 10.2.1 (Termination for Cause).
1.95.“Option” has the meaning set forth in Section 2.1 (Option).
1.96.“Option Exercise Notice” has the meaning set forth in Section 2.1 (Option).
1.97.“Parties” and “Party” have the meaning set forth in the preamble.
- 10 -
1.98.“Patent Right” means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any patent term extensions, supplementary protection certificates, pediatric exclusivity periods and the like) of the foregoing patents or patent applications ((a), (b), and (c)); and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.
1.99.“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization or Governmental Authority, or any other entity not specifically listed in this Section 1.99 (Person).
1.100.“Phase I Clinical Study” means a human clinical trial of a Licensed Compound or Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the applicable Regulatory Authority, including the trials referred to in 21 C.F.R. §312.21(a), as amended.
1.101.“Phase II Clinical Study” means a human clinical trial of a Licensed Compound or Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of a Phase III Clinical Study or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.
1.102.“Phase III Clinical Study” means a human clinical trial of a Licensed Compound or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
1.103.“Phase IV Clinical Study” means a post-marketing human clinical study for a Product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.
1.104.“PHSA” means the Public Health Service Act (42 U.S.C. § 201 et seq.), as amended.
1.105.“Pre-Clinical Proof of Concept Activities” means experiments conducted in vitro, ex vivo, or in vivo in animals or animal models of disease to assess the pathophysiology of a disease or condition, a biological mechanism or a biomarker associated to a disease or condition, the effect of a treatment on a disease or condition, or the impact of a disease or condition on a treatment.
- 11 -
1.106.“Pre-Clinical Proof of Concept Demonstration” means clinical, biological, histopathological and statistical data from Pre-Clinical Proof of Concept Activities supporting, in the reasonable judgement of Coya, the desired effect of a treatment on a disease or condition.
1.107.“Pricing Approval” means, in a country in which Regulatory Authorities authorize reimbursement for, or approve or determine pricing for, pharmaceutical or biologic products to be marketed and sold or reimbursed in such country, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).
1.108.“Product” means a Mono Product or Combination Product, as applicable.
1.109.“Proposed In-Licensed Rights” has the meaning set forth in Section 2.5 (In- License Agreements).
1.110.“Quality Agreement” has the meaning set forth in Section 3.3.2 (Quality Agreement).
1.111.“Recovery” has the meaning set forth in Section 6.3.4 (Recovery).
1.112.“Regulatory Approval” means, with respect to a country or other regulatory jurisdiction in the Territory, all approvals of the applicable Regulatory Authority necessary for the commercial marketing or sale of a product in such country or regulatory jurisdiction, including, where applicable, (a) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), (b) approval of the expansion or modification of the label for additional indications or uses and (c) any Pricing Approval.
1.113.“Regulatory Approval Application” means (a) a BLA, or (b) any other corresponding foreign application in the Territory to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction.
1.114.“Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local governmental or regulatory authority, agency, department, bureau, commission or council, or any other entity (e.g., the FDA, EMA or Japan PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Licensed Compound or Products in the Territory.
1.115.“Regulatory Filing” means all (a) applications (including all INDs and Regulatory Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files and (c) data contained or relied upon in any of the foregoing, in each case ((a), (b), and (c)) relating to a Licensed Compound or Product.
1.116.“ROFR Exercise Notice” has the meaning set forth in Section 2.7.1 (Third Party Interest).
1.117.“Royalties” has the meaning set forth in Section 5.3 (Royalties).
1.118.“Royalty Rates” has the meaning set forth in Section 5.3 (Royalties).
- 12 -
1.119.“Royalty Term” has the meaning set forth in Section 5.4 (Royalty Term).
1.120.“Safety Data Exchange Agreement” has the meaning set forth in Section 4.2 (Safety and Adverse Event Reporting).
1.121.“Skipped Milestone Event” has the meaning set forth in Section 5.2 (Development Milestone Payments).
1.122.“Subcontractor” has the meaning set forth in Section 2.3.2 (Subcontracting).
1.123.“Sublicense” means a sublicense granted by Coya under the rights granted to it by ARScience Bio under Section 2.2 (Licenses to Coya) to any Third Party.
1.124.“Sublicensee” has the meaning set forth in Section 2.3.1 (Sublicensing).
1.125.“Sublicensing Income” means all consideration (including, without limitation, upfront payments, license fees, milestone payments, the difference for discounted services between the fair market value of such services and the amount actually paid for such discounted services and royalties) received by Coya in consideration for the grant by Coya of a Sublicense to a Sublicensee; provided that Sublicensing Income will not include any such payment received by Coya or any of its Affiliates from any such Sublicensee in return for, as payment or consideration for, or otherwise in respect of: (a) debt, equity, or equity-related rights of Coya or its Affiliate purchased by such Sublicensee, (b) payments to Coya or its Affiliates to the extent such is consideration for the Manufacture and supply of the Product, (c) reimbursement for the performance of services (including Development and Commercialization activities) by Coya or its Affiliate under any such Sublicense, (d) the sale of Coya or its Affiliate or any line of business thereof in whole or in part to a Third Party, (e) payments to Coya or any of its Affiliates to the extent such is for the purpose of funding the costs of Development or Commercialization activities related to the Product performed by or on behalf of Coya or its Affiliates, (f) consideration to the extent for the grant of rights under any intellectual property rights other than ARScience Bio Technology, (g) amounts received with respect to the Exploitation of products other than a Product, (h) any milestone payment made by a Sublicensee to Coya for achievement of substantially the same milestone for which Coya is obligated to make a payment under Section 5.2 (Development Milestone Payments); provided, that any amount received by Coya in respect of such milestone payment in excess of the amount owed by Coya to ARScience Bio upon the achievement of such substantially same milestone shall be treated as Sublicensing Income; or (i) to the extent that a payment not explicitly tied to a Product is made under such Sublicense that grants rights both to one or more Products and one or more other products (e.g., an upfront payment), then a pro rata portion of such payment will be considered Sublicensing Income which pro rata portion will be determined based on the number of products with respect to which rights are granted under such Sublicense and the relative value of such products.
1.126.“Supply Agreement” has the meaning set forth in Section 3.3.1 (Supply Agreement).
1.127.“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, penalties and additions thereto) imposed by a Governmental Authority.
1.128.“Technology Transfer Plan” has the meaning set forth in Section 3.4.1 (Technology Transfer Plan).
1.129.“Term” has the meaning set forth in Section 10.1 (Term).
- 13 -
1.130.“Territory” means worldwide.
1.131.“Third Party” means any Person that is neither a Party nor an Affiliate of a Party.
1.132.“Third Party Additional Mono Product Indication” has the meaning set forth in Section 2.7.1 (Third Party Interest).
1.133.“Third Party Claims” has the meaning set forth in Section 9.1 (Indemnification by
Coya).
1.134.“Third Party Payments” has the meaning set forth in Section 5.5.3 (Third Party Payments).
1.135.“Trademark” means any word, name, symbol, color, shape or designation, or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered, and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with or symbolized by any of the foregoing.
1.136.“United States” or “U.S.” means the United States of America and all of its territories and possessions.
1.137.“Valid Claim” means, with respect to a particular country, (a) a claim of any issued and unexpired patent in such country whose validity, enforceability, or patentability has not been terminated by any of the following: (i) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (ii) a holding, finding, or decision of invalidity, unenforceability, or non-patentability, from which decision no appeal can be further taken, or (b) a claim within a patent application in such country that has not been pending for more than seven years from the earliest date to which such claim or the applicable patent application is entitled to claim priority and which claim has not been revoked, cancelled, withdrawn, held invalid, or abandoned.
ARTICLE 2
OPTION; LICENSE GRANTS
2.1.1.Option and Option Deadline. Effective as of the Execution Date, ARScience Bio hereby grants Coya and its Affiliates an option to receive the licenses set forth in Section 2.2 (Licenses to Coya) and the benefit of all other provisions of this Agreement, other than those provisions which are specified to be effective as of the Execution Date (the “Option”). This Section 2.1.1 (Option and Option Deadline), Section 5.1.1 (Option Fee), Section 10.2.5 (Automatic Termination), Article 7 (Confidentiality) (other than Section 7.5 (Publications)) and Article 11 (Miscellaneous) are effective as of the Execution Date. The Option may be exercised by written notice to ARScience Bio (an “Option Exercise Notice”) at any time beginning on the Execution Date and continuing for a period 90 days following the Execution Date (“Initial Option Exercise Period”). If ARScience Bio fails to provide, within five days of written request by Coya, any materials or information related to this Agreement requested by Coya to complete its diligence during the Initial Option Exercise Period, then Coya may extend the Initial Option Exercise Period by written notice to ARScience Bio by one day for each day by which ARScience Bio fails to so provide such materials or information within such 5-day period and for each occasion for which such failure occurs (as applicable, the “Extended Option Exercise Period”). As of the date of delivery of an Option
- 14 -
Exercise Notice (such date of delivery, the “Effective Date”), ARScience Bio will automatically be deemed to have granted to Coya the licenses set forth in Section 2.2 (Licenses to Coya) and all provisions of this Agreement will be deemed effective as of the Effective Date. If Coya fails to timely exercise the Option in accordance with this Section 2.1.1 (Option and Option Deadline), the Option shall expire and be of no further force or effect and this Agreement shall automatically terminate in accordance with Section 10.2.5 (Automatic Termination).
2.2.1.Exploitation License. As of the Effective Date, ARScience Bio hereby grants to Coya and its Affiliates an exclusive, royalty-bearing, license, with the right to grant sublicenses through multiple tiers (subject to Section 2.3 (Sublicensing & Subcontracting Rights)), under the ARScience Bio Technology to Exploit the Licensed Compound and Products in the Field in the Territory (the “Exploitation License”).
2.2.2.ROFR License. For purposes of Coya’s performance of the Pre- Clinical Proof of Concept Activities described in Section 2.7.1 (Third Party Interest) and Section 2.7.2 (Coya Interest), as of the Effective Date, ARScience Bio hereby grants to Coya and its Affiliates an exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers (subject to Section 2.3 (Sublicensing & Subcontracting Rights)), under the ARScience Bio Technology to perform the Pre-Clinical Proof of Concept Activities.
2.3.Sublicensing & Subcontracting Rights.
2.3.1.Sublicensing. Coya shall have the right to grant and authorize sublicenses under the rights granted to it under Section 2.2 (Licenses to Coya) to any of its Affiliates and Third Parties through multiple tiers (each such Third Party, a “Sublicensee”); provided that each sublicense will be subject to a written agreement consistent with the terms and conditions of this Agreement. In no event will any sublicense relieve Coya of any obligations under this Agreement. Coya will promptly provide ARScience Bio copies of all Sublicense agreements, other than any vendor agreements or other agreements pursuant to which a Third Party is acting on behalf of Coya, which shall be kept confidentially by ARScience Bio in accordance with the confidentiality provisions herein and subject to Coya’s right to redact terms that are competitively sensitive and do not relate to any rights or obligations that would be applicable to ARScience Bio as licensor.
2.3.2.Subcontracting. Coya shall have the right to engage Affiliates or Third Party subcontractors (each, a “Subcontractor”) to perform any of its activities under this Agreement; provided that (a) Coya shall cause any Subcontractor engaged by it to be bound by written obligations of confidentiality and non-use consistent with this Agreement prior to performing any such activities under this Agreement (provided that the scope of such confidentiality obligations shall be consistent with customary obligations for the nature of such Subcontractor), and (b) Coya shall remain directly responsible and obligated for such activities and shall be directly responsible for the performance of its Subcontractors.
2.3.3.IP Assignment Obligation. Each Party shall cause all Persons who perform activities for such Party or its Affiliates under this Agreement or who conceive, reduce to practice, discover, develop or otherwise make any inventions on behalf of such Party or its Affiliates under this Agreement to assign their rights in any inventions resulting therefrom to such Party, other than any invention that constitutes an improvement to any background technology of such Person. In the event that a Person is prohibited by applicable Law from assigning such rights in inventions to such Party, then such Party shall require that such Person grants to such Party an exclusive, irrevocable, perpetual, sublicensable and royalty-free license in and to such inventions for all uses in the Territory.
- 15 -
2.4.No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent Rights or other intellectual property rights of the other Party or any of its Affiliates, including items owned, controlled, developed or acquired by the other Party or any of its Affiliates, or provided by the other Party to the first Party at any time pursuant to this Agreement.
2.5.In-License Agreements. If ARScience Bio or any of its Affiliates intends to become a party to a license, sublicense or other agreement pursuant to which it obtains additional rights to any Know-How or Patent Rights that would be included in the ARScience Bio Technology if Controlled by ARScience Bio, then (a) ARScience Bio shall use commercially reasonable efforts to ensure that rights to such Know-How or Patent Rights are licensable or sublicensable to Coya and (b) ARScience Bio shall inform Coya and provide Coya with such license, sublicense, or other agreement, subject to redaction of terms that are competitively sensitive and do not relate to any rights or obligations that would be applicable to Coya as a licensee or sublicensee (“Proposed In-Licensed Rights”) promptly following execution of such agreement. If Coya notifies ARScience Bio in writing that it wishes to have such Proposed In- Licensed Rights be included in the ARScience Bio Technology and to be bound by any obligations that are required to be applied to Coya as a licensee or sublicensee of such Proposed In-Licensed Rights, then (i) the Proposed In-Licensed Rights shall automatically be included in the ARScience Bio Technology hereunder, (ii) Coya agrees to abide by all applicable terms and conditions of such license, sublicense or other agreement, as it relates to Coya as a licensee or sublicensee thereunder, (iii) Coya will be responsible for any payments under such license, sublicense or other agreement that become payable as a result of Coya’s activities under this Agreement, and (iv) such license, sublicense or other agreement shall be an “In-License Agreement” hereunder. Otherwise, notwithstanding anything to the contrary in this Agreement, the Proposed In-Licensed Rights will not be included within the ARScience Bio Know-How or ARScience Bio Patents and such license, sublicense or other agreement shall not be an “In- License Agreement” hereunder.
2.6.Rights in Bankruptcy.
2.6.1.Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by a Party to the other, including those set forth in Section 2.2 (Licenses to Coya) (collectively, the “Intellectual Property”) are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code and any foreign counterpart thereto. The Parties acknowledge and agree that only the payments made under Section 5.3 (Royalties) shall constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction.
2.6.2.Rights of non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the non-debtor Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Intellectual Property and all embodiments of such Intellectual Property, which, if not already in the non-debtor Party’s possession, shall be delivered to the non-debtor Party within five Business Days of such request; provided that the debtor Party is excused from its obligation to deliver the Intellectual Property to the extent the debtor Party continues to perform all of its obligations under this Agreement and the Agreement has not been rejected pursuant to the Bankruptcy Code or any analogous provision in any other country or jurisdiction.
- 16 -
2.7.Right of First Refusal.
2.7.1.Third Party Interest. If, during the Term, ARScience Bio is interested in granting, or entering into negotiations to grant, a Third Party rights under any Patent Rights or Know-How Controlled by ARScience Bio to Exploit a Mono Product in an Indication outside of the Mono Product Field, then, prior to engaging in any negotiations with any Third Party regarding the grant of such rights, ARScience Bio will provide prompt written notice to Coya, which notice will specify the Indication for which ARScience Bio is interested in granting such Third Party rights (such Indication, the “Third Party Additional Mono Product Indication”). Thereafter, Coya will have an exclusive right exercisable no later than 60 days after receipt of such written notice to notify ARScience Bio in writing of its desire to conduct Pre-Clinical Proof of Concept Activities for the Mono Product in the Third Party Additional Mono Product Indication (a “ROFR Exercise Notice”). If Coya provides such ROFR Exercise Notice to ARScience Bio within such 60-day period, then Coya will have the exclusive right for 90 days (as may be extended by mutual agreement of the Parties) from the date of ARScience Bio’s receipt of the ROFR Exercise Notice to conduct Pre-Clinical Proof of Concept Activities for the Mono Product in the Third Party Additional Mono Product Indication and, during such period, ARScience Bio will not engage in discussions with any Third Party regarding the grant of such rights. If either (a) Coya does not provide a ROFR Exercise Notice to ARScience Bio within such 90-day period, or (b) Coya does not achieve Pre-Clinical Proof of Concept Demonstration for the Mono Product in the Third Party Additional Mono Product Indication during such 90-day period, then, in each case ((a) and (b)), subject to the terms of this Agreement, ARScience Bio will be free to enter into negotiations or an agreement with any Third Party relating to any license, grant, or other transfer of rights with respect to the Mono Product in the Third Party Additional Mono Product Indication in the one-year period following the expiration of the applicable 90-day periods described in the foregoing clauses (a) or (b). For clarity, in the event ARScience Bio does not enter into an agreement with a Third Party relating to the Mono Product in the relevant Third Party Additional Mono Product Indication during the one-year period following either of the 90-day periods described in clauses (a) or (b) of the foregoing sentence, ARScience Bio may not grant to any Third Party any license, grant or other transfer of rights with respect to the Mono Product in the Third Party Additional Mono Product Indication without again complying with this Section 2.7.1 (Third Party Interest).
2.7.2.Coya Interest. If, during the Term, Coya is interested in Exploiting a Mono Product in an Indication outside of the Mono Product Field, then Coya will provide written notice to ARScience Bio, which notice will specify the Indication for which Coya is interested in receiving rights (such Indication, the “Coya Additional Mono Product Indication”). Within ten business days of receipt of such notice, ARScience Bio will provide written notice to Coya confirming whether or not rights to such Coya Additional Mono Product Indication have been granted to a Third Party pursuant to Section 2.7.1 (Third Party Interest). If rights to such Coya Additional Mono Product Indication have not been granted to a Third Party pursuant to Section 2.7.1 (Third Party Interest), Coya will have the exclusive right for 90 days (as may be extended by mutual agreement of the Parties) from the date of ARScience Bio’s notice confirming rights to such Coya Additional Mono Product Indication have not been granted to a Third Party to conduct Pre-Clinical Proof of Concept Activities for the Mono Product in the Coya Additional Mono Product Indication.
2.7.3.Mono Product Field Expansion. If Coya achieves Pre-Clinical Proof of Concept Demonstration for a Mono Product in a Third Party Additional Mono Product Indication in accordance with Section 2.7.1 (Third Party Interest) or in a Coya Additional Mono Product Indication in accordance with Section 2.7.2 (Coya Interest), in each case, during the applicable 90 day period (as such period may be extended by mutual agreement of the Parties), then Coya will provide ARScience Bio with prompt written notice of such demonstration including the documentation showing the Pre-Clinical Proof of
- 17 -
Concept Demonstration, and the Third Party Additional Mono Product Indication or the Coya Additional Mono Product Indication, as applicable, will be added to the definition of “Mono Product Field” from the date of such notice.
ARTICLE 3
DEVELOPMENT, COMMERCIALIZATION AND MANUFACTURING
3.1.1.Development Responsibility. Coya, directly or through any Affiliates or Sublicensees, shall have sole responsibility for the conduct of Development activities under this Agreement and shall bear all costs and expenses incurred in connection with such Development activities. Notwithstanding the foregoing, Coya shall use Commercially Reasonable Efforts, either directly or through any Affiliates or Sublicensees, to Develop and obtain Regulatory Approval for at least one Product, in the United States, the Major EU Markets or Japan.
3.1.2.Development Plans. Within 90 days after the Effective Date, Coya will provide to ARScience Bio a high level development plan for Products, describing at a high level the Development activities for Products to be carried out by Coya or its Affiliates or Sublicensees, including the specific objectives and an anticipated timeline for such activities (as may be updated from time to time in accordance with this Agreement, the “Development Plan”). At any time during the Term and, in any event, not less frequently than annually, Coya may provide to ARScience Bio an updated Development Plan.
3.1.3.Development Reports. Until the First Commercial Sale of a Product, Coya will provide to ARScience Bio, within 60 days after the end of each Calendar Year, a written report summarizing Coya’s and its Affiliates’ and Sublicensees’ activities to Develop the Licensed Compound and Products, including (a) a high-level summary of the data and results of such Development efforts and (b) identification of (i) the Regulatory Approval Applications that Coya or its Affiliates or Sublicensees have filed, sought or obtained in the prior 12-month period and (ii) any such filings they reasonably expect to make, seek or attempt to obtain in the following 12-month period. Within 30 days after receipt of each report under this Section 3.1.3 (Development Reports), ARScience Bio may request a meeting (including by teleconference or videoconference) with representatives of Coya to discuss the report and the status of Development of Products, the location and date of such meeting to be mutually agreed upon by the Parties.
3.1.4.Compliance. All Development activities to be conducted by Coya under this Agreement shall be conducted in compliance with applicable Laws, including all applicable cGMP requirements, good laboratory practice requirements and good clinical practice requirements.
3.2.1.Commercialization Responsibility. Coya, directly or through any Affiliates or Sublicensees, shall have sole responsibility for the conduct of Commercialization activities under this Agreement and shall bear all costs and expenses incurred in connection with such Commercialization activities. Notwithstanding the foregoing, Coya, either directly or through any Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Commercialize at least one Product, in the United States, the Major EU Markets or Japan following Regulatory Approval of such Product in each such country.
3.2.2.Commercial Report. Within 30 days after the First Commercial Sale of a Product by Coya or any of its Affiliates or Sublicensees, and on a Calendar Year basis thereafter within 30 days prior to the commencement of each such Calendar Year in which Coya is conducting any Commercialization activities for any Products, Coya shall provide to ARScience Bio a written report summarizing Coya’s and its Affiliates’ and Sublicensees’ efforts to Commercialize the Products over the prior Calendar Year.
- 18 -
3.3.Supply.
3.3.1.Supply Agreement. As soon as possible and practicable following the Effective Date, but no later than 90 days following the Effective Date, the Parties will execute a clinical supply agreement containing supply terms and conditions consistent with the terms set forth on Exhibit A hereto (Supply Agreement Key Terms) and such other terms as are customary for such agreements, and will include a fully negotiated commercial supply agreement that will be attached to the clinical supply agreement which the Parties will execute at a mutually agreed time prior to anticipated commercial launch of a Product (the “Supply Agreement”), pursuant to which ARScience Bio will Manufacture and supply to Coya and its Sublicensees the Licensed Compound and Products for the Territory for pre-clinical, clinical and commercial purposes.
3.3.2.Quality Agreement. Within 120 days following the Effective Date, the Parties shall enter into a separate quality agreement that describes the responsibilities of each Party in the area of technical cooperation and quality assurance with respect to the supply of the Licensed Compound and Products for the Territory and containing terms and conditions customary for such agreements (the “Quality Agreement”).
3.3.3.Technology Transfer and Cooperation. During the Term, Coya may request ARScience Bio establish a Third Party manufacturer as a second source for the fill and finish manufacturing steps. ARScience Bio shall establish the Third Party manufacturer at Coya’s expense.
3.4.Technology Transfer.
3.4.1.Technology Transfer Plan. The Parties have established a mutually agreed-upon Technology Transfer Plan to enable Coya’s use of ARScience Bio Technology for the Products, included in ARScience Bio Technology (the “Technology Transfer Plan”), attached hereto as Exhibit B. The Parties will use commercially reasonable efforts to carry out the Technology Transfer Plan on the timeline set forth therein.
3.4.2.Regulatory Filings. Within 30 days following the Effective Date, ARScience Bio will assign to Coya all Regulatory Filings filed by ARScience Bio or any of its Affiliates or licensees with any Regulatory Authority that relate to the Licensed Compound and all associated supporting documents and data, including the Regulatory Filings described in Schedule 3.4.2 (Regulatory Filings).
3.5.Records and Audits. Coya shall, and shall require its Affiliates, Subcontractors and Sublicensees to, maintain complete, current and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development and Commercialization activities under this Agreement, and all results, data, developments and Know-How made in conducting such activities. Such records shall accurately reflect all such work done and results achieved in sufficient detail to verify compliance with its obligations under this Agreement and shall be in good scientific manner appropriate for applicable patent and regulatory purposes. ARScience Bio shall have the right, during normal business hours and upon reasonable notice but not more frequently than once per Calendar Year, to inspect and copy those records of Coya, and Coya will use reasonable efforts to require its Affiliates, Subcontractors and Sublicensees to permit the same, maintained pursuant to this Section 3.5 (Records and Audits); provided that ARScience Bio shall maintain any Confidential Information of Coya and as applicable, its Affiliates, Subcontractors and Sublicensees in such records in confidence in accordance with Article 7 (Confidentiality).
- 19 -
ARTICLE 4
REGULATORY
4.1.Regulatory Activities. As of the Effective Date, Coya, directly or through any Affiliates or Sublicensees, shall have the sole right to prepare, obtain and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, Pricing Approvals and other submissions and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for the Products. ARScience Bio shall cooperate with Coya as may be reasonably necessary in preparing and filing INDs and obtaining Regulatory Approvals and Pricing Approvals for the Products and in the activities in support thereof.
4.2.Safety and Adverse Event Reporting. At least 90 days prior to submission of the initial IND for the first Product, the Parties will meet to discuss and determine the desirability of entering into a separate, related safety data exchange agreement (the “Safety Data Exchange Agreement”) providing details related to managing adverse events that occur during Clinical Studies, safety issues arising from pre-clinical research and other safety and reporting practices and procedures in compliance with all applicable Laws. If the Parties determine that a separate, written Safety Data Exchange Agreement is desirable, then the Parties will negotiate the terms of such agreement in good faith. Any breach of the Safety Data Exchange Agreement by either Party shall not, in and of itself, be deemed to be a breach of this Agreement.
ARTICLE 5
5.1.Option Fee; Upfront Fee.
5.1.1.Option Fee. No later than ten days following the Execution Date, Coya shall pay ARScience Bio a one-time, non-refundable, non-creditable option fee of [***].
5.1.2.Upfront Fee. No later than ten days following the Effective Date, Coya shall pay ARScience Bio a one-time, non-refundable, non-creditable upfront payment of
[***].
5.2.Development Milestone Payments. In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product,
- 20 -
as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c)below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya.
By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.
- 21 -
Development Milestone |
Development Milestone Payments For: |
|||
Combination Product in a New Indication |
(b) any Combination Product in each subsequent New Indication |
(c) first Mono Product in a New Indication |
(d) any Mono Product in each subsequent New Indication |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
The Development Milestone Events are intended to be successive. If a Development Milestone Event is not achieved prior to the achievement of the next successive Development Milestone Event (such unachieved Development Milestone Event, the “Skipped Milestone Event,” and such next successive Development Milestone Event, the “Achieved Milestone Event”), then such Skipped Milestone Event shall be deemed to have been achieved upon the achievement of the Achieved Milestone Event. The Development Milestone Payment corresponding to a Skipped Milestone Event shall be due at the same time as the Development Milestone Payment corresponding to the Achieved Milestone Event.
5.3.Royalties. In further consideration of the licenses and other rights granted to Coya, subject to Section 5.5 (Royalty Adjustments) and Section 5.6 (Sublicensing Income), on a country-by-country basis, Coya shall pay to ARScience Bio royalties in the amount of the marginal royalty rates set forth in the table below (“Royalty Rates”) based on the aggregate Net Sales resulting from the sale of all Products in the Territory during each Calendar Year of the applicable Royalty Term for each Product in each country (the “Annual Net Sales,” and such payments, “Royalties”).
Annual Net Sales of all Products |
Marginal Royalty Rate (% of Annual Net Sales) |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] or less than [***] |
[***] |
- 22 -
Annual Net Sales of all Products |
Marginal Royalty Rate (% of Annual Net Sales) |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] and less than [***] |
[***] |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] and less than [***] |
[***] |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] and less than [***] |
[***] |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] and less than [***] |
[***] |
For that portion of Annual Net Sales with respect to all Products greater than or equal to [***] |
[***] |
5.4.Royalty Term. On a country-by-country and Product-by-Product basis, Coya’s obligation to pay Royalties for a Product in a country in the Territory shall commence upon the First Commercial Sale of such Product in such country and shall expire upon the later of: (a) the expiration of the last-to-expire Valid Claim in an ARScience Bio Patent that Covers such Product in such country; (b) the expiration of all regulatory exclusivity including data exclusivity periods, if any, for such Product in such country; and (c) the tenth anniversary of the First Commercial Sale of such Product in such country (the applicable “Royalty Term”). Upon expiration of the Royalty Term for a given Product in a given country (i) no further Royalties will be payable in respect of sales of such Product in such country, and (ii) the licenses granted to Coya under Section 2.2.1 (Exploitation License) with respect to the Exploitation of such Product in such country will automatically become fully paid-up, perpetual, irrevocable, and royalty free. For clarity, only a single Royalty will be payable as a result of one or more Valid Claims in an ARScience Bio Patent that Covers such Product in such country during the applicable Royalty Term.
5.5.1.Valid Claim Expiration. On a Product-by-Product and country-by- country basis, from and after the date on which a Product is sold in a particular country and is not Covered by a Valid Claim of an ARScience Bio Patent Covering of such Product in such country, the Royalty Rates for such Product with respect to such country shall be reduced by [***] for the remainder of the Royalty Term for such Product in such country, subject to Section
5.5.4 (Mechanics of Adjustment to Royalties).
5.5.2.Biosimilar Competition. If, in a particular country, a Third Party obtains approval for and sells a Biosimilar Product with respect to a particular Product and achieves Biosimilar Competition in such country with respect to such Product, then the Net Sales for such Product in such country will be reduced by [***] for the remainder of the Royalty Term for such Product in such country, subject to Section 5.5.4 (Mechanics of Adjustment to Royalties).
- 23 -
5.5.3.Third Party Payments. If Coya makes a payment under any agreement with a Third Party, other than payments made by Coya to a Third Party licensor of intellectual property rights related to CTLA-4 pursuant to an agreement between Coya and such Third Party, pursuant to which Coya obtains a license or other rights to any Patent Rights owned or controlled by such Third Party (whether by acquisition or license) that has a Valid Claim Covering a Product, then Coya shall be entitled to deduct from the Royalties due under Section 5.3 (Royalties) for such Product in a Calendar Quarter an amount equal to [***] of the amounts paid by Coya or any of its Affiliates to such Third Party under such agreement (including upfront payments, milestone payments, and royalties) (“Third Party Payments”) to the extent applicable to such Product during such Calendar Quarter and subject to Section 5.5.4 (Mechanics of Adjustment to Royalties).
5.5.4.Mechanics of Adjustments to Royalties. In no event will the Royalties payable to ARScience Bio in a given Calendar Quarter be reduced by more than [***] of the aggregate amount that would otherwise be payable to ARScience Bio in respect to such Royalties in such Calendar Quarter as a result of the aggregate reductions permitted pursuant to Section 5.5.1 (Valid Claims Expiration), Section 5.5.2 (Biosimilar Competition), and Section 5.5.3 (Third Party Payments). Coya may carry forward any such reductions permitted under Section 5.5.1 (Valid Claims Expiration), Section 5.5.2 (Biosimilar Competition), and Section 5.5.3 (Third Party Payments), that are incurred or accrued in a Calendar Quarter but are not applied against Royalties due to ARScience Bio in such Calendar Quarter as a result of the foregoing floors and apply such amounts against Royalties due to ARScience Bio in the subsequent Calendar Quarter (subject in all cases to the minimum floor set forth in this Section
5.5.4(Mechanics of Adjustment to Royalties)) until the amount of such reduction has been fully applied against Royalties due to ARScience Bio.
5.6.Sublicensing Income. On a Product-by-Product basis, if Coya enters into a Sublicense for a Mono Product, then Coya will pay to ARScience Bio [***] of the Sublicensing Income for such Product under such Sublicense. On a Product-by-Product basis if Coya enters into a Sublicense for a Combination Product, then Coya will pay to ARScience Bio [***] of the Sublicensing Income for such Product under such Sublicense.
5.7.Reports; Payment. During the Term, Coya shall furnish to ARScience Bio a written report within 45 days after the end of each Calendar Quarter that contains the following information for the applicable Calendar Quarter, on a Product-by-Product basis: (a) Net Sales (including reasonable detail for deductions from gross sales to Net Sales) in both the local currency in which such amounts are invoiced and Dollars, (b) the royalties payable under this Article 5 (Payments) specifying in reasonable detail each adjustment, if any, to the royalty rate(s) as provided in Section 5.5 (Royalty Adjustments), and (c) any Sublicensing Income. Royalties with respect to Net Sales of Products and payments with respect to Sublicensing Income shall be due and payable on the date such report is due.
5.8.Financial Records. Coya shall, and shall cause its Affiliates to, keep full, clear, and accurate records pertaining to Net Sales and Sublicensing Income for a minimum period of three years after the relevant payment is owed pursuant to this Agreement, in sufficient detail to enable royalties and compensation payable to ARScience Bio hereunder to be calculated and verified.
5.9.Audit; Audit Dispute.
5.9.1.Audit. Upon reasonable prior notice by ARScience Bio, Coya shall, and shall cause its Affiliates and will use reasonable efforts to require its Sublicensees to, permit an independent public accounting firm of nationally recognized standing designated by ARScience Bio and reasonably acceptable
- 24 -
to Coya, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Section 5.8 (Financial Records) to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (a) be conducted for any Calendar Quarter more than three years after the end of such quarter, (b) be conducted more than once in any Calendar Year, or (c) be repeated for any Calendar Quarter. The accounting firm shall disclose its report and basis for any determination to both Parties. Except as provided below, the cost of such audit shall be borne by ARScience Bio, unless the audit reveals a variance of more than five percent from the reported amounts, in which case Coya shall bear the cost of the audit. Unless disputed pursuant to Section 5.9.2 (Audit Dispute), if such audit concludes that (i) additional amounts were owed by Coya, then Coya shall pay the additional amounts, with interest from the date originally due as provided in Section 5.12 (Overdue Payments), or (ii) excess payments were made by Coya, then ARScience Bio shall reimburse such excess payments, in either case ((i) or (ii)), within 30 days after the date on which such audit is completed.
5.9.2.Audit Dispute. In the event of a dispute with respect to any audit under Section 5.9.1 (Audit), ARScience Bio and Coya shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within 30 days, then the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party’s certified public accountants or to such other Person as the Parties shall mutually agree (the “Audit Arbitrator”). The decision of the Audit Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Audit Arbitrator shall determine. Not later than 30 days after such decision and in accordance with such decision, Coya shall pay the additional amounts, with interest from the date originally due as provided in Section 5.12 (Overdue Payments), or ARScience Bio shall reimburse the excess payments, as applicable.
5.10.Accounting. All payments hereunder shall be made in Dollars. Royalties shall be calculated based on Net Sales in Dollars, with the conversion of Net Sales in each country to Dollars according to the Coya Standard Exchange Rate Methodology.
5.11.Taxes. In the event any Taxes are required to be withheld under the applicable Law of any jurisdiction on any of the payments made by Coya to ARScience Bio pursuant to this Agreement, (a) Coya shall reduce the payment to ARScience Bio by the amount of such withholding Taxes and pay such withholding Taxes to the appropriate Governmental Authority, (b) Coya shall provide ARScience Bio with reasonable proof of payment of such withholding Taxes, and (c) any such withholding Taxes shall be treated as having been paid by Coya to ARScience Bio for all purposes of this Agreement. The Parties shall provide Tax forms (including an IRS Form W-9 or appropriate IRS Form W-8) reasonably requested by the other Party in connection with payments made under this Agreement and cooperate reasonably in completing and filing documents required under the provisions of any Laws in connection with the making of any required withholding Tax payment, or in connection with any claim to a refund of or credit for any such payment.
5.12.Overdue Payments. If a Party does not receive payment of any undisputed sum due to it on or before the due date set forth under this Agreement, then simple interest will thereafter accrue on the sum due to such Party from the due date until the date of payment at a per-annum rate of one percentage point (one hundred basis points) over the then-current prime rate reported in The Wall Street Journal or the maximum rate allowable under applicable Law, whichever is lower.
- 25 -
INTELLECTUAL PROPERTY RIGHTS
6.1.Ownership of Intellectual Property; Disclosure.
6.1.1.Ownership.
(a)Background IP and Improvements to Background IP.
(i)ARScience Bio shall be the sole owner of the ARScience Bio Technology and all improvements, modifications or enhancements to the ARScience Bio Technology made solely by ARScience Bio arising during the Term.
(ii)Coya shall be the sole owner of the Coya Background IP and all improvements, modifications or enhancements to such Coya Background IP solely made by Coya arising during the Term.
(b)Agreement IP. For purposes of determining ownership under this Section 6.1 (Ownership of Intellectual Property; Disclosure), inventorship will be determined in accordance with United States patent laws (regardless of where the applicable activities occurred).
(i)As between the Parties, ARScience Bio will be the sole owner of any Agreement Know-How discovered, developed, invented, or created solely by ARScience Bio or its Affiliates or Third Parties acting on its or their behalf (“ARScience Bio Agreement Know-How”) and any Agreement Patents that cover such ARScience Bio Agreement Know-How (“ARScience Bio Agreement Patents” and together with the ARScience Bio Agreement Know-How, the “ARScience Bio Agreement Technology”), and will retain all of its rights thereto, subject to any assignment, rights or licenses expressly granted by ARScience Bio to Coya under this Agreement.
(ii)As between the Parties, Coya will be the sole owner of any Agreement Know-How discovered, developed, invented or created solely by Coya or its Affiliates or Third Parties acting on its or their behalf (“Coya Agreement Know-How”) and any Patent Rights that Cover Coya Agreement Know-How (“Coya Agreement Patents” and together with the Coya Agreement Know-How, the “Coya Agreement Technology”), and will retain all of its rights thereto.
(iii)Any Agreement Know-How discovered, developed, invented or created jointly by (a) Coya, its Affiliates or Third Parties acting on its or their behalf and (b) ARScience Bio, its Affiliates or Third Parties acting on its or their behalf (such Agreement Know-How, “Joint Agreement Know-How”), and any Agreement Patents that claim or cover such Joint Agreement Know-How (“Joint Agreement Patents,” and together with the Joint Agreement Know-How, the “Joint Agreement Technology”), will be owned jointly by Coya and ARScience Bio on an equal and undivided basis, including all rights thereto, subject to any rights or licenses expressly granted by one Party to the other Party under this Agreement. Except as expressly provided in this Agreement, neither Party will have any obligation to account to the other for profits with respect to, or to obtain any consent of the other Party to license or exploit, Joint Agreement Technology by reason of joint ownership thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such consent or accounting. The parties shall promptly disclose to each other any inventions they wish to prosecute that constitute Agreement Patents.
- 26 -
6.2.Patent Prosecution and Maintenance.
6.2.1.ARScience Bio Patents and ARScience Bio Agreement Patents. ARScience Bio, acting through patent counsel or agents of its choice, shall have the first right (but not the obligation) with respect to the (a) ARScience Bio Patents and (b) ARScience Bio Agreement Patents, in each case, (a) and (b), to prepare, file, prosecute and maintain any such patents and at its cost and expense and in its sole discretion. With respect to the prosecution of any ARScience Bio Patents and the ARScience Bio Agreement Patents, ARScience Bio shall provide Coya with any proposed filings reasonably in advance of such filings to give Coya the opportunity to provide comments on and make requests of ARScience Bio concerning such filings and the prosecution of such patents and will consider such comments and requests in good faith and incorporate all reasonable comments provided by Coya. If ARScience Bio decides to abandon an ARScience Bio Patent or ARScience Bio Agreement Patents, ARScience Bio will provide Coya with notice at least 60 days prior to the date such abandonment would become effective. Following such notice, Coya may elect, upon written notice to ARScience Bio, to control such prosecution and maintenance of such ARScience Bio Patent at Coya’s own expense in Coya’s name and ARScience Bio will execute an appropriate assignment of such patent or patent application. If Coya elects to take over prosecution, Coya agrees to keep ARScience Bio reasonably informed with respect to such prosecution and maintenance and consult in good faith with ARScience Bio regarding such matters.
6.2.2.Coya Background IP Patents, Coya Agreement Patents and Joint Agreement Patents. Coya, acting through patent counsel or agents of its choice, shall have the (a) sole right (but not the obligation) with respect to all Patent Rights within the Coya Background IP and Coya Agreement Patents and (b) first right (but not the obligation) with respect to the Joint Agreement Patents, in each case, (a) and (b), to prepare, file, prosecute and maintain any such patents and at its cost and expense and in its sole discretion. If Coya decides to abandon a Joint Agreement Patent, Coya will provide ARScience Bio with notice at least 60 days prior to the date such abandonment would become effective. Following such notice, ARScience Bio may elect, upon written notice to Coya, to control such prosecution and maintenance of such Joint Agreement Patent at its own expense in ARScience Bio’s name. ARScience Bio agrees to keep Coya reasonably informed with respect to such prosecution and maintenance and consult in good faith with Coya regarding such matters.
6.2.3.Cooperation. Each Party agrees to cooperate reasonably with the other Party in the preparation, filing, prosecution and maintenance of any Patent Rights pursuant to this Section 6.2 (Patent Prosecution and Maintenance). Such cooperation includes executing all papers and instruments or requiring employees or others to execute such papers or instruments, so as to effectuate the ownership of such Patent Rights set forth in this Agreement and to enable the filing, prosecution, maintenance and extension thereof in any country or region. In addition, each Party shall reasonably cooperate with the other Party in obtaining patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to the ARScience Bio Patents and Agreement Patents.
6.3.Enforcement of Patent Rights.
6.3.1.Notice. If either Party becomes aware of any possible infringement of any ARScience Bio Patents or Agreement Patents by a Third Party exploiting a product that is competitive with a Product in the Field (an “Infringement”), such Party shall promptly notify the other Party and provide it with all details of such Infringement of which it is aware.
6.3.2.Enforcement of ARScience Bio Patents and Agreement Patents. Coya shall have the (a) first right (but not the obligation) with respect to any ARScience Bio Patent, Joint Agreement Patent or ARScience Bio Agreement Patent and (b) sole right (but not the obligation) with respect to any Coya Agreement Patent and any Patent Rights within the Coya Background IP, in each case (a) and (b), to take action to eliminate an Infringement at its discretion, which may include the institution of legal proceedings
- 27 -
or other action at its cost. If Coya fails to initiate an action within 90 days after notice of such Infringement is provided by a Party under Section 6.3.1 (Notice), ARScience Bio will have the right to initiate and control any action to eliminate such Infringement with respect to any ARScience Bio Patent, ARScience Bio Agreement Patent or Joint Agreement Patent by counsel of its own choice and at its own expense. Coya will have the right, at its own expense, to be represented in any such action by counsel of its own choice. For the avoidance of doubt, Coya has the sole right to take action to eliminate an Infringement with respect to any Patent Rights within the Coya Background IP.
6.3.3.Cooperation. In any action, suit or proceeding instituted under this Section 6.3 (Enforcement of Patent Rights), the Parties shall cooperate with and assist each other in all reasonable respects. Upon the request of the Party initiating such action, suit or proceeding, if necessary to maintain standing in such action, suit or proceeding, the other Party shall join such action, suit or proceeding and shall be represented by counsel of its own choice, at the requesting Party’s expense.
6.3.4.Recovery. Unless otherwise mutually agreed by the Parties, any damages, amounts received in settlement, judgment or other monetary awards recovered by either Party pursuant to this Section 6.3 (Enforcement of Patent Rights), whether by settlement or judgment (“Recovery”), shall be allocated in the following order:
(a)First, the Recovery shall be distributed to the controlling Party for its costs and expenses incurred in connection with the applicable action, suit or proceeding and then to the other Party for its costs and expenses incurred in connection with such action, suit or proceeding;
(i)to the extent the remaining Recovery recovered represent a Third Party’s infringing sales with respect to Products in the Field, (A) ARScience Bio shall receive an amount out of such remaining Recovery equal to the royalties that would have been due upon sales of the infringing product as if such infringing sales had been incremental Net Sales of a Product sold by Coya (the “Deemed Royalty Portion”), and (B) Coya shall receive the amount of such remaining Recovery representing such Third Party’s infringing sales with respect to Products, minus the Deemed Royalty Portion; or
(ii)to the extent the remaining Recovery recovered represent Coya’s lost profits with respect to Products, the amount of such Recovery shall be grossed up to an amount equivalent to what would have been Net Sales (taking into account Coya’s costs of manufacture and sale relative to such Third Party’s costs of manufacture and sale) and ARScience Bio shall receive the Deemed Royalty Portion of such calculated Net Sales and Coya shall receive the amount of such remaining Recovery representing Coya’s lost profits with respect to Products, minus the Deemed Royalty Portion; or
(iii)to the extent the remaining Recovery recovered represent royalties from sales of a product that infringes any ARScience Bio Patents and any other Patent Rights owned by or licensed to Coya or one of its Affiliates or Sublicensees, and the applicable decision-making authority in the action, suit or proceeding has not allocated the Recovery between ARScience Bio and the owner of such other Patent Rights, then the Parties shall agree, in good faith, to an allocation of such Recovery based on the relevant contributions of the ARScience Bio Patents and such other Patent Rights to the applicable product; provided that if the Parties are unable to agree in good faith as to the allocation of such Recovery on such basis, then the Parties shall submit such matter for determination to a mutually agreed upon independent patent counsel who (and whose firm) is not at the time of the dispute, and was not at any time during the five years prior to such dispute, performing services for either Party or their respective Affiliates (or, in the case of Coya, its Sublicensees); provided that the determination of such independent patent
- 28 -
counsel shall be final and binding upon the Parties; and
(c)Third,
(i)if Coya is the controlling Party, then Coya shall retain all Recovery remaining after the distributions described in Sections 6.3.4(a) (First) and 6.3.4(b) (Second) above, including those for any multiple damages, punitive damages or other non- compensatory damages, which are applicable to the Products; or
(ii)if ARScience Bio is the controlling Party, then ARScience Bio shall retain all Recovery remaining after the distributions described in Sections 6.3.4(a) (First) and 6.3.4(b) (Second) above, including those for any multiple damages, punitive damages or other non-compensatory damages.
6.4.Defense of Claims. If any action, suit or proceeding is brought or threatened against either Party or an Affiliate or Sublicensee alleging infringement of the intellectual property of a Third Party by reason of use by Coya or an Affiliate or Sublicensee of the ARScience Bio Technology in the Exploitation of any Product, the Party first receiving notice of such actual or threatened action, suit or proceeding shall notify the other Party promptly, and the Parties shall as soon as practicable thereafter confer in good faith regarding the appropriate response.
6.5.Product Trademarks. All Products shall be sold under one or more Trademarks selected and owned by Coya or its Affiliates or Sublicensees in the Territory. As between the Parties, Coya shall control the preparation, prosecution and maintenance of applications related to all such Trademarks in the Territory, at its sole cost and expense and at its sole discretion. ARScience Bio shall notify Coya promptly upon learning of any actual, alleged or threatened infringement of a Trademark applicable to a Product in the Territory, or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses in the Territory. As between the Parties, all of the costs, expenses and legal fees in bringing, maintaining and prosecuting any action to maintain, protect or defend any Trademark owned by Coya or its Affiliate or Sublicensee hereunder, and any damages or other recovery, shall be Coya’s sole responsibility, and taken in its sole discretion.
ARTICLE 7
7.1.Confidentiality Obligations. At all times during the Term and for a period of ten years following termination or expiration hereof in its entirety, each Party shall, and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is necessary or reasonably useful for the performance of, or the exercise of such Party’s rights under, this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 7.1 (Confidentiality Obligations) with respect to any Confidential Information shall not include any information that:
7.1.1.has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party;
- 29 -
7.1.2.has been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
7.1.3.is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party;
7.1.4.that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or
7.1.5.has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party’s Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination is in the public domain or in the possession of the receiving Party.
7.2.Permitted Disclosures.
7.2.1.Each Party may disclose the Confidential Information of the other Party to the extent that such disclosure is:
(a)in the reasonable opinion of the receiving Party’s legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Section 7.4 (Public Announcements)); provided that the receiving Party shall, to the extent permissible under the law, first have given prompt written notice (and to the extent possible, at least five Business Days’ notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for example, quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information that the receiving Party is advised by counsel is legally required to be disclosed and shall to the extent possible require that the information be kept confidential by the recipient;
(b)made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with applicable Law; or
(c)made by or on behalf of the receiving Party to a patent authority as may be necessary or reasonably useful for purposes of preparing, obtaining, defending or enforcing a Patent Right in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information, to the extent such protection is available.
- 30 -
7.2.2.Each Party and its Affiliates (and, in the case of Coya, its Sublicensees) may disclose Confidential Information of the other Party to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, sublicensees, or other Third Parties in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information that are no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 7 (Confidentiality) (provided that the term of such confidentiality obligations shall be consistent with customary terms for the nature of such Third Party).
7.2.3.Each Party may disclose the existence and terms of this Agreement to the extent that such disclosure is:
(a)made by the receiving Party or its Affiliates to their respective financial and external legal advisors who have a need to know the existence and terms of this Agreement and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, no less restrictive than those set forth in this Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and external legal advisors to treat such Confidential Information as required under this Article 7 (Confidentiality); or
(b)made by the receiving Party or its Affiliates to potential or actual investors, acquirers, (sub)licensees, lenders and other financial or commercial partners as may be necessary in connection with their evaluation of such potential or actual investment, acquisition, (sub)license, debt transaction or collaboration; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information that are no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 7 (Confidentiality).
7.3.Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 7.3 (Use of Name) shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Party’s counsel, is required by applicable Law; provided that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon.
7.4.Public Announcements. The Parties will agree upon the content of a press release, which press release may be a joint release or a release issued by either Party, as agreed to by the Parties, and shall coordinate to make such release promptly upon execution of this Agreement. ARScience Bio shall not issue any other public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without Coya’s prior written consent, except for any such disclosure by ARScience Bio that is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which the securities of ARScience Bio are listed. In the event that either Party is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which its securities are listed to make such a public disclosure, such Party shall submit the proposed disclosure (together with the reasons for the disclosure requirement and notification of the time and place where the disclosure shall be made) in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon, and such first Party shall consider the other Party’s comments thereon in good faith.
- 31 -
7.5.Publications. Coya shall have the sole right to publish, present or otherwise disclose the results of its Development of the Licensed Compound and Products; provided that at least 60 days prior to making any such publication, presentation or disclosure, Coya shall provide ARScience Bio with a copy of such publication, presentation or disclosure (and the intended date of such publication, presentation or disclosure) and Coya shall (a) review and consider in good faith any comments provided by ARScience Bio and (b) redact any Confidential Information of ARScience Bio upon ARScience Bio’s request.
7.6.Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) as soon as reasonably practicable, deliver to the requesting Party, at the other Party’s expense, all copies of such Confidential Information in the possession of the other Party; provided that the other Party shall be permitted to retain one copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by applicable Law, or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Party’s standard archiving and back-up procedures, but not for any other use or purpose.
7.7.Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 7.1 (Confidentiality Obligations).
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1.Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
8.1.1.such Party is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
8.1.2.such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
8.1.3.this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
8.1.4.the execution, delivery and performance of this Agreement by such Party will not constitute a default under or conflict with any agreement, instrument, obligation or understanding, oral or written, to which either entity is a party or by which either entity is bound, or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; and
- 32 -
8.1.5.such Party has obtained all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons or entities required to be obtained by it in connection with the execution and delivery of this Agreement.
8.2.Representations and Warranties of ARScience Bio.ARScience Bio hereby represents and warrants to Coya as of the Effective Date:
8.2.1.the ARScience Bio Technology constitutes all of the Patent Rights and Know-How owned by or licensed to ARScience Bio or its Affiliates that are necessary or useful to Exploit the Licensed Compound and Products in the Field;
8.2.2.ARScience Bio is the sole and exclusive owner of the ARScience Bio Technology, all of which is free and clear of any liens, charges and encumbrances, and, as of the Effective Date, neither any license granted by ARScience Bio or its Affiliates to any Third Party, nor any agreement between any Third Party and ARScience Bio or its Affiliates, conflicts with the licenses or other rights grants to Coya hereunder and ARScience Bio is entitled to grant all rights and licenses (or sublicenses, as the case may be) it purports to grant to Coya under this Agreement;
8.2.3.ARScience Bio has disclosed to Coya in Schedule 1.16 (ARScience Bio Patents), all ARScience Bio Patents existing as of the Effective Date;
8.2.4.the ARScience Bio Patents are subsisting and are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged the extent, validity or enforceability of such patents (including by way of example through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority);
8.2.5.to its knowledge, no Third Party is infringing or threatening to infringe any of the ARScience Bio Patents or misappropriating or threatening to misappropriate any ARScience Bio Know-How;
8.2.6.it has complied with all applicable Laws, including any disclosure requirements of the United States Patent and Trademark Office or any analogous foreign Governmental Authority, in connection with the prosecution and maintenance of the ARScience Bio Patents and has timely paid all filing and renewal fees payable with respect to any such Patent Rights for which it controls prosecution and maintenance;
8.2.7.there is no agreement between ARScience Bio or any of its Affiliates and any Third Party pursuant to which ARScience Bio or its Affiliate has acquired Control of any of the ARScience Bio Technology;
8.2.8.ARScience Bio and its Affiliates have taken commercially reasonable measures consistent with industry practices to protect the secrecy, confidentiality and value of all ARScience Bio Know-How that constitutes trade secrets under applicable Law (including requiring all employees, consultants and independent contractors to execute binding and enforceable agreements requiring all such employees, consultants and independent contractors to maintain the confidentiality of such ARScience Bio Know-How) and, to ARScience Bio’s knowledge, such ARScience Bio Know-How has not been used, disclosed to or discovered by any Third Party except pursuant to such confidentiality agreements and there has not been a breach by any party to such confidentiality agreements;
- 33 -
8.2.9.the ARScience Bio Technology has not been created pursuant to, and is not subject to, any funding agreement with any Governmental Authority or any Third Party, and is not subject to the requirements of the Bayh-Dole Act or any similar provision of any applicable Law;
8.2.10.to its knowledge, the Exploitation by ARScience Bio or Coya (or their respective Affiliates or Sublicensees) of the Licensed Compound or Product does not and will not infringe any issued Patent Rights of any Third Party;
8.2.11.the conception, development, and reduction to practice of the ARScience Bio Technology have not constituted or involved the misappropriation of any Know- How of any Third Party, and the practice of the ARScience Bio Know-How in the Exploitation by ARScience Bio or Coya (or their respective Affiliates or Sublicensees) of the Licensed Compound or Product as contemplated by this Agreement does not and will not constitute a misappropriation of any Know-How of any Third Party;
8.2.12.there are no judgments or settlements against or owed by ARScience Bio or its Affiliates or, to its knowledge, pending or threatened claims or litigation, in either case relating to the ARScience Bio Technology;
8.2.13.there is no action, claim, demand, suit, proceeding, arbitration, grievance, citation, summons, subpoena, inquiry or investigation of any nature, civil, criminal, regulatory or otherwise, in law or in equity, pending or, to the best of its knowledge, threatened against ARScience Bio, any of its Affiliates or any Third Party, in each case in connection with the ARScience Bio Technology, the Licensed Compound, the Products, or otherwise relating to the transactions contemplated by this Agreement;
8.2.14.ARScience Bio has not employed (and, to the best of its knowledge, has not used a contractor or consultant that has employed) any Person debarred by the FDA (or subject to a similar sanction of EMA or foreign equivalent), or any Person that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent), in any capacity in connection with this Agreement; and
8.2.15.the representations and warranties of ARScience Bio in this Agreement, and the information, documents and materials furnished to Coya in connection with its period of diligence prior to the Effective Date do not, taken as a whole, (a) contain any untrue statement of a material fact, or (b) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.
8.3.Additional Mutual Representations, Warranties, and Covenants.
8.3.1.Each Party hereby covenants to the other Party that in performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and its and their (sub)licensees/Sublicensees, shall comply with all applicable Law, including all anti-corruption Laws and anti-bribery Laws.
8.3.2.Each Party and its Affiliates have not ever been and are not currently the subject of a proceeding that could lead to it or its Affiliates becoming a Debarred Entity, Excluded Entity or Convicted Entity and such Party and its Affiliates shall not use in any capacity, in connection with the obligations to be performed under this Agreement, any person who is a Debarred Individual, Excluded Individual or a Convicted Individual.
- 34 -
8.4.ARScience Bio Covenants. ARScience Bio hereby covenants to Coya that:
8.4.1.neither ARScience Bio nor any of its Affiliates will effect any corporate restructuring or enter into any new agreement or otherwise obligate itself to any Third Party or Affiliate, in each case, in a manner that restricts, limits, or encumbers the rights granted to Coya under this Agreement or the obligations of ARScience Bio or its Affiliates under this Agreement;
8.5.ARScience Bio will not, and will cause its Affiliates not to, (a) license, sell, assign or otherwise transfer to any Person any ARScience Bio Technology (or agree to do any of the foregoing), (b) negotiate with, offer to, or grant any license to any Person, or (c) incur or permit to exist, with respect to any ARScience Bio Technology, any lien, encumbrance, charge, security interest, mortgage, liability, grant of license to Third Parties or other restriction (including in connection with any indebtedness), in each case ((a) through (c)), that would conflict with, limit, impair or restrict the rights and licenses granted to Coya hereunder or would cause any ARScience Bio Technology to cease to be Controlled by ARScience Bio;
8.6.ARScience Bio will maintain and not breach, and will cause its Affiliates to maintain and not breach, in each case, in a manner that could reasonably be expected to give rise to a termination right of any party thereto, any In-License Agreement;
8.7.ARScience Bio will promptly notify Coya in writing of any claim or potential claim of material breach by ARScience Bio or its Affiliate of any In-License Agreement of which it is aware, and will, to the extent such material breach was failure to pay amounts due, permit Coya to cure such breach on ARScience Bio’s or its Affiliate’s behalf by payment of such outstanding amounts upon Coya’s request; provided, however, that Coya shall not have the right to admit any fault or wrongdoing on behalf of ARScience Bio or its Affiliates, shall discuss in good faith the circumstances of such material breach with ARScience Bio and shall not cure such breach until after five Business Days prior to the expiration of any period to cure such breach prior to such In-License Agreement being terminated; and
8.8.ARScience Bio will not, and will cause its Affiliates not to, amend, modify or terminate any In-License Agreement in a manner that would adversely affect Coya’s rights hereunder without first obtaining Coya’s written consent, which consent shall not be unreasonably withheld, conditioned or delayed.
8.9.Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. COYA AND ARSCIENCE BIO UNDERSTAND THAT EACH PRODUCT IS THE SUBJECT OF ONGOING RESEARCH AND DEVELOPMENT AND THAT NEITHER PARTY CAN ASSURE THE SAFETY, USEFULNESS OR COMMERCIAL OR TECHNICAL VIABILITY OF ANY PRODUCT.
ARTICLE 9
9.1.Indemnification by Coya. Coya shall indemnify, defend and hold harmless ARScience Bio, its Affiliates, their respective directors, officers, employees, consultants and agents, and their respective successors, heirs and assigns (the “ARScience Bio Indemnitees”), from and against all liabilities, damages, losses and expenses (including reasonable attorneys’ fees and expenses of litigation)
- 35 -
(collectively, “Losses”) incurred by or imposed upon the ARScience Bio Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments, including personal injury and product liability matters (collectively, “Third Party Claims”), to the extent arising out of:
9.1.1.a breach by Coya of any of its representations, warranties or covenants set forth in this Agreement;
9.1.2.the Exploitation of any Product by Coya or any of its Affiliates, Sublicensees, Subcontractors, Distributors or agents; or
9.1.3.the negligence, recklessness or willful misconduct of Coya or any of its Affiliates, Sublicensees, Subcontractors, Distributors or agents; except in each case to the extent any such Third Party Claim or Losses result from a material breach of this Agreement by ARScience Bio, or the negligence, recklessness or willful misconduct of ARScience Bio or any of its Affiliates or subcontractors; provided that with respect to any such Third Party Claim for which ARScience Bio also has an obligation to any Coya Indemnitee pursuant to Section 9.2 (Indemnification by ARScience Bio), Coya shall indemnify each ARScience Bio Indemnitee for its Losses to the extent of Coya’s responsibility, relative to ARScience Bio (or to Persons for whom ARScience Bio is legally responsible), for the facts underlying the Third Party Claim.
9.2.Indemnification by ARScience Bio. ARScience Bio shall indemnify, defend and hold harmless Coya, its Affiliates, their respective directors, officers, employees, consultants and agents, and their respective successors, heirs and assigns (the “Coya Indemnitees”), from and against all Losses incurred by or imposed upon the Coya Indemnitees, or any of them, in connection with any Third Party Claims to the extent arising out of:
9.2.1.any claims of any nature arising out of ARScience Bio’s or its Affiliate’s or any other of ARScience Bio’s licensee’s Exploitation of the Licensed Compound or any Product prior to or after the Effective Date;
9.2.2.a breach by ARScience Bio of any of its representations, warranties or covenants set forth in this Agreement; or
9.2.3.the negligence, recklessness or willful misconduct of ARScience Bio or any of its Affiliates or subcontractors;
except in each case to the extent any such Third Party Claim or Losses result from a material breach of this Agreement by Coya, or the negligence, recklessness or willful misconduct of Coya or any of its Affiliates, Sublicensees, Subcontractors, Distributors or agents, or the Exploitation of any Product by Coya or any of its Affiliates, Sublicensees, Subcontractors, Distributors or agents; provided that with respect to any such Third Party Claim for which Coya also has an obligation to any ARScience Bio Indemnitee pursuant to Section 9.1 (Indemnification by Coya), ARScience Bio shall indemnify each Coya Indemnitee for its Losses to the extent of ARScience Bio’s responsibility, relative to Coya (or to Persons for whom Coya is legally responsible), for the facts underlying the Third Party Claim.
9.3.Conditions to Indemnification. A Person seeking indemnification under this Article 9 (the “Indemnified Party”) in respect of a Third Party Claim shall give prompt notice of such Third Party Claim to the Party from which recovery is sought (the “Indemnifying Party”) and shall permit the Indemnifying Party to assume direction and control of the defense of the Third Party Claim, provided that the Indemnifying Party shall (a) act reasonably and in good faith with respect to all matters relating
- 36 -
to the defense or settlement of such Third Party Claim as the defense or settlement relates to the Indemnified Party, and (b) not settle or otherwise resolve such Third Party Claim without the Indemnified Party’s prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed); provided that the Indemnifying Party may, without the Indemnified Party’s prior written consent, agree or consent to any settlement or other resolution of such Third Party Claim which requires solely money damages paid by the Indemnifying Party, and which includes as an unconditional term thereof the giving by such claimant or plaintiff to the Indemnified Party of a release from all liability in respect of such Third Party Claim.
9.4.Insurance Proceeds. Any indemnification payment hereunder shall be made net of any insurance proceeds which the Indemnified Party is entitled to recover; provided, however, that if, following the payment to the Indemnified Party of any amount under this Article 9 (Indemnification), such Indemnified Party becomes entitled to recover any insurance proceeds in respect of the claim for which such indemnification payment was made, the Indemnified Party shall promptly pay an amount equal to the amount of such proceeds (but not exceeding the amount of such indemnification payment) to the Indemnifying Party. For clarity, insurance will not be construed to create a limit of ARScience Bio’s or Coya’s liability with respect to its indemnification obligations under this Article 9 (Indemnification).
9.5.Insurance. Each Party will procure and maintain during the Term of this Agreement and until the later of: (a) three years after termination or expiration of this Agreement, or (b) the date that all statutes of limitation covering claims or suits that may be instituted for personal injury based on the sale or use of a Product have expired, commercial general liability insurance from a minimum of “A-” AM Bests rated insurance company or insurer reasonably acceptable to the other Party, including contractual liability and product liability or clinical trials, if applicable, with coverage limits customary for similar Person’s conducting the activities contemplated by this Agreement. Each of ARScience Bio and Coya will provide the other Party with evidence of such insurance promptly following execution by both Parties of this Agreement, upon a Party’s request, and prior to expiration of any one coverage. Each of ARScience Bio and Coya will provide the other Party with written notice at least 60 days prior to the cancellation or non-renewal of, or material changes in, such insurance.
9.6.Limitation of Liability. EXCEPT (A) FOR A BREACH OF Article 7 (CONFIDENTIALITY) OR (B) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS Article 9 (INDEMNIFICATION), NEITHER ARSCIENCE BIO NOR COYA, NOR ANY OF THEIR RESPECTIVE AFFILIATES, LICENSORS, LICENSEES OR SUBLICENSEES, SHALL BE LIABLE TO THE OTHER PARTY, ITS AFFILIATES OR SUBLICENSEES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR ROYALTIES, LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.
- 37 -
ARTICLE 10
TERM AND TERMINATION
10.1.Term. This Agreement shall commence as of the Effective Date and, unless terminated earlier pursuant to this Article 10 (Term and Termination), will continue, on a Product-by- Product and country-by-country basis, in full force and effect until (i) with respect to
Products Commercialized by Coya or its Affiliates, the expiration of the Royalty Term applicable to such Product and such country and (ii) with respect to Products Commercialized by a Sublicensee, the receipt by Coya of all payments that may become due under the applicable Sublicense, and will expire in its entirety upon the expiration of the last Royalty Term and payment under any such Sublicense, as applicable (the “Term”).
10.2.Termination.
10.2.1.Termination for Cause. Either Party may terminate this Agreement, effective upon written notice to the other Party, upon any material breach by the other Party (the “Breaching Party”) of this Agreement that remains uncured 90 days (or 30 days if the breach is a failure by Coya to make any payment required hereunder) after the non-breaching Party (the “Non-Breaching Party”) first gives written notice of such breach to the Breaching Party describing such breach in reasonable detail; provided, however, that if the nature of the asserted breach (other than a breach for non-payment) is such that more than 90 days are reasonably required to cure, then the cure period shall be extended for a period not to exceed an additional 60 days so long as the Party seeking to cure the asserted breach is diligently pursuing such cure to completion. Notwithstanding anything to the contrary contained herein, if the allegedly Breaching Party (a) disputes either (i) whether a material breach has occurred or (ii) whether the material beach has been timely cured, and (b) provides written notice of such dispute to the Non- Breaching Party within the above time periods, then the matter shall be addressed under the dispute resolution provisions of Section 11.1.2 (Dispute Resolution), and Non-Breaching Party may not terminate this Agreement until it has been determined under Section 11.1.2 (Dispute Resolution) that the allegedly Breaching Party is in material breach of this Agreement, and such Breaching Party further fails to cure such breach within 90 days (or such longer or shorter period as determined by the arbiter, if any, of such dispute resolution) after the conclusion of the dispute resolution procedure; provided, however, that the foregoing shall not apply to any breach for non-payment of any payments required hereunder.
10.2.2.Termination for Insolvency. In the event that either Party (or a parent of such Party) (a) files for protection under bankruptcy or insolvency Laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within 90 days after such filing,
(a)is a party to any dissolution or liquidation, or (e) files a petition under any bankruptcy or insolvency act or has any such petition filed against it that is not discharged within 60 days of the filing thereof, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.
10.2.3.Termination for Convenience. Coya will be entitled to terminate this Agreement in its entirety at its sole discretion at any time upon 120 days’ prior written notice to ARScience Bio thereof.
10.2.4.Termination for Cessation of Development or Commercialization. If Coya and its Affiliates and their respective Sublicensees do not conduct any material Development or Commercialization activities with respect to any Product for a continuous period of twenty-four (24)
- 38 -
months, then ARScience Bio may, in its sole discretion, terminate this Agreement upon 60 days’ prior written notice to Coya if Coya has not undertaken any such material Development or Commercialization activities within such 60-day period. Notwithstanding any provision to the contrary set forth in this Agreement, the foregoing 24- month period will automatically be tolled for any period that such inactivity is due to (a) a decision to stop or delay further Development or Commercialization, as applicable, due to a safety concern or (b) any event of Force Majeure. For clarity, material activities undertaken to resolve a clinical hold imposed by an applicable Regulatory Authority or to resolve an issue regarding supply of Products or to address any other issue outside of Coya’s, its Affiliates or its Sublicensees reasonable control will be considered material Development or Commercialization activities.
10.2.5.Automatic Termination. If Coya does not timely exercise the Option in accordance with Section 2.1.1 (Option and Option Deadline) during the Initial Option Exercise Period or any Extended Option Exercise Period, as applicable, this Agreement shall automatically terminate with no further action by the Parties. Following the Effective Date, no termination of this Agreement may occur pursuant to this Section 10.2.5 (Automatic Termination).
10.3.1.Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement in its entirety, all rights and licenses granted to Coya under this Agreement shall immediately terminate and Coya and its Affiliates shall cease any and all Exploitation of the Licensed Compound and Products; provided that, any sublicense by Coya to a Third Party under any sublicense or license granted by ARScience Bio to Coya under this Agreement shall, at the Sublicensee’s written election delivered to ARScience Bio within 30 days of Coya being provided with written notice of such termination, survive such termination on the condition that the relevant Sublicensee is not, at the time of such termination, in material breach of any of its obligations under such sublicense. In order to effect this provision, at the request of the Sublicensee, ARScience Bio shall enter into a direct license with the Sublicensee on substantially the same terms as the applicable sublicense to the extent such terms relate to the sublicensed technology, provided that the financial terms of such direct license shall provide that ARScience Bio receive the same payment amounts as it would have received from Coya at the time of termination with respect to the sublicensed technology.
10.3.2.Notwithstanding the termination of Coya’s licenses and other rights under this Agreement, Coya and its Affiliates shall have the right for six months after the effective date of such termination to sell or otherwise dispose of all Products then in its or their respective inventory; provided that any revenue obtained from such disposal shall be treated as Net Sales, and the provisions of Article 5 (Payments) shall apply to such Net Sales.
10.3.3.Effective upon termination by Coya pursuant to Section 10.2.3 (Termination for Convenience) or by ARScience Bio pursuant to 10.2.1 (Termination for Cause) and subject to any licenses granted by ARScience Bio pursuant to Section 10.3.1 (Effects of Termination), Coya hereby grants to ARScience Bio a non-exclusive, royalty-bearing, sublicensable license, under all Agreement IP Controlled by Coya or its Affiliates to Exploit the Licensed Compound and Products in the Field in the Territory in the form that such Licensed
Compound and Products were being exploited on the date of such termination; provided, that if the grant of such license to ARScience Bio with respect to any Know-How or Patent Right included in the Agreement IP or ARScience Bio’s exercise of such license would trigger a royalty or other payment to a Third Party or would require compliance with any provision of any license between Coya and a Third Party, Coya will so notify ARScience Bio in writing and such Know-How or Patent Right will only be
- 39 -
included in the foregoing license if, following receipt of such notice, ARScience Bio agrees in writing to reimburse Coya for all such payments to such Third Party and comply with any such provision; and provided, further, that such license will not grant ARScience Bio any rights with respect to any active ingredient in a Product that is not the Licensed Compound.
10.3.4.In the event the license contemplated by 10.3.3 (Effects of Termination) is granted by Coya to ARScience Bio, ARScience Bio will pay Coya a [***] royalty for the Annual Net Sales of all Products which are Covered by a Valid Claim of a Patent Right included in the Agreement IP or the Exploitation of which uses any Know-How included in the Agreement IP. The terms of Sections 1.92 (Net Sales), 5.4 (Royalty Term), 5.7 (Reports; Payment), 5.10 (Accounting), and 5.11 (Taxes) will apply with respect to ARScience Bio’s payment of such royalty, mutatis mutandis and, for clarity, clause (a) of the definition of Royalty Term for purposes of the royalty obligation described in this Section 10.3.4 (Effects of Termination) shall continue to apply to Valid Claims of Patent Rights within Agreement IP.
10.3.5.Upon early termination by Coya pursuant to Section 10.2.3 (Termination for Convenience) or by ARScience Bio pursuant to Section 10.2.1 (Termination for Cause), Coya will promptly transfer to ARScience Bio possession and ownership of all Regulatory Approvals owned by Coya solely relating to the Exploitation of the Licensed Compound or Product in the Field in the Territory.
10.4.Alternative Remedy in Lieu of Termination. ARScience Bio stipulates and agrees that Coya’s decision to enter into this Agreement and invest in the Development of the Licensed Compounds and Products is premised upon the assumption that ARScience Bio will perform its obligations under this Agreement, and that a material breach of the Agreement by ARScience Bio will undermine the economic fundamentals of the transaction for Coya, and that in such event Coya’s damages arising from ARScience Bio’s breach would be of uncertain amount and difficult to prove. Accordingly, if Coya has the right to terminate this Agreement pursuant to Section 10.2.1 (Termination for Cause) or Section 10.2.2 (Termination for Insolvency), then as the sole monetary remedy available to Coya (other than any equitable remedies), in lieu of terminating this Agreement, Coya may, in its sole discretion, exercise an alternative remedy as follows, which ARScience Bio stipulates and agrees would be a reasonable remedy in such circumstance and not a penalty:
10.4.1.Coya may retain all of its licenses and other rights granted under this Agreement, subject to all of its payment and other obligations; except that (a) the then-unearned Development Milestone Payments, Royalties and percentage of Sublicensing Income payable thereafter under this Agreement, in each case, will be reduced by [***] and (b) Coya’s diligence obligations under Section 3.1.1 (Development Responsibility) and Section 3.2.1 (Commercialization Responsibility) will terminate; and
10.4.2.any Confidential Information of Coya provided to ARScience Bio pursuant to this Agreement will be promptly returned to Coya or destroyed, and Coya will be released from its ongoing disclosure and information exchange obligations with respect to activities after the date of such election.
For the avoidance of doubt, except as set forth in this Section 10.4 (Alternative Remedy in Lieu of Termination), if Coya exercises the alternative remedy set forth above in this Section 10.4 (Alternative Remedy in Lieu of Termination), then all rights and obligations of both Parties under this Agreement will continue unaffected, unless and until this Agreement is subsequently terminated by either Party pursuant to this Article 10 (Term and Termination).
10.5.Accrued Rights; Surviving Provisions of the Agreement.
10.5.1.Accrued Rights. Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination. Except as expressly set forth
- 40 -
hereunder, any expiration or termination of this Agreement will be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including any payment obligation that accrued prior to the effective date of such expiration or termination.
10.5.2.Surviving Provisions of the Agreement. Without limiting Section 10.5.1 (Accrued Rights), the following provisions, as well as any other provisions which by their nature are intended to survive termination or expiration, will survive termination or expiration of this Agreement, in accordance with their respective terms and conditions, and for the duration stated, and where no duration is stated, shall survive indefinitely: Article 1 (Definitions), other than in the case of termination of this Agreement, the penultimate sentence of Section 5.4 (Royalty Term), the remainder of Article 5 (Payments) (solely to the extent payment obligations accrue prior to the effective date of expiration or termination), Article 7 (Confidentiality) (for the time period set forth therein), Article 9 (Indemnification), Article 10 (Term and Termination), Article 11 (Miscellaneous), Section 2.4 (No Other Rights), Section 6.1 (Ownership of Intellectual Property; Disclosure), Section 8.9 (Disclaimer) and this Section 10.5.2 (Surviving Provisions of the Agreement).
MISCELLANEOUS
11.1.Governing Law; Dispute Resolution.
11.1.1.Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the Laws of the State of New York without reference to conflicts of laws principles; provided that all questions concerning (a) inventorship and ownership of Patent Rights under this Agreement shall be determined in accordance with United States law and (b) the construction or effect of Patent Rights shall be determined in accordance with the Laws of the country or other jurisdiction in which the particular Patent Right has been filed or granted, as the case may be. The provisions of the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement or any subject matter hereof.
11.1.2.Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 5.9.2 (Audit Dispute) or Section 11.9 (Equitable Relief), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 11.1 (Dispute Resolution).
(a)Negotiation; Escalation. The Parties will negotiate in good faith and use reasonable efforts to settle any Dispute under this Agreement. Any Dispute as to the breach, enforcement, interpretation, or validity of this Agreement will be referred to the Executive Officers for attempted resolution. The Executive Officers shall (i) exchange their respective positions related to the Dispute in writing and (ii) hold a minimum of one in-person or telephonic meeting, in each case of (i) and (ii), within 15 Business Days after such Dispute is referred to them. If the Executive Officers are unable to resolve such Dispute within 15 Business Days after the Executive Officers exchange their respective positions in writing, then, upon the written request of either Party to the other Party, other than a Dispute relating to the scope, validity, enforceability, or infringement of any Patent Rights or trademark rights (which will be determined in accordance with Section 11.1.4 (Patent Dispute)), the Dispute will be subject to arbitration process in accordance with Section 11.1.2(b) (Arbitration).
- 41 -
(b)Arbitration. Any unresolved Dispute that was subject to Section 11.1.2(a) (Negotiation; Escalation) will be finally settled by arbitration without the right to appeal administered in New York, New York before a panel of three arbitrators under the American Arbitration Association (AAA) Rules. Each Party will nominate an arbitrator, and the Party-nominated arbitrators will agree upon the third arbitrator who will be the chair of the arbitrate tribunal. If the two Party-nominated arbitrators are unable to agree upon the chair, then the chair will be selected as provided in the AAA Rules. The arbitration award will be binding upon the Parties and enforceable by any court of competent jurisdiction. The arbitration award will include an award as to costs including attorney fees.
(c)Injunctive Relief. Notwithstanding any provision to the contrary set forth in this Agreement, in the event of an actual or threatened breach hereunder, the aggrieved Party may seek equitable relief (including specific performance or other injunctive relief) in any court or other forum, without first submitting to the dispute resolutions procedures set forth in Section 11.1.2(a) (Negotiation; Escalation) and 11.1.2(b) (Arbitration).
11.1.3.Confidentiality. Any and all activities conducted under this Section 11.1 (Governing Law; Dispute Resolution), including any and all non-public proceedings and decisions under Section 11.1.2(b) (Arbitration), will be the Confidential Information of each of the Parties and will be subject to the terms of Article 7 (Confidentiality).
11.1.4.Patent Dispute. Notwithstanding anything to the contrary contained herein, a Dispute between the Parties relating to the validity, enforceability or patentability of any Patent Right, Trademark or other intellectual property rights shall be submitted to a court or patent office of competent jurisdiction in the relevant country in which such Patent Right was issued or, if not issued, in which the underlying patent application was filed. Each Party hereby submits to the jurisdiction of such court or patent office and irrevocably waives any assertion that the case should be heard in a different venue or forum.
11.2.Assignment. This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except as provided in Section 2.3.2 (Subcontracting)), whether by operation of law or otherwise, in whole or in part, by either Party without the written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed, except that such consent shall not be required in connection with any assignment to (a) an Affiliate of the assigning Party or (b) a Third Party in connection with a sale or transfer of the business to which this Agreement relates, or to any successor Person resulting from any merger or consolidation of such Party with or into such Person; provided that the assignee shall have agreed in writing to assume all of the assignor’s obligations hereunder and the other Party shall be notified promptly after such assignment has been effected. Any such assignment shall not relieve the assigning Party of any liabilities or obligations owed to the other Party hereunder. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement. All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any purported assignment in violation of this Section 11.2 (Assignment) shall be void.
- 42 -
11.3.Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics or pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement) and for so long as such failure or delay continues to be caused by or result from such force majeure event. The non-performing Party shall notify the other Party of such force majeure within 30 days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. For as long as any force majeure circumstance continues, the non-performing Party shall, at the other Party’s reasonable request, provide the other Party written summaries of its mitigation efforts and its estimates of when normal performance under the Agreement shall be able to resume. The Parties acknowledge and agree that the effects of the Coronavirus (COVID- 19) pandemic that are ongoing as of the Effective Date shall be considered a force majeure only to the extent those effects are not reasonably foreseeable by the Parties as of the Effective Date, and any government orders, including those requiring personnel to stay home or the closure of facilities, issued as of the Effective Date shall not be considered a force majeure.
11.4.Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by e-mail transmission (with transmission confirmed), or (c) by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in this Section 11.4 (Notices) or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 11.4 (Notices). Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. Any notice delivered by e-mail shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Section 11.4 (Notices) is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
If to Coya, |
|
|
|
|
|
addressed to: |
Coya Therapeutics, Inc. |
|
|
|
5850 San Felipe St. Suite 500 |
|
|
Houston, TX 77057 |
|
|
|
with a copy (which shall not constitute notice) to: |
||
|
||
|
|
Ropes & Gray LLP |
|
|
800 Boylston Street, Prudential Tower Boston, MA 02199 |
|
|
Attention: Marc Rubenstein |
|
|
Email: [***] |
- 43 -
|
|
|
If to ARScience Bio, |
|
|
|
|
|
addressed to: |
|
|
|
|
|
|
|
CEO |
|
|
1400 112th Ave SE, Suite 100 |
|
|
Bellevue, Washington 98004 |
11.5.Export Clause. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the writtenconsent to do so from the appropriate agency or other governmental entity in accordance with applicable Law.
11.6.Waiver; Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.
11.7.Further Assurance. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all other such acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
11.8.Severability. If any provision of this Agreement shall be held by a court of competent jurisdiction, or declared under any law, rule or regulation of any government having jurisdiction over the Parties hereto, to be illegal, invalid or unenforceable, then such provision shall, to the extent permitted by the court or government, not be voided, but shall instead be construed to give effect to the intentions of the Parties to the maximum extent permissible under applicable Law, and the remainder of this Agreement shall remain in full force and effect in accordance with its terms.
11.9.Equitable Relief. Each Party acknowledges and agrees that the restrictions, rights and obligations set forth in Article 6 (Intellectual Property Rights) and Article 7 (Confidentiality) are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions, rights and obligations and that any breach or threatened breach of any provision of such Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Articles, the Non-Breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such Non-Breaching Party may be entitled in law or equity.
- 44 -
11.10.Entire Agreement; Amendments. This Agreement, together with the Schedules and Exhibits attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby (including the CDA). Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
11.11.Relationship of the Parties. It is expressly agreed that ARScience Bio, on the one hand, and Coya, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for all Tax purposes. Neither ARScience Bio, on the one hand, nor Coya, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
11.12.Headings; Construction; Interpretation. Headings and any table of contents used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall apply against the Party which drafted such terms and provisions. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, or Schedule shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause, or Schedule, of or to, as the case may be, this Agreement. Except where the context otherwise requires, (a) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Law includes all rules and regulations thereunder and any successor Law, in each case as from time to time enacted, repealed or amended, (c) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, (d) the words “include,” “includes,” “including,” “exclude,” “excludes,” and “excluding,” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import, (e) the word “or” is used in the inclusive sense (and/or), (f) words in the singular or plural form include the plural and singular form, respectively, (g) references to any gender refer to each other gender, (h) references to a particular Person include such Person’s successors and assigns to the extent not prohibited by this Agreement, (i) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term that is defined herein shall be interpreted in a correlative manner, (j) all references to “will” are interchangeable with the word “shall” and shall be understood to be imperative or mandatory in nature, and (k) whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days.
11.13.Books and Records. Any books and records to be maintained under this Agreement by a Party or its Affiliates or Sublicensees shall be maintained in accordance with applicable Accounting Standards.
11.14.English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any
- 45 -
translation into any other language shall not be an official version thereof, and in the event
of any conflict in interpretation between the English version and such translation, the English version shall control.
11.15.Parties in Interest. All of the terms and provisions of this Agreement shall be binding upon, and shall inure to the benefit of and be enforceable solely by the Parties and their respective successors, heirs, administrators and permitted assigns and they shall not be construed as conferring any rights on any other Persons.
11.16.Counterparts. This Agreement may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies from separate computers or printers. Signatures transmitted via e-mail, including PDFs or any electronic signature complying with the U.S. Federal ESIGN Act of 2000, shall be treated as original signatures.
- 46 -
[Signature page to follow]
IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Coya Therapeutics, Inc. |
||
By: |
|
/s/ Howard Berman |
|
|
|
Name: |
|
Howard Berman |
|
|
|
Title: |
|
CEO |
ARScience Biotherapeutics Inc. |
||
By: |
|
/s/ Gustavo Mahler |
|
|
|
Name: |
|
Gustavo Mahler, PhD |
|
|
|
Title: |
|
CEO |
[Signature Page to License Agreement]
- 47 -
Exhibit A
Supply Agreement Key Terms
Parties |
ARScience Biotherapeutics Inc. (“ARScience”) and Coya Therapeutics Inc (“Coya”) |
[***] |
[***] |
Term and pricing |
The parties will enter into an GMP exclusive Manufacturing Agreement with ARScience to provide Product at the lesser of (a) cost (to be defined in the definitive supply agreement) plus 10% and (b) [***] per unit for the duration of the License Agreement. |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS.
COMMON STOCK PURCHASE WARRANT
COYA THERAPEUTICS, INC.
Warrant Shares: ____ |
Issue and Initial Exercise Date: ______, 2020 |
THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, ____ or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “Initial Exercise Date”) and on or prior to 5:00 p.m. (New York City time) on _______, 2025 (the “Termination Date”) but not thereafter, to subscribe for and purchase from Coya Therapeutics, Inc., a Delaware corporation (the “Company”), up to ____ shares (as subject to adjustment hereunder, the “Warrant Shares”) of Common Stock. The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).
Section 1. Definitions. In addition to the terms defined elsewhere in this Warrant, the following terms have the meanings indicated in this Section 1:
“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.
“Bid Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Company and reasonably acceptable to the Holder, the fees and expenses of which shall be paid by the Company.
“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Commission” means the United States Securities and Exchange Commission.
“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.
“Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.
“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“Trading Day” means a day on which the Common Stock is traded on a Trading Market.
“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange (or any successors to any of the foregoing.
“Transfer Agent” means the then current transfer agent of the Company.
“VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Company and reasonably acceptable to the Holder, the fees and expenses of which shall be paid by the Company.
Section 2. Exercise.
a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined in Section 2(d)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price for the shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has
been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.
Without limiting the rights of a Holder to receive Warrant Shares on a “cashless exercise” and without limiting the liquidated damages provision in Section 2(d)(i) and the buy-in provision in Section 2(d)(iv), in no event will the Company be required to net cash settle a Warrant exercise.
b) Exercise Price. The exercise price per share of Common Stock under this Warrant shall be $[_]1, subject to adjustment hereunder (the “Exercise Price”).
c) Cashless Exercise. This Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where
|
(A) |
= |
as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(64) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the Common Stock on the principal Trading Market as reported by Bloomberg L.P. as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; |
|
|
|
|
|
(B) |
= |
the Exercise Price of this Warrant, as adjusted hereunder; and |
|
|
|
|
|
(X) |
= |
the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. |
4 |
|
If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the characteristics of this Warrant, and the holding period of the Warrant Shares being issued may be tacked on to the holding period of this Warrant. The Company agrees not to take any position contrary to this Section 2(c).
|
1 |
NTD: To equal 120% of the Series A Preferred Stock price per share. |
NAI-1515117987v3 2
Notwithstanding anything herein to the contrary, on the Termination Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2(c).
d) Mechanics of Exercise.
i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) the Warrant Shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144 (assuming cashless exercise of the Warrants), and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earliest of (i) two (2) Trading Days after the delivery to the Company of the Notice of Exercise, (ii) one (1) Trading Day after delivery of the aggregate Exercise Price to the Company and (iii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise; provided that no Warrant Shares shall be required to be delivered by the Company if the Exercise Price is not delivered to the Company (such date, the “Warrant Share Delivery Date”). Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the Warrant Shares, provided that the Notice of Exercise contains no material deficiencies and payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Stock as in effect on the date of delivery of the Notice of Exercise.
ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.
iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.
iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if, at any time that the
NAI-1515117987v3 3
Warrant Shares are registered under the Exchange Act, the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (i) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (ii) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of the Warrant as required pursuant to the terms hereof.
v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.
vi. Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.
vii. Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.
e) Holder’s Exercise Limitations. If, at any time that the Warrant Shares are registered under the Exchange Act, the Company shall not affect any exercise of this Warrant, and a Holder shall not have the
NAI-1515117987v3 4
right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% (or, upon election by a Holder prior to the issuance of any Warrants, 9.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.
Section 3. Certain Adjustments.
a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of
NAI-1515117987v3 5
doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification.
b) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).
c) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise, other than cash (including, without limitation, any distribution of stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).
d) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock or
NAI-1515117987v3 6
any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, without regard to any limitation in Section 2(e) on the exercise of this Warrant, the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section 3(d) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant with the same effect as if such Successor Entity had been named as the Company herein.
e) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.
f) Notice to Holder.
i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by facsimile or email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.
NAI-1515117987v3 7
ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock other than a stock dividend or stock split, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by facsimile or email to the Holder at its last facsimile number or email address as it shall appear upon the Warrant Register of the Company, at least four (4) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Company may satisfy this notice requirement by filing such information in a Current Report on Form 8-K. If the Company is a reporting company under the Exchange Act, to the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.
Section 4. Transfer of Warrant.
a) Transferability. This Warrant is not transferable without the written consent of the Company, except to permissible assigns of the Holder, which shall include, and is not limited to, officers, directors, employees, partners and contractors of Allele Capital Partners, LLC and Tribal Capital Markets, LLC. Pursuant to FINRA Rule 5110(g)(1), neither this Warrant nor any Warrant Shares issued upon exercise of this Warrant shall 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 of the offering pursuant to which this Warrant is being issued, except the transfer of any security:
|
(i) |
by operation of law or by reason of reorganization of the Company; |
|
|
|
|
(ii) |
to any FINRA member firm participating in the offering and the officers and partners thereof, if all securities so transferred remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period; |
|
|
|
|
(iii) |
if the aggregate amount of securities of the Company held by the Holder or related person do not exceed 1% of the securities being offered; |
NAI-1515117987v3 8
|
|
|
|
(iv) |
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 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 received remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period. |
Subject to the foregoing restriction, this Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date the Holder delivers an assignment form to the Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.
b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Initial Exercise Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.
c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.
d) Transfer Restrictions. If, at the time of the surrender of this Warrant in connection with any transfer of this Warrant, the transfer of this Warrant shall not be either (i) registered pursuant to an effective registration statement under the Securities Act and under applicable state securities or blue sky laws or (ii) eligible for resale without volume or manner-of-sale restrictions or current public information requirements pursuant to Rule 144, the Company may require, as a condition of allowing such transfer, that the Holder or transferee of this Warrant, as the case may be, provides to the Company an opinion of counsel, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that the transfer of this Warrant does not require registration under the Securities Act.
e) Representation by the Holder. The Holder, by the acceptance hereof, represents and warrants that it is acquiring this Warrant and, upon any exercise hereof, will acquire the Warrant Shares issuable upon such exercise, for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in violation of the Securities Act or any applicable state securities law, except pursuant to sales registered or exempted under the Securities Act.
Section 5. Miscellaneous.
NAI-1515117987v3 9
a) No Rights as Stockholder Until Exercise. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as expressly set forth in Section 3.
b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.
c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding Business Day.
d) Authorized Shares.
The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).
Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.
Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.
e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees
NAI-1515117987v3 10
that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, will have restrictions upon resale imposed by state and federal securities laws, unless exercised utilizing cashless exercise six months or more after the date hereof and permitted under state and federal securities laws.
g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.
h) Notices. Any and all notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at 12645 Memorial Drive, Suite F1 #305, Houston, Texas 77024, Attention: Chief Operating Officer, email address: jani@nicoya.health, or such other facsimile number, email address or address as the Company may specify for such purposes by notice to the Holders. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service addressed to each Holder at the facsimile number, e-mail address or address of such Holder appearing on the books of the Company. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given. To the extent that any notice provided hereunder constitutes, or contains, material, non-public information regarding the Company or any subsidiaries, the Company shall promptly file such notice with the Commission pursuant to a Current Report on Form 8-K.
i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of
NAI-1515117987v3 11
the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.
j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.
k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.
l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holders of a majority in interest of the Warrants issued on this date then outstanding, on the other hand.
m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.
n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.
********************
(Signature Page Follows)
NAI-1515117987v3 12
IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.
|
COYA THERAPEUTICS, INC. |
|
|
|
|
|
By: |
|
|
Name: |
|
|
Title: |
|
|
|
NAI-1515117987v3 13
NOTICE OF EXERCISE
To: |
COYA THERAPEUTICS, INC. |
(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.
(2) Payment shall take the form of (check applicable box):
[ ] in lawful money of the United States; or
[ ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c).
(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:
_______________________________
The Warrant Shares shall be delivered to the following DWAC Account Number:
_______________________________
_______________________________
_______________________________
(4) Accredited Investor. The undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.
[SIGNATURE OF HOLDER]
Name of Investing Entity: ________________________________________________________________________
Signature of Authorized Signatory of Investing Entity: _________________________________________________
Name of Authorized Signatory: ___________________________________________________________________
Title of Authorized Signatory: ____________________________________________________________________
Date: ________________________________________________________________________________________
|
|
NAI-1515117987v3 14
ASSIGNMENT FORM
(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.)
FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to
Name: |
|
|
(Please Print) |
|
|
Address: |
|
|
(Please Print) |
|
|
Phone Number: |
|
|
|
Email Address: |
|
|
|
Dated: _______________ __, ______ |
|
|
|
Holder’s Signature: ____________________________ |
|
|
|
Holder’s Address: _____________________________ |
|
|
|
NAI-1515117987v3 15
Exhibit 10.14
NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS.
COMMON STOCK PURCHASE WARRANT
COYA THERAPEUTICS, INC.
Warrant Shares: ____ |
Issue Date: ______, 2022 |
THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, ____ or its registered assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the closing of a Qualified Equity Financing (as defined below)(the “Initial Exercise Date”) and on or prior to 5:00 p.m. (New York City time) on fifth anniversary of Initial Exercise Date (the “Termination Date”) but not thereafter, to subscribe for and purchase from Coya Therapeutics, Inc., a Delaware corporation (the “Company”), at the Exercise Price (as defined in Section 2(b) below) then in effect, upon exercise of this Warrant such number of fully paid and non-assessable Warrant Shares (as defined blow), subject to adjustment as herein provided.
Section 1. Definitions. In addition to the terms defined elsewhere in this Warrant, the following terms have the meanings indicated in this Section 1:
“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.
“Bid Price” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the bid price of the Common Stock for the time in question (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Company and reasonably acceptable to the Holder, the fees and expenses of which shall be paid by the Company.
“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Commission” means the United States Securities and Exchange Commission.
“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.
-1-
“Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Note(s)” means the Series 1 Unsecured Convertible Promissory Note(s) of the Company issued pursuant to the Offering.
“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Qualified Equity Financing” means the offer and sale for cash by the Company of any of its equity securities with the principal purpose of raising capital and that results in aggregate gross proceeds to the Company of at least Twenty Million Dollars ($20,000,000) (excluding any portion of the indebtedness under the Notes that shall be automatically converted into the Company’s equity securities pursuant to the terms of the Note, or any other convertible debt issued by the Company that are exchanged for equity securities of the Company in such financing).
“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.
“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“Trading Day” means a day on which the Common Stock is traded on a Trading Market.
“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange (or any successors to any of the foregoing.
“Transfer Agent” means the then current transfer agent of the Company.
“VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Company and reasonably acceptable to the Holder, the fees and expenses of which shall be paid by the Company.
-2-
“Warrant Shares” means the product of (i) [_____ (__%)];1 and (ii) the aggregate number of shares of stock issued upon conversion of the Notes (as defined above) issued pursuant to that certain Confidential Offering Memorandum dated [__] (the “Offering”).
Section 2. Exercise.
a) Exercise of Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined in Section 2(d)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price for the shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.
Without limiting the rights of a Holder to receive Warrant Shares on a “cashless exercise” and without limiting the liquidated damages provision in Section 2(d)(i) and the buy-in provision in Section 2(d)(iv), in no event will the Company be required to net cash settle a Warrant exercise.
b) Exercise Price. The exercise price per share of Common Stock under this Warrant shall be an amount equal to 120% of the per share price in the Qualified Equity Financing, subject to adjustment hereunder (the “Exercise Price”).
|
1 |
Drafting Note: Individual percentage allocations to be provided by Placement Agent, which in the aggregate will total 7%. |
-3-
c) Cashless Exercise. This Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where
|
(A) |
as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(64) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the Common Stock on the principal Trading Market as reported by Bloomberg L.P. as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; |
|
(B) |
the Exercise Price of this Warrant, as adjusted hereunder; and |
|
(X) |
the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. |
If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the characteristics of this Warrant, and the holding period of the Warrant Shares being issued may be tacked on to the holding period of this Warrant. The Company agrees not to take any position contrary to this Section 2(c).
Notwithstanding anything herein to the contrary, on the Termination Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2(c).
d) Mechanics of Exercise.
i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) the Warrant Shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144 (assuming cashless exercise of the Warrants), and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earliest of (i) two (2) Trading Days after the delivery to the Company of the Notice of Exercise, (ii) one (1) Trading Day after delivery of the aggregate Exercise Price to the Company and (iii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise; provided that no Warrant Shares shall be required to be delivered by the Company if the Exercise Price is not delivered to the Company (such date, the “Warrant Share Delivery Date”). Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the Warrant Shares, provided that the Notice of Exercise contains no material deficiencies and payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received within the earlier of (i) two (2)
-4-
Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Stock as in effect on the date of delivery of the Notice of Exercise.
ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.
iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.
iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if, at any time that the Warrant Shares are registered under the Exchange Act, the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (i) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (ii) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of the Warrant as required pursuant to the terms hereof.
-5-
v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.
vi. Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.
vii. Closing of Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.
e) Holder’s Exercise Limitations. If, at any time that the Warrant Shares are registered under the Exchange Act, the Company shall not affect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report
-6-
filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% (or, upon election by a Holder prior to the issuance of any Warrants, 9.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.
Section 3. Certain Adjustments.
a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification.
b) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).
-7-
c) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise, other than cash (including, without limitation, any distribution of stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).
d) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, without regard to any limitation in Section 2(e) on the exercise of this Warrant, the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section 3(d) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form
-8-
and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant with the same effect as if such Successor Entity had been named as the Company herein.
e) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.
f) Notice to Holder.
i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by facsimile or email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.
ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock other than a stock dividend or stock split, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by facsimile or email to the Holder at its last facsimile number or email address as it shall appear upon the Warrant Register of the Company, at least four (4) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Company may satisfy this notice requirement by filing such information in a Current Report on Form 8-K. If the Company is a reporting company under the Exchange Act, to the extent that any notice provided in
-9-
this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.
Section 4. Transfer of Warrant.
a) Transferability. This Warrant is not transferable without the written consent of the Company, except to permissible assigns of the Holder, which shall include, and is not limited to, officers, directors, employees, partners and contractors of Allele Capital Partners, LLC and Tribal Capital Markets, LLC. Pursuant to FINRA Rule 5110(g)(1), neither this Warrant nor any Warrant Shares issued upon exercise of this Warrant shall 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 of the offering pursuant to which this Warrant is being issued, except the transfer of any security:
(i) by operation of law or by reason of reorganization of the Company;
(ii)to any FINRA member firm participating in the offering and the officers and partners thereof, if all securities so transferred remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period;
(iii)if the aggregate amount of securities of the Company held by the Holder or related person do not exceed 1% of the securities being offered;
(iv)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 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 received remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period.
Subject to the foregoing restriction, this Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date the Holder delivers an assignment form to the Company assigning this Warrant in full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.
b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges
-10-
shall be dated the Issue Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.
c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.
d) Transfer Restrictions. If, at the time of the surrender of this Warrant in connection with any transfer of this Warrant, the transfer of this Warrant shall not be either (i) registered pursuant to an effective registration statement under the Securities Act and under applicable state securities or blue sky laws or (ii) eligible for resale without volume or manner-of-sale restrictions or current public information requirements pursuant to Rule 144, the Company may require, as a condition of allowing such transfer, that the Holder or transferee of this Warrant, as the case may be, provides to the Company an opinion of counsel, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that the transfer of this Warrant does not require registration under the Securities Act.
e) Representation by the Holder. The Holder, by the acceptance hereof, represents and warrants that it is acquiring this Warrant and, upon any exercise hereof, will acquire the Warrant Shares issuable upon such exercise, for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in violation of the Securities Act or any applicable state securities law, except pursuant to sales registered or exempted under the Securities Act.
Section 5. Miscellaneous.
a) No Rights as Stockholder Until Exercise. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as expressly set forth in Section 3.
b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.
c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding Business Day.
d) Authorized Shares.
The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes,
-11-
liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).
Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.
Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.
e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Warrant (whether brought against a party hereto or their respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If either party shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, will have restrictions upon resale imposed by state and federal securities laws, unless exercised utilizing cashless exercise six months or more after the date hereof and permitted under state and federal securities laws.
g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.
-12-
h) Notices. Any and all notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at 5850 San Felipe St., Suite 500, Houston, Texas 77057 Attention: Chief Operating Officer, email address: [__], or such other facsimile number, email address or address as the Company may specify for such purposes by notice to the Holders. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile or e-mail, or sent by a nationally recognized overnight courier service addressed to each Holder at the facsimile number, e-mail address or address of such Holder appearing on the books of the Company. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or via e-mail at the e-mail address set forth in this Section on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given. To the extent that any notice provided hereunder constitutes, or contains, material, non-public information regarding the Company or any subsidiaries, the Company shall promptly file such notice with the Commission pursuant to a Current Report on Form 8-K.
i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.
j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.
k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.
l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holders of a majority in interest of the Warrants issued on this date then outstanding, on the other hand.
m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.
n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.
o) Registration Rights. The Warrant Shares shall have registration rights substantially similar to those set forth in that certain First Amended and Restated Investors’ Rights Agreement, to be dated on or about _____, 2022, by and between the Company and the other parties thereto.
********************
(Signature Page Follows)
-13-
IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.
|
COYA THERAPEUTICS, INC. |
|
|
|
|
|
By: |
|
|
Name: |
|
|
Title: |
|
|
|
-14-
NOTICE OF EXERCISE
To: |
COYA THERAPEUTICS, INC. |
(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.
(2) Payment shall take the form of (check applicable box):
[ ] in lawful money of the United States; or
[ ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c).
(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:
_______________________________
The Warrant Shares shall be delivered to the following DWAC Account Number:
_______________________________
_______________________________
_______________________________
(4) Accredited Investor. The undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.
[SIGNATURE OF HOLDER]
Name of Investing Entity: ________________________________________________________________________
Signature of Authorized Signatory of Investing Entity: _________________________________________________
Name of Authorized Signatory: ___________________________________________________________________
Title of Authorized Signatory: ____________________________________________________________________
Date: ________________________________________________________________________________________
|
|
-15-
ASSIGNMENT FORM
(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.)
FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to
Name: |
|
|
(Please Print) |
|
|
Address: |
|
|
(Please Print) |
|
|
Phone Number: |
|
|
|
Email Address: |
|
|
|
Dated: ________________ __, _______ |
|
|
|
Holder’s Signature: ____________________________ |
|
|
|
Holder’s Address: _____________________________ |
|
|
|
-16-
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We hereby consent to the use in the Prospectus constituting a part of this Registration Statement of our report dated March 15, 2022, relating to the financial statements of Coya Therapeutics, Inc. as of December 31, 2020 and 2021, which is contained in that Prospectus.
We also consent to the reference to our firm under the heading “Experts” in the prospectus.
/s/ Weaver and Tidwell, L.L.P.
Austin, Texas
November 18, 2022
Exhibit 107
Calculation of Filing Fee Tables
Form S-1
(Form Type)
Coya Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered Securities
|
Security Type |
Security Class Title |
Fee Calculation or Carry Forward Rule |
Maximum Aggregate Offering Price (1)(2) |
Fee Rate |
Amount of Registration Fee |
Fees to Be Paid |
Equity |
Common Stock, par value $0.0001 per share (3) |
(1) |
$17,250,000 |
0.00011020 |
$1,900.95 |
|
Other |
Underwriters’ Warrants |
(4) |
-- |
-- |
-- |
|
Equity |
Common Stock, par value $0.0001 per share, underlying Underwriters’ Warrants |
(5) |
$1,509,375 |
0.00011020 |
$166.33 |
|
Total Offering Amounts |
18,759,375 |
|
$2,067.28 |
||
|
Total Fees Previously Paid |
|
|
-- |
||
|
Total Fee Offsets |
|
|
-- |
||
|
Net Fee Due |
|
|
$2,067.28 |
|
1. |
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended (the “Securities Act”). |
|
2. |
Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price. |
|
3. |
Includes shares of common stock which may be issued on exercise of a 45-day option granted to the underwriters to cover over-allotments, if any. |
|
4. |
No separate registration fee required pursuant to Rule 457(g) under the Securities Act. |
|
5. |
Estimated solely for the purposes of calculating the registration fee pursuant to Rule 457(g) under the Securities Act. We have calculated the proposed maximum aggregate offering price of the common stock |
|
underlying the underwriters’ warrants by assuming that such warrants are exercisable at a price per share equal to 125% of the price per share sold in this offering. |
&_!P;?_U5KEIM6/T-P%=U+G3:+/4)XW-<&UUO'_;6Q_\ +6LT
MJAE'KEYM[$?1'R2A241PG43*I))9V/B95>:;7G27E]FXDV!W\TPU_F>E_P"<
M)*="4I424T]DDTRE/*A[O I!R2:2)*(*D$EK_]'N.K7FW*;CC^;H L>/&QW\
MT#_Q+/TG]>RM4_@B9!)S _=>Z][]U[K@3;4ZL8RL;J6'U)TZU8'@J4-K?7Z>[6^9R/]7 ]
M.7Z+^ZXR3G/_ !\=&]BE$\:3BP^X'GL!I"F V&RQST^GPCK.(RKD6!^GX/-P/\>!_C[U3Y]6ZE(GY_K_ $_W
MH>]$TZ]UD(()4<6MS_2XO_M_>O*O7NLB<"UN!^?Z_GVRWQ'JO ]YQM!>*GN-9QKJ6!VQ^1AUT^CZGZ/U++K\G\^RBUJ.B]2KOJO=F%SV
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MRJDDI^JDE\JI)*?JI)?*J22GZJ27RJDDI^JDE\JI)*?_V0#_VP!# $! 0$!
M 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$! 0$" @(" @("
M @(" @,# P,# P,# P/_VP!# 0$! 0$! 0$! 0$" @$" @,# P,# P,# P,#
M P,# P,# P,# P,# P,# P,# P,# P,# P,# P,# P,# P,# P/_P 1" $G
M =0# 1$ A$! Q$!_\0 'P 8" P$ !P@&!00) PH" 0 +
M_\0 M1 @$#! $# P(# P,"!@EU 0(#!!$%$@8A!Q,B @Q%$$R(Q4)44(6
M820S%U)Q@1ABD25#H;'P)C1R"AG!T34GX5,V@O&2HD1496H!#C_31?] ]
M/1\N\O)_HW\I?^@NDN.GL;AJI\GL+<^YMBYE@?\ *L%D7!U:U=9/.[#*I*KH
M&5XZJ-E(!!%A[>DNH;^W\/=+<&[8$.":@BN 0H"D:0.'YYKTHCM);&77MT_^
M)CX<#\_B);XB>/Y8Z&?:OR7^3/4:Q+N/[+N?:,,D5+5QSP/'NB"FCA01EZO%
MT;U\\SJH+U.0I\P0M_TW! (W'VUL-T.JU B;RH*CAPH7 )R=.DD^?&HSL/<
M.]VN@F8O3U(]2>/AGU_U>1]^D_E;U/W:L&,P.:_A&[Q$YJMEYN)!2LL
M>+FE,.*S))BD*_;3MXXD)G\#WC$/\Q_^/OW7NNO?NO=
VJ>'V<:=
M:/7(3<"_U_U_\?\ 6]^J?3KU.D_NC=&*VGAJS<>8J/!18N!R/I>29[F*)+D!
MY)9&"@?U/MNTM);K<' PN/0_A/S'IUN\N$MK%7U5;./]L///K7JL7L#L/<'8
MN
$6L!]+$@_3C
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M>'4-I2&LR%6 74I*DHUAJ4Z2UBK7X-F_U0!N!HBAZ,(345ZCR2
.8K7:+9HRAD8<*&A-:'((.D5(%WX13!-12A^6:CTZJ\^;WSGDZGJYNH>H9*3*=N5PI*+(93_)ZN#9R5L:5L-+
M14E9 ]!G=PST9^\IZ2J44M!#(E96 J\-+,"N;N:$L4=+,UNN%>.GX1BJTK]O
M#\\99>Q'W?KGGB4
4
M;%=':NO-?68>70455/,]P^KNHN*?\*]>MV1C8_2]F/\ Q(]@U#4!>AD!2.E?
M]5>BY?*+K//=G]7R4.U(HZO<^V,YC]WX+&324\4.5J*&GK<7D,6TU4\5/#45
MF"RU7]L7>.,58A\DD<;.ZT/95>-.M0T"+_J\^J_(N]J7 8^7;6VTOZ:E/\Z]9UECT:O)"
M\+@E)0T526 N"?+3F4M8\?3CZ?CW[7'Z_P"'IDVNY?A6G^\_Y^FBLW#@<>J1
MU.4H=9UE8"[B1 '8,?%)!!-+Z@?\WY/R."" T;UE_=>ZX^_=>Z\>!P/]?GZ_P"\?7W[KW78:Z@$?U_/TY/^'OW7
MNL;6_/O?ET\E:"G7'\?2X_K^?]Z]^ZOY\<]<"+CZ7_V//^]<^TS_ !'K9ZPM
M ']5[$_BW(_'UN+\#W6GSZUUB,6G@$_[$6/^\>_=/(>T=8C$W^/^W!'^V^OO
MW5J]$?\?\ DDC_ 'H^_=>KUUX3_C_R=_Q7W[KU>N_$?\?^22?][/OW7J]<
MQ$W^/^W%O]XY]^Z]7K,L7^^ _P")/OW3+_$>L@0 VL;_ .')_P!];WKJO6=0
M!^+?['G_ (GW[KW7,+
)^6G_"?M_9^71%%N1+:;B#P_SU?X!]G[>GLA0-3.@O^ P;C\>I25-QSP2/
M9:T,]27CHWI4'^?1JLD#@%):K]AZXC2>0UQ_6WMDQRC_ $/^8Z> A/\ HW\C
MUR_P]J(J!!K-&]./261],C*@U*//A7'IUW86X+$_TT\?[>_MSL_C_ETXH=OP
M]<>;VMS_ *D?J_VWMLBX)/AP:H_(Z@*_D<\<=6)MT[9)Z2>8TD_S&.'39E\U
MBL!2-7YFNIL92"Z)+73P4S5%5;4E+14\DHJ \R*]/;?R]
M>;Y='PI"D)IF@8#!X]R^:]6F_'OXR;+Z$Q3R4CG
'5@*YZY@?GW[B:]7 ZY>]]6Z\!S?_"P_UOK[UU<<.N7OW6^O>_=>Z][]
MU[KWOW7NO>_=>Z][]U[KWOW7NO>_=>Z][]U[KK2#^![]U[KCH7_$?[[_ !]^
MZ]UUX_\ '_>/?NO=>\?]#_OO]Y]^Z]UUH/\ A_O/_%/?NO=>T'_#_>?^*>_=
M>Z]H/^'^\_\ %/?NO==^/_'_ 'C_ (W[]U[KO0/R3_OO]O[]U[KO0O\ 3_>?
M?NO=