UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): December 17, 2015
Microlin Bio, Inc.
(Exact name of small business issuer as specified in its charter)
Delaware | 45-4507811 |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
135 East 57th Street, 24th Floor, New York, NY 10022 |
(Address of principal executive offices) |
(646) 406-6243 |
(Issuer’s telephone number) |
American Boarding Company, 358 Frankfort Street, Daly City, CA 94104 (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Section 1 – Registrant’s Business and Operations
Item 1.01 Entry Into a Material Definitive Agreement
On December 17, 2015, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Microlin Bio, Inc., a private Delaware corporation (“Microlin”), and our subsidiary formed for the purposes of the transaction, Microlin Merger Sub, Inc. (the “Merger Sub”). Pursuant to the Merger Agreement, Microlin merged with and into the Merger Sub, which resulted in Microlin becoming our wholly-owned subsidiary (the “Acquisition”). Immediately following the Acquisition, the Merger Sub was merged with and into our Corporation. In connection with this subsequent subsidiary merger, we changed our corporate name to “Microlin Bio, Inc.”
In addition, pursuant to the terms and conditions of the Merger Agreement:
• | The holders of all of the capital stock of Microlin issued and outstanding immediately prior to the closing of the Acquisition exchanged their shares on a pro-rata basis for 19,000,000 newly-issued shares of our common stock. |
• | Following the closing of the Acquisition, four of our shareholders canceled and returned a total of 8,635,000 shares of common stock. |
• | As a result, immediately following the Acquisition, there were 20,000,000 shares of our common stock issued and outstanding. |
• | Our officers and directors immediately prior to the Acquisition, Reza Noorkayhani and Joseph Marshall, resigned from the board and from all offices. |
• | Joseph Hernandez, who was the sole director of Microlin prior to the Acquisition, was appointed as our new sole director, effective ten (10) days after mailing to shareholders of our Schedule 14f-1 regarding the change in our board, which was filed with the Commission and mailed to shareholders of record on December 16, 2015. |
• | Our board also appointed the following new officers and directors, each of who had served in the same capacity as an officer of Microlin prior to the acquisition: |
• | Concurrently with the Acquisition, the holders of certain of our issued and outstanding promissory notes in the total amount of $87,844 agreed to amend the notes to remove the conversion features contained therein. In addition, we have committed to pay all of our pre-Acquisition liabilities, up to a total maximum amount of $90,000, within 120 days of the Acquisition. Our former CEO, Reza Noorkayhani, has agreed to indemnify us for any pre-Acquisition liabilities in excess of $90,000. |
As of the date of the Merger Agreement and currently, there are no material relationships between us or any of our affiliates and Microlin, other than with regard to the Merger Agreement.
The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Merger Agreement, which is filed as Exhibit 2.1 hereto and incorporated herein by reference.
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Section 2 – Financial Information
Item 2.01. Completion of Acquisition or Disposition of Assets
Information about the Company and the principal terms of the Acquisition are set forth below.
The Acquisition. On December 17, 2015, in accordance with the Merger Agreement, Microlin merged with and into the Merger Sub, which resulted in Microlin becoming our wholly-owned subsidiary. Immediately following the Acquisition, the Merger Sub was merged with and into our corporation. In exchange for all of the issued and outstanding shares of Microlin, the shareholders of Microlin received a total of 19,000,000 shares of our common stock.
There were 9,635,000 shares of our common stock outstanding before giving effect to the stock issuances in the Acquisition and the cancellation of 8,635,000 shares by four of our shareholders. Following these events, there were 20,000,000 shares outstanding, including:
Shares Held by:
19,000,000 former Microlin shareholders
1,000,000 existing shareholders
20,000,000
The issuance of shares of our common stock to the former holders of Microlin’s capital stock and convertible debentures in connection with the Acquisition was not registered under the Securities Act of 1933, as amended (the “Securities Act”), but was performed in reliance upon the exemption from registration provided by Section 4(2) of the Securities Act and/or Regulation D promulgated under that section, which exempts transactions by an issuer not involving any public offering.
Prior to the Acquisition, there were no material relationships between us and Microlin, or any of their respective affiliates, directors or officers, or any associates of their respective officers or directors.
General Changes Resulting from the Acquisition. Following the Acquisition, we intend to carry on the business of Microlin as our sole line of business. We have relocated our principal executive offices to 135 East 57th Street, 24th Floor, New York, NY 10022. Our telephone number is now (646) 406-6243.
Changes to the Board of Directors. Reza Noorkayhani and Joseph Marshall resigned from the board and from all offices. Joseph Hernandez, who was the sole director of Microlin prior to the Acquisition, was appointed as our new sole director, effective ten (10) days after mailing to shareholders of our Schedule 14f-1 regarding the change in our board, which was filed with the Commission and mailed to shareholders of record on December 16, 2015.
All directors hold office for one-year terms until the election and qualification of their successors. Officers are elected by the board of directors and serve at the discretion of the board.
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Accounting Treatment; Change of Control. The Acquisition is being accounted for as a “reverse acquisition,” as the stockholders of Microlin possess majority voting control of the company immediately following the Acquisition and now control our board of directors. Microlin is deemed to be the accounting acquirer in the reverse acquisition. Consequently, the assets and liabilities and the historical operations of Microlin prior to the Merger will be reflected in the financial statements and will be recorded at the historical cost basis of Microlin. Our consolidated financial statements after completion of the Acquisition will include the assets and liabilities of both companies, the historical operations of Microlin, and our operations from the closing date of the Acquisition. Following the Acquisition our fiscal year-end has been changed from December 31 to September 30. As a result of the issuance of the shares of our common stock pursuant to the Acquisition, a change in control of the Company occurred on December 17, 2015. Except as described herein, no arrangements or understandings exist among present or former controlling stockholders with respect to the election of members of our board of directors and, to our knowledge, no other arrangements exist that might result in a future change of control of the Company. We will continue to be a “small business issuer,” as defined under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), following the Acquisition.
We were incorporated as American Boarding Company in the State of Delaware on January 27, 2013. American Boarding Company was originally a real estate based company with a principle business objective of acquisition, design, development, lease, and management services of student housing communities located within close proximity of colleges and universities in the United States.
On December 17, 2015, we entered into the Merger Agreement with Microlin, whereby we acquired all of the issued and outstanding common stock of Microlin through a subsidiary. Following the Acquisition, we merged the subsidiary with and into our corporation, and changed our name to “Microlin Bio, Inc.” as part of that process. As a consequence of the Acquisition, we will no longer pursue our former business plan.
As a result of entering into the Merger Agreement, we are now a biotechnology company focused on microRNA based therapeutics for Oncology.
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Cautionary Note Regarding Forward-Looking Statements
The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ ‘‘will,’’ ‘‘would’’ or the negative of those terms, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:
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These forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from plans, intentions and expectations disclosed in the forward-looking statements that we make. We have based these forward-looking statements largely on our current expectations and projections about future events, and trends that we believe may affect our business, financial condition and operating results. We operate in a very competitive and rapidly changing environment and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. We have included important factors in the cautionary statements included in this Current Report, particularly in the ‘‘Risks Factors’’ section, that could cause actual future results or events to differ materially from the forward- looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
The forward-looking statements in this Current Report represent our views as of the date of this Current Report. We anticipate that subsequent events and developments will cause our views to change. However, although we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward- looking statements as representing our views as of any date subsequent to the date of this Current Report. You should read this report and the documents that we reference in this report and have filed as exhibits completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Current Report by these cautionary statements.
Overview
We are a development stage emerging therapeutic company focusing on microRNA and its role in oncology. MicroRNAs are naturally-occurring RNA molecules (composed of 19 to 25 nucleotides) that do not encode proteins but instead regulate gene expression and play a critical role in regulating networks of biological pathways. MicroRNAs were discovered fairly recently, and scientific research has shown that the improper balance of microRNAs is linked to many diseases, including cancer. MicroRNAs represent targets for a new class of therapeutics, which we believe may be more effective in the treatment of cancer, and diseases in general, with the potential for mitigated side effects in comparison with conventional small molecule drugs. We are working to develop and market, antimiR therapies, and miR replacement therapies. Our ultimate goal is to change the field of cancer treatment, minimize unnecessary healthcare costs and improve patients’ quality of life. We are focused on four types of cancer: lung, ovarian, colorectal and prostate.
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We have in-licensed a broad intellectual property portfolio of granted and pending patents and patent applications. In September 2013, we signed five exclusive licensing agreements with OSIF for approximately 138 pending patent applications and 132 granted patents covering numerous microRNAs. In addition, we licensed a novel delivery technology, which we call QTsomeTM. We have assembled a scientific advisory board with deep expertise in microRNA biology and broad business experience in biotechnology and drug development. We have also initiated the preclinical development of our lead therapeutic product candidate, LumiralinTM, including in vitro and in vivo animal studies. We believe that there is a significant clinical need for the type of therapeutics we are seeking to develop for lung, ovarian, colorectal and prostate cancers. We believe that these elements will allow us to successfully compete against existing companies who focus on microRNA therapeutics, even though our competitors are more established and have greater resources at their disposal.
Our Strategy
Our strategy thus far has been to build a company that has a limited infrastructure with flexibility to react to a wide variety of potential outcomes of our validation, clinical and preclinical work. Since we are an early stage company, being able to change direction easily, quickly and at minimal cost allows us flexibility which will be critical to the success of our company. We will need to react to critical events that will determine the course of our company, including the success and timing of our fundraising efforts, the results of our preclinical work, and the various stages of our clinical trials. Based on the outcomes of these events, we may need to alter our development plan and advance certain clinical programs over others based on resource constraint or clinical viability.
We intend for our clinical therapeutics programs to focus on areas of oncology where the current standard of care offers limited hope for patients suffering from cancer. Our product candidates are intended to employ a novel mechanism that could, alone or in combination, potentially help to eradicate or slow the progression of cancer.
A key component to our strategy is engaging seasoned executives to manage our outsourcing strategy. Another key component is our relationship with OSU. We believe OSU has been in the forefront of the discovery of microRNAs and their role in cancer. We intend to partner with OSU on several fronts, including on the preclinical work, the development of the delivery technology and on the clinical trials development. Further, one of our scientific advisors is a current professors at OSU. We view this relationship as a key component to our strategy.
Our strategy is to outsource as many elements of the development and manufacturing process as possible, which is a trend in the biotechnology industry. We believe this outsourcing strategy will allow us to avoid capital expenditures, keep fixed costs to a minimum and maximize the flexibility of our programs as we gather data and determine to which programs we should devote our resources. Outsourcing our developmental functions eliminates the need to establish a sizeable research and development facility, which is time consuming and capital intensive. We intend to work with consultants, CROs and CMOs to perform the critical work for our development and manufacturing processes. Under this model, we can leverage the expertise of established consultants, the capabilities of partner academic institutions and the experience of CROs and CMOs, resulting in an overall efficient process for drug development. To execute this strategy, we intend to work mostly as a virtual company, with members of our management team working remotely to execute our strategic plan, carry out operational management tasks and coordinate activities at the sites of our consultants, CROs and CMOs.
As part of this strategy, we currently do not own any facilities and plan instead to enter into as many consulting agreements, as opposed to employment agreements, as possible. We also plan to engage regulatory consultants to help us work through the various stringent regulations required by the relevant regulatory authorities, in particular the FDA, to acquire regulatory approval and comply with any post-approval regulatory requirements.
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An Overview of microRNA
The Biology of microRNA
In a cell, DNA transcribed into messenger RNA (mRNA) as well as non-coding RNA. mRNA is ‘‘translated’’ into proteins, which performs various cellular functions. In contrast, microRNAs (miRNAs or miRs) are non-coding RNAs (ncRNAs) that regulate the expression of genes. First, miRNA genes are transcribed to long primary transcripts that are long precursors (‘‘pri-miRNA’’) and then processed in the nucleus by an enzyme called Drosha into another precursor (‘‘pre-miRNA’’). The pre-miRNA is then transported into the cytoplasm by exportin-5, where it is further cut into 19 to 25 nt double-stranded miRNA: miRNA* duplexes. Next, miRNA: miRNA duplexes are incorporated into RNA-Induced Silencing Complexes (RISC), followed by unwinding of the duplex and retention of the mature miRNA strand in the RISC, while the complementary miRNA* strand is degraded. The mature miRNA serves as a guide molecule for RISC by directing it to partially complementary sites located predominantly in the 3’ untranslated regions (UTRs) of target mRNAs, resulting in translational repression and/or mRNA degradation of the target mRNAs (Figure 1). Over 2,000 potential microRNAs have been identified thus far, more than one-third of all human genes are predicted to be regulated by microRNAs, and each miRNA can regulate hundreds of mRNA and ncRNA targets. Since a single miRNA can regulate an entire network of genes, miRNAs operate as master regulators of the genome.
Figure 1. Mechanism of gene regulation by miRNA
Small-interfering-RNA (siRNA) and miRNAs are similar in that both utilize the RISC to reduce target gene expression. However, there are some important differences between them. siRNAs are mostly exogenous molecules custom-designed to target a specific gene. In contrast, miRNAs are naturally expressed by cells and are regulatory molecules with multiple mRNA gene targets. The multiple mRNA targets of each microRNA have been selected by evolution and thus often play important roles in cellular pathways and networks of pathways that control specific functions. Studies have shown that changes in miRNA level in tissues and blood may be linked to various diseases, including cancer.
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The discovery of miRNAs has opened up new opportunities in the discovery of new biomarkers and new drugs. Because levels of miRNAs are altered in many diseases, they can act as biomarkers for these diseases for their diagnosis and prognosis, for prediction of response to therapy, and for post-treatment monitoring. In addition, pathological changes caused by miRNA dysregulation can potentially be reversed by miR-based therapy. There are multiple approaches for miR-based therapy. One is miR-replacement therapy (MRT), in which an exogenous ‘‘miRNA mimic’’ for a miRNA that has a reduced level of expression is introduced. Another approach is antimiR therapy (AMT) in which an inhibitor for a miRNA that is overexpressed is introduced. These miRNA-modulating agents are synthetic oligonucleotides with sequences that are identical or complementary to the targeted miRNAs.
Designing of MRT or AMT therapeutic candidates is relatively straight forward because the sequences of the target miRNAs are already known. Because miRNA mimics and antimiRs are sequence specific, compared to the conventional small molecule chemotherapy, fewer adverse sides effects are expected for miRNA-based therapies along with much greater probability of hitting their targets. Many targets that were previously deemed undruggable can now be targeted using AMT or MRT. Finally, blood-based miRNA biomarker tests and miR-based therapeutics can be used in combination because patients most likely to benefit from therapy can be identified based on their miR expression profile and can then be treated with the corresponding miR-based therapy.
The Role of microRNA in Cancer
The role of miRNAs in cancer development was first reported in 2002 by Dr. Carlo Croce, who is a member of the National Academy of Sciences, Professor and Chairman of the Department of Molecular Virology, Immunology and Medical Genetics at the OSU College of Medicine. miRNAs expression patterns are altered in all types of cancer, with each cancer type displaying a distinctive signature miR expression pattern. miR expression profiling, therefore, potentially enables differentiation of the type of the tumor and its tissue of origin. It has been shown that changes in miRNAs can promote tumor development by increasing the expression of oncogenes that promote tumor growth and by decreasing the expression of tumor-suppressor genes. MiRNAs have been linked to tumor development, invasion, metastasis, new blood vessel generation, and tumor resistance to chemotherapy and radiotherapy. Each miR can affect multiple tumor types whereas multiple miRs may be changed in each tumor type. For example, miR-21 is increased in glioma, breast, lung, prostate, colon, stomach, esophageal, and cervical cancers, as well as diffuse large B-cell lymphoma. Meanwhile, inhibition of miR-21 has been shown to inhibit tumor growth by increasing the expression of certain tumor suppressors.
Our microRNA Product Platform
Scientists have shown in animal models that AMT inhibiting oncogenic miRs that are increased in a tumor, such as a miR-21 and members of miR-17-92 cluster, can inhibit tumor growth, tumor cell invasion, new blood vessel development (angiogenesis), and/or reverse resistance to chemotherapy and radiotherapy treatments. AntimiRs are ‘‘mirror images’’ of their miR targets and act by forming a stable complex with them, thereby inhibiting their biological function. Conversely, MRT replacing tumor suppressor miRNAs that are decreased in a tumor, such as miR-484 and miR-34a, with synthetic miR mimics can similarly achieve therapeutic benefits. Therefore, AMR and MRT and their combinations constitute miR-based therapies, a novel modality for the treatment of cancer.
We plan to develop four miR-based therapeutics: LumiralinTM (antimiR-21 AMT), OmiralinTM (miR-484 MRT), ColomiralinTM (antimiR-17-5p AMT), and PromiralinTM (miR-34 mimic MRT). Since both miR-21 and miR-17-5p are elevated in many types of cancer, LumiralinTM and ColomiralinTM may be useful in treating multiple tumor types. miR-34 is also reduced in multiple tumor types, so PromiralinTM will also have therapeutic potential in multiple tumor types. miR-based therapeutics can potentially be used in combination with each other in a common delivery vehicle. Furthermore, because of their ability to decrease therapeutic resistance, miR-based therapy could potentially be combined with standard chemotherapy or radiotherapy and could potentially produce a synergistic effect.
We have in-licensed a portfolio of approximately 138 pending patent applications and 132 granted patents covering various aspects of applications of miRNAs in cancer from OSIF. The subject matter covered by these patents was developed, in whole or in part, by Dr. Carlo Croce, a pioneer and recognized leader in the field of miRNA, and by Dr. Robert Lee, a recognized expert on nanoparticle-based miRNA delivery technology. Dr. Robert Lee is a member of our scientific advisory board and a consultant to the company. The other members of our scientific advisory board also have extensive experience in miRNA biology and in oligonucleotide therapeutics design and development.
In contrast to conventional chemotherapy, miR-based therapy is biomarker-driven and its miR targets are expected to affect entire gene-regulatory networks that are believed to serve as the master switches of tumor survival. The networks usually control several different points in the course of cancer development. Therefore, miR-based therapy is likely to be more effective with fewer side effects. Rather than screening a large library of hundreds of thousands of compounds for lead identification, which is routinely done in traditional drug discovery, miR-based drug discovery is relatively straightforward because the therapeutic oligonucleotide sequence is defined by that of the miR target. The drug directly targets the dysregulated microRNA based on sequence complementarity. If successfully developed, manufactured and commercialized with all the required regulatory approvals, we believe this has the potential to alter the landscape of the oncology market.
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Delivery Technology for miR-Based Therapeutics
A significant challenge to clinical development of miR-based therapeutics is the need for a delivery system. This is because human serum is rich in nucleases and the cell membrane is a formidable barrier to the intracellular delivery of oligonucleotides, which makes it difficult to bring the therapeutics to the target site. Other factors, such as renal and reticuloendothelial system clearance, also hinder delivery. The problem of delivery has been a major impediment in previous efforts toward clinical development of siRNA therapeutics and antisense oligonucleotides, as shown by the limited success of these classes of agents in the clinic.
The critical importance of in vivo delivery is well-recognized in the field of siRNA therapeutics as a bottleneck in their clinical development. The approval of ISIS and Genzyme’s KynamroTM as the first systemically administered antisense oligonucleotide therapy in humans for familial hypercholesterolemia in early 2013 was a watershed event in the field of oligonucleotide therapeutics. However, many antisense drugs have performed poorly in the clinic, which may be attributed to inadequacy in the delivery system. On the other hand, if an effective delivery technology is found, it would have broad applications to many types of potential oligonucleotide therapies.
There are two general strategies to addressing the delivery problem of oligonucleotides: chemical modification and nanoparticle formulation. Our delivery approach is expected to incorporate both of these strategies, based on what we believe are strong scientific rationale and strong patent positions.
This dual approach can be seen in the example of one of our therapeutic product candidates, LumiralinTM (antimiR-21). The antimiR-21 oligonucleotide is defined as the drug substance or active pharmaceutical ingredient (API) for the product. To achieve optimum activity, modifications are incorporated to increase its affinity for the miR-21 target and endonuclease stability while reducing non-specific immune system activation which may lead to side effects. While with these modifications the antimiR design is considered ‘‘optimized’’ for an unformulated free or ‘‘naked’’ agent, previous studies have shown that free antimiRs are mostly taken up by the liver and that a high dose is required for therapeutic activity, which in turn leads to potential kidney and liver toxicity.
QTsomeTM is a proprietary lipid nanoparticle-based delivery platform developed by Dr. Robert Lee, a member of our scientific advisory board, and a Professor at the OSU College of Pharmacy. QTsomesTM comprise an optimum combination of two cationic lipids, one with a quaternary amine headgroup and the other with a tertiary amine headgroup. These components can provide a stable nanoparticle and facilitate efficient delivery of the antimiR into the cytoplasm of the target cell. In addition, QTsomesTM incorporate PEG-DPPE, which cause them to stay in the blood circulation for a long time and to passively target delivery to solid tumors based on the enhanced permeability and retention (EPR) effect. This EPR effect is due to the increased blood vessel permeability of solid tumors and reduced lymphatic drainage, which lead to higher QTsomeTM uptake by the tumor.
The benefits of QTsomesTM include high efficiency, low toxicity, rational design, and, in our belief, our strong patent position. QTsomesTM utilize off-the-shelf cationic lipids and helper lipid components that are available in cGMP grade from commercial suppliers. This removes a potential barrier to clinical translation. According to Dr. Lee, production of QTsomesTM can readily be up-scaled to gram- and kilogram levels using standard and scaleable pharmaceutical manufacturing technologies such as diafiltration, sterile filtration, and lyophilization. The feasibility of large-scale production is an important advantage of the QTsomesTM formulation. Due to its higher efficacy and tumor selectivity, a lower clinical dose would be required than free antimiRs or miR mimics, and we therefore expect reduced adverse side effects.
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The QTsomeTM technology has been validated in Dr. Lee’s laboratory at OSU. Antimir-21 (AM-21) was shown to upregulate tumor suppressor genes RECK and PTEN in A549 lung cancer cells (Figure 2).
Figure 2. Upregulation of tumor suppressor genes in A549 lung cancer cells by AM-21
AM-21 were then loaded into QTsomesTM and evaluated in tumor cell lines and in a mouse tumor model. The QTsomesTM were small in size (~100 nm) based on dynamic light-scattering measurement and had a low surface charge. These properties are ideal for in vivo delivery. The QTsomesTM effectively inhibited miR-21’s biological functions and unregulated tumor suppressor genes RECK and PTEN in A549 cells and sensitized these cells to a chemotherapy agent paclitaxel (PTX) (Figure 3). Additionally, treatment of A549 cells with OTsomeTM/AM-21 resulted in a reduced capacity to migrate on a plastic dish (Figure 3a). This ability to reduce migration is often interpreted as a potential for the drug to be anti-metastatic. Furthermore, QTsomesTM carrying AM-21 completely inhibited the growth of A549 xenograft tumors in nude mice (Figure 3b) without causing overt toxicity to the mice as indicated by increased weight gain and no significant changes in organ weights in the treated group (data not shown).
Cell Viability (% of untreated cells)
Figure 3. QTsomeTM/AM-21 sensitized A549 cells to chemotherapy drug paclitaxel (PTX)
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Figure 3a. QTsomeTM/AM-21 treatment of A549 lung cancer cells reduced their ability to migrate into an open space on a tissue culture dish caused by a scratch through a monolayer of cells.
Figure 3b. Inhibition of A549 xenograft tumor growth by QTsomeTM/AM-21. Mice were inoculated s.c. with A549 cells and randomized into two groups of seven after tumors reach >50 mm3 (~1 week after inoculation). The treatment group was injected intravenously with 2 mg/kg by i.v. injection 3 times in the first week and once a week thereafter.
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QTsomeTM/AM-21 was also evaluated in KB tumor cells. As shown in Figure 4, QTsomesTM/AM-21 upregulated tumor suppressor gene PTEN over untreated control and more effectively than free AM-21. In a preliminary pilot study in vivo, intravenous delivery of an antimiR-21 formulated in QTsomesTM resulted in inhibition of miR-21 as demonstrated by upregulation of miR-21 target genes (Figure 5) and a trend toward tumor growth inhibition (data not shown). The study did not have large enough group sizes to detect the tumor growth inhibition with confidence, so larger follow up studies are underway.
Figure 4. Upregulation of tumor suppressor gene PTEN by QTsomeTM/AM-21 in KB cells.
Normalized gene expression (% of untreated tumors)
Figure 5. Upregulation of miR-21 target genes in KB cell xenograft tumors after delivery of QTsomeTM formulated antimiR-21.
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Collectively, these results support the further development of QTsomeTM/AM-21 nanoparticles for lung cancer therapy, either alone or in combination with standard chemotherapy. We have recently identified early lead antimiR-21 compounds with a proprietary design that are more potent than the publicly available antimiR-21 compounds we used in the preclinical data here. We believe this will allow us to move forward into additional in vivo studies with proprietary compounds formulated in QTsomesTM while also performing more screens to identify additional lead compounds to enter the in vivo studies to ensure we identify the best potential clinical candidate.
Dr. Lee’s laboratory also made progress on designing enhanced versions of QTsomesTM (licensed by the company). It was found that adding the small peptide, gramicidin, into QTsomesTM was able to improve delivery in the presence of serum. These peptide-enhanced QTsomesTM were found to be very effective in delivery of both siRNA, which is similar to miR mimics, and antimiRs. In a study recently published in the Journal of Controlled Release, a targeted version of QTsomesTM loaded with antimiR-155, with enhancement by gramicidin addition, was shown to be highly active in blocking miR-155 function in liver cancer cells. In this study, a glycolipid, Lactosyl-DOPE, was also added to make these QTsomeTM nanoparticles selective for liver cancer cells, which express the asialoglycoprotein receptor. This improved both the efficiency of antimiR delivery and the selectivity for the targeted cells. The design of the antimiR incorporated chemical modifications (OMe and phosphorothioate), which improved the stability and bioactivity of the oligonucleotide. The particles synthesized were compact in size (73 nm), were slightly positively charged and had high encapsulation efficiency for the antimiR (88%). These are properties that are conducive to in vivo delivery. Treatment of the cancer cells greatly increased the expression of two tumor suppressor genes, CEBP/beta and FOXP3, by 4 and 16-fold, respectively. Importantly, these QTsomesTM were highly active when injected intravenously at a relatively low dose (1.5 mg/kg) into mice and induced similar biological effects in vivo, increasing expression of a tumor suppressor CEBP/beta and FOXP3 by 6.9 and 2.2-fold, respectively. We believe this is significant since in vivo delivery efficiency is the key towards development of a suitable delivery vehicle for clinical applications.
In summary, we have licensed a proprietary lipid nanoparticle-based miR delivery technology (QTsomeTM) for AMT and MRT from OSIF, which we believe will provide us with an advantage in addressing the problem of AMT and MRT delivery with respect to our proposed therapeutics.
Our miR-BASED THERAPEUTIC PRODUCT CANDIDATES
We intend to develop a series of miR-based AMT and MRT agents for lung, ovarian, colorectal and prostate cancers. The initial clinical development candidates are listed in the table below:
Therapeutic Candidate | miR Target | Modality | Cancer Targets | ||||
LumiralinTM | miR-21 | AMT | Lung | ||||
OmiralinTM | miR-484 | MRT | Ovarian | ||||
ColomiralinTM | miR-17-5p | AMT | Colorectal | ||||
ProstamiralinTM | miR-34a | MRT | Prostate |
Market Opportunity
NSCLC, which includes adeno-, squamous-cell and large-cell carcinoma, is the leading cause of cancer deaths both in men and in women. Lung cancer causes more deaths than the next three most common cancers combined (colon, breast and prostate). According to the American Cancer Society, an estimated 160,340 Americans were expected to die from lung cancer in 2012, accounting for approximately 28 percent of all cancer deaths. According to a 2009 report by Global Industry Analysis, the global market for NSCLC therapeutics is set to reach $13 billion in year 2015, representing a large potential market.
Diagnosis and Current Treatment
Lung cancer is diagnosed using computed tomography (CT) X-ray-scan and tissue biopsy. Serum markers CEA and CYFRA 21-1 are often used as prognostic and predictive markers. Lung cancer treatment depends on the stage of
the disease. Early stage NSCLC is managed by surgery followed by combination chemotherapy. However, this is associated with serious side effects and limited response rates. A new molecularly targeted agent gifitinib (Iressa) has shown some early promise. However, approval of this drug was withdrawn by the FDA in 2005 due to lack of evidence that it extended life. Molecular classification of lung cancer patients is beginning to improve therapy for small subsets of patients. However, the majority of NSCLC patients (e.g., patents with mutated K-ras gene) still have no effective molecularly targeted therapy. Development of additional novel therapeutic and diagnostic strategies for NSCLC, therefore, is urgently needed to better match additional NSCLC patients to effective novel therapies. We believe that our product candidates are different from other molecularly targeted agents due to our intended targets and proprietary delivery methods.
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LumiralinTM AMT
miR-21 may arguably be the most validated oncomiR in cancer. It is commonly elevated in many cancer types including lung, ovarian, colorectal, prostate, liver, kidney, breast and brain cancers. miR-21 targets tumor suppressor gene such as PTEN. AntimiR-21 AMT has been shown to inhibit tumor growth, migration and invasion, and to reverse chemotherapy and radiotherapy resistance of cancer cells.
miR-21 is the most frequently over-expressed miR over all cancer types and its genomic locus is amplified in some cancer types. Expression of miR-21 correlates with poor patient outcome in many cancer types, including lung cancer. miR-21 expression is known to be driven by several well characterized oncogenes including STAT3, K-ras, C-raf, and PI3K pathways. Inhibition of miR-21 with an anti-miR leads to reduced tumor formation and prolonged survival in a Ras driven model of HCC.
In one study, a mouse model was constructed in which miR-21 could be inducibly over-expressed in the hematopoietic system. When miR-21 was induced, hematopoietic organ grew to 20 times the normal size, which resulted in an acute lymphoma. After lymphomas were formed, miR-21 was shut off and the tumors completely regressed within 2 weeks. This demonstrates that these tumors were not only formed due solely to over-expression of miR-21, but the tumors were also ‘‘addicted’’ to the expression of miR-21.
In a K-ras mouse model, miR-21 expression was found to cooperate with K-ras to form lung cancer. In this model mutant K-ras was expressed only in the lungs. Knockout of miR-21 reduced tumor formation in the model, as shown in Figure 6.
Figure 6. Knockout of miR-21 reduced tumor formation in a K-ras model (adapted from Hatley et al., 2010, Cancer Cell 18: 282-293)
We believe we have established a strong patent position on miR-21-based AMT therapy in lung cancer. Free antimiR-21 (without nanoparticles as carriers) is currently under clinical development by Regulus and Sanofi for hepatocellular carcinoma (HCC) and for kidney fibrosis. In comparison, our antimiR-21 AMT drug candidate, LumiralinTM, incorporates the proprietary delivery technology based on QTsomeTM lipid nanoparticles and we believe is likely to be more potent. LumiralinTM AMT is expected to have therapeutic activity in multiple tumor types, which we believe makes it a logical choice as a lead product for rapid clinical development. LumiralinTM AMT will be designed to be used by intravenous infusion either as a monotherapy or as a combination with standard chemotherapy in patients with recurrent disease, with extension of survival as the expected clinical endpoint. Because miR-21 is unregulated in many cancers including lung and ovarian, we will evaluate whether we can feasibly conduct human clinical trials in both lung and ovarian cancer patients and seek orphan drug status for LumiralinTM AMT.
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Ovarian Cancer
Market Opportunity
Ovarian cancer is a leading cause of cancer death among women. The American Cancer Society estimates that approximately 22,000 new cases of ovarian cancer will be diagnosed in 2013 in the United States and approximately 14,000 of the diagnosed individuals will die. While the mortality rate of other major cancers have declined, the mortality rate for ovarian cancer changed little in the past 40 years, making it the most lethal of all gynecologic cancers. Ovarian cancer therapies are eligible for orphan drug status under the Orphan Drug Act of 1983, which provides seven years of market exclusivity. According to a 2013 report by BCC Research, the global ovarian cancer drug and diagnostic market is projected to reach $34.6 billion by 2018.
Diagnosis and Current Treatment
Ovarian cancer is diagnosed by physical exam, CT scan, ultrasound, PET scan, laparoscopy, colonoscopy, and biopsy. Serum CA-125 test is also routinely used in diagnosis and post-therapy monitoring. Early stage ovarian cancer can be effectively treated with surgery. However, most ovarian cancer patients are at an advanced stage at the time of diagnosis. The standard therapy for an ovarian cancer patient is platinum/taxane combination or Doxil therapy. Due to the frequent abdominal involvement of the disease, intraperitoneal chemotherapy can be added to intravenous chemotherapy. An antibody drug, Avastin, is sometimes added as well. There has been less success with molecularly characterizing ovarian cancer patients compared to many other cancer types and this is a factor in the poor response to current therapies. Given the poor survival rates of ovarian cancer patients and the prominent role of early diagnosis, development of new therapeutic and diagnostic strategies is urgently needed.
OmiralinTM MRT
It has been found that miR-484 expression is frequently lowered in ovarian carcinomas. This miR has been shown to regulate the mitochodrial network and programmed cell death. miR-484 MRT has been shown to inhibit tumor growth when combined with chemotherapy. We believe we have established a strong patent position on miR-484 based therapy in cancer. Our miR-484 mimic MRT drug candidate, OmiralinTM, incorporates the proprietary delivery technology based on QTsomeTM lipid nanoparticles. It is designed to be administered by intravenous infusion or intravenous/intraperitoneal combination, and can be used alone or in combination with standard chemotherapy in patients with recurrent disease, with extension of survival as the clinical endpoint.
The important role of miR-484 in cancer was discovered in Dr. Croce’s lab at OSU. miR-484 targets VEGF-B and VEGFR2 (along with many other genes) to block the angiogenic process needed by tumors.
Low circulating levels of miR-484 in ovarian cancer patients can be used to predict patient response to chemotherapy. Meanwhile, increased expression of miR-484 sensitizes ovarian tumors to chemotherapy. Ovarian cancer can be potentially treated by ‘‘local’’ intraperitoneal delivery, in combination with chemotherapeutics.
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Colorectal Cancer
Market Opportunity
Colorectal cancer is the third leading cause of cancer deaths in the United States among men and women. According to the American Cancer Society, it is estimated to cause 50,830 deaths in 2013. If diagnosed early, when the disease is local, 5-year survival rate is approximately 90%. However, only 40% are diagnosed at this early stage. According to a 2010 report by Global Data, the global colorectal cancer therapy market is projected to grow to $11.6 billion in 2016 with a CAGR of 9.8%.
Diagnosis and Current Treatment
Colorectal cancer is detected by colonoscopy, CT and PET scans, ultrasound, blood tests, and biopsy. Serum CEA and CA19-9 tests are also routinely used in monitoring of the disease. Early stage colon cancer can be effectively treated with surgery. However, a large portion of colon cancer patients are at an advanced stage at the time of diagnosis. The standard therapies for colorectal cancer include a combination of surgery, radiation therapy, and chemotherapy. Given the prevalence of colorectal cancer patient and the critical role of early diagnosis in the management of this disease, new therapeutic and diagnostic strategies are urgently needed.
ColomiralinTM AMT
miR-17-92 cluster consists of 6 microRNAs that are frequently elevated in lung, gastric, colon, liver, pancreatic, renal, prostate, and breast cancers. These are a family of microRNAs encoded in three genomic clusters. Because members of a microRNA ‘‘family’’ share the same seed sequence, it is possible to design a single anti-miR to inhibit multiple family members. The miR-17 family is the only family with at least two members in each cluster. The targets of the miR-17 family include important genes in cell cycle and cell surface receptor driven proliferation. The miR-17 family is well validated alone, but the compound nature of the clusters will require more work to determine the best AMT strategy. AntimiR-17-5p AMT has been shown to inhibit tumor growth. We believe we have a strong patent position on miR-17-5p based therapy in colorectal cancer. Our antimiR-17-5p AMT drug candidate, ColomiralinTM, incorporates the proprietary delivery technology based on QTsomeTM lipid nanoparticles. ColomiralinTM AMT is designed to be used by intravenous infusion as monotherapy or in combination with standard chemotherapy as a second-line therapy, with extension of survival as the clinical endpoint.
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Prostate Cancer
Market Opportunity
Prostate cancer is very common and is the second leading cause of cancer death among men. The American Cancer Society estimates that approximately 238,590 new cases of prostate cancer will be diagnosed in the United States in 2013 and 29,720 of the diagnosed individuals will die from it. According to Decision Resources, a man has a 1 in 6 chance of diagnosis of prostate cancer in his lifetime. While the 5- year survival rate of local (Stage I, II) and regional (Stage III) disease is 100%, Stage IV prostate cancer with distant metastasis has a survival rate of only 28%. According to a report by Decision Resources, the global market for prostate cancer drug will grow from $3.6 billion in 2010 to $10.1 billion in 2020, a CAGR of
10.8%.
Diagnosis and Current Treatment
Prostate cancer is diagnosed through screening tests such as prostate-specific antigen (PSA) test and digital rectal exam, and confirmed by a biopsy. Treatment of prostate cancer includes radiation therapy, hormone therapy, orchiectomy, prostatectomy, cryoablation, high intensity focused ultrasound thermoablation, and chemotherapy. Since advanced prostate cancer is often resistant to standard chemotherapy drugs, novel therapeutic strategies are needed.
PromiralinTM MRT
miR-34a is a tumor suppressor microRNA that is significantly lowered in prostate cancer. The genomic locus of miR-34a is frequently methylated in tumors to silence expression and is also repressed by cell surface oncogenic receptor tyrosine kinases (RTKs). miR-34 potentiates the p53 tumor suppressor pathway and inhibits proliferation pathways downstream of oncogenic growth factors. The targets of miR-34a include CDK4, CDK8, Met, Myc and E2F3. Delivery of miR-34 mimics into tumor cells leads to a G1 cell cycle block. In prostate cancer, its expression is associated with less aggressive diseases. Accordingly, miR-34 MRT has been shown to inhibit tumor cell growth including in tumors with a mutated p53. miR-34 MRT, therefore, is a promising novel therapeutic modality against prostate cancer. Mirna Therapeutics, Inc. is conducting a Phase I clinical trial for MRX34 in patients with unresectable liver cancer or liver metastasis. MRX34 utilizes the SMARTICLES as the delivery vehicle, which is based on a proprietary ‘‘charge-reversing’’ lipid nanoparticle formulation. We believe we have a strong patent position on miR-34 MRT in prostate cancer. Our miR-34 mimic MRT candidate therapeutic, PromiralinTM, incorporates the proprietary delivery technology based on QTsomesTM lipid nanoparticles. PromiralinTM MRT is designed to be used by intravenous infusion as a monotherapy or in combination with standard chemotherapy in patients with metastatic disease, with extension of survival as the clinical endpoint.
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OUR miR-BASED THERAPEUTIC PRODUCT PIPELINE
We have identified four miR-based therapeutic products (LumiralinTM AMT, OmiralinTM MRT, ColomiralinTM AMT, and PromiralinTM MRT) as our initial pipeline candidates. Lung, ovarian, colorectal, and prostate cancers have been selected as lead indications because of their established clinical need and large market potential. In addition, we believe we have strong intellectual property positions on these product candidates, which incorporate advanced delivery technology based on QTsomesTM. Each of the product candidates we have identified can target multiple tumor types given the prevalence of the corresponding miR targets in these tumors. In addition, it is possible to combine miR therapeutics to match a specific miR profile. For example, for a tumor that is high in miR-21 and low in miR-34, a therapy combination of LumiralinTM AMT and PromiralinTM MRT can be used to produce a synergistic effect. This miR combination can also be developed as a new drug product by combining the antimiR and miR-mimic into the same QTsomeTM lipid nanoparticle. This strategy can generate additional product candidates for our pipeline. Our therapeutic development strategy is to initially focus our resources on preclinical development and clinical translation of our current lead product candidate, LumiralinTM AMT, while continuing with validation of pipeline product candidates through preclinical research. We intend to seek strategic partners to develop pipeline product candidates.
OUR OUTSOURCING-BASED PRODUCT DEVELOPMENT STRATEGY
Outsourcing
An emerging trend in the biotechnology industry is to outsource developmental functions. This eliminates the need to establish a sizeable research and development facility, which is time consuming and capital intensive. By outsourcing our developmental functions, we are able to keep fixed costs to a minimum and flexibility to a maximum. Under this outsourcing model, we can leverage the established expertise of consultants and capabilities at partner academic institutions and CROs resulting in an overall efficient process for drug development. Our management will execute the strategic plan and carry out operational management and coordinate activities at sites of contractors and CROs. We are engaged in multiple discussions with CROs covering all stages of preclinical development and clinical trials. However, there is no assurance that we will enter into agreements with CROS or any other parties on acceptable terms, or at all.
Preclinical Research: Relationship with OSU
We have entered into license agreements with OSIF, an affiliate of OSU, covering approximately 138 pending patent applications and 132 granted patents covering various aspects of applications of miRNAs in cancer, as well as on miR therapeutic delivery, and as a result, we have developed a strategic relationship with OSU. The key inventor of the licensed delivery technology, Dr. Robert Lee, have extensive experience and resources to conduct preclinical research geared towards product development. Dr. Lee serves on our scientific advisory board and is a consultant to the company. Substantial complementary resources are available from the OSU Comprehensive Cancer Center, the OSU College of Medicine, the OSU College of Pharmacy, the NIH-funded Center for Clinical and Translational Sciences, the Drug Development Institute, and the NSF-funded Nanoscale Science and Engineering Center. We expect to enter into a contract with OSU and Dr. Lee pursuant to which Dr. Lee will serve as the Principal Investigator for our preclinical studies. However, we cannot provide any assurance that we will be successful in entering into such an agreement on acceptable terms, or at all.
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Manufacturing of the Active Pharmaceutical Ingredient and the Therapeutic Product
A drug product is composed of active pharmaceutical ingredient (API) and excipients. The manufacturing of the drug product for clinical trial must be carried out under cGMP.
Sourcing of API
AntimicroRNAs and miR mimics are manufactured as custom synthetic oligonucleotides. These oligonucleotides will carry chemical modifications. For clinical development, the drug product needs to be synthesized at 100 − 1,000 gram-scale at a cGMP-compliant CMO. We are engaged in discussions and have obtained price quotes on the quantity of materials needed for preclinical development and clinical trials.
Chemical modifications will increase the potency of anti-miR compounds. Oligonucleotide therapeutic compounds have chemical modifications of the backbone or sugar of the oligonucleotide to increase potency and stability and reduce off target effects. Our QTsomeTM delivery technology, which protects the compounds in circulation, allows us more freedom around modifications. Our first library of potential anti miR-21 leads contains compounds with phosphorothioate and 2’-O-methyl modifications, both of which are in the public domain and will result in active compounds. In addition, we intend to enter into agreements with companies to license proprietary modifications that could further increase the potency of our lead compounds. We can provide no assurance, however, that we will be able to enter into such agreements on favorable terms, or at all. The resulting lead compounds that are identified in our ongoing product candidate screens will be unique chemical entities and will be proprietary to us.
Sourcing of Excipients
QTsomesTM include several key lipid ingredients. These will be acquired in cGMP-grade from excipient suppliers. Other excipients include USP grade glycine, trehalose are available from many suppliers. By design, for the QTsomesTM, all excipients are available through commercial suppliers.
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Drug Product Manufacturing
We plan that QTsomeTM lipid nanoparticles will be manufactured at a cGMP compliant CMO. There are many CMOs to choose from, and we have engaged several CMOs in discussion. However we can provide no assurance that we will be able to enter into an agreement with a CMO on favorable terms, or at all. Each of these CMOs has established expertise on lipid-based formulations. Lipid nanoparticles are a relatively complicated formulation. Dr. Robert Lee has extensive expertise in the manufacturing of lipid nanoparticles and will advise us throughout this process. Processes and analytical methods developed in his laboratory at OSU and from the API CMO will be transferred to the CMO for making the drug product. When and if we are ready for manufacturing, the manufacturing process will be scaled up to the necessary scale for the clinical trials and performed under cGMP. Smaller non-GMP batches will be manufactured with the same product specifications prior to the clinical batch and used for IND-directed good laboratory practice (GLP) toxicology studies and stability studies. The manufacturing process includes continuous mixing, diafiltration, sterile filtration, aseptic filling, and lyophilization. The product specifications for quality control will include API content, particle size and polydispersity, zeta potential, pH, appearance and colloidal stability. In addition, stability, sterility, and pyrogen tests will be carried out. Data obtained will be incorporated into the IND in the section on Chemistry, Manufacturing, and Control (CMC).
Toxicology Testing
We expect that IND-directed toxicology testing will be carried out at a GLP-compliant toxicology CRO. There are many CROs to choose from and we have engaged a few CROs in discussion. However, we can provide no assurance that we will be able to enter into an agreement with any of these parties on acceptable terms, or at all. Materials used for the GLP toxicology study are to be provided by the CMO that produces the clinical trial material. However, a non-GMP batch manufactured to the same specifications can be used in the toxicology testing to accelerate the developmental process. The toxicology studies will include dose-escalation studies in rat and in a non-human primate and will include genotoxicity studies.
IND Filing with the FDA
We plan to retain a regulatory consultant to handle regulatory filings. During the development process, we expect to arrange a pre-IND meeting with the FDA to obtain input on various aspects of the product development plan. The regulatory consultant will help us organize preclinical efforts to ensure all preclinical work is completed in a timely fashion. As described above, the information relating to the Animal Pharmacology and Toxicology Studies is expected to be based on OSU studies and the GLP Toxicology Study data, which is expected to be collected by a CRO. Meanwhile, materials for the CMC section are expected to come from the CMO that manufactures the drug product. Finally, a section on Clinical Protocols and Investigator Information is expected to be generated in close collaboration with the OSU Division of Medical Oncology and the Clinical Trials Office. Clinical protocols are expected to be developed by physician scientists Dr. Miguel Villalona and Dr. John Hayes, who have extensive experience designing and leading Phase I clinical trials. If so, the clinical trial protocol will be reviewed and approved by OSU’s Institutional Review Board (IRB). In addition, we expect to draft an Investigator’s Brochure to be included in the IND application. The regulatory consultant will be expected to compile all relevant information and assemble the complete IND application and submit to the FDA and, if necessary, follow up with responses if questions are raised by the FDA.
Phase I Clinical Trials on Lumiralin in Lung Cancer and Ovarian Cancer Patients
We plan to retain the service of a CRO to conduct Phase I clinical trials at the OSU Comprehensive Cancer Center on our lead product candidate, LumiralinTM. The Phase I trial will be based on a 3x3 design of dose escalation plus an expansion cohort. This study will involve 12 − 36 patients. Patient blood samples will be analyzed for pharmacokinetics of the drug product and for biomarkers. The CRO and lead physician scientists at OSU will work closely to conduct trial planning and design, patient recruitment, data management, laboratory analysis, and reporting and oversight to ensure data integrity and adherence to good clinical practices (GCP).
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OUR RELATIONSHIP WITH OSU
We have established relationships with multiple departments across OSU. In September 2013 we entered into five exclusive licensing agreements with OSIF, an affiliate of OSU, to exclusively in-license approximately 138 pending patent applications and 132 granted patents covering various aspects of applications of miRNAs in cancer as well as a novel delivery technology known as QTsomes. In addition, Dr. Robert Lee, the inventor of the QTsomeTM technology, serves as members of our scientific advisory board and is a consultant to the company.
We expect to engage Dr. Lee as the Principal Investigator for our preclinical studies, which will then be conducted in his lab at OSU. Throughout the manufacturing process, Dr. Lee will continue to advise and oversee the work with our third party contractor. Further, we expect to work with Dr. Lee and others at OSU in designing our clinical trials, which we expect will be carried out at the OSU Comprehensive Cancer Center. We cannot guarantee, however, that we will be able to enter into definitive agreements with these parties on acceptable terms, if at all.
We believe that our relationship with OSU will be beneficial to our company because of OSU’s deep research expertise and experience in the microRNA and oncology fields. Further, we expect that the OSU Comprehensive Cancer Center will provide us with guidance in running clinical trials as well as a large patient population pool.
OUR INTELLECTUAL PROPERTY
We have a portfolio of approximately 138 pending patent applications and 132 granted patents worldwide, which we have exclusively licensed from OSIF for use in the diagnosis, prognosis and therapy of certain types of cancer. The portfolio comprises 21 patent families having expiries between 2026 and 2035, not including any patent term adjustments or extensions, which may have been granted or which may be available, respectively. Protection of the intellectual property is being sought in major markets, including the United States, Europe, China, Japan, Australia and Canada. The portfolio embraces claims directed to composition of matter, methods of use, treatment, diagnosis, prognosis and/or stratification of patient populations and evaluation of cancer risk for ovarian, lung, colorectal and prostate cancers, including solid tumors and leukemia. Worldwide, the portfolio includes 6 granted patents directed to ovarian cancer, 37 granted patents directed to lung cancer, 92 granted patents directed to colorectal cancer and 16 granted patents directed to prostate cancer. Our product candidates are based upon the exploitation of these compositions and methods relating to the detection, measurement and/or stratification of microRNA levels or signatures in patients. Our intellectual property portfolio provides us with exclusive access to certain microRNAs and their applications in certain types of cancer as well as a proprietary delivery technology.
We believe that this intellectual property is critical to our business and we strive to strengthen and protect it. We also will rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. Our success will depend significantly on our ability to maintain and defend our patents and other proprietary protection for commercially important technology, inventions and know-how related to our business, defend and enforce our patents, and preserve the confidentiality of our trade secrets. We also rely on know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of microRNA therapeutics. We intend to continue to seek opportunities to in-license relevant intellectual property as it is necessary to develop our product candidates and defend our competitive position in the marketplace.
COMPETITION
The biotechnology and pharmaceutical space is very competitive and rapidly changing, with new companies entering and working to develop new technologies and proprietary products. In addition, our field is tied to the advancement of the related fields of science, which continue to evolve and generate new insights and intellectual property.
We are aware of many competitors working in the therapeutic space for microRNA. Therapeutic competitors include miRagen Therapeutics, Inc., Mirna Therapeutics, Inc., and Regulus Therapeutics, Inc. These competitors compete with us in terms of recruiting talent, acquiring intellectual property and receiving potential funding during our development phase. Our competitors are better established, are further along in their development efforts and have greater resources at their disposal than us.
In addition, we expect that for each type of cancer for which we develop a therapeutic product candidate, we will compete against a different set of companies that market therapeutics for that given disease utilizing other approaches and technologies. For example, Mirna Therapeutics, Inc. is conducting a Phase I clinical trial for MRX34 in patients with unresectable liver cancer or liver metastasis. MRX34 utilizes the SMARTICLES as the delivery vehicle, which is based on a proprietary ‘‘charge-reversing’’ lipid nanoparticle formulation. The key competitive factors that will affect the success of any of our product candidates, if developed, manufactured and commercialized after obtaining all required regulatory approvals, are likely to be their safety, convenience, and efficacy.
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GOVERNMENT REGULATION AND PRODUCT APPROVAL
Government authorities in both the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. The process of developing and obtaining regulatory approvals for our product candidates, as well as the subsequent compliance with applicable federal, state, local and foreign statutes and regulations, require the expenditure of substantial time and financial resources.
U.S. Therapeutic Regulations
U.S. Drug Development Process
In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with the appropriate federal, state, local and foreign laws and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial civil or criminal sanctions. FDA sanctions may include clinical holds, refusals to approve pending applications, withdrawal of an existing approval, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, debarment, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
Before testing any compounds with potential therapeutic value in humans, the drug candidate enters the preclinical testing stage. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the drug candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including GLP. The sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. The FDA may also impose clinical holds on a drug candidate at any time before or during clinical trials due to safety concerns or non-compliance. Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.
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Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA and written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. The FDA or the sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
U.S. Review and Approval Processes
The results of product development, nonclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances. In addition, under the Pediatric Research Equity Act, an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
The FDA reviews all NDAs submitted to determine if they are substantially complete before it accepts them for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA targets 10 months in which to complete its initial review of a standard NDA and respond to the applicant, and six months for a priority NDA. The FDA often does not meet its PDUFA goal dates for standard and priority NDAs.
After the NDA submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. The FDA may refer applications for novel drug or biological products or drug or biological products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured.
The NDA review and approval process is frequently lengthy and complex and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical data or other data and information. Even if such data and information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.
If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials testing, which involves clinical trials designed to further assess a drug safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.
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U.S. Foreign Corrupt Practices Act
The U.S. Foreign Corrupt Practices Act, to which we are subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
Federal and State Fraud and Abuse Laws
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in the biopharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims statutes. We could face substantial penalties if we are unable to fully comply with these laws.
The federal healthcare program anti-kickback statute prohibits, among other things, persons or entities from knowingly and willfully offering, paying, providing, soliciting, or receiving remuneration, directly or indirectly, to induce or in return for purchasing, leasing, ordering, or arranging for the purchase, lease, or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.
The federal physician self-referral prohibition, commonly known as the Stark Law, prohibits physicians from referring Medicare or Medicaid patients to providers of ‘‘designated health services’’ with whom the physician or a member of the physician’s immediate family has an ownership interest or compensation arrangement, unless a statutory or regulatory exception applies.
Federal false claims laws prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false claim for payment from Medicare, Medicaid or other third-party payors to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the company’s marketing of the product for unapproved, and thus non-reimbursable, uses. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines, and imprisonment.
In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:
If our operations are found to be in violation of any of the laws and regulations described above or any other governmental laws or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in Medicare, Medi-Cal or other state or federal health care programs and/or the curtailment or restructuring of our operations, and we could be required to refund payments received by us. Any of the foregoing consequences could have a material adverse effect to our business, results of operations and financial condition.
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EMPLOYEES
Currently, our only employee is our founder, Chief Executive Officer and Executive Chairman, Joseph Hernandez. Mr. Hernandez, together with several select consultants and scientific advisory board members, has overseen the negotiation of our intellectual property licenses, building of our management and scientific team and relationships with third parties, and development of our strategic plan. We expect to convert many of our current consultants to full time employees post financing.
FACILITIES
Our corporate headquarters are located in New York, New York. We lease part of an office space and shared facilities, which in total encompasses approximately 2,000 square feet. Our lease began on May 1, 2014 and expires on June 30, 2016. Our monthly rent payments are $8,000 and our future minimum annual rental payments total $32,000 in fiscal year ending 2014, $96,000 in fiscal year ending 2015 and $72,000 in fiscal year ending 2016. These payments continue to accrue. We currently do not own or lease any laboratory space. We believe that our current facility (and future facility) is suitable and adequate to meet our needs and that additional space for our office and laboratory needs will be available as and when needed.
LEGAL PROCEEDINGS
From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities, especially since the biotechnology and pharmaceutical space is particularly litigious. Although the results of litigation and claims cannot be predicted with certainty, we are not currently party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business.
Management’s Discussion and Analysis
THE FOLLOWING DISCUSSION SHOULD BE READ TOGETHER WITH THE INFORMATION CONTAINED IN THE FINANCIAL STATEMENTS AND RELATED NOTES INCLUDED ELSEWHERE IN THIS CURRENT REPORT ON FORM 8-K.
Plan of Operations
Since our inception, we have focused on identifying product candidates, obtaining in-licenses for critical intellectual property rights, recruiting a scientific advisory board, formulating a development plan for our product candidates and initiating preclinical studies for our lead product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies.
We plan to perform preclinical and toxicology studies as well as work to initiate our manufacturing with CROs or at OSU. Overall, we do not plan to engage any employees for the development process, but may hire consultants or utilize the services of other third parties as necessary. We have developed business relationships that will likely be critical to us throughout our development process as we advance in our programs. Based on our relationship with Dr. Robert Lee, an advisor and consultant to the company, we expect to complete our preclinical work at Dr. Lee’s laboratory at OSU. Finally, we have a relationship with the OSU Comprehensive Cancer Center, which is expected to conduct our initial clinical trials for our therapeutic product candidates. We cannot provide any assurance that we will enter into agreements with these parties on acceptable terms, or at all.
Initially, we plan to continue preclinical studies on our lead product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies. We also intend to validate our delivery technology which, if successfully developed, could be used for any of our four product candidate applications.
Our therapeutic product candidates face a long road to commercialization. Before filing an IND and initiating our clinical trial programs, we must successfully complete the requisite preclinical and toxicology studies and engage CMC manufacturing for all therapeutic product candidates, and the pre-IND work for one therapeutic product candidate. We expect to complete our preclinical development of LumiralinTM by the end of 2016, at which time we will be able to file an IND and initiate clinical trials for LumiralinTM at the OSU Comprehensive Care Center. We can provide no assurance, however, that we will be able to complete the preclinical development of LumiralinTM or any of our other therapeutic product candidates.
We also intend to validate our delivery technology which, if successfully developed, could be used for any of our four product candidate applications.
For our therapeutic product candidates, there are a number of risks associated with the development and subsequent marketing of our candidate products, and we may never be able to successfully obtain approval or become profitable in the anticipated timeframe, if at all. For a more comprehensive discussion of these risks, please refer to the ‘‘Risk Factors’’ section of this Current Report.
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Results of Operations of Microlin, Bio, Inc. for the Fiscal Years Ended September 30, 2015 and September 30, 2015
We have not earned any revenues since the inception or our operations. During the fiscal year ended September 30, 2015, we incurred total expenses and a net loss of $1,965,631. Our expenses consisted of research and development expenses (principally the costs to obtain our patent portfolio) in the amount of $894,528, general and administrative expenses of $985,485, and interest expense of $85,617. By comparison, during the fiscal year ended September 30, 2014, we incurred expenses and a net loss of $4,469,236. Our expenses during the fiscal year ended September 30, 2014 consisted of research and development (also principally costs to obtain our patent portfolio) of $1,631,234, general and administrative expenses of $2,753,233, and interest expense of $84,769.
We were incorporated on July 30, 2013, and there is limited financial information about us upon which to base an evaluation of our performance. We are in development stage operations, have minimal assets and have not generated any revenues. We have incurred net losses in each month since our inception in July 2013 and have an accumulated deficit since inception of approximately $12,289,000. We expect to continue to incur significant losses in at least our first five years of operation and anticipate that our expenses will increase substantially as we:
· | initiate, accelerate and expand our research and development efforts, including our clinical development activities; |
· | add personnel to support our product development and, at a later time, commercialization efforts; |
· | maintain, expand and protect our intellectual property portfolio; and |
· | operate as a public company. |
We have incurred substantial research and development costs, consisting principally of our technology license costs, and these costs did not meet the capitalization criteria under US GAAP and therefore been expensed. We expect our research and development and specifically our clinical development expenses to increase for the foreseeable future as we continue the development of LumiralinTM and initiate the development our other product candidates and advance into clinical trials. Specifically, we expect to devote our capital primarily to the expense of the preclinical studies as well as seeking to commence Phase I of clinical trials, which may include the expense of manufacturing our therapeutic product candidates, patient expense and administrative expense. As we increase our development activity, we will need to increase the size of our management team to oversee the management of this work. If we are able to commercialize our therapeutic product candidates, we will also need to engage additional personnel to oversee the commercialization efforts.
Further, our intellectual property is central to our business, and we may need to acquire additional intellectual property in order to create a viable product. We may need to expend resources protecting our exclusive intellectual property rights from misuse by competitors and other parties through litigation or other legal action.
In addition, operating as a public company requires a number of compliance efforts, including financial reporting and other disclosures, and we will incur significant expense as a public company.
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Liquidity and Capital Resources
As of September 30, 2015, we had limited cash on hand and working capital deficit of $9,651,201. Our current liabilities consisted of $1,652,183 in accounts payable, accrued expenses of $4,377,727, notes payable to OSIF in the amount of $2,446,213, loans from our founder, Joseph Hernandez, in the amount of $430,379, and derivative liability resulting from certain equity anti-dilution rights held by OSIF in the amount of $752,700.
Sources of Liquidity
We have incurred losses and cumulative negative cash flows from operations since our inception. We anticipate that we will continue to incur losses for at least the next five years. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations. We will seek additional financing through equity offerings, debt financings, government or other third-party funding and other collaborations, strategic partnerships and licensing arrangements. However, there is no guarantee that we will be able to obtain additional financing on favorable terms, or at all.
From our inception, we have funded our operations principally with an advances from Joseph Hernandez, our founder, Chief Executive Officer and Executive Chairman. As of September 30, 2015, these advances totaled $430,379. The advances are short-term, non-collateralized, and non-interest bearing.
Cash Flows
For the periods ended September 30, 2015 and September 30, 2014, our cash flows were $0 and $1, respectively.
Future Funding Requirements
To date, we have not generated any revenue. We do not know when, or if, we will generate any revenue. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research and development of our lead therapeutic product candidate, LumiralinTM, and initiate the research and development of our other product candidates. In addition, we expect to incur additional costs associated with operating as a public company and hiring key personnel.
We expect to devote substantially all of the capital we may raise to the preclinical and initial clinical development of our therapeutic product candidates, the validation of our delivery technology, as well as the acquisition of other intellectual property rights as necessary for our business. The exact amount of cash required to move our business forward is difficult to forecast and will depend on many factors, including:
· | the need to expand our research and develop activities; |
· | the timing of the initiation and completion of therapeutic preclinical studies, clinical studies and the cost of these studies; |
· | clinical trial design and the associated number of patients; |
· | the outcome, costs and timing of seeking and obtaining FDA and other regulatory approvals; |
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· | results of our CLIA validation, preclinical studies and clinical work and the number of product candidates that we choose to advance as a result; |
· | the dynamics of the regulatory space; |
· | our need and ability to hire additional management and scientific personnel; |
· | the costs of acquiring, licensing and enforcing intellectual property rights; |
· | timing and costs associated with our marketing efforts; and |
· | the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future. |
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding and other collaborations, strategic partnerships and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or acquiring or disposing of certain assets. If we raise additional funds through other third-party agreements, such as licensing arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. We can provide no assurance, however, that we will be able to obtain additional financing on favorable terms, or at all.
License Agreements with OSIF
In September 2013, we entered into five patent and technology license agreements with OSIF, whereby we obtained certain intellectual property rights (OSIF Patent Rights), from OSIF relating to miR diagnostics, prognostics and therapeutics for lung cancer, colorectal cancer, prostate cancer and ovarian cancer, as well as a novel nucleic acid delivery technology that may be used to deliver miR therapies to cancer cells. The term of each agreement continues until the last to expire of the applicable patent rights licensed thereunder. In consideration of the licenses:
1. We paid OSIF a total non-refundable license initiation fee of $25,000 ($5,000 for each of the five licensing agreements) and is required to pay an additional fee of $500,000 ($95,000 for each of the four licensing agreements and $120,000 for one of the five licensing agreements) in year 2;
2. We issued 280,000 shares of common stock which have been assigned amounts equivalent to the estimated fair value of the securities issued during the year ended September 30, 2013.
3. OSIF received anti-dilution rights equal to 7% of our issued and outstanding share capital of the Company on a fully diluted basis. In January 2014, we issued an additional 30,258 common shares to OSIF pursuant to anti-dilution provisions in our licensing agreements with OSIF. The right shall lapse following a raise of at least $10,000,000 in a single transaction or a series of transactions of equity financing. The anti-dilution provision was determined to be a derivative liability, as the timing and number of shares which may be issuable are not determinable at September 6, 2013 (date of the OSIF agreements). The maximum liability of the instrument of $752,700 was charged to research and development expense during the year ended September 30, 2013. This liability is based upon the estimated value of shares potentially required to be issued under such agreements and is considered a level 3 measurement.
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4. We executed a term note with OSIF in the amount of approximately $2,363,000. The terms of the note require four payments of principal and interest in fixed installments of $100,000 beginning October 31, 2013 through December 31, 2014, and eight payments of principal and interest in fixed installments of approximately $273,000 beginning June 30, 2015 through March 31, 2017. The entire amount becomes immediately due in the event that we receive external funding of at least $10,000,000. Interest is charged at a 3.5% interest rate. In the event we do not make note payments as required, the agreements are technically in default with the patent portfolio reverting back to OSIF. In January 2014, we executed an amendment to one of the license agreements which increases the number of patents for which we have exclusive licensing rights. As consideration for the additional patents, we have agreed to pay additional upfront licensing costs of $25,000 and have agreed to increase the term note from approximately $2,363,000 to $2,446,000. Such amounts have not yet been paid. The execution of the note payable resulted in charges to research and development expense of approximately $83,000 for the year ended September 30, 2013. At September 30, 2015 and 2014, we have not made the payments as required under the license agreement. Although OSIF has informally accepted the deferral of the payments currently due until consummation of external funding by the Company, we have recorded the entire amount as current as of September 30, 2015 and 2014 due to the technical default.
5. We will pay OSIF annual license maintenance fees of $95,000 (in contract year 3), $35,000 (in contract year 4), $60,000 (in contract year 5) and $10,000 (each contract year thereafter);
6. We may be required to make future milestone payments upon the achievement of various milestones relating to regulatory approval or commercial events under the five licensing agreements plus additional occurrence specific costs which will depend on international and commercial growth; and
7. We will be required to pay OSIF a varying low single digit royalty rate of net sales relating to the licensed products. The license agreements also require annual minimum royalties, as defined in the agreements, beginning in the contract year ending December 31, 2015 and continuing in all contract years thereafter (minimum royalty payments will escalate annually through contract year December 31, 2019).
Under the terms of the license agreements, we are allowed to grant sublicenses or assign the license agreements to third parties. If the grant of a sublicense occurs, then we will be obligated to pay OSIF a varying percentage of all payments received from the sublicensees. If an assignment of any of the license agreements occur, we will be obligated to pay the greater of a specified amount or percentage, as defined in the agreements, of the gross consideration of the total transaction for contract years beginning December 31, 2014 and continuing in all contract years thereafter. The term of each agreement continues until the last to expire of the applicable patent rights licensed thereunder. We may terminate the agreements at any time upon 90 days' prior written notice. Four of the agreements require us to pay a termination penalty of $2,500,000 if the agreement is terminated by us in the first two years of the contract.
Going Concern
We have a working capital deficit and have suffered recurring losses from operations. For these reasons, our auditor has raised substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, results or operations, liquidity, capital expenditures or capital resources that is deemed material.
Critical Accounting Policies
In December 2001, the SEC requested that all registrants list their most “critical accounting polices” in the Management Discussion and Analysis. The SEC indicated that a “critical accounting policy” is one which is both important to the portrayal of a company’s financial condition and results, and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. As of September 30, 2015, we believe the following policies currently fit this definition:
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Equity-based compensation:
The Company recognizes compensation expense for all equity-based payments. Stock based compensation issued to employees is accounted for under Accounting Standard Codification (“ASC”) ASC 718-10, Compensation— Share Compensation” (“ASC 718-10”). The Company utilizes the Black- Scholes valuation method to recognize compensation expense over the vesting period. Certain assumptions need to be made with respect to utilizing the Black-Scholes valuation model, including the expected life, volatility, risk-free interest rate and anticipated forfeiture of the stock options.
The Company accounts for stock-based transactions with non-employees in which services are received in exchange for the equity instruments based upon the fair value of the equity instruments issued, in accordance with Accounting Standards Codification (“ASC”) 718-10 and ASC 505-50, Equity-Based Payments to Non-Employees. The value of such options, computed utilizing the Black-Scholes valuation model, is remeasured at the end of each period for any change in fair value from the previous valuation until the award vests. The Company begins expensing the awards to non-employees at the service commencement date.
Accounting for share-based compensation granted by the Company requires fair value estimates of the equity instrument granted. If the Company’s estimate of the fair value of stock-based compensation is too high or too low, it will have the effect of overstating or understating expenses. When stock-based grants are granted in exchange for the receipt of goods or services, the Company estimates the value of the stock-based compensation based upon the value of its common stock.
Derivative Instrument:
The Company accounts for its derivative instruments in accordance with ASC 815-10, “Derivatives and Hedging”. ASC 815-10 establishes accounting and reporting standards requiring that derivative instruments, including derivative instruments embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value. ASC 815-10 also requires that changes in the fair value of derivative instruments be recognized currently in results of operations unless specific hedge accounting criteria are met. The Company has not entered into hedging activities to date but has entered into a derivative (Note D).
Research and development:
One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in ASC 730, “Research and Development.” The Company’s patent portfolio consists of a large number of compounds and methodologies, substantially all of which are in the very early stage of development, and there is significant uncertainty as to future use and ability to make required payments to the licensor. Based on this consideration, the Company expensed payments made to in-license such patent portfolio. These costs are reflected in research and development expense in the statement of operations.
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The following are certain identifiable risk factors for Microlin’s business operations. Risk factors related to our former business operations have been excluded but can be found in prior filings with the Securities and Exchange Commission.
Risks Related to Our Financial Condition and Capital Requirements
We have a very limited operating history, have minimal assets, have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
We are a developmental stage emerging therapeutics company with minimal assets and a very limited operating history. Since our inception in July 2013, our operations have focused primarily on acquiring and in-licensing critical intellectual property rights from the Ohio State Innovation Foundation (OSIF), recruiting a management team and a scientific advisory board, preclinical development activities, as well as developing strategic company plans to identify and develop our therapeutics and bring them to market. We have only initiated preclinical studies on our lead therapeutic product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies, and have not yet initiated any clinical trials or obtained regulatory approvals for any of our commercial product candidates, or generated any revenue. We expect to continue incurring significant expenses and increasing operating losses for the foreseeable future. Our prior losses, combined with expected future losses, may have a material adverse effect on business, results of operations and financial condition.
We are unable to predict the timing and amount of additional expenses that we will incur in our efforts to generate revenue and become profitable, if we are successful at all. We anticipate that our expenses will continue to increase significantly in the foreseeable future due to the high costs associated with developing therapeutic product candidates. We intend to devote a significant amount of our capital to preclinical research and development of product candidates, acquisitions or in-licensing of intellectual property, if necessary, initiating clinical trials and seeking regulatory approval, complying with federal and state regulatory requirements, developing our intellectual property portfolio and hiring additional personnel to support our growth as a public company. Even if we obtain regulatory approval to market a product candidate, or obtain or develop critical intellectual property rights, our future revenues will depend on our ability to achieve sufficient market acceptance and adequate market share for our product candidates in those markets. If we continue to incur significant operating losses without the ability to offset such losses with revenue streams or the raising of additional capital, our business, results of operations and financial condition will be materially adversely affected.
We may be unable to fulfill our contractual commitments to OSIF. As a result, we may incur significant financial fees and may be required to terminate our license agreements with OSIF, which would have a material adverse effect on our business, results of operations and financial condition.
In September 2013, we entered into five patent and technology license agreements with OSIF, whereby we obtained the exclusive, worldwide rights and license to use, develop, manufacture, market and commercialize certain intellectual property rights. Each agreement requires us to make payments to OSIF upon the achievement of certain developmental and commercialization milestones relating to the licensed intellectual property rights. In addition, we will be required to pay to OSIF a royalty on the net sales of products and services whether or not they utilize the intellectual property rights. As we develop our product candidates, we expect to incur significant expenses and increasing operating losses for the foreseeable future without the ability to generate enough revenue to offset such expenses and losses. If we are unable to satisfy our milestone and royalty payment obligations to OSIF, we would be in default under the license agreements and may be required to return the licensed intellectual property rights to OSIF, which would have a material adverse effect on our business, results of operations and financial condition.
We have the right to terminate any of the license agreements upon prior written notice to OSIF. However, upon our breach of certain provisions in the license agreements, OSIF has the option to terminate the applicable agreement, change the applicable field of use or territory or change the license granted from an exclusive license to a non-exclusive license. We may be unable to pay the termination fee required under the agreements if we terminate one of the four miR-related agreements, which could cause OSIF to pursue a claim against us in court and cause us to incur additional costs. In addition, if we commit a breach and OSIF decides to terminate an agreement or modify the applicable field of use or territory in a license agreement, we may be unable to continue developing our product candidates and may never generate any revenue. If OSIF changes a license or all of the licenses to a non-exclusive license, our competitors may be able to license the same intellectual property rights on more favorable terms. Any of these events would have a material adverse effect on our business, results of operations and financial condition.
The terms of the license agreements, as amended, also require us to reimburse OSIF pursuant to a scheduled payment plan for patent costs, which amount to approximately $2,446,000 in the aggregate (including $200,000 in scheduled payments we have yet to make) as well as future patent costs to maintain the patents, which can be substantial. The unpaid patent costs accrue interest at a rate of 3.5% per annum.
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We have minimal assets and have never generated any revenue. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability.
Our company has two potential sources for revenue: out-licensing of our intellectual property, therapeutic revenue, and long-term partnership deals. As an emerging growth company with minimal assets and a limited operating history, we have yet to generate any revenue from these potential sources and do not expect to be profitable in the foreseeable future, if ever. Our ability to generate future revenues depends on our success in:
· | building our intellectual property portfolio by acquiring or in-licensing critical intellectual property rights; |
· | completing research and preclinical development of our product candidates; |
· | seeking and obtaining regulatory approvals of our therapeutic product candidates on a timely basis; |
· | entering into and maintaining long-term relationships with strategic partners on favorable terms; |
· | solidifying a commercialization process or producing a product at a reasonable cost by scaling up our manufacturing process; |
· | launching a product candidate for which we obtain regulatory and marketing approval and obtaining market acceptance of such product; |
· | building a sales force that can adequately create a distribution for our product; |
· | addressing regulatory changes and market developments in a cost-efficient manner; |
· | identifying and testing new product candidates; |
· | attracting, hiring and retaining qualified personnel; and |
· | addressing competing businesses and products in the market. |
Due to the uncertainties of clinical trials and pharmaceutical development, we may never generate revenue from product sales, or be able to predict the amount of additional expense we will incur in our efforts to achieve product sales. We may never become profitable if our product candidates or fail in clinical trials or do not gain regulatory approval or market acceptance. If we are able to obtain regulatory approval of a product candidate and bring it to market, we will incur significant costs that may substantially offset any revenue generated from the sale of such product. In addition, the market may not accept our product candidates or another competing business may infringe on our intellectual property and develop a similar and more cost efficient product. Even if we are able to successfully commercialize any potential product, we may never become profitable and may need to turn to alternative sources of funding to continue our operation, which may have a material adverse effect on our business, results of operations and financial condition.
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We will require substantial financing in order to pursue our business plan, which may not be available on acceptable terms, or at all.
We are currently undergoing preclinical research and development of product candidates and will need to raise additional capital in our efforts to advance such product candidates through clinical trials and ultimately bring them to market. Developing therapeutics is expensive and, as products move through the regulatory process to commercialization, unpredictable costs often arise. We expect that the cost for preclinical development of our four therapeutic product candidates up to Phase 1 will be approximately $10 to $14 million.
The process of raising capital could divert the attention of our management from the day-to-day operations of the company, which could delay or detract our ability to commercialize our product candidates, out-license our intellectual property or form strategic partnerships that are critical to our business. We may seek funding through a combination of equity offerings, debt financings, government or other third-party arrangements and other collaborations, strategic alliances and licensing arrangements. We may be forced to accept capital on non-ideal or onerous terms, which could adversely affect the holdings or the rights of our stockholders. If we are unable to obtain capital on a timely basis, on favorable terms, or at all, we may be required to significantly delay or discontinue one or more of our research or development programs, which could have a material adverse effect on the company. We may also be required to relinquish rights to some of our technologies or product candidates. Any of these events may have a material adverse effect on our business, results of operations and financial condition.
Our common stock could become diluted and the market price of our common stock could decline if we raise capital through equity or debt that converts into equity.
We may raise funds through the issuance of equity or debt securities which convert into equity. The issuance of these securities could substantially dilute the holdings of our stockholders. Furthermore, the terms of these securities may contain liquidation preferences or other preferences that adversely affect the rights of stockholders. The market price of our common stock may also decline if we issue additional securities, whether equity or debt. If we incur additional debt by issuing debt securities, a significant portion of our cash flow may be committed to the payment of principal and interest to cover such indebtedness, and we may be subject to restrictive financial covenants which inhibit our ability to incur additional debt, issue additional equity or license, acquire or dispose of strategic assets or intellectual property rights. Any of these developments could have a material adverse effect on our business, results of operations and financial condition.
Our recurring losses from operations may raise substantial doubt regarding our ability to continue as a going concern.
Our recurring losses from operations and lack of funding raise substantial doubt about our ability to continue as a going concern. As of September 30, 2015, we had not funded the company and as of September 30, 2015, we limited cash on hand. Joseph Hernandez has paid, and continues to pay, certain bills on our behalf. If not funded, we will not be able to meet certain obligations, including our obligations to OSIF under license agreements (including certain patent costs which remain unpaid), as they become due. Sufficient financing may not be available to us when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations, which could have a material adverse effect on our business, results of operations and financial condition.
Risks Related to Development of Our Product Candidates
We are highly dependent on the success of microRNA technology and we may not be able to develop the technology, successfully obtain regulatory or marketing approval for, or successfully commercialize, our therapeutic product candidates.
Our therapeutic focus is entirely based on microRNA technology, including the application of microRNA technology in cancer, and the success of our company is based on the viability of this technology and the development of our product candidates. Since our inception, we have focused our efforts on acquiring strategic intellectual property related to microRNA technology, recruiting a management team and board of directors, who have agreed to serve upon consummation of this offering, and establishing a scientific advisory board with substantial experience working with microRNA. Neither we nor any other company has received FDA regulatory approval to market therapeutics targeting microRNAs. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. The evidence that these microRNAs will work as a therapeutic is limited to mostly animal data and in vitro data, which does not reflect the full human in vivo condition. The effect of microRNAs as a therapeutic in humans has not been extensively tested and, as a result, the long-term safety, toxicology and efficacy of the therapy with respect to humans remains unknown. If our microRNA technology is found to be unsafe in humans, or if it never receives regulatory approval for commercialization, we will never be able bring our product candidates to market and may never become profitable.
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Further, our efforts are concentrated not only in microRNA technology, but also in its application in cancer. Our current strategy and licensed intellectual property is focused on targeting microRNA in only four types of cancer. This lack of diversification increases the risk associated with the ownership of our common stock. If we are unsuccessful in developing and commercializing microRNA technology and its application in these four types of cancer, we may have to alter the scope and direction of our company and steer away from the intellectual property we have acquired as well as the core capabilities of our management team and scientific advisory board. Without successful commercialization of our potential therapeutic products, we may never become profitable, which would have a material adverse effect on our business, results of operations and financial condition.
It is difficult to predict the time and cost of developing a viable microRNA-based product since it is a novel technology.
MicroRNA-based technologies are novel and relatively unproven. MicroRNAs are novel elements in the human genome, just recently understood, and their role in cancer was discovered less than ten years ago. The scientific knowledge related to microRNAs, their intracellular mechanism and their role in various forms of cancer continues to evolve and grow. For these reasons, it is difficult to predict the time and expense of developing a microRNA-based therapeutic product for cancer. This uncertainty may make it difficult for us to budget accurately, raise capital and hire appropriately, which are all elements critical to the success of our business. Delays and costs that are greater than expected may have a material adverse effect on our business, results of operations and financial condition.
All of our programs are still in preclinical development. Validation, preclinical testing and future clinical trials may not be successful or may experience delays, which would have a material adverse effect on our business, results of operation and financial condition.
To date, we have devoted our resources to identifying and developing product candidates and acquiring and in-licensing the intellectual property upon which we are building our clinical therapeutic product candidates. Our clinical therapeutic product candidates are currently in a preclinical development phase. We have only initiated preclinical studies on our lead therapeutic product candidate for lung cancer, LumiralinTM, including in vitro and in vivo animal studies. None of our product candidates have generated any revenue.
We may not be able to successfully complete the preclinical testing necessary to advance our therapeutic product candidates into clinical development, including animal pharmacology and toxicity studies. The results of any preclinical work may indicate that our therapeutic product candidates do not have the safety or efficacy necessary to file an Investigational New Drug (IND) with the FDA in order to move our product on to the clinical development process.
We expect to work with third party sites to conduct our clinical trials. If we are unable to sign up enough sites to conduct the trials, or manage the sites properly, there could be delays, increased costs or termination of the clinical trials all together.
Once we initiate the clinical development of our product candidates, it may be difficult to identify and qualify patients to participate in future clinical trials for our product candidates, and the timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing as well as completion of required follow-up periods. If patients are unwilling to participate in our clinical trials due to concerns over the safety of the product or for other reasons, the timeline for conducting the trials and obtaining regulatory approval may be delayed. Furthermore, we may also compete for patients with other companies conducting similar clinical trials. Any delays in our future clinical trials could result in increased costs, delays in product development or termination of the clinical trials altogether.
Any of these events could have a material adverse effect on our business, results of operations and financial condition.
We may fail to obtain orphan drug status for our product candidates.
We intend to seek orphan drug status from the FDA for LumiralinTM and OmiralinTM, two of our product candidates, for the treatment of ovarian cancer. In addition, we may seek orphan drug status for our other product candidates to the extent such product candidates are developed for ovarian cancer. Ovarian cancer therapies are eligible for orphan drug status under the Orphan Drug Act of 1983. The orphan drug status gives the manufacturer specific financial incentives to develop a pharmacological agent. If a product that has an orphan drug designation receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same medication for the same indication, except in very limited circumstances, for seven years. Failure to obtain an orphan drug designation for LumiralinTM and/or OmiralinTM may have a material adverse effect on our business, results of operations and financial condition.
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We may fail to demonstrate the safety and efficacy of our therapeutic product candidates in accordance with regulatory standards and may incur delays and substantial costs in our clinical trials.
In order to commercialize our therapeutic product candidates, we must conduct extensive clinical trials demonstrating the safety and efficacy of our product candidates in humans. The clinical testing process is expensive, difficult to design and implement, will take many years to complete and is unpredictable in both its duration and outcome. A failure of one or more clinical trials can occur at any stage of testing. There is a high failure rate for drugs and biological products proceeding through clinical trials. The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country to country. We are not permitted to market our product candidates as a prescription pharmaceutical product in the United States until we receive approval of a New Drug Application (NDA), from the FDA, or in any foreign countries until we receive the requisite approval from such countries. In the United States, the FDA generally requires the completion of preclinical testing and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before an NDA is approved. Regulatory authorities in other jurisdictions impose similar requirements. Of the large number of drugs in development, only a small percentage result in the submission of an NDA to the FDA and even fewer are eventually approved for commercialization. We have not submitted an NDA to the FDA or comparable applications to other regulatory authorities. Preclinical and clinical data is often susceptible to varying interpretations and types of analyses and regulatory authorities may fail to approve our product. In addition, even if we successfully complete early clinical trials, such results may not be indicative of the success or results of our later clinical trials.
Our successful completion of clinical trials may be materially adversely affected by many factors, including:
· | ineffective trial design and disagreement with the FDA on final trial design; |
· | imposition of a clinical hold following an inspection of our clinical trial operations by the FDA or other regulatory authorities; |
· | difficulties or delays in reaching an agreement with a contract research organization (CRO), and clinical trial sites; |
· | delays in obtaining required institutional review board (IRB) approval for each trial site; |
· | data collected from clinical trials may not be sufficient to support the submission of a NDA or other submission or to obtain regulatory approval in the United States or elsewhere; |
· | delays or difficulties in recruiting suitable patients to participate in clinical trials; |
· | delays in manufacturing or delivering products and materials to clinical trial sites; |
· | delays or difficulties caused by lack of patient adherence to treatment or post-treatment follow-up; |
· | delays caused by patients dropping out of a trial and the need for recruiting additional patients; and |
· | delays caused by clinical sites dropping out of the trial and the time required to recruit a new site. |
Any of the these delays or difficulties could cause us to be delayed in obtaining marketing approval from regulatory authorities, if at all, or allow us to obtain approval for specific indications or patient populations that are not as broad as currently targeted. In addition, such delays or difficulties may cause our development costs or our time to bring our product candidates to market to increase, may weaken our competitive positioning in the market and may have a material adverse effect on our business, results of operations and financial condition.
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Any of our therapeutic product candidates may cause adverse effects or have properties that could delay or prevent their regulatory approval or limit the scope of any specific indications or market acceptance.
Adverse events caused by our potential therapeutic product candidates could cause interruptions, delays or the halting of our clinical trials. If adverse effects are observed in any clinical trials for our therapeutic product candidates, we may be unable to obtain timely, or any, regulatory approval of our therapeutic product candidates. Adverse effects caused by our product candidates could also subject us to litigation and liability, which could have a material adverse effect on our business, results of operations and financial condition.
In addition, if any of our product candidates are approved for commercialization and are found to cause serious or unpredicted side effects, serious consequences may result, including but not limited to, the withdrawal of marketing approval by regulatory authorities, restrictions on distribution by regulatory authorities, the need to conduct additional clinical trials, litigation and potential liability for personal injury to patients and damage to our reputation. Furthermore, our ability to achieve and/or maintain profitability may be permanently impaired. Any of these events could have a material adverse effect on our business, results of operations and financial condition.
We cannot predict if or when we will receive regulatory approval to commercialize a therapeutic product candidate.
We cannot commercialize a product candidate until the appropriate regulatory authorities, such as the FDA or a state regulating authority, have reviewed and approved the product candidate. Even if our product candidates demonstrate safety and efficacy in clinical trials, regulatory agencies may not complete their review processes in a timely manner, and we may not be able to obtain timely regulatory approval. We may never be able to receive regulatory approval for our product candidates at all. Additional delays may result if an FDA advisory committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory agency policy during the period of product development, clinical trials and the review process. Regulatory agencies also may approve a product candidate for fewer or more limited indications than requested or may grant approval subject to the performance of post-marketing studies. In addition, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our treatment candidates. Delays or failure to obtain necessary regulatory approvals could have a material adverse effect on our business, results of operations and financial condition.
Even if we obtain regulatory approval for a product candidate, we will remain subject to extensive regulatory scrutiny.
Even if we obtain regulatory approval in the United States for our product candidates, the FDA and/or other appropriate regulatory agencies may still impose significant restrictions or delays, including restriction of patient population or indications or additional costly studies. Any changes to the approved product or its labeling or manufacturing process would require FDA approval. Any advertisements or promotions must comply with FDA regulations and are subject to FDA review as well as state and federal laws. Drug product manufacturers are subject to continual review and inspection by the FDA and other regulatory authorities to comply with cGMP. If the FDA or other regulatory authority finds previously undiscovered compliance issues with products, such as unanticipated adverse effects or issues with the manufacturing facility, the FDA or other regulatory authority may:
· | issue a warning letter asserting that we are in violation of law; |
· | seek an injunction; |
· | impose civil or criminal penalties or monetary fines; |
· | suspend or withdraw regulatory approval; |
· | suspend currently ongoing clinical trials; |
· | refuse any pending applications; |
· | seize product; or |
· | prohibit us from entering into beneficial or necessary contracts such as supply or government contracts. |
Any government investigation of alleged violations of law could require us to expend significant time and resources in response, could result in litigation and litigation-related expense and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue, which would have a material adverse effect on our business, results of operations and financial condition.
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In addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Any regulatory approval that we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render our products not commercially viable. For example, regulatory authorities may approve our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve our products with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that indication. Further, the FDA may place conditions on approvals including potential requirements or risk management plans and the requirement for a Risk Evaluation and Mitigation Strategy (REMS) to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our product candidates.
Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of our product candidates and have a material adverse effect on our business, results of operations and financial condition.
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our product candidates, when and if developed and approved, we may not be able to successfully commercialize our product candidates.
Market acceptance and sales of our product candidates, when and if developed and approved, will depend on reimbursement policies and may be affected, among other things, by future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. Reimbursement by a third party payor may depend on a number of factors, including whether lower cost alternatives are available. Since each third party payor makes its own decision as to whether to establish a policy or enter into a contract to reimburse our product candidates, seeking these approvals is a time-consuming and costly process, and we may never secure reimbursement from any third party payors. Reimbursement may not be available for our product candidates. In addition, reimbursement
policies may reduce the demand for, or the price paid for, our product candidates. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize our product candidates. Further, physicians may not order or prescribe our clinical therapeutic product candidates unless third party payors reimburse a substantial portion of the price.
In addition, hospital formulary approval and reimbursement may not be available for our therapeutic product candidates, which could make it difficult for us to sell products profitably. In order for government or third party payors to reimburse hospitals for our therapeutic product candidates, such product candidates must be added to the hospital formularies. Obtaining formulary approval can be an expensive and time consuming process and we may not be able to obtain such approval. Failure to obtain timely formulary approval may limit our commercial success.
In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) changed the way Medicare covers and pays for pharmaceutical products. The legislation established Medicare Part D, which expanded Medicare coverage for outpatient prescription drug purchases by the elderly but provided authority for limiting the number of drugs that will be covered in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices for physician-administered drugs. Any negotiated prices for our product candidates covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain in the United States. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payors.
The United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our product candidates profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. We expect to experience pricing pressures in connection with the sale of any products that we develop, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals.
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In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, ‘‘ACA’’) became law in the United States. The goal of ACA is to reduce the cost of health care and substantially change the way health care is financed by both governmental and private insurers. Although we cannot predict what impact on federal reimbursement policies this legislation will have in general or on our business specifically, the ACA may result in downward pressure on pharmaceutical reimbursement, which could negatively affect market acceptance of our product candidates. In addition, some members of the U.S. Congress have been seeking to overturn at least portions of the ACA and we expect they will continue to review and assess this legislation and alternative health care reform proposals. We cannot predict whether new proposals will be made or adopted, when they may be adopted or what impact they may have on us if they are adopted.
Any of these developments and events could have a material adverse effect on our business, results of operations and financial condition.
Risks Related to Our Reliance on Third Parties
We plan to rely on third parties to conduct our preclinical testing and clinical trial design and management for our potential therapeutic products, and these third parties may not perform satisfactorily.
We have a relationship with a laboratory at OSU for preclinical testing of our therapeutic product candidates and with the OSU Comprehensive Cancer Center for clinical trial design and management. Our success in developing our potential therapeutic product candidates is dependent on the success of our relationships with these third parties. These third parties could be unable or unwilling to meet our needs and timelines for clinical trial design and management for a number of reasons, including, but not limited to:
· | turnover of staff; |
· | unexpected and unprojected costs; |
· | new leadership with a changing focus for the organization; |
· | occurrence of unexpected events which may delay completion of the work; |
· | difficulties in obtaining internal review board approval; |
· | difficulties in gaining access to necessary materials and samples; or |
· | difficulties in recruiting suitable patients for clinical trials. |
If we enter into formal agreements with either of these third parties for preclinical testing or clinical trial design and management, either party may fail to successfully carry out their contractual obligations, meet expected deadlines or conduct studies in accordance with regulatory requirements or our stated protocols, causing us to delay or stop the completion of the preclinical studies and clinical trials required for approval of our product candidates. We may also face liability for their failure to comply with regulatory requirements. Either of these third parties may also decide to end their relationship with us at any time upon the occurrence of certain conditions. If we need to enter into alternative arrangements, our product candidates development activities may be critically delayed, which could have a material adverse effect on our business, results of operations and financial condition. In addition, we may be unable to enter into agreements with the OSU Comprehensive Cancer Center or with other third parties on favorable terms, or at all.
The concentration of our clinical efforts with OSU also means that our success is closely tied to a single relationship. If OSU were to terminate this relationship, or if adverse effects beyond our control caused the University to neglect its contractual obligations to us, our business would be materially impaired. Specifically, if OSIF terminates our license agreements whereby we have exclusively in-licensed a portfolio of issued and pending patents, our business, results of operations and financial condition may suffer materially, as this intellectual property in central to the therapeutic parts of our business. Without access to this intellectual property, we may be unable to continue in the clinical development or commercialization processes, which would have a material adverse effect on our business, results of operations and financial condition.
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We intend to rely on third party manufacturers to produce the preclinical, clinical trial, and commercial supply of our product candidates.
We do not currently have, nor do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredient (API) in our product candidates for use in our clinical trials or for commercial products, if any. In addition, we do not have the capability to encapsulate our product candidates as a finished drug product for commercial distribution. We intend to rely on third parties to manufacture the supplies for our preclinical and clinical trials for our potential therapeutic products. Reliance on third-party manufacturers creates exposure to risks to which we would not be subject if we manufactured the product candidates ourselves, including:
· | the inability to meet any product specifications and quality requirements consistently; |
· | a delay or inability to procure or expand manufacturing capacity as necessary; |
· | issues with product quality as manufacturing production scales up; |
· | the inability to negotiate with suppliers on reasonable terms; |
· | reliance on certain sources for raw materials and in some cases single sources; |
· | operations of our third party manufactures could be disrupted by conditions unrelated to our business or condition; |
· | failure to deliver products in a timely manner; |
· | increased costs that cannot be controlled; and |
· | non-compliance with regulatory requirements, including cGMP standards. |
Any of these events could lead to delays in the development of our product candidates, including delays in our preclinical and clinical trials, or it could impact our ability to successfully commercialize our current product candidates or any future products. Some of these events could be the basis for action from regulatory authorities, including injunction, or partial or total suspension of our production. In addition, we may be unable to enter into agreements with suppliers or manufacturers on favorable terms, or at all.
Additionally, to the extent we rely on third parties as sole suppliers of critical materials used in our development and production process, we may not be able to find alternative sources if our suppliers are no longer able to provide these materials. If we are unable to procure such materials from alternative sources, we could experience an interruption to our operations. Such an interruption could slow or stop our development processes and cause us to fail to meet certain critical milestones, impair customer and third party relationships, lead to the termination of our license agreements and negatively affect our ability to generate revenue, which may have a material adverse effect on our business, results of operations and financial condition.
The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit our NDA to the FDA. We will not control the manufacturing process of, and will be completely dependent on, our contract manufacturing partners for compliance with cGMPs for manufacture of both active drug substances and finished drug products. These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our product candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
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Our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. We will not have control over our contract manufacturers’ compliance with these regulations and standards.
Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market our product candidates, delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market our product candidates. Any of these events could have a material adverse effect on
our business, results of operations and financial condition.
Our reliance on third-party relationships will subject us to the downstream effects that any of our future partners’ may experience.
Our business model is to outsource processes and operations wherever possible and we, therefore, expect be dependent on third parties for multiple aspects critical to our business. As such, any events or changes that have an effect on the third parties that we work with will likely have an effect on our business as well. Events for our third party partners that could have a significant effect on our business include:
· | employee turnover causing interruptions or delays in production; |
· | leadership change causing shift in organizational goals; |
· | bankruptcy or other financial issues halting or shutting down operations; |
· | surges in costs triggering renegotiation of contracts or inability to renew contracts on mutually satisfactory terms; or |
· | a natural disaster which halts operations. |
We may not be able to anticipate the effect such events or changes will have on our business or our relationship with our third party partners. If such events or changes materially affect the ability of our third party partners to adequately perform their contractual obligations, we may be unable to complete our clinical trials or product development in a timely and cost-effective manner, which may affect our ability to become profitable and have a material adverse effect our business, results of operations and financial condition.
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Interruptions in the supply of product or inventory loss may have a material adverse effect on our business, results of operations and financial condition.
Our product candidates will likely be manufactured and distributed using technically complex processes requiring specialized facilities, specific raw materials and other production constraints. The complexity of these processes, as well as strict company and government standards for the manufacture and storage of our future products, will subject us to production risks. While product batches released for use in clinical trials will undergo sample testing, some defects may only be identified following product release. In addition, process deviations or unanticipated effects of approved process changes may result in these intermediate products not complying with stability requirements or specifications. Our product candidates will also need to be stored and transported at temperatures within a certain range. If environmental conditions deviate, our product candidates’ remaining shelf-lives could be impaired or their efficacy and safety could be adversely affected. The occurrence or suspected occurrence of production and distribution difficulties can lead to lost inventories, and in some cases, product recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays, substantial expense, lost sales and delays of new product launches. Any interruption in the supply of finished products or the loss thereof and any unforeseen failure in the storage of the product or loss in supply could delay our clinical trials and, if our product candidates are approved for commercialization, result in a loss of our market share. Any of these events could have a material adverse effect on our business, results of operations and financial condition.
We may never form any long-term partnership deals due to our clinical program results, the perceived value of our intellectual property or the competitive environment of therapeutics.
We may never be able to engage a pharmaceutical or biotech partner to move forward and form a long-term partnership. Our clinical data may not be clinically relevant to potential partners or the results of our preclinical and clinical work may not be sufficient to develop clinically viable products. Potential partners may not perceive any value in the intellectual property that we have licensed, or the competitive environment may change such that our intellectual property or clinical programs are believed to be lacking in value or not having a market opportunity. Our inability to form such partnerships, as needed, may have a material adverse effect on our business, results of operations and financial condition.
Risks Related to Our Intellectual Property
Our failure to comply with our obligations in the agreements under which we license intellectual property rights from third parties could cause us to lose license rights that are critical to our business.
We have built our portfolio of intellectual property rights through exclusive in-licensing deals with OSIF that are important to the development of our business and we expect that we may need to enter into additional license agreements in the future. Our existing license agreements impose certain developmental and commercial milestones which we must meet in order to maintain the exclusivity of our licenses. We are also obligated under the license agreements to make certain payments to OSIF, including payment for the remaining balance of the upfront fee for each license agreement, which we have agreed with OSIF to pay from the net proceeds of this offering. Our failure to meet the terms of these license agreements could result in non-exclusivity or revocation of our intellectual property rights, which would have a material adverse effect on our business, results of operations and financial condition.
We expect that we will need to enter into additional licensing agreements in the future as we develop and build our therapeutic product candidates and move them towards commercialization. We may be unable to obtain key licenses on commercially reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected therapeutic product candidates, which would have a material adverse effect on our business, results of operations and financial condition.
Licensing intellectual property is critical to our business and involves complex legal, business and scientific issues. Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including disputes related to the scope of rights granted under the agreement. Disputes with our licensors may hinder our ability to maintain our current licensing arrangements on acceptable terms, which may jeopardize the successful development and commercialization of the affected therapeutic product candidates and have a material adverse effect on our business, results of operations and financial condition.
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We may not be successful in obtaining or maintaining the rights to microRNA intellectual property, which would have a material adverse effect on our business, results of operations and financial condition.
We currently have the rights to intellectual property related to certain microRNAs through licenses from third parties to develop therapeutic and diagnostic product candidates. Because our programs may involve additional therapeutic or diagnostic product candidates that may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license or maintain these proprietary rights.
In order to protect the intellectual property to which we have rights, we rely on a combination of issued and pending patents which we have licensed, patent applications, trade secret protection and confidentiality agreements with various parties. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we in-license or may own in the future may fail to result in issued patents with claims that cover the products in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to our licensed and future patents and patent applications has been or will be found, which can invalidate a patent or prevent a patent from issuing based on a pending patent application. Even if patents do successfully issue, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed or invalidated. Furthermore, even if they are unchallenged, our licensed and future patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims.
If the patent applications we hold or have in-licensed with respect to our programs or product candidates fail to issue or if their breadth or strength of protection is threatened, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize, future products. We may never have a patent issued and our patents may be found to be invalid and unenforceable or threatened by third parties.
We may also be unable to acquire or in-license any additional third-party intellectual property rights due to:
· | companies that perceive us to be a competitor being unwilling to license; |
· | an inability to come to mutually agreeable terms with universities, companies or other third parties who hold critical intellectual property rights; |
· | delays in coming to agreeable terms; and |
· | competitors with greater resources and a more established business seeking to license the same rights. |
In addition, the United States Patent and Trade Office (USPTO) could decide not to grant us intellectual property rights to currently pending patent applications which will be integral to our business, which may have a material adverse effect on the development of our product candidates. Our failure to acquire the necessary intellectual property rights to commercialize viable therapeutic product candidates in a reasonable timeframe could have a material adverse effect on our business, results of operations and financial condition.
Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced. Since patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we may not be the first to file any patent application related to a product candidate. Furthermore, if third parties have filed such patent applications, an interference or derivation proceeding in the United States can be initiated by a third party to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. In addition, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Once the patent life has expired for a product, we may be open to competition from generic medications.
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In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our drug discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Although we expect our employees to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we face risks of not all such agreements being duly executed or enforceable, our trade secrets and other confidential proprietary information being disclosed, and competitors otherwise gaining access to our trade secrets or independently developing substantially equivalent information and techniques. In addition, others may independently discover our trade secrets and proprietary information.
Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our market.
Any of these events may have a material adverse effect on our business, results of operations and financial condition.
We may be involved in lawsuits relating to intellectual property, either to protect or enforce any future patents we may develop or the patents of our licensors, or to defend against third party claims of intellectual property infringement, which may prevent or delay our development and commercialization efforts and could be expensive, time consuming and unsuccessful.
Disputes relating to ownership of intellectual property in the biotechnology and pharmaceutical fields often lead to litigation. We may choose or be forced by our licensors to file lawsuits against third parties to protect against infringement of our large portfolio of licensed intellectual property rights which we would have to fully fund or risk losing exclusivity to those patents involved to any alleged infringer, or any intellectual property we may develop in the future. In addition, there may be third party claims filed against us asserting that we are employing third party proprietary technology without the appropriate authorizations, such as claims related to the materials, formulations, manufacturing processes or treatment protocol for our therapeutic product candidates which we would also be forced to fund pursuant to our license agreements. Litigation can be expensive and time-consuming, cause a substantial diversion of our resources and time and could distract management focus from critical decisions, lead to disclosure of our confidential information, and damage the perception of our business by investors and potential partners, causing a decline in the price of our common stock.
Legal proceedings may never result in a favorable outcome for our business. In an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid, is unenforceable and/or is not infringed, or may refuse to stop the other party from using the technology at issue on the grounds that our patents or the patents of our licensors do not cover the technology in question. A third-party defendant may also request post reexamination, grant review or inter parties review by the USPTO of any patent we assert.
An adverse result in any litigation or defense proceedings could put one or more of our licensed patents or any future patents we develop at risk of being invalidated or interpreted narrowly and could put any of our future patent applications at risk of not issuing, which would have material adverse effect on our business, results of operations and financial condition as our intellectual property is a fundamental part of what distinguishes us from competitors.
Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our therapeutic product candidates. Because patent applications can take many years to issue, third parties may have currently pending patent applications which may later result in issued patents that our product candidates may infringe, or which such third parties claim are infringed by the use of our technologies. If any third-party patents are held by a court of competent jurisdiction to cover any aspect of the manufacturing process for any of our therapeutic product candidates, any molecules formed during the manufacturing process, or any final therapeutic product candidate, including the formulation or method of use of such product candidate, the holders of any such patents may be able to block our ability to commercialize such product candidates unless we obtained a license under the applicable patents, or until such patents expire. In any such case, such a license may not be available on commercially reasonable terms, or at all.
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Parties making claims against us for infringement of their intellectual property rights may obtain injunctive or other equitable relief, which could effectively block our ability to develop one or more of our product candidates. In the event of a successful claim of infringement against us, we could be required to redesign our infringing product candidates or obtain a license from such third party to continue developing and/or commercializing these products candidates. We may be unable to obtain any required license on commercially reasonable terms, or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. It may be impossible to redesign our product candidates and technology, or it may require substantial time and monetary expenditure, which could force us to cease commercialization of one or more of our product candidates, or some of our business operations, which could have a material adverse effect on our business, results of operations and financial condition. In addition, in any such proceeding, we may be required to pay substantial damages, including treble damages and attorneys’ fees in the event we are found liable for willful infringement.
Interference or derivation proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions with respect to any of our future patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Any of these developments may have a material adverse effect on our business, results of operations and financial condition.
Risks Related to Commercialization of Our Product Candidates
We face significant competition from other biotechnology and pharmaceutical companies and our business, results of operations and financial condition will suffer if we fail to compete effectively.
The biotechnology and pharmaceutical space is highly competitive. We have competitors in the therapeutic space in the United States and internationally. We are aware of several other companies with microRNA-based therapeutics, including miRagen Therapeutics, Inc., Regulus Therapeutics, Inc., and Mirna Therapeutics, Inc.. Many of these and other competitors draw from substantially greater financial, scientific and other resources, including a large development staff, a built-out operation, experienced manufacturers as well as stronger and more strategic relationships and partnerships within the industry.
Any of our competitors could succeed in developing a therapeutic product that is more effective, less costly or more marketable or integrates more easily into the standard of care. Our competitors could commercialize and market their products sooner than us, and we could have difficulty in converting physicians to our product. Once other competing products are established, our product candidates would have to show incremental efficacy or price point advantage in order to convert physicians to our product candidates. The inability to do so, or the extra effort required to do so, could have a material adverse effect on our business, results of operations and financial condition.
The commercial success of our product candidates will depend upon the degree of market acceptance by the medical community, including physicians, patients and third party payors.
The commercial success of our product candidates will depend in part on the medical community, patients and third-party payors accepting microRNA therapeutic products as medically useful, cost-effective and safe. If our product candidates do not achieve an adequate level of market acceptance, we may not generate meaningful or any product revenue and may never become profitable. The degree of market acceptance of these product candidates, if approved for commercial sale, will depend on a number of factors, including:
· | the potential and perceived efficacy and advantages of such product candidate as compared to alternative treatments; |
· | the clinical indications for which the product candidate is approved; |
· | the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling; |
· | relative convenience and ease of administration; |
· | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
· | acceptance by physicians and patients of the product as a safe and effective treatment; |
· | the existence of other microRNA therapeutic products; |
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· | the safety of such product candidate seen in a broader patient group; |
· | the cost of treatment in relation to alternative treatments; |
· | the strength of marketing and distribution support and timing of market introduction of competitive products; |
· | the effectiveness of our sales and marketing efforts; |
· | publicity concerning our product candidates or competing products and treatments; and |
· | sufficient third-party insurance coverage or reimbursement. |
Even if a potential product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of the product candidates may require significant resources and may never be successful. Such efforts to educate the marketplace may require more resources than are required by the conventional technologies marketed by our competitors. If we do not obtain significant additional resources or our product candidates are unable to achieve the level of acceptance by all of these parties, our sales volume will likely suffer and our business, results of operations and financial condition could suffer as well.
Furthermore, market acceptance and sales of any future product candidates that we develop will depend on reimbursement policies and may be affected by future healthcare reform measures. Government authorities and third party payors, such as private health insurers, hospitals and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels. Reimbursement may not be available for any future product candidates. Also, reimbursement amounts may reduce the demand for, or the price of, our future product candidates. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize future product candidates that we develop.
Any of these events would have a material adverse effect on our business, results of operations and financial condition.
If we are unable to establish sales and marketing capabilities to effectively sell our product candidates, we may be unable to generate any revenues.
We currently do not have a sales force available to market either our potential therapeutic product candidates. In order to generate revenues from an approved product candidate, we will either have to build our own sales and marketing team or contract with third parties to create a sales and marketing function. We may be unable to create a team or a capability that will effectively be able to market our product candidates at the volume and price point that we require for the success of our business. Our sales force will likely be competing with those of companies with more sales and marketing experience and which have access to better resources, financial or otherwise. We may be unable to build an effective sales and marketing team, which may materially affect our profitability and materially adversely impact our business, results of operations and financial condition.
If we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure, or if we do not successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing our product candidates, which would have a material adverse effect on our business, operating results and financial condition. Outside the United States, we intend to commercialize our product candidates by entering into collaboration agreements with pharmaceutical partners. We may not be able to enter into such agreements on terms acceptable to us, or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties.
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We may not be able to produce our therapeutic product candidates within a viable cost structure.
Even if we are able to prove safety and efficacy for our product candidates and obtain regulatory approval, we may fail to produce our therapeutic product candidates within a reasonable cost structure. As a result, we may not be able to market our product candidates at a price point that will allow us to be profitable. Further, as we move through the validation and development processes, we may need to incorporate additional materials into our product candidates to meet regulatory guidelines. These additional materials may raise our cost of production in a way that we cannot anticipate. If our production costs are elevated, it is possible that we will be unable to offset such costs, which may negatively affect our profitability and materially adversely impact our business, results of operations and financial condition.
Risk Related to Our Business Operations and Industry
Our future success depends on our ability to attract and retain talent for our management team, board of directors and staff.
We are highly dependent on the members of our executive management team to drive the success of our business. As the corporation has only been in existence for less than three years, we currently only have one employee (our Chief Executive Officer) and several consultants. We face a risk that one or more individuals who have agreed to serve as members of our management team upon the consummation of this offering may be unwilling or unable to do so. The loss of any of the members of our management team could adversely affect our operations and could cause significant delays in the development of our product candidates. The search for a replacement could be costly, time consuming and distracting from our core business. Recruiting and retaining our non-managerial employees is also critical for our business, including scientific and technical personnel. There is currently a dearth of qualified executives and skilled personnel in our industry, and as a result, competition for such talent will be very strong between us and our competitors and turnover rates may be high. Any difficulties in these areas could compromise our validation, development or commercial processes and have a material adverse effect on our business, results of operations and financial condition.
We have scientific and clinical advisors and consultants who assist us in formulating our research, development and clinical strategies. These advisors are not full-time employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us and typically they will not enter into non-compete agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. Any difficulties in these areas could have a material adverse effect on our business, results of operations and financial condition.
As our business evolves and grows in scale, we will have to expand our organization and may face difficulties in managing this growth, which could slow or halt our operations.
Our business is currently in its very early stages, and we expect that our headcount and number of functions will grow significantly as we progress through the validation and development process and the potential commercialization of our product candidates. This will require us to recruit, maintain, manage and motivate additional employees. Given the shortage of skilled employees in our field, it may be difficult to recruit the necessary number of additional employees.
In addition, we may be unable to effectively manage the growth of our organization, which may result in weakness or inefficiencies in our infrastructure. Expansion may also require significant capital expenditure that could require us to seek additional capital. This expansion could divert the focus of our management and employees from our core business and divert our financial resources. If we do not effectively manage our growth, this could have negative consequences on our ability to commercialize and effectively market our product candidates, which could have a material adverse effect on our business, results of operations and financial results.
Our employees, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business, results of operation and financial results.
We are exposed to the risk of fraudulent conduct or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional recklessness and/or negligent conduct that fails to: comply with FDA regulations or regulations from other authorities, provide accurate information to the FDA, comply with healthcare fraud and abuse laws in the United States, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. Such misconduct could lead to governmental investigations or other claims or lawsuits. If we face any of these actions and are not able to successfully defend ourselves, we could face significant penalties or sanctions and damage to our reputation, which could have a material adverse effect on our business, results of operations and financial condition.
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We face potential product liability, and, if successful claims are brought against us, we may incur substantial litigation, costs and damage to our reputation.
The use or misuse of our product candidates in clinical trials and the sale of any products for which we obtain marketing approval expose us to the risk of product liability claims. Product liability claims may be brought against us by a number of parties, including physicians, patients, biotechnology or pharmaceutical companies, hospitals, manufacturing personnel, or anyone who comes into contact with our product or our personnel. There is a risk that our product candidates may induce adverse effects or fail to perform as intended. If we are unable to successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:
· | harm to our business and product reputations; |
· | withdrawal of clinical trial participants; |
· | substantial costs due to litigation, monetary awards to patients or other claimants; |
· | inability to commercialize our future products; |
· | decrease in demand for our candidate products; and |
· | product recalls, withdrawals or labeling, marketing or promotional restrictions. |
Upon the consummation of this offering, we plan to obtain, but do not currently have in place, limited product liability insurance coverage for our preclinical and any subsequent clinical activities in the United States. Our insurance coverage, once in place, may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. In addition, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to product liability. A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, or if brought at the time when we do not have such insurance coverage, could have a material adverse effect on our business, results of operations and financial condition.
Interruptions to our business could delay the development, validation, production and sale of our product candidates.
Our headquarters are in New York City, NY and our clinical trials are expected to be conducted in Columbus, OH. If we enter into this relationship, we will be vulnerable to natural disasters in any of these locations or other disasters such as terrorist attacks, which is a particular threat to New York City where our headquarters are located.
Columbus, OH, is prone to tornadoes and other natural disasters. We do not have insurance against natural disasters and such an event could cause a significant delay in our operations, which could have a material adverse effect on our business, results of operations and financial condition.
In addition, as described above, our strategy is to outsource as many of our development and manufacturing functions as possible. Currently, we are still in discussions to determine which third party suppliers we will engage. However, once we engage with various third parties, we are also exposed to the risks of interruptions to their businesses, which could cause interruptions in our own business, delay our operations and have a material adverse effect on our business, results of operations and financial condition.
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If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, results of operations and financial condition.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. For our research and manufacturing operations, we intend to contract with third parties and cannot completely eliminate the risk that such third parties will be non-compliant with these regulations. We could be held liable for damages as well as incur fines or penalties, which could create additional costs and materially harm our business. In addition, we could suffer damage to our reputation, which could affect our ability to successfully build and grow our business. Any of these events could have a material adverse effect on our business, results of operations and financial condition.
We are subject to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.
We are subject to health care fraud and abuse regulation and enforcement by both the federal government and the states in which we conduct our business. These health care laws and regulations include, for example:
· | the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs; |
· | the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients to providers of ‘‘designated health services’’ with whom the physician or a member of the physician’s immediate family has an ownership interest or compensation arrangement, unless a statutory or regulatory exception applies; |
· | the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which established federal crimes for knowingly and willfully executing a scheme to defraud any health care benefit program or making false statements in connection with the delivery of or payment for health care benefits, items or services; |
· | federal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us to the extent that our interactions with customers may affect their billing or coding practices; and |
· | state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers. |
If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the violation, including civil and criminal penalties, damages and fines, and/or exclusion from participation in Medicare, Medi-Cal or other state or federal health care programs, we could be required to refund payments received by us, and we could be required to curtail or cease our operations. Any of the foregoing consequences could have a material adverse effect on our business, results of operations and financial condition.
Our business, results of operations and financial condition would suffer in the event of system failures.
Our internal computer systems and those of our current and potential collaborators, contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. If any material system failure, accident or security breach were to occur and cause interruptions to our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Confidential information sensitive to the development of our product candidates could also be disclosed. Likewise, we intend to rely on third parties to manufacture our product candidates and conduct our clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business, results of operations and financial condition. 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 liabilityand the further development of our product candidates could be delayed, which could have a material adverse effect on our business, results of operations and financial condition.
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We may become subject to litigation, which could materially adversely affect us.
We may become subject to litigation, including claims relating to our operations, security offerings and otherwise in the ordinary course of business. Although we intend to defend any such lawsuits vigorously, any such claims and lawsuits could divert our management’s attention, cause us to incur defense costs, and could result in judgments against us. We cannot be certain of the ultimate outcomes of any claims that may arise, and any significant judgments could materially adversely impact us.
Risks Related to Ownership of Our Common Stock
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
The trading market for our common stock will depend on the research and reports that securities or industry analysts publish about us or our business. We do not have any control over these analysts. There can be no assurance that analysts will cover us or provide favorable coverage. If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our share price would likely decline. 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 could cause our share price or trading volume to decline.
Our shares are held by two principal stockholders who may be able to exert significant control over the company. Joseph Hernandez, our Chief Executive Officer and Executive Chairman, and OSIF currently hold all issued and outstanding shares of our common stock.
Joseph Hernandez, our Chief Executive Officer and Executive Chairman, and OSIF beneficially own a total of 95% of all of our issued and outstanding shares of our common stock. These stockholders may be able to determine all matters requiring stockholder approval, and, if acting together, may be able to control the amending of our organizational documents, the election of directors or the approval of corporate transaction. This control may deter investors or unsolicited acquisition proposals or offers for our common stock or our business that you may believe are in your best interest as a stockholder. Any of these events could have a material adverse effect on our business, results of operations and financial condition.
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 are an ‘‘emerging growth company,’’ as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not ‘‘emerging growth companies,’’ including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports 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. We could be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier, including if the market value of our common stock held by non-affiliates exceeds $700 million as of any fiscal year end before that time or if we have total annual gross revenue of $1.0 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company as of fiscal year end or, if we issue more than $1.0 billion in non-convertible debt during any three year period before that time, we would cease to be an emerging growth company immediately.
Even after we no longer qualify as an emerging growth company, we may still qualify as a ‘‘smaller reporting company,’’ which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. Some investors may find our common stock less attractive because we rely on these exemptions, there may be a less active trading market for our common stock and our stock price may be more volatile.
We have elected not to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(2) of the JOBS Act that allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Section 107 provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.
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If we are unable to establish and maintain effective disclosure controls and procedures, including an effective system of internal control over financial reporting, our business, results of operations and financial condition could be materially adversely affected.
We must maintain effective disclosure controls and procedures, including internal control over financial reporting, to provide reliable financial reports and to prevent and detect fraud and other improprieties. Since inception we have had a limited number of transactions and have not yet established an internal control system. Accordingly, we do not have effective internal controls over financial reporting. If we are unable to maintain effective disclosure controls and procedures, including an effective system of internal control over financial reporting, our investors could lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the market price of our stock, which could have a material adverse effect on our business, results of operations and financial condition.
We will face increased administrative costs as a public company.
As a result of the Acquisition, Microlin has become a public reporting company. We will incur significant legal, accounting and other expenses in order to comply with the Sarbanes-Oxley Act and other rules implemented by the SEC that we did not incur as a private company. Although we are exempt from certain regulations as an ‘‘emerging growth company’’ as well as a ‘‘smaller reporting company,’’ we are still subject to multiple regulations for which compliance will require significant financial resource and management and employees. For example, we will adopt additional internal controls and disclosures controls and procedures, we may pay higher rates for director and officer liability insurance, and we may incur internal and external costs of preparing and distributing periodic public reports in compliance with our obligations under the federal securities laws. An increase in any of these costs could have a material adverse effect on our business, results of operations and financial condition.
Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution for our stockholders and could cause our stock price to fall.
We expect that we will need significant additional capital in the future to continue along our development process towards approval and subsequent commercialization of our therapeutic product candidates. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders.
In addition, the terms of our licensing agreements with OSIF provide that OSIF is to hold a 7% equity interest in the company on a fully-diluted basis until we raise at least $10,000,000 in a single transaction or a series of transactions of equity financing. In the event we raise more than $10,000,000 of equity financing, the licensing agreements grant OSIF the right to participate in any sale of equity securities on the same terms as other purchasers so as to maintain its equity interest in the company. The issuance of additional shares to OSIF pursuant to these anti-dilution provisions may result in dilution to our stockholders, especially in instances where our stockholders may not be provided the opportunity to participate in a sale of equity securities or choose not to participate.
We do not intend to pay cash dividends on our common stock so any returns on our common stock will be limited to an appreciation in the value of our common stock, if any.
We have never declared or paid any cash dividends on our common stock and do not currently intend to declare or pay any cash dividends for the foreseeable future. As a result, stockholders may only receive a return on our common stock if the market price appreciates in value. Investors seeking cash dividends should not invest in our common stock.
If we fail to remain current on our reporting requirements, we could be removed from quotation on the OTCQB, which would limit the ability of broker-dealers to sell our securities and the ability of stockholders to sell their securities in the secondary market.
Companies trading on the OTCQB, such as us, must be reporting issuers with the Securities and Exchange Commission and must be current in their reports in order to maintain price quotation privileges on the OTCQB tier of the electronic quotation system operated by OTC Markets, Inc. As a result, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of stockholders to sell their securities in the secondary market.
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Because our common stock could be deemed a low-priced “Penny” stock, it would be cumbersome for brokers and dealers to trade in our common stock, making the market for our common stock less liquid and negatively affect the price of our stock.
We may be subject to certain provisions of the Securities Exchange Act of 1934, commonly referred to as the “penny stock” as defined in Rule 3a51-1. A penny stock is generally defined to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. If our stock is deemed to be a penny stock, trading will be subject to additional sales practice requirements of broker-dealers. These require a broker-dealer to:
• | Deliver to the customer, and obtain a written receipt for, a disclosure document; |
• | Disclose certain price information about the stock; |
• | Disclose the amount of compensation received by the broker-dealer or any associated person of the broker-dealer; |
• | Send monthly statements to customers with market and price information about the penny stock; and |
• | In some circumstances, approve the purchaser’s account under certain standards and deliver written statements to the customer with information specified in the rules. |
Consequently, penny stock rules may restrict the ability or willingness of broker-dealers to trade and/or maintain a market in our common stock. Also, prospective investors may not want to get involved with the additional administrative requirements, which may have a material adverse effect on the trading of our shares.
Because we became a public company through a reverse acquisition, we may not be able to attract the attention of major brokerage firms.
There may be risks associated with our becoming public through a reverse acquisition. Securities analysts of major brokerage firms may not provide coverage of our Company since there is no incentive to brokerage firms to recommend the purchase of our common stock. No assurance can be given that brokerage firms will want to conduct any secondary offerings on behalf of our post-merger company in the future.
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Directors and Executive Officers
The following table sets forth information regarding the members of our board of directors and our executive officers and other significant employees. All of our officers and directors were appointed on the effective date of the Merger. All of our directors hold office until the next annual meeting of stockholders and their successors are duly elected and qualify. Executive officers serve at the request of the board of directors.
Name |
Age | Office(s) held |
Joseph Hernandez | 43 | President, Chief Executive Officer (CEO), Chief Financial Officer (CFO), Executive Chairman, and Director |
Bruce Galton | 63 | Chief Operating Officer (COO) |
Richard S. Dondero | 65 | Vice President of Clinical Development |
Sonya Zabludoff, Ph.D. | 52 | Head of Preclinical Drug Discovery |
John Bonfiglio, Ph.D. | 60 | Director |
Set forth below is a brief description of the background and business experience of each of our current executive officers and directors.
Joseph Hernandez is our newly-appointed President, CEO, CFO, Executive Chairman, and sole member of our Board of Directors. Mr. Hernandez is the founder of several biotechnology companies, including Prolias Technologies, Inc., a molecular diagnostics company focusing on thyroid cancer, where he has served as a director since 2010, and Innovative Biosensors, Inc., a MIT-based technology company that develops, manufactures and markets rapid pathogen detection and diagnostic systems comprised of biosensors, where he served as President and Chief Executive Officer from 2003 until 2009. From July 2010 to March 2012, Mr. Hernandez also served as President and Chief Executive Officer of Signal Genetics, LLC, a privately-held company focused on oncology and the development of innovative diagnostic services. Additionally, Mr. Hernandez currently serves as the Executive Chairman of Ember Therapeutics, a late stage biotech company focusing on osteoarthritis since 2014. Mr. Hernandez has held numerous business development and marketing roles, having served in such roles at Digene Corp. (which has since been acquired by Qiagen NV (QGEN)), a molecular diagnostics company that develops, manufactures and markets gene-based testing systems for the screening, monitoring and diagnosis of certain human diseases, such as women’s cancers and infectious diseases, from 2001 to 2003, and at Affymetrix, Inc. (AFFX), a publicly-held Silicon Valley biotech company that develops DNA microarrays, from 2000 to 2001. From 1998 to 2000, Mr. Hernandez worked in sales and marketing for the publicly-held pharmaceutical company Merck & Co. (MRK). Mr. Hernandez was recently a member of the board of directors of MdBIO, a life science industry association based in the Mid-Atlantic region, and a member of the board of directors of Shady Grove Hospital. Mr. Hernandez holds an M.S. in Microbiology and Molecular Genetics from the University of Florida, an MBA from the University of Florida and a B.S. in Neuroscience from the University of Florida.
Bruce C. Galton, Bruce Galton has served as President and CEO and a Director of Senesco Technologies, Inc. a gene technology company pursuing oncology and anti-inflammatory applications (now Sevion Therapeutics, Inc. SVON), President and Chief Operating Officer and a Director of Annovis, Inc. which made specialty chemicals for DNA synthesis and was acquired by Transgenomic, Inc. and President and Chief Executive Officer of Cistron Biotechnology, Inc., which pursued cytokines and cytokine antibodies until it was acquired by CellTech. Prior to that, Mr. Galton was employed by Becton Dickinson and Company in a variety of financial positions including international treasury, financial manager of a domestic assay kit manufacturing division and as financial manager of an international lab equipment sales division. Currently, Mr. Galton is the principal of Galton Consulting, LLC, a life science advisory firm.
Richard S. Dondero. Richard S. Dondero has agreed to serve as our Vice President of Clinical Development. Mr. Dondero most recently was Senesco Technologies’ Vice President of Research and Development (2004-2014). Senesco’s platform technology is based upon the identification and characterization of specific genes that regulate cell death in plants (senescence) and humans (apoptosis). From July 2002 to July 2004, Mr. Dondero was a Group Leader in Proteomics Operations for Molecular Staging Inc., a company engaged in Bio-Marker Discovery and Whole Genome Amplification. From 1985 to 2001, Mr. Dondero held positions of increasing responsibility including Vice President of Operations at Cistron Biotechnology. Cistron activities were focused in the research and development of certain pro-inflammatory cytokines which are important mediators in a number of disease states. Prior to Cistron, Mr. Dondero was employed at Johnson & Johnson and Becton Dickerson. Mr. Dondero received his Masters of Science degree in Biology from Seton Hall University and Bachelor of Arts degree in Biology from New Jersey City University.
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Dr. Sonya Zabludoff. Sonya Zabludoff, Ph.D., has agreed to serve as our Head of Preclinical Drug Discovery. Dr. Zabludoff has extensive experience as a scientific director in preclinical drug discovery and has worked in both large pharmaceutical companies and biotech. In 2012, she joined Regulus Therapeutics Inc. (RGLS), a publicly-held biopharmaceutical company focused on the development of microRNA-based drugs targeting fibrosis, metabolism and cardiovascular diseases, cancer, HCV and immune-related diseases, and served as the Senior Director of Oncology. Dr. Zabludoff previously served as Senior Director of Oncology at Pfizer, Associate Director of Oncology at AstraZeneca and Senior Scientist in Oncology at Novartis. Dr. Zabludoff was a post-doctoral fellow at California Institute of Technology, received her Ph.D. in Reproductive Biology from the Johns Hopkins University and a B.S. in Biology from University of Rochester.
John N. Bonfiglio, Ph.D. has agreed to serve as a member of our board of directors. Dr. Bonfiglio has served as the President, Chief Executive Officer and a director of Oragenics, Inc. (OGEN), a publicly-traded biotechnology company focused on the development of novel and innovative therapeutics for oral health, since May 2011. Dr. Bonfiglio previously served as the Chief Executive Officer, President and as a director of Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company that developed non-invasive, topically delivered products, between May 2010 and April 2011. From January 2007 to March 2010, Dr. Bonfiglio served as the President and Chief Executive Officer of Argos Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of personalized immunotherapies for the treatment of cancer and infectious diseases. From November 2005 to December 2006, he served as an independent consultant to two medical device companies, a therapeutic company and a medical communications company. From January 2003 to October 2005, Dr. Bonfiglio served as the Chief Executive Officer of The Immune Response Corporation, an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. From 2001 to 2002, he was the Chief Operating Officer and Executive Vice President of Cypress Biosciences, Inc., a company providing therapeutics and personalized medicine services, and from 1997 to 2001 he served as the Chief Executive Officer and President of Peregrine Pharmaceuticals, Inc. (PPHM), a publicly-held biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections. Dr. Bonfiglio has also held senior management positions with Baxter Healthcare Corporation (BAX) and Allergan, Inc. (AGN). Dr. Bonfiglio received his B.S. in Chemistry from the State University of New York at Stony Brook in 1976 and earned his Ph.D. in Synthetic Organic Chemistry from the University of California at San Diego in 1980. He later went on to serve as a postdoctoral fellow in organometallic chemistry at the University of California at Berkeley in 1981 and earned an M.S. in Business Administration from Pepperdine University in 1992.
Scientific Advisory Board
Our executive team is supported by our scientific advisory board, the members of which include scientists experienced in the fields of microRNA and cancer biology.
Robert Lee, Ph.D., Professor of Pharmaceutics at the OSU College of Pharmacy, has experience in developing novel targeted drug delivery systems for cancer based on lipid and polymer nanoparticles, including novel nanocarrier formulations of oligonucleotides Dr. Lee also has previous experience in the private sector, in which he served as the Vice President of Research and Development at Endocyte, Inc. (ECYT), a publicly-held biopharmaceutical company focused on the development of targeted therapies for the treatment of cancer and other serious diseases.
Philip Tsichlis, M.D., Professor of Hematology and Oncology at the Tufts University School of Medicine, serves as the Executive Director of the Molecular Oncology Research Institute at the Tufts Medical Center. Dr. Tsichlis is an expert in various molecular pathways involved in cancer.
Sakari Kauppinen, Ph.D., Professor at the Department of Haematology, Aalborg University Hospital in Denmark, is an expert in miRNA research and discovery and development of miRNA-based therapeutics. Dr. Kauppinen also owns a firm which consults to pharmaceutical companies and previously served as the Senior Director of microRNA Research at Santaris Pharma. Dr. Kauppinen has published 90 scientific papers and is co-inventor on 60 patent applications.
George Calin, M.D., Ph.D., is both a Professor for the Department of Experimental Therapeutics and Co- Director of The RNA Interference and non-coding RNA Center at the The University of Texas MD Anderson Cancer Center. Dr. Calin has hundreds of scientific publications and a strong focus on microRNA biology.
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Directors
Our bylaws authorize no less than one (1) and no more than twelve (12) directors. We currently have one director. Pursuant to the terms of the Acquisition, Joseph Hernandez, who prior to the Merger was the sole director of
Microlin, was appointed as our director. It is our intention to immediately expand the Board of Directors with Industry Veterans.
All directors hold office for one-year terms until the election and qualification of their successors. Officers are elected by the board of directors and serve at the discretion of the board.
There are no family relationships between or among the directors, executive officers or persons nominated or chosen by the Company to become directors or executive officers.
Committees of the Board
We do not currently have a compensation committee, executive committee, or stock plan committee.
Audit Committee
We do not have a separately-designated standing audit committee. The entire Board of Directors performs the functions of an audit committee, but no written charter governs the actions of the Board when performing the functions of what would generally be performed by an audit committee. The Board approves the selection of our independent accountants and meets and interacts with the independent accountants to discuss issues related to financial reporting. In addition, the Board reviews the scope and results of the audit with the independent accountants, reviews with management and the independent accountants our annual operating results, considers the adequacy of our internal accounting procedures and considers other auditing and accounting matters including fees to be paid to the independent auditor and the performance of the independent auditor. Our Board of Directors, which performs the functions of an audit committee, does not have a member who would qualify as an “audit committee financial expert” within the definition of Item 407(d)(5)(ii) of Regulation S-K.
Nomination Committee
Our Board of Directors does not maintain a nominating committee. As a result, no written charter governs the director nomination process. Our size and the size of our Board, at this time, do not require a separate nominating committee.
When evaluating director nominees, our directors consider the following factors:
· The appropriate size of our Board of Directors;
· Our needs with respect to the particular talents and experience of our directors;
· The knowledge, skills and experience of nominees, including experience in finance, administration or public service, in light of prevailing business conditions and the knowledge, skills and experience already possessed by other members of the Board;
· Experience in political affairs;
· Experience with accounting rules and practices; and
· The desire to balance the benefit of continuity with the periodic injection of the fresh perspective provided by new Board members.
Our goal is to assemble a Board that brings together a variety of perspectives and skills derived from high quality business and professional experience. In doing so, the Board will also consider candidates with appropriate non-business backgrounds.
Other than the foregoing, there are no stated minimum criteria for director nominees, although the Board may also consider such other factors as it may deem are in our best interests as well as our stockholders. In addition, the Board identifies nominees by first evaluating the current members of the Board willing to continue in service. Current members of the Board with skills and experience that are relevant to our business and who are willing to continue in service are considered for re-nomination. If any member of the Board does not wish to continue in service or if the Board decides not to re-nominate a member for re-election, the Board then identifies the desired skills and experience of a new nominee in light of the criteria above. Current members of the Board are polled for suggestions as to individuals meeting the criteria described above. The Board may also engage in research to identify qualified individuals. To date, we have not engaged third parties to identify or evaluate or assist in identifying potential nominees, although we reserve the right in the future to retain a third party search firm, if necessary. The Board does not typically consider shareholder nominees because it believes that its current nomination process is sufficient to identify directors who serve our best interests.
Code of Ethics
As of September 30, 2015, we had not adopted a Code of Ethics for Financial Executives, which would include our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.
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Compensation Discussion and Analysis
Joseph Hernandez
We entered into an Employment Agreement with Mr. Hernandez in July 2013. Pursuant to the agreement, Mr. Hernandez is paid an annual base salary of $460,000. This salary is subject to an annual review by our board of directors. Mr. Hernandez is also eligible for an annual performance-based cash bonus equivalent to 50% of his base salary, subject to the discretion of our board of directors and attainment by our company of reasonable performance goals approved by the board of directors in its sole discretion. Mr. Hernandez is also entitled to reimbursement from our company for his out-of-pocket cost for life and disability insurance premiums in an amount not to exceed $10,000 annually. Mr. Hernandez’s agreement also provides for a grant of stock options exercisable for an aggregate of 60,000 shares of our common stock at an exercise price of $6.33 per share.
Upon termination of Mr. Hernandez’s employment for Cause or at Mr. Hernandez’s election other than for Good Reason, he will receive payment for any accrued but unpaid salary through the date of termination and any amount arising from his participation in or benefits under any employee benefit plans, programs, or arrangements. If Mr. Hernandez’s employment is terminated by us other than for Cause or is terminated by Mr. Hernandez for Good Reason, we will make a lump sum payment to Mr. Hernandez in the amount equal to twenty-four (24) months of his salary as in effect immediately prior to the date of termination, in addition to payment for any accrued but unpaid salary through the date of termination and any amount arising from his participation in or benefits under any employee benefit plans, programs, or arrangements.
Under the employment agreement, ‘‘Cause’’ is defined as (a) a material breach of fiduciary duty or material breach of the terms of the employment agreement or any other agreement between Mr. Hernandez and us (including without limitation any agreements regarding confidentiality, inventions assignment and non-competition), which, in the case of a material breach of the terms of the employment agreement, remains uncured for a period of sixty (60) days following receipt of written notice from our Board of Directors specifying the nature of such breach; (b) the commission by Mr. Hernandez of any act of embezzlement, fraud, larceny, or theft on or from us; (c) substantial and continuing neglect or inattention by Mr. Hernandez of the duties of his employment, refusal to perform the lawful and reasonable directives of the Board of Directors or the willful misconduct or gross negligence of Mr. Hernandez in connection with the performance of such duties which remains uncured for a period of sixty (60) days following receipt of written notice from the Board of Directors specifying the nature of such breach; (d) the commission by Mr. Hernandez of any crime involving moral turpitude or a felony; and (e) Mr. Hernandez’s performance or omission of any act which, in the judgment of the Board of Directors, if known to our customers, clients, stockholders or any of our regulators, would have a material and adverse impact on our business.
‘‘Good Reason’’ is defined as (a) a material breach of the agreement by us; (b) a material and substantial reduction of Mr. Hernandez’s responsibilities that is inconsistent with Mr. Hernandez’s status as a senior executive with us; or (c) the requirement by us that Mr. Hernandez perform any act or refrain from performing any act that would be in violation of applicable law.
Bruce C. Galton
We entered into a Consulting Agreement with Mr. Galton on May 21, 2015 (the “Agreement”). Under the Agreement, Mr. Galton has agreed to serve as our COO for a period of one (1) year. Mr. Galton will receive consulting fees of $187.50 per hour, and has agreed to devote at least twenty (20) hours per week to the company. In addition, the Agreement calls for Mr. Galton to be issued options to purchase 20,000 of our common stock, which shall vest in equal installments over four (4) years.
Richard S. Dondero
We entered into a Consulting Agreement with Mr. Dondero on May 29, 2015 (the “Agreement”). Under the Agreement, Mr. Dondero has agreed to serve as our Vice President of Clinical Development for a period of one (1) year. Mr. Dondero will receive consulting fees of $150 per hour, and has agreed to devote at least twenty (20) hours per week to the company. In addition, the Agreement calls for Mr. Dondero to be issued options to purchase 20,000 of our common stock, which shall vest in equal installments over four (4) years.
Sonya Zabludoff
We entered into a Consulting Agreement with Ms. Zabludoff on June 8, 2015 (the “Agreement”). Under the Agreement, Ms. Zabludoff has agreed to serve as our head of pre-clinical development for a period of one (1) year. Ms. Zabludoff will receive consulting fees of $225 per hour, and has agreed to devote at least twenty (20) hours per week to the company. In addition, the Agreement calls for Ms. Zabludoff to be issued options to purchase 10,000 of our common stock, which shall vest in equal installments over four (4) years.
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2013 Equity Incentive Plan
Pursuant to the terms of the Merger Agreement, we have adopted Microlin’s 2013 Equity Incentive Plan (the “Plan”). The Plan provides for the grant of incentive stock options, or ISOs, within the meaning of Section 422 of the IRC, nonstatutory stock options, or NSOs, stock appreciation rights, restricted stock awards, restricted stock unit awards, share-based awards, and other forms of equity compensation, or collectively, stock awards, all of which may be granted to employees, including officers, and to non-employee directors and consultants. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants.
Share Reserve
The aggregate number of shares of our common stock that may be issued pursuant to stock awards under the Plan is 500,000 shares. As of the date of this Current Report, stock options to purchase 182,000 shares of our common stock are outstanding under the Plan.
If a stock award is granted under the Plan but shares of our common stock are not acquired pursuant to the stock award (due to expiration, forfeiture, cancelation, surrender or termination of the stock award, cash settlement of the stock award, or otherwise), the shares not acquired again will become available for subsequent issuance under the Plan.
Administration
Our board of directors has the authority to administer the Plan. Our board of directors may delegate its authority to administer the Plan to our compensation committee. Our board of directors may also delegate to one or more of our officers (1) the authority to designate employees to be recipients of certain stock awards, and determine the number of shares of common stock to be subject to such stock awards, and (2) such other authority under the Plan as the board may determine. Subject to the terms of the Plan, our board of directors or the authorized delegate, referred to herein as the plan administrator, determines recipients, dates of grant, the numbers and types of stock awards to be granted and the terms and conditions of the stock awards, including the period of their exercisability and vesting schedule applicable to a stock award. Subject to the limitations set forth below, the plan administrator will also determine the exercise price, strike price or purchase price of awards granted and the types of consideration to be paid for the award.
The plan administrator has the power to modify outstanding awards under the Plan. Subject to the terms of the Plan, the plan administrator has the authority, at any time, to (1) provide that all or a portion of a stock award may be exercised, (2) provide that all or part of any time-based vesting restrictions shall lapse or that all or part of any performance-based criteria shall be deemed to be satisfied, or (3) waive any other limitation or requirement under any stock award.
Stock Options
Incentive and nonstatutory stock options are granted pursuant to stock option agreements adopted by the plan administrator. The plan administrator determines the exercise price for a stock option, within the terms and conditions of the Plan, provided that the exercise price of a stock option generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Options granted under the Plan vest at the rate specified by the plan administrator.
The plan administrator determines the term of stock options granted under the Plan, up to a maximum of 10 years. Unless the terms of an optionee’s stock option agreement provides otherwise, if an optionee’s service relationship with us, or any of our affiliates, ceases for any reason other than disability, death or cause, the optionee may generally exercise any vested options for a period of three months following the cessation of service. The option term may be extended in the event that exercise of the option following such a termination of service is prohibited by applicable securities laws or our insider trading policy. If an optionee’s service relationship with us, or any of our affiliates, ceases due to disability or death, the optionee or a beneficiary may generally exercise any vested options for a period of 12 months after the termination of the service relationship. In the event of a termination for cause, options generally terminate immediately upon the termination of the individual for cause. In no event may an option be exercised beyond the expiration of its term.
Acceptable consideration for the purchase of common stock issued upon the exercise of a stock option will be determined by the plan administrator and may include (1) cash or its equivalent, (2) a cashless exercise, (3) the tender of shares of our common stock previously owned by the optionee, (4) a net exercise of the option if it is a nonstatutory option, and (5) other legal consideration approved by the plan administrator.
Unless the plan administrator provides otherwise, options generally are not transferable except by will, the laws of descent and distribution, or pursuant to a domestic relations order. An optionee may designate a beneficiary, however, who may exercise the option following the optionee’s death.
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Tax Limitations on Incentive Stock Options
The aggregate fair market value, determined at the time of grant, of our common stock with respect to ISOs that are exercisable for the first time by an optionee during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed such limit will generally be treated as NSOs. No ISO may be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our affiliates unless (1) the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant, and (2) the term of the ISO does not exceed five years from the date of grant.
Restricted Stock Awards
Restricted stock awards may be granted, on terms and conditions determined by the plan administrator, pursuant to restricted stock award agreements adopted by the plan administrator. During any restriction period, the restricted shares are not transferable, but may entitle the holder to voting rights and a right to dividends and distributions paid with respect to the restricted shares.
Restricted Stock Unit Awards
Restricted stock unit awards may be granted, on terms and conditions determined by the plan administrator, pursuant to restricted stock unit award agreements adopted by the plan administrator. Restricted stock unit awards may be granted in consideration for any form of legal consideration. A restricted stock unit award may be settled by cash, delivery of stock, a combination of cash and stock as deemed appropriate by the plan administrator, or in any other form of consideration set forth in the restricted stock unit award agreement. Dividend equivalents may be credited in respect of shares covered by a restricted stock unit award.
Stock Appreciation Rights
Stock appreciation rights may be granted, on terms and conditions determined by the plan administrator, pursuant to stock appreciation grant agreements adopted by the plan administrator. The plan administrator determines the strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Upon the exercise of a stock appreciation right, we will pay the participant an amount equal to the product of (1) the excess of the per share fair market value of our common stock on the date of exercise over the strike price, multiplied by (2) the number of shares of common stock with respect to which the stock appreciation right is exercised. A stock appreciation right granted under the Plan vests at the rate specified in the stock appreciation grant agreement as determined by the plan administrator.
Other Stock Award
The plan administrator may grant other awards based in whole or in part by reference to our common stock. The plan administrator will set the number of shares under the stock award and all other terms and conditions of such awards.
Changes to Capital Structure
In the event that there is a specified type of change in our capital structure, such as a stock split or recapitalization, appropriate adjustments will be made to (1) the class and maximum number of shares reserved for issuance under the Plan, (2) the class and maximum number of shares that may be issued upon the exercise of ISOs, (3) the class and maximum number of shares subject to stock awards that can be granted in a calendar year (as established under the Plan pursuant to Section 162(m) of the IRC) and (4) the class and number of shares and exercise price, strike price, or purchase price, if applicable, of all outstanding stock awards.
Change in Control
The Plan provides that the plan administrator may take actions that it deems necessary with respect to any stock awards, including the acceleration of vesting, settlement and exercisability in the event of a change in control. For example, a stock award may provide for accelerated vesting upon the participant’s termination without cause or resignation for good reason in connection with a change in control. In the absence of such action or provision, no such acceleration of the stock award will occur. Under the Plan, a change in control is generally (1) the acquisition by a person or entity of more than 50% of our combined voting power other than by merger, consolidation or similar transaction; (2) a consummated merger, consolidation or similar transaction immediately after which our stockholders cease to own more than 50% of the combined voting power of the surviving entity; or (3) a sale of all or substantially all of our assets to a person or entity that is not our affiliate or controlled by the our stockholders.
Amendment and Termination
Our board of directors has the authority to amend, suspend, or terminate our Plan, provided that such action does not materially impair the existing rights of any participant without such participant’s written consent. No stock awards may be granted after the tenth anniversary of the effective date of the Plan.
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Summary Compensation Table
The table below summarizes all compensation awarded to, earned by, or paid to each named executive officer for our last two completed fiscal years for all services rendered to us.
SUMMARY COMPENSATION TABLE | ||||||||||
Name and principal position |
Year |
Salary ($) |
Bonus ($) |
Stock Awards ($) |
Option Awards ($) |
Non-Equity Incentive Plan Compensation ($) |
Nonqualified Deferred Compensation Earnings ($) |
All Other Compensation ($) |
Total ($) | |
Joseph Hernandez, CEO, CFO, Exec. Chairman |
2014 2013 |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a | |
Bruce C. Galton, COO |
2014 2013 |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a | |
Richard S. Dondero, V.P. of Clinical Dev. |
2014 2013 |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a | |
Sonya Zabludoff, Head of Pre-Clinical Dev. |
2014 2013 |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a |
n/a n/a | |
Reza Noorkayhani, former officer |
2014 2013 |
0 0 |
0 0 |
180,000 0 |
0 0 |
0 0 |
0 0 |
0 0 |
180,000 0 | |
Joseph Marshall, former officer |
2014 2013 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Narrative Disclosure to the Summary Compensation Table
Our current executive officers were appointed in connection with the recent Acquisition and did not serve during our last two fiscal years.
Our employment and compensation arrangement with our current named executive officers are as set forth above under “Compensation Discussion and Analysis.”
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Stock Option Grants
We have not granted any stock options to the executive officers or directors since our inception. Microlin Bio, Inc. has issued options to its officers and directors as follows:
Name | # of Shares |
Joseph Hernandez | 60,000 |
Bruce Galton | 20,000 |
Richard S. Dondero | 20,000 |
Sonya Zabludoff | 10,000 |
John Bonfiglio | 20,000 |
Outstanding Equity Awards At Fiscal Year-end Table
The table below summarizes all unexercised options, stock that has not vested, and equity incentive plan awards for each named executive officer outstanding as of the end of our last completed fiscal year.
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END | |||||||||
OPTION AWARDS | STOCK 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 |
Number of Shares or Shares of Stock That Have Not Vested (#) |
Market Value of Shares or Shares of Stock That Have Not Vested ($) |
Equity Incentive Plan Awards: Number of Unearned Shares, Shares or Other Rights That Have Not Vested (#) |
Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Shares or Other Rights That Have Not Vested (#) |
Joseph Hernandez, CEO, CFO, Exec. Chairman | - | - | - | - | - | - | - | - | - |
Bruce C. Galton, COO | - | - | - | - | - | - | - | - | - |
Richard S. Dondero, V.P. of Clinical Dev. | - | - | - | - | - | - | - | - | - |
Sonya Zabludoff, Head of Pre-Clinical Dev. | - | - | - | - | - | - | - | - | - |
Reza Noorkayhani, former officer | - | - | - | - | - | - | - | - | - |
Joseph Marshall, former officer | - | - | - | - | - | - | - | - | - |
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Compensation of Directors Table
The table below summarizes all compensation paid to our directors for our last completed fiscal year.
DIRECTOR COMPENSATION | |||||||
Name |
Fees Earned or Paid in Cash ($) |
Stock Awards ($) |
Option Awards ($) |
Non-Equity Incentive Plan Compensation ($) |
Non-Qualified Deferred Compensation Earnings ($) |
All Other Compensation ($) |
Total ($) |
Joseph Hernandez | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
John Bonfiglio | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
Reza Noorkayhani, former director | -0 | -0 | -0 | -0 | -0 | -0 | -0 |
Joseph Marshall, former director | -0 | -0 | -0 | -0 | -0 | -0 | -0 |
Narrative Disclosure to the Director Compensation Table
We have not previously provided any compensation to directors for their service as directors. Our new directors, Joseph Hernandez and John Bonfiglio, did not serve during our last fiscal year.
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth the beneficial ownership of our capital stock by each executive officer and director, by each person known by us to beneficially own more than 5% of any class of stock and by the executive officers and directors as a group. Except as otherwise indicated, all Shares are owned directly and the percentage shown is based on 20,000,000 shares common stock issued and outstanding following the Acquisition and the related events described herein. All addresses are c/o Microlin Bio, Inc. 135 East 57th Street, 24th Floor, New York, NY 10022 unless otherwise stated.
Title of class |
Name and address of beneficial owner (1) |
Amount of beneficial ownership |
Percent
|
Current Executive Officers & Directors: | |||
Common Stock | Joseph Hernandez | 17,597,000(2) | 87.99% |
Common Stock | Bruce Galton | 20,000(3) | 0.1% |
Common Stock | Richard S. Dondero | 20,000(4) | 0.1% |
Common Stock | Sonya Zabludoff | 10,000(5) | 0.05% |
Common Stock | John Bonfiglio | 20,000(6) | 0.1% |
Total of All Current Directors and Officers: | |||
Common Stock | 17,667,000 | 88.34% | |
More than 5% Beneficial Owners | |||
Common Stock |
Ohio State University Foundation, Inc. 1524 North High Street Columbus, OH 43201 |
1,463,000 | 7.32% |
(1) |
As used in this table, "beneficial ownership" means the sole or shared power to vote, or to direct the voting of, a security, or the sole or shared investment power with respect to a security (i.e., the power to dispose of, or to direct the disposition of, a security). In addition, for purposes of this table, a person is deemed, as of any date, to have "beneficial ownership" of any security that such person has the right to acquire within 60 days after such date. |
(2) | The total shares for Joseph Hernandez include 17,537,000 shares of common stock and options to purchase 60,000 shares of common stock at a price of $6.33, exercisable for 10 years |
(3) | Includes options to purchase 20,000 shares of common stock |
(4) | Includes options to purchase 20,000 shares of common stock |
(5) | Includes options to purchase 10,000 shares of common stock |
(6) | Includes options to purchase 20,000 shares of common stock |
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Certain Relationships and Related Transactions and Director Independence
The following is a description of transactions that were entered into with our executive officers, directors or greater than 5% stockholders since our inception on July 30, 2013.
Since our inception on July 30, 2013 through March 31, 2014, we have funded our operations through non-interest bearing, unsecured advances from Joseph Hernandez, our founder, Chief Executive Officer and Executive Chairman. As of September 30, 2015 , Mr. Hernandez had advanced us $430,379.
On July 30, 2013, in connection with our incorporation, we issued 3,720,000 shares of common stock to Joseph Hernandez, our founder, Chief Executive Officer and Executive Chairman. We also entered into an Employment Agreement with Mr. Hernandez in July 2013. For a description of the terms of Mr. Hernandez’s Employment Agreement, please see Compensation Discussion and Analysis, above.
If approved by our board of directors, we may enter into certain business transactions with a CRO or other entities controlled, directly or indirectly, by Joseph Hernandez, our founder, Chief Executive Officer and Executive Chairman.
We have entered into Consulting Agreements with Mr. Galton, Mr. Dondero, and Ms. Zabludoff as set forth above.
Director Independence
We are not a “listed issuer” within the meaning of Item 407 of Regulation S-K and there are no applicable listing standards for determining the independence of our directors. Applying the definition of independence set forth in Rule 4200(a)(15) of The Nasdaq Stock Market, Inc., we do not believe that we currently have any independent directors.
Description of Securities
Our authorized capital stock consists of 90,000,000 shares of common stock, $0.001 par value per share, and 10,000,000 shares of preferred stock, par value $0.001 per share. Immediately following the Acquisition and the events reported herein, there were 20,000,000 shares of our common stock issued and outstanding and no shares of preferred stock issued and outstanding
Common Stock
The holders of common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative voting. The holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by the board of directors out of legally available funds. However, the current policy of the board of directors is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in all assets that are legally available for distribution. The holders of common stock have no preemptive, subscription, redemption or conversion rights.
In the event of any merger or consolidation with or into another company in connection with which shares of our common stock are converted into or exchangeable for shares of stock, other securities or property (including cash), all holders of our common stock will be entitled to receive the same kind and amount of shares of stock and other securities and property (including cash). Holders of our common stock have no pre-emptive rights, no conversion rights and there are no redemption provisions applicable to our common stock.
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Preferred Stock
Our board of directors is authorized by our articles of incorporation to divide the authorized shares of our preferred stock into one or more series, each of which must be so designated as to distinguish the shares of each series of preferred stock from the shares of all other series and classes. Our board of directors is authorized, within any limitations prescribed by law and our articles of incorporation, to fix and determine the designations, rights, qualifications, preferences, limitations and terms of the shares of any series of preferred stock including, but not limited to, the following:
Provisions in Our Articles of Incorporation and By-Laws That Would Delay, Defer or Prevent a Change in Control
Our articles of incorporation authorize our board of directors to issue a class of preferred stock commonly known as a "blank check" preferred stock. Specifically, the preferred stock may be issued from time to time by the board of directors as shares of one (1) or more classes or series. Our board of directors, subject to the provisions of our Articles of Incorporation and limitations imposed by law, is authorized to adopt resolutions; to issue the shares; to fix the number of shares; to change the number of shares constituting any series; and to provide for or change the following: the voting powers; designations; preferences; and relative, participating, optional or other special rights, qualifications, limitations or restrictions, including the following: dividend rights, including whether dividends are cumulative; dividend rates; terms of redemption, including sinking fund provisions; redemption prices; conversion rights and liquidation preferences of the shares constituting any class or series of the preferred stock.
In each such case, we will not need any further action or vote by our shareholders. One of the effects of undesignated preferred stock may be to enable the board of directors to render more difficult or to discourage an attempt to obtain control of us by means of a tender offer, proxy contest, merger or otherwise, and thereby to protect the continuity of our management. The issuance of shares of preferred stock pursuant to the board of director's authority described above may adversely affect the rights of holders of common stock. For example, preferred stock issued by us may rank prior to the common stock as to dividend rights, liquidation preference or both, may have full or limited voting rights and may be convertible into shares of common stock. Accordingly, the issuance of shares of preferred stock may discourage bids for the common stock at a premium or may otherwise adversely affect the market price of the common stock.
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Delaware Anti-Takeover Laws
We are subject to the provisions of Section 203 of the Delaware General Corporation Law, which applies to "business combinations" such as a merger, asset or stock sale or other transaction that result in financial benefit to an "interested stockholder". An "interested stockholder" is a person who, together with affiliates and associates, owns, or within three years prior, did own, 15% or more of a corporation's outstanding voting stock. Section 203 generally prohibits a publicly held Delaware corporation from engaging in a "business combination” with an "interested stockholder" for a period of three years following the time that the stockholder became an interested stockholder, unless:
This provision may have the effect of delaying, deterring or preventing a change in control over us without further actions by our stockholders.
Options and Warrants
In connection with the Acquisition, we adopted Microlin’s 2013 Equity Incentive Plan (the “Plan”) and have agreed to assume the terms of all stock options issued thereunder.
The following is a summary of the status of stock options outstanding at September 30, 2015:
Outstanding Options | Exercisable Options | ||
Exercise Price | Number |
Weighted Average Contractual Life |
Number |
$6.325 | 182,000 | 8.25 years | 81,583 |
OSIF Anti-Dilution and Conversion Rights
In connection with the Acquisition, we adopted and assumed certain non-dilution rights and conversion rights granted by Microlin to the Ohio State University Foundation, Inc. (“OSIF”). Under its License Agreements with Microlin, OSIF received anti-dilution rights equal to 7% of the company’s issued and outstanding share capital on a fully diluted basis. The right shall lapse following a raise of at least $10,000,000 in a single transaction or a series of transactions of equity financing.
In addition, our agreements with OSIF, as amended, provide for certain rights to convert amounts due under the agreements to common stock, with the conversion prices expressed in terms of an initial public offering price. The details of the agreements are subject to ongoing discussion with OSIF. In connection with the Acquisition, we also adopted and assumed all equity conversion rights currently enjoyed by OSIF under its agreements with Microlin.
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Market Price and Dividends
Microlin is, and has always been, a privately-held company. There has never been a public market for the securities of Microlin has never declared or paid any cash dividends on its capital stock. In addition, there has never been a trading market for Microlin’s common stock.
Indemnification of Directors and Officers
Our officers and directors are indemnified as provided by Delaware General Corporation Law and our bylaws.
Under the governing Delaware General Corporation Law, director immunity from liability to a company or its shareholders for monetary liabilities applies automatically unless it is specifically limited by a company's Certificate of Incorporation. Our Certificate of Incorporation do not contain any limiting language regarding director immunity from liability. Excepted from this immunity are:
1. | a willful failure to deal fairly with the company or its shareholders in connection with a matter in which the director has a material conflict of interest; |
2. | a violation of criminal law (unless the director had reasonable cause to believe that his or her conduct was lawful or no reasonable cause to believe that his or her conduct was unlawful); |
3. | a transaction from which the director derived an improper personal profit; and |
4. | willful misconduct. |
Our bylaws provide that we will indemnify our directors and officers to the fullest extent not prohibited by Delaware General Corporation Law; provided, however, that we may modify the extent of such indemnification by individual contracts with our directors and officers; and, provided, further, that we shall not be required to indemnify any director or officer in connection with any proceeding (or part thereof) initiated by such person unless:
1. | such indemnification is expressly required to be made by law; |
2. | the proceeding was authorized by our Board of Directors; |
3. | such indemnification is provided by us, in our sole discretion, pursuant to the powers vested us under Delaware law; or; |
4. | such indemnification is required to be made pursuant to the bylaws. |
Our bylaws provide that we will 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 executive officer of another company, partnership, joint venture, trust or other enterprise, prior to the final disposition of the proceeding, promptly following request therefore, all expenses incurred by any director or officer in connection with such proceeding upon receipt of an undertaking by or on behalf of such person to repay said amounts if it should be determined ultimately that such person is not entitled to be indemnified under our bylaws or otherwise.
Our bylaws provide that no advance shall be made by us 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: (a) by the board of directors by a majority vote of a quorum consisting of directors who were not parties to the proceeding, or (b) if such quorum is not obtainable, or, even if obtainable, a quorum of disinterested directors so directs, 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.
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Trading Information
Our common stock is quoted under the symbol “AMIB” on the OTC Pink Current (SEC Reporting) tier of the market operated by OTC Markets Group, Inc. Due to our recent name change, we expect our trading symbol to change in the near future.
The following tables set forth the range of high and low prices for our common stock for the each of the periods indicated as reported by OTC Markets Group. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
Fiscal Year Ending December 31, 2015 | ||||||||||
Quarter Ended | High $ | Low $ | ||||||||
September 30, 2015 | $ | 0.40 | $ | 0.40 | ||||||
June 30, 2015 | $ | 0.51 | $ | 0.40 | ||||||
March 31, 2015 | $ | 1.45 | $ | 0.50 | ||||||
Fiscal Year Ending December 31, 2014 | ||||||||||
Quarter Ended | High $ | Low $ | ||||||||
December 31, 2014 | $ | 1.50 | $ | 0.51 | ||||||
September 30, 2014 | 1.50 | 0.25 | ||||||||
June 30, 2014 | n/a | n/a | ||||||||
March 31, 2015 | n/a | n/a |
The last quoted price of our common stock was $0.40 per share on December 18, 2015.
Penny Stock
The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a market price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker's or dealer's duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer's account.
In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.
These disclosure requirements may have the effect of reducing the trading activity for our common stock. Therefore, stockholders may have difficulty selling our securities.
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Holders of Our Common Stock
As of December 22, 2015 we had 20,000,000 shares of our common stock issued and outstanding, held by thirty (30) shareholders of record.
Transfer Agent
The transfer agent for our common stock is VStock Tranfer, LLC.
Section 3 – Securities and Trading Markets
Item 3.02. Unregistered Sales of Equity Securities
In connection with the Acquisition, the previous shareholders of Microlin received 19,000,000 shares of our common stock. The 19,000,000 shares of our common stock which were issued to the former holders of common stock of Microlin on the effective date of the Acquisition were issued in reliance on the exemption from registration afforded by Section 4(2) of the Securities Act.
Section 5 – Corporate Governance and Management
Item 5.01. Changes in Control of Registrant
Reference is made to the disclosure set forth under Item 2.01 of this Current Report on Form 8-K, which disclosure is incorporated herein by reference.
Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers
At the effective time of the Acquisition, Reza Noorkayhani resigned as our Chief Executive Officer, Chief Financial Officer, and President, and Joseph Marshall resigned as our Chief Operations Officer, and Secretary. In addition, Mr. Noorkayhani and Mr. Marshall resigned from our Board of Directors effective ten (10) days after mailing to shareholders of our Schedule 14f-1 regarding the change in our board, which was filed with the Commission and mailed to shareholders of record on December 16, 2015. There was no known disagreement with Mr. Noorkayhani and Mr. Marshall on any matter relating to our operations, policies, or practices. Pursuant to the terms of the Merger Agreement, our new directors and officers are as set forth herein. Reference is made to the disclosure set forth under Item 2.01 of this Current Report on Form 8-K, which disclosure is incorporated herein by reference.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
In connection with the Acquisition, the Company’s fiscal year end has changed from December 31 to September 30, effective for fiscal year 2015.
In addition, in connection with this subsequent subsidiary merger discussed herein, we changed our corporate name to “Microlin, Bio, Inc.”
Item 5.06 Change in Shell Company Status
As a result of the Acquisition and related transactions as described herein, to the extent that we were previously considered a “shell company” as defined in Rule 12b-2, we have ceased to be a shell company. The material terms of the transaction are described herein.
In addition, to the extent required under applicable regulations, the information contained in this Current Report is intended to provide "Form 10 information" within the meaning of Rule 144(i)(3) under the Securities Act of 1933.
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Section 9 – Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits
Financial Statements of Businesses Acquired. In accordance with Item 9.01(a), the audited financial statements of our accounting predecessor, Microlin Bio, Inc., a Delaware corporation, for the years ended September 30, 2015 and 2014, are filed with this Current Report on Form 8-K as Exhibit 99.1.
Pro Forma Financial Information. In accordance with Item 9.01(b), our pro forma financial combined statements are filed in this Current Report on Form 8-K as Exhibit 99.2.
(c) Exhibits.
The exhibits listed in the following Exhibit Index are filed as part of this Current Report on Form 8-K.
*Documents redacted; the company will request confidential treatment
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Microlin Bio, Inc.
/s/ Joseph Hernandez
Joseph Hernandez
Executive Chairman and CEO
Date: December 17, 2015
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AGREEMENT AND PLAN OF MERGER
by and among
American Boarding Company,
Microlin Merge Sub, Inc.
and
Microlin Bio, Inc.
December 17, 2015
TABLE OF CONTENTS
Page | |
ARTICLE I DEFINITIONS | 5 |
Section 1.1 Definitions. | 5 |
ARTICLE II THE MERGER | 10 |
Section 2.1 Merger.. | 10 |
Section 2.2 Effective Time. | 10 |
Section 2.3 Certificate of Incorporation; | 10 |
Section 2.4 Effects of the Merger. | 11 |
Section 2.5 Closing. | 11 |
Section 2.6 Tax-Free Merger. | 12 |
ARTICLE III MERGER CONSIDERATION; CONVERSION AND EXCHANGE OF SECURITIES | 12 |
Section 3.1 Manner and Basis of Converting and Exchanging Capital Stock. | 12 |
Section 3.2 Surrender and Exchange of Certificates. | 12 |
Section 3.3 Options, Warrants. | 10 |
Section 3.4 Parent Common Stock. | 14 |
Section 3.5 Parent Liabilities as of the Effective Time; Payment and Modification of Terms | 14 |
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE COMPANY | 15 |
Section 4.1 Organization. . | 15 |
Section 4.2 Authorization; Validity of Agreement. . | 15 |
Section 4.3 Capitalization. . | 15 |
Section 4.4 Consents and Approvals; No Violations. | 15 |
Section 4.5 Financial Statements. | 16 |
Section 4.6 No Undisclosed Liabilities. | 16 |
Section 4.7 Litigation. | 16 |
Section 4.8 No Default; Compliance with Applicable Laws. | 16 |
Section 4.9 Broker’s and Finder’s Fees. | 17 |
Section 4.10 Contracts. | 17 |
Section 4.11 Tax Returns and Audits. | 17 |
Section 4.12 Patents and Other Intangible Assets. | 18 |
Section 4.13 Employee Benefit Plans; ERISA. | 18 |
Section 4.14 Title to Property and Encumbrances. | 19 |
Section 4.15 Condition of Properties.. | 19 |
Section 4.16 Insurance Coverage. . | 19 |
Section 4.17 Environmental Matters. | 19 |
Section 4.18 Disclosure. | 20 |
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ARTICLE V REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB | 21 |
Section 5.1 Organization. . | 21 |
Section 5.2 Authorization; Validity of Agreement. | 21 |
Section 5.3 Consents and Approvals; No Violations. | 21 |
Section 5.4 Litigation. . | 22 |
Section 5.5 No Default; Compliance with Applicable Laws. | 22 |
Section 5.6 Broker’s and Finder’s Fees; Broker/Dealer Ownership. . | 22 |
Section 5.7 Capitalization of Parent. | 22 |
Section 5.8 Merger Sub | 18 |
Section 5.9 Validity of Shares. | 23 |
Section 5.10 SEC Reporting and Compliance. | 23 |
Section 5.11 Financial Statements. | 24 |
Section 5.12 No General Solicitation. | 24 |
Section 5.13 Absence of Undisclosed Liabilities. | 24 |
Section 5.14 Changes. | 24 |
Section 5.15 Tax Returns and Audits. | 25 |
Section 5.16 Employee Benefit Plans; ERISA. | 25 |
Section 5.17 Interested Party Transactions. . | 26 |
Section 5.18 Questionable Payments. . | 26 |
Section 5.19 Obligations to or by Stockholders. | 27 |
Section 5.20 Schedule of Assets and Contracts. | 27 |
Section 5.21 Environmental Matters. | 27 |
Section 5.22 Employees. | 28 |
Section 5.23 Title to Property and Encumbrances. | 28 |
Section 5.24 Condition of Properties. | 28 |
Section 5.25 Insurance Coverage. | 29 |
Section 5.26 Disclosure. . | 29 |
Section 5.27 No Liabilities | 29 |
ARTICLE VI CONDUCT OF BUSINESSES PENDING THE MERGER | 29 |
Section 6.1 Conduct of Business by the Company Pending the Merger. | 29 |
Section 6.2 Conduct of Business by Parent and Merger Sub | 30 |
ARTICLE VII ADDITIONAL AGREEMENTS | 31 |
Section 7.1 Access and Information. | 31 |
Section 7.2 Additional Agreements. . | 32 |
Section 7.3 Publicity. | 32 |
Section 7.4 Appointment of Directors. . | 32 |
Section 7.5 Stockholder Consent. | 32 |
ARTICLE VIII CONDITIONS OF PARTIES’ OBLIGATIONS | 33 |
Section 8.1 Company Obligations. | 33 |
Section 8.2 Parent and Merger Sub Obligations. | 34 |
ARTICLE IX INDEMNIFICATION AND RELATED MATTERS | 36 |
Section 9.1 Indemnification by Parent. | 36 |
Section 9.2 Survival. | 36 |
3 |
Section 9.3 Time Limitations. | 36 |
Section 9.4 Limitation on Liability. | 37 |
Section 9.5 Notice of Claims. | 37 |
ARTICLE X TERMINATION PRIOR TO CLOSING | 37 |
Section 10.1 Termination of Agreement. | 37 |
Section 10.2 Termination of Obligations. | 38 |
ARTICLE XI MISCELLANEOUS | 38 |
Section 11.1 Amendments. | 38 |
Section 11.2 Notices. | 39 |
Section 11.3 Entire Agreement. | 39 |
Section 11.4 Expenses. | 39 |
Section 11.5 Severability. | 39 |
Section 11.6 Successors and Assigns; Assignment. | 40 |
Section 11.7 No Third Party Beneficiaries. | 40 |
Section 11.8 Counterparts; Delivery by Facsimile. | 40 |
Section 11.9 Waiver. | 40 |
Section 11.10 No Constructive Waivers. | 40 |
Section 11.11 Further Assurances. | 41 |
Section 11.12 Recitals. | 41 |
Section 11.13 Headings. | 41 |
Section 11.14 Governing Law. | 41 |
Section 11.15 Dispute Resolution. | 41 |
Section 11.16 Interpretation. | 41 |
LIST OF SCHEDULES AND EXHIBITS
Schedule 1 | Issuances of Parent Common Stock to be made to Holders of Company Common Stock at the Effective Time |
Schedule 2 | Company Stock Options |
Exhibit A | Articles of Incorporation of Surviving Corporation |
Exhibit B | By-laws of Surviving Corporation |
Exhibit C | Directors of Parent Pre-Effective Time and Post-Effective Time |
Exhibit D | Articles of Incorporation of Parent |
Exhibit E | Bylaws of Parent |
Exhibit F | Parent Liabilities as of the Effective Time |
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AGREEMENT AND PLAN OF MERGER
THIS AGREEMENT AND PLAN OF MERGER is entered into as of December 17, 2015 by and among American Boarding Company, a Delaware corporation (“Parent”), Microlin Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (“Merger Sub”), and Microlin Bio, Inc. a Delaware corporation (the “Company”).
W I T N E S S E T H:
WHEREAS, the respective Boards of Directors of each of Parent, Merger Sub and the Company have approved, and deem it advisable and in the best interests of their respective stockholders to consummate, the acquisition of the Company by Parent, which acquisition is to be effected by the merger of the Company with and into the Merger Sub, with the Merger Sub being the surviving entity (the “Merger”), upon the terms and subject to the conditions set forth in this Agreement (as defined herein);
WHEREAS, the parties hereto intend that the Merger shall qualify as a reorganization within the meaning of Section 368(a)(1)(A) of the Internal Revenue Code of 1986, as amended (the “Code”), by reason of Section 368(a)(2)(E) of the Code; and
NOW, THEREFORE, in consideration of the mutual agreements and covenants hereinafter set forth, the parties hereto agree as follows:
ARTICLE
I
DEFINITIONS
Section 1.1 Definitions. Capitalized terms used in this Agreement shall have the following meanings:
“Merger Sub” shall have the meaning given to such term in the preamble to this Agreement.
“Acquisition Proposal” shall have the meaning given to such term in Section 6.2 hereof.
“Action” shall mean any claim, action, suit, proceeding, investigation or order.
“Affiliate” shall mean, with respect to any Person, any Person directly or indirectly controlling, controlled by or under common control with, such Person. For the purposes of this definition, “control” (including, with correlative meaning, the terms “controlling,” “controlled by” and “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of management and policies of such Person through the ownership of voting securities, by contract or otherwise.
“Agreement” shall mean this Agreement and Plan of Merger, including the exhibits attached hereto or referred to herein, as the same may be amended or modified from time to time in accordance with the provisions hereof.
“Balance Sheet” shall have the meaning given to such term in Section 4.5 hereof.
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“Balance Sheet Date” shall have the meaning given to such term in Section 4.5 hereof.
“By-laws” shall have the meaning given to such term in Section 2.3(b) hereof.
“Certificate of Incorporation” shall have the meaning given to such term in Section 2.3(a) hereof.
“Closing” shall have the meaning given to such term in Section 2.5 hereof.
“Closing Date” shall have the meaning given to such term in Section 2.5 hereof.
“Code” shall have the meaning given to such term in the second recital to this Agreement.
“Commission” shall mean the United States Securities and Exchange Commission.
“Company” shall have the meaning given to such term in the preamble to this Agreement.
“Company Capital Stock” shall mean, collectively, the Company Common Stock and the Company Preferred Stock, if any.
“Company Common Stock” shall mean the common stock, par value $0.01, of the Company.
“Company Convertible Debentures” shall mean the 5% secured convertible debentures issued by the Company and outstanding as of the Effective Time.
“Company Material Adverse Effect” shall mean any change, effect or circumstance that is materially adverse or is reasonably likely to be materially adverse to the business, assets, liabilities, condition (financial or otherwise) or operations of the Company and its subsidiaries, taken as a whole, other than any such change, effect or circumstance relating to general economic, regulatory or political conditions, except to the extent such change, effect or circumstance disproportionately affects the Company and its subsidiaries, taken as a whole.
“Company Stock Options” shall have the meaning given to such term in Section 3.3(a) hereof.
“Contract” shall have the meaning given to such term in Section 4.4 hereof.
“Consents” shall mean any permits, filings, notices, licenses, consents, authorizations, accreditation, waivers, approvals and the like of, to, with or by any Person.
“Determination Date” shall have the meaning given to such term in Section 9.6 hereof.
“Dissenting Shares” shall have the meaning given to such term in Section 3.2(d) hereof.
“Effective Time” shall have the meaning given to such term in Section 2.2 hereof.
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“Employee Benefit Plans” shall have the meaning assigned to it in Section 4.13 hereof.
“Environmental Law” shall mean the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. §§ 9601 et seq.; the Emergency Planning and Community Right-to-Know Act of 1986, 42 U.S.C. §§ 11001 et seq.; the Resource Conservation and Recovery Act, 42 U.S.C. §§ 6901 et seq.; the Toxic Substances Control Act, 15 U.S.C. §§ 2601 et seq.; the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 136 et seq. and comparable state statutes dealing with the registration, labeling and use of pesticides and herbicides; the Clean Air Act, 42 U.S.C. §§ 7401 et seq.; the Clean Water Act (Federal Water Pollution Control Act), 33 U.S.C. §§ 1251 et seq.; the Safe Drinking Water Act, 42 U.S.C. §§ 300f et seq.; and the Hazardous Materials Transportation Act, 49 U.S.C. §§ 1801 et seq., as any of the above referenced statutes have been amended as of the date hereof, all rules, regulations and policies promulgated pursuant to any of the above referenced statutes, and any other foreign, federal, state or local law, statute, ordinance, rule, regulation or policy governing environmental matters, as the same have been amended as of the date hereof.
“ERISA” shall mean the Employee Retirement Income Securities Act of 1974, as amended, and the regulations issued thereunder.
“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended, and the rules and regulations issued thereunder.
“Fair Market Value” shall mean, with respect to a share of Common Stock on any Determination Date, the average of the daily closing prices for the 10 consecutive business days prior to such date. The closing price for each day shall be the last sales price or in case no sale takes place on such day, the average of the closing high bid and low asked prices, in either case (a) as officially quoted on the OTC Bulletin Board, the NASDAQ Stock Market or such other market on which the Common Stock is then listed for trading or quoted, or (b) if, in the reasonable judgment of the Board of Directors of Parent, the OTC Bulletin Board or the NASDAQ Stock Market is no longer the principal United States market for the Common Stock, then as quoted on the principal United States market for the Common Stock as determined by the Board of Directors of Parent, or (c) if, in the reasonable judgment of the Board of Directors of the Parent, there exists no principal United States market for the Common Stock, then as reasonably determined in good faith by the Board of Directors of Parent.
“Federal Securities Laws” means the Securities Act, the Exchange Act and the rules and regulations promulgated thereunder.
“GAAP” shall mean generally accepted accounting principles as in effect from time to time in the United States consistently applied.
“Hazardous Material” means any substance or material meeting any one or more of the following criteria: (a) it is or contains a substance designated as or meeting the characteristics of a hazardous waste, hazardous substance, hazardous material, pollutant, chemical substance or mixture, contaminant or toxic substance under any Environmental Law; (b) its presence at some quantity requires investigation, notification or remediation under any Environmental Law; (c) it contains, without limiting the foregoing, asbestos, polychlorinated biphenyls, petroleum
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hydrocarbons, petroleum derived substances or waste, pesticides, herbicides, crude oil or any fraction thereof, nuclear fuel, natural gas or synthetic gas; or (d) mold.
“Incentive Plans” shall have the meaning given to such term in Section 3.3(d) hereof.
“Indebtedness” shall mean any obligation of the Company that under GAAP is required to be shown on the Balance Sheet of the Company as a Liability. Any obligation secured by a Lien on, or payable out of the proceeds of production from, property of the Company shall be deemed to be Indebtedness even though such obligation is not assumed by the Company.
“Indebtedness for Borrowed Money” shall mean (a) all Indebtedness in respect of money borrowed including, without limitation, Indebtedness which represents the unpaid amount of the purchase price of any property and is incurred in lieu of borrowing money or using available funds to pay such amounts and not constituting an account payable or expense accrual incurred or assumed in the ordinary course of business of the Company, (b) all Indebtedness evidenced by a promissory note, bond or similar written obligation to pay money, or (c) all such Indebtedness guaranteed by the Company or for which the Company is otherwise contingently liable.
“Information Statement” shall have the meaning given to such term in Section 7.7 hereof.
“Intellectual Property” shall have the meaning given to such term in Section 4.12(b) hereof.
“Investment Company Act” shall mean the Investment Company Act of 1940, as amended.
“Letter of Transmittal” shall have the meaning assigned to it in Section 3.2 hereof.
“Liability” shall mean any and all liability, debt, obligation, deficiency, Tax, penalty, fine, claim, cause of action or other loss, cost or expense of any kind or nature whatsoever, whether asserted or unasserted, absolute or contingent, accrued or unaccrued, liquidated or unliquidated, and whether due or to become due and regardless of when asserted.
“Lien” shall mean any mortgage, pledge, security interest, encumbrance, lien or charge of any kind, including, without limitation, any conditional sale or other title retention agreement, any lease in the nature thereof and the filing of or agreement to give any financing statement under the Uniform Commercial Code of any jurisdiction and including any lien or charge arising by statute or other law.
“Merger” shall have the meaning given to such term in the second recital to this Agreement.
“DGCL” shall mean the Delaware General Corporation Law, as amended.
“Parent” shall have the meaning given to such term in the preamble to this Agreement.
“Parent Balance Sheet” shall have the meaning assigned to such term in Section 5.13 hereof.
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“Parent Balance Sheet Date” shall have the meaning assigned to it in Section 5.13 hereof.
“Parent Common Stock” shall mean the common stock, par value $0.001 per share, of Parent.
“Parent Employee Benefit Plans” shall have the meaning assigned to such term in Section 5.16 hereof.
“Parent Financial Statements” shall have the meaning assigned to such term in Section 5.10 hereof.
“Parent Material Adverse Effect” means any change, effect or circumstance that is materially adverse or is reasonably likely to be materially adverse to the business, assets, liabilities, condition (financial or otherwise) or operations of Parent and its subsidiaries, taken as a whole, other than any such change, effect or circumstance relating to general economic, regulatory or political conditions, except to the extent such change, effect or circumstance disproportionately affects Parent and its subsidiaries, taken as a whole.
“Parent SEC Documents” shall have the meaning assigned to such term in Section 5.9 hereof.
“Parent Warrants” shall mean the warrants to purchase common stock in the Parent to be issued to the holders of the Company Convertible Debentures, the form of which is shown in Exhibit F.
“Permitted Liens” shall mean (a) Liens for taxes and assessments or governmental charges or levies not at the time due or in respect of which the validity thereof shall currently be contested in good faith by appropriate proceedings; (b) Liens in respect of pledges or deposits under workmen’s compensation laws or similar legislation, carriers’, warehousemen’s, mechanics’, laborers’ and materialmens’ and similar Liens, if the obligations secured by such Liens are not then delinquent or are being contested in good faith by appropriate proceedings; and (c) Liens incidental to the conduct of the business of the Company that were not incurred in connection with the borrowing of money or the obtaining of advances or credits and which do not in the aggregate materially detract from the value of its property or materially impair the use made thereof by the Company in its business.
“Person” shall mean any individual, corporation, limited liability company, partnership, joint venture, trust or other entity or organization, including any government or political subdivision or an agency or instrumentality thereof.
“Securities Act” shall mean the Securities Act of 1933, as amended, and the rules and regulations issued thereunder.
“Stockholder” shall mean any record holder of Company Capital Stock.
“Surviving Corporation” shall have the meaning given to such term in Section 2.1 hereof.
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“Tax” or “Taxes” shall mean (a) any and all taxes, assessments, customs, duties, levies, fees, tariffs, imposts, deficiencies and other governmental charges of any kind whatsoever (including, but not limited to, taxes on or with respect to net or gross income, franchise, profits, gross receipts, capital, sales, use, ad valorem, value added, transfer, real property transfer, transfer gains, transfer taxes, inventory, capital stock, license, payroll, employment, social security, unemployment, severance, occupation, real or personal property, estimated taxes, rent, excise, occupancy, recordation, bulk transfer, intangibles, alternative minimum, doing business, withholding and stamp), together with any interest thereon, penalties, fines, damages costs, fees, additions to tax or additional amounts with respect thereto, imposed by the United States (federal, state or local) or other applicable jurisdiction; (b) any liability for the payment of any amounts described in clause (a) as a result of being a member of an affiliated, consolidated, combined, unitary or similar group or as a result of transferor or successor liability, including, without limitation, by reason of Code Section 1.1502-6; and (c) any liability for the payments of any amounts as a result of being a party to any Tax Sharing Agreement or as a result of any express or implied obligation to indemnify any other Person with respect to the payment of any amounts of the type described in either clauses (a) or (b).
“Tax Return” shall include all returns and reports (including elections, declarations, disclosures, schedules, estimates and information returns (including Form 1099 and partnership returns filed on Form 1065)) required to be supplied to a Tax authority relating to Taxes.
“Tax Sharing Agreements” shall have the meaning given to such term in Section 4.15 hereof.
ARTICLE
II
THE MERGER
Section 2.1 Merger. Upon the terms and subject to the conditions of this Agreement, at the Effective Time, the Company shall be merged with and into Merger Sub in accordance with applicable Delaware corporate law. Following the Effective Time, the separate corporate existence of the Company shall cease, and Merger Sub shall continue as the corporation surviving the Merger (sometimes hereinafter referred to as the “Surviving Corporation”).
Section 2.2 Effective Time. The Parent, the Company and Merger Sub shall cause a certificate of merger to be filed on the Closing Date (or on such other date as the Company and Parent may agree in writing) with the Secretary of State of the State of Delaware as provided in the DGCL, and shall make all other filings or recordings required by the DGCL in connection with the Merger. The Merger shall become effective at such time as the certificate of merger is duly filed in accordance with the DGCL or such later time as specified in the certificate of merger, and such time is hereinafter referred to as the “Effective Time.”
Section 2.3 Certificate of Incorporation; By-laws; Directors and Officers.
(a) The certificate of incorporation of Merger Sub as in effect immediately prior to the Effective Time, a copy of which is attached as Exhibit A hereto, shall be the certificate of incorporation of the Surviving Corporation (the “Certificate of Incorporation”)
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from and after the Effective Time until thereafter changed or amended as provide therein or in accordance with applicable law.
(b) The by-laws of Merger Sub as in effect immediately prior to the Effective Time, a copy of which is attached as Exhibit B hereto, shall be the by-laws of the Surviving Corporation (the “By-laws”) from and after the Effective Time until thereafter changed or amended as provided therein or in accordance with applicable law.
(c) One or more of the directors of the Company immediately prior to the Effective Time shall be the initial directors of the Surviving Corporation and shall hold office from the Effective Time until their respective successors have been duly elected or appointed and qualified or until their earlier death, resignation or removal in accordance with the Certificate of Incorporation and By-laws. The officers of the Company immediately prior to the Effective Time shall be the initial officers of the Surviving Corporation and shall hold office from the Effective Time until their respective successors have been duly elected or appointed and qualified or until their earlier death, resignation or removal in accordance with the Certificate of Incorporation and By-laws.
(d) At the Effective Time as contemplated by Section 2.2 hereof, the officers and directors of the Parent shall be as designated on Exhibit C hereto, who shall immediately take such offices or who shall take such offices upon compliance with the Federal Securities Laws, as the case may be. The appointment of new directors in accordance with the terms of this Section 2.3(d) shall be accomplished through the filling of vacancies in the Board of Directors of the Parent in compliance with the applicable provisions of the DGCL and the by-laws of the Parent and without the vote (by written consent or otherwise) of the shareholders of the Parent.
Section 2.4 Effects of the Merger. The Merger shall have the effects set forth in the DGCL. Without limiting the generality of the foregoing, at the Effective Time, except as otherwise provided herein, all of the property, rights, privileges, powers and franchises of the Company and Merger Sub shall vest in the Surviving Corporation, and all debts, liabilities and duties of the Company and Merger Sub shall become the debts, liabilities and duties of the Surviving Corporation. The Company acknowledges that, from and after the Effective Time, Parent shall have the absolute and unqualified right to deal with the assets and business of the Surviving Corporation as its own property without limitation on the disposition or use of such assets or the conduct of such business.
Section 2.5 Closing. The consummation of the transactions contemplated by this Agreement, including the Merger (the “Closing”), shall take place: (a) at the offices of Laxague Law, Inc., 1 East Liberty, Suite 600, Reno, Nevada 89501 on the date on which all of the conditions to the Closing set forth in Article VIII hereof shall be fulfilled or waived in accordance with this Agreement (other than conditions that can be satisfied only at the Closing, but subject to the fulfillment or waiver of those conditions at the Closing); or (b) at such other place, time and date as the Company and Parent may agree in writing (the “Closing Date”).
Section 2.6 Tax-Free Merger. The parties hereto intend that the Merger will be treated as a tax-free reorganization under Section 368 of the Code.
ARTICLE III
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MERGER CONSIDERATION; CONVERSION AND EXCHANGE OF SECURITIES
Section 3.1 Manner and Basis of Converting and Exchanging Capital Stock. At the Effective Time, by virtue of the Merger and without any action on the part of the Company, Parent or Merger Sub or the holders of any outstanding shares of capital stock or other securities of the Company, Parent or Merger Sub:
(a) Merger Sub Stock. Each share of common stock, par value $0.001 per share, of Merger Sub issued and outstanding immediately prior to the Effective Time shall be converted into and become one validly issued, fully paid and non-assessable share of capital stock, no par value per share, of the Surviving Corporation, such that Parent shall be the holder of all of the issued and outstanding shares of capital stock of the Surviving Corporation following the Merger.
(b) Parent Common Stock To Be Issued To Company Shareholders In Exchange For Company Common Stock. All of the Shares of the Company Common Stock issued and outstanding immediately prior to the Effective Time shall be exchanged for the right to receive Parent Common Stock in the specific amounts and denominations set forth on Schedule 1 hereto.
(c) Treasury Stock. Notwithstanding any provision of this Agreement to the contrary, each share of Company Capital Stock held in the treasury of the Company and each share of Company Capital Stock, if any, owned by Parent or any direct or indirect wholly-owned subsidiary of Parent immediately prior to the Effective Time shall be canceled in the Merger and shall not be converted or exchanged into the right to receive any shares of capital stock or other securities of Parent.
(d) No Fractional Securities. No fractional Parent Securities shall be issued as a result of the Merger. If a fractional Parent Security would otherwise result from the Merger, the number of securities required to be issued to such record holder shall be rounded to the nearest whole number of shares, warrants, or dollars, as applicable.
Section 3.2 Surrender and Exchange of Certificates.
(a) Letter of Transmittal. Promptly after the Effective Time, Parent shall mail, or cause to be mailed, to each record holder of certificate(s) formerly representing ownership of Company Capital Stock that was converted into the right to receive securities in the Parent pursuant to Section 3.1 hereof (i) a letter of transmittal (“Letter of Transmittal”) for delivery of such certificate(s) to Parent and (ii) instruction for use in effecting the surrender of certificate(s), in each case in form and substance mutually agreeable to the Company and Parent. Delivery shall be effected, and risk of loss and title to the issuable Parent securities shall pass, only upon delivery to the Parent (or a duly authorized agent of Parent) of certificate(s) formerly representing ownership of Company Capital Stock (or an affidavit of lost certificate and indemnification or surety bond) and a properly completed and duly executed Letter of Transmittal, as described in Section 3.2(b) hereof. Notwithstanding the foregoing, Parent shall not be required to mail, or cause to be mailed, a Letter of Transmittal to any record holder of
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certificate(s) formerly representing ownership of Company Capital Stock if such holder has previously agreed or consented to the exchange of certificates that are held in custody by the Company for the benefit of such holder.
(b) Exchange Procedures. Parent shall issue to each former record holder of Company Capital Stock, upon delivery to Parent (or a duly authorized agent of Parent) of (i) certificate(s) formerly representing ownership of Company Capital Stock endorsed in blank or accompanied by duly executed stock powers (or an affidavit of lost certificate and indemnification in form and substance reasonably acceptable to Parent stating that, among other things, the former record holder has lost his or her certificate(s) or that such certificate(s) have been destroyed) and (ii) a properly completed and duly executed Letter of Transmittal in form and substance reasonably satisfactory to Parent, the Parent Securities that such former record holder is entitled to receive in accordance with Section 3.1 hereof. Subject to Section 3.2(d) hereof, until the certificate(s) (or affidavit) is delivered together with the Letter of Transmittal in the manner contemplated by this Section 3.2(b), each certificate (or affidavit) previously representing ownership of Company Capital Stock shall be deemed at and after the Effective Time to represent only the right to receive Parent Securities as set forth herein and the former record holders thereof shall cease to have any other rights with respect to his or her Company Capital Stock.
(c) Termination of Exchange Process. Any Parent Securities issuable hereunder that remain unclaimed by a former record holder of Company Capital Stock at the first anniversary of the Effective Time may be deemed “abandoned property” subject to applicable abandoned property, escheat and other similar laws in the State in which the former record holder resides. None of the Company, Parent, Merger Sub or the Surviving Corporation shall be liable to any person in respect of any Parent Securities delivered to a public official pursuant to any applicable abandoned property, escheat or similar law.
(d) Dissenting Shares. Notwithstanding any provision of this Agreement to the contrary, shares of Company Capital Stock issued and outstanding immediately prior to the Effective Time and held by a Stockholder who has not voted in favor of the Merger or consented thereto in writing and who has demanded appraisal for such shares of Company Capital Stock (“Dissenting Shares”) shall not be entitled to vote for any purpose or receive dividends, shall not be converted into the right to receive Parent Securities in accordance with Section 3.1 hereof, and shall only be entitled to receive such consideration as shall be determined pursuant to the DGCL; provided, however, that if, after the Effective Time, such Stockholder fails to perfect or withdraws or loses his or her right to appraisal or otherwise fails to establish the right to be paid the value of such Stockholder’s shares of Company Capital Stock under the NRS, such shares of Company Capital Stock shall be treated as if they had converted as of the Effective Time into the right to receive Parent Securities in accordance with Section 3.1 hereof, and such shares of Company Capital Stock shall no longer be Dissenting Shares. All negotiations with respect to payment for Dissenting Shares shall be handled jointly by Parent and the Company prior to the Closing and exclusively by Parent thereafter. In the event that one percent (1%) or more of the outstanding shares of the Company are Dissenting Shares, the Parent has the sole discretion to terminate this Agreement, which shall forthwith become void and of no further force and effect and the parties hereto shall be released from any and all obligations hereunder; provided,
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however, that nothing herein shall relieve any party hereto from liability for the breach of any of its representations, warranties, covenants or agreements set forth in this Agreement.
(e) Stock Transfer Books. At the Effective Time, the stock transfer books of the Company will be closed and there will be no further registration of transfers of shares of Company Capital Stock thereafter on the records of the Company. If, after the Effective Time, certificates formerly representing Company Capital Stock are presented to the Surviving Corporation, these certificates shall be canceled and exchanged for the Parent Securities to which the former record holder may be entitled pursuant to Section 3.1 hereof.
(f) Further Rights in Company Stock. All Parent Securities issued upon exchange of shares of Company Capital Stock in accordance with the terms hereof shall be deemed to have been issued in full satisfaction of all rights pertaining to such shares of Company Capital Stock.
Section 3.3 Company Options; OSIF Conversion Rights
(a) The Company has adopted the Microlin Bio, Inc. Equity Incentive Plan, under which 500,000 shares of common stock have been reserved for issuance upon exercise of options granted under the Plan. As of the Effective Time, the Company warrants that there are outstanding options issued under the Plan to purchase a total of 182,000 shares of Company Common Stock (the “Company Stock Options”), as more specifically set forth in Schedule 2 hereto.
(b) At the Effective Time, the Parent shall be deemed to have adopted the Microlin Bio, Inc. Equity Incentive Plan, and the Company Stock Options shall be deemed exchanged for options to purchase an equal number of shares of common stock of the Parent on the same terms as currently govern the Company Stock Options. The Parent shall take all corporate action necessary to reserve a sufficient number of shares for future issuance pursuant to the Company Stock Options and such additional securities as may be issued under the Microlin Bio, Inc. Equity Incentive Plan.
(c) The Company has entered into certain agreements under which the Company’s financial obligations to the Ohio State Innovation Foundation and/or the Ohio State University Foundation, Inc. (collectively, the “Ohio State Obligations”) may be convertible, in whole or in part, to shares of Parent Common Stock. Further, the Company has entered into certain agreements under which common stock currently issued to Ohio State University Foundation, Inc. may be protected from dilution under certain conditions and within certain limits (the “Ohio State Anti-Dilution Rights”). The Ohio State Obligations and the Ohio State Anti-Dilution Rights, as currently documented and as may be modified by such additional agreements as are now under review by the parties thereto, shall be deemed to have been adopted and ratified in full by the Parent as of the Effective Time. All rights to receive Company common stock under the Ohio State Obligations shall be deemed exchanged for a rights to receive an equal number and/or proportion, as appropriate, of shares of Parent Common Stock. Further, all anti-dilution rights which may accrue to Ohio State University Foundation, Inc. under the Ohio State Anti-Dilution Rights shall continue in full force and effect with regard to the Parent Common Stock to be issued to Ohio State University Foundation, Inc.
Section 3.4
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Parent Common Stock. Parent shall reserve a sufficient number of shares of Parent Common Stock to complete the conversion and exchange of Company Capital Stock into Parent Capital Stock contemplated by Sections 3.1 and 3.2 hereof. Parent covenants and agrees that immediately prior to the Effective Time there will be approximately 9,635,00 shares of Parent Common Stock issued and outstanding, and that no other common or preferred stock or equity securities of the Parent, or any options, warrants, rights or other agreements or instruments convertible, exchangeable or exercisable into common or preferred stock or equity securities of the Parent, shall be issued or outstanding immediately prior to the Effective Time, except as disclosed herein.
Section 3.5 Parent Liabilities as of the Effective Time; Payment and Modification of Terms. The complete list of all Liabilities of the Parent is as set forth in Exhibit F. All such liabilities, up to a maximum total amount of $90,000, shall be paid in full by the Company and/or the Parent within one hundred twenty (120) days of the Effective Time. To the extent that any of the Liabilities as set forth on Exhibit F are, by their terms, convertible into any capital stock of the Parent, the terms of all such Liabilities shall be modified in writing to remove any such right to conversion.
ARTICLE
IV
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The Company hereby represents and warrants to Parent as follows:
Section 4.1 Organization. The Company (i) is duly organized, validly existing and in good standing (or its equivalent) under the laws of the State of Delaware, (ii) has all licenses, permits, authorizations and other Consents necessary to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and (iii) has all requisite corporate or other applicable power and authority to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and presently proposed to be conducted, except where such failure would not have, or be reasonably likely to have, a Company Material Adverse Effect. The Company is duly qualified or authorized to conduct business and is in good standing (or its equivalent) as a foreign corporation or other entity in all jurisdictions in which the ownership or use of its assets or nature of the business conducted by it makes such qualification or authorization necessary, except where the failure to be so duly qualified, authorized and in good standing would not have a Company Material Adverse Effect.
Section 4.2 Authorization; Validity of Agreement. The Company has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby. The execution, delivery and performance by the Company of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by the Board of Directors of the Company and no other action (except the approval of the requisite Stockholders solely with respect to consummation of the Merger) on the part of the Company or any of its Stockholders or subsidiaries is necessary to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby. This Agreement has been duly executed and delivered by the Company and (assuming due and valid authorization, execution and delivery hereof by Parent and Merger Sub) is a valid and binding obligation of the Company, enforceable against the Company in accordance with its terms,
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except as such enforcement is limited by bankruptcy, insolvency and other similar laws affecting the enforcement of creditors’ rights generally and by general principles of equity.
Section 4.3 Capitalization. As of the Effective Date the authorized and issued capital stock of the Company shall consist of 4,030,258 shares of common stock. All the outstanding shares of Company Capital Stock are duly authorized, validly issued, fully paid and non-assessable. As of the Effective Time, there shall be no rights in favor of any person to purchase any Company Capital Stock, except as such rights arise under the Company Stock Options and the Ohio State Obligations and the Ohio State Anti-Dilution Rights.
Section 4.4 Consents and Approvals; No Violations. Except for (a) approval of the Merger by the requisite Stockholders and (b) filing of the certificate of merger with the Secretary of State of the State of Delaware, neither the execution, delivery or performance of this Agreement by the Company nor the consummation of the transactions contemplated hereby will (i) violate any provision of its certificate of incorporation or by-laws; (ii) violate, conflict with or result in a breach of any provision of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, require the consent of or result in the creation of any encumbrance upon any of the properties of the Company or any of its subsidiaries under any material note, bond, mortgage, indenture, deed of trust, license, franchise, permit, lease, contract, agreement or other instrument (collectively, “Contract”) to which the Company or any its subsidiaries or any of their respective properties may be bound; (iii) require any Consent, approval or authorization of, or notice to, or declaration, filing or registration with, any governmental entity by or with respect to the Company or any of its subsidiaries; or (iv) violate any order, writ, judgment, injunction, decree, law, statute, rule or regulation applicable to the Company or any of its subsidiaries or any of their respective properties or assets; except, in the cases of clauses (ii), (iii) and (iv), any such violations, conflicts, breaches, defaults or encumbrances, or any failure to receive any such Consent, approval or authorization, or to make any such notice, declaration, filing or registration as will not result in, or could reasonably be expected to result in, a Company Material Adverse Effect.
Section 4.5 Financial Statements. The Company has delivered or made available as of the date hereof or shall, prior to the Closing Date, deliver or make available to Parent (x) the audited comparative balance sheet of the Company for the fiscal years ended September 30, 2015 and 2014 (hereinafter, September 30, 2015 shall be referred to as the “Balance Sheet Date”), and (y) the related audited consolidated and consolidating statements of income, stockholders’ equity and cash flows of the Company for the fiscal years ended September 30, 2015 and 2014. The foregoing financial statements (including any notes thereto) (i) have been prepared based upon the books and records of the Company, (ii) have been prepared in accordance with GAAP (except as otherwise noted therein), and (iii) present fairly, in all material respects, the financial position, results of operations and cash flows of the Company as at their respective dates and for the periods then ended. To the knowledge of the Company, since the Balance Sheet Date, no fact or condition exists that has not been disclosed to Parent that has had or could reasonably be expected to have a Company Material Adverse Effect.
Section 4.6 No Undisclosed Liabilities. As of the date hereof, except (a) for Liabilities reflected on the face of the balance sheet dated September 30, 2015 (the “Balance Sheet”) and (b) Liabilities of the same type, magnitude and scope as those reflected on the
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Balance Sheet which have arisen since the Balance Sheet Date in the ordinary course of business, and which would not, in the aggregate, result in a Company Material Adverse Effect, the Company does not have any Liability.
Section 4.7 Litigation. There is no Action pending or, to the knowledge of the Company, threatened, involving the Company or its subsidiaries or affecting any of the officers, directors or employees of the Company or its subsidiaries with respect to the Company’s or any subsidiary’s business by or before any governmental entity or by any third party that has had or could reasonably be expected to have a Company Material Adverse Effect and neither the Company nor any of its subsidiaries have received written notice that any such Action is threatened. Neither the Company nor any of its subsidiaries is in default under any judgment, order or decree of any governmental entity applicable to its business, which default could reasonably be expected to have a Company Material Adverse Effect.
Section 4.8 No Default; Compliance with Applicable Laws. The Company is not in default or violation of any material term, condition or provision of (i) its certificate of incorporation or by-laws or (ii) to the Company’s knowledge, any law applicable to the Company or its property and assets, and the Company has not received written notice of any violation of or Liability under any of the foregoing (whether material or not).
Section 4.9 Broker’s and Finder’s Fees. To the knowledge of the Company, no Person has, or as a result of the transactions contemplated or described herein will have, any right or valid claim against the Company for any commission, fee or other compensation as a finder or broker, or in any similar capacity.
Section 4.10 Contracts.
(a) The Company is not in violation or breach of any material contract, except such violations that, in the aggregate, would not result in, or would not reasonably be expected to result in, a Company Material Adverse Effect. There does not exist any event or condition that, after notice or lapse of time or both, would constitute an event of default or breach under any material Contract on the part of the Company or, to the knowledge of the Company, any other party thereto or would permit the modification, cancellation or termination of any material Contract or result in the creation of any lien upon, or any person acquiring any right to acquire, any assets of the Company, other than any events or conditions that, in the aggregate would not result in, or would not reasonably be expected to result in, a Company Material Adverse Effect. The Company has not received in writing any claim or threat that the Company has breached any of the terms and conditions of any material Contract, other than any material Contracts the breach of which, in the aggregate, would not result in, or would not reasonably be expected to result in, a Company Material Adverse Effect.
(b) The consent of, or the delivery of notice to or filing with, any party to a material Contract is not required for the execution and delivery by the Company of this Agreement or the consummation of the transactions contemplated under the Agreement.. The Company has made available to Parent and Merger Sub true and complete copies of all Contracts and other documents requested by Parent or Merger Sub
Section 4.11
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Tax Returns and Audits. All required federal, state and local Tax Returns of the Company have been accurately prepared and duly and timely filed, and all federal, state and local Taxes required to be paid with respect to the periods covered by such returns have been paid. The Company is not and has not been delinquent in the payment of any Tax. The Company has not had a Tax deficiency proposed or assessed against it and has not executed a waiver of any statute of limitations on the assessment or collection of any Tax. None of the Company’s federal income Tax Returns nor any state or local income or franchise Tax Returns has been audited by governmental authorities. The reserves for Taxes reflected on the Balance Sheet are and will be sufficient for the payment of all unpaid Taxes payable by the Company as of the Balance Sheet Date. Since the Balance Sheet Date, the Company has made adequate provisions on its books of account for all Taxes with respect to its business, properties and operations for such period. The Company has withheld or collected from each payment made to each of its employees the amount of all Taxes (including, but not limited to, federal, state and local income taxes, Federal Insurance Contribution Act taxes and Federal Unemployment Tax Act taxes) required to be withheld or collected therefrom, and has paid the same to the proper Tax receiving officers or authorized depositaries. There are no federal, state, local or foreign audits, actions, suits, proceedings, investigations, claims or administrative proceedings relating to Taxes or any Tax Returns of the Company now pending, and the Company has not received any notice of any proposed audits, investigations, claims or administrative proceedings relating to Taxes or any Tax Returns. The Company is not obligated to make a payment, nor is it a party to any agreement that under certain circumstances could obligate it to make a payment, that would not be deductible under Section 280G of the Code. The Company has not agreed nor is required to make any adjustments under Section 481(a) of the Code (or any similar provision of state, local and foreign law) by reason of a change in accounting method or otherwise for any Tax period for which the applicable statute of limitations has not yet expired. The Company is not a party to, is not bound by and does not have any obligation under, any Tax sharing agreement, Tax indemnification agreement or similar contract or arrangement, whether written or unwritten (collectively, “Tax Sharing Agreements”), nor does it have any potential liability or obligation to any Person as a result of, or pursuant to, any Tax Sharing Agreements.
Section 4.12 Patents and Other Intangible Assets.
(a) To the knowledge of the Company, the Company (i) owns or has the right to use, pursuant to a valid license, sublicense, agreement, or permission, free and clear of all Liens, all patents, trademarks, service marks, trade names, copyrights, licenses and rights with respect to the foregoing used in or necessary for the conduct of its business as now conducted or proposed to be conducted without infringing upon or otherwise acting adversely to the right or claimed right of any Person under or with respect to any of the foregoing.
(b) To the knowledge of the Company, the Company owns and has the right to use all trade secrets, if any, including know-how, negative know-how, formulas, patterns, programs, devices, methods, techniques, inventions, designs, processes, computer programs and technical data and all information that derives independent economic value, actual or potential, from not being generally known or known by competitors (collectively, “Intellectual Property”) required for or incident to the development, operation and sale of all products and services sold by the Company, free and clear of any right, Lien or claim of others. All Intellectual Property
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can and will be transferred by the Company to the Surviving Corporation as a result of the Merger and without the consent of any Person other than the Company.
Section 4.13 Employee Benefit Plans; ERISA.
(a) All “employee benefit plans” (within the meaning of Section 3(3) of the ERISA) of the Company and other employee benefit or fringe benefit arrangements, practices, contracts, policies or programs of every type, other than programs merely involving the regular payment of wages, commissions, or bonuses established, maintained or contributed to by the Company, whether written or unwritten and whether or not funded, are in material compliance with the applicable requirements of ERISA, the Code and any other applicable state, federal or foreign law.
(b) There are no pending claims or lawsuits that have been asserted or instituted against any Employee Benefit Plan, the assets of any of the trusts or funds under the Employee Benefit Plans, the plan sponsor or the plan administrator of any of the Employee Benefit Plans or against any fiduciary of an Employee Benefit Plan with respect to the operation of such plan, nor does the Company have any knowledge of any incident, transaction, occurrence or circumstance which might reasonably be expected to form the basis of any such claim or lawsuit.
(c) There is no pending or, to the knowledge of the Company, threatened investigation, or pending or possible enforcement action by the Pension Benefit Guaranty Corporation, the Department of Labor, the Internal Revenue Service or any other government agency with respect to any Employee Benefit Plan and the Company has no knowledge of any incident, transaction, occurrence or circumstance which might reasonably be expected to trigger such an investigation or enforcement action.
(d) No actual or, to the knowledge of the Company, contingent Liability exists with respect to the funding of any Employee Benefit Plan or for any other expense or obligation of any Employee Benefit Plan, except as disclosed on the Balance Sheet, and no contingent Liability exists under ERISA with respect to any “multi-employer plan,” as defined in Section 3(37) or Section 4001(a)(3) of ERISA.
(e) No events have occurred or are reasonably expected to occur with respect to any Employee Benefit Plan that would cause a material change in the costs of providing benefits under such Employee Benefit Plan or would cause a material change in the cost of providing such Employee Benefit Plan.
Section 4.14 Title to Property and Encumbrances. The Company has good and valid title to all properties and assets used in the conduct of its business (except for property held under valid and subsisting leases which are in full force and effect and which are not in default) free of all Liens except Permitted Liens and such ordinary and customary imperfections of title, restrictions and encumbrances as do not in the aggregate constitute a Company Material Adverse Effect.
Section 4.15
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Condition of Properties. All facilities, machinery, equipment, fixtures and other properties owned, leased or used by the Company are in operating condition, subject to ordinary wear and tear, and are adequate and sufficient for the Company’s existing business.
Section 4.16 Insurance Coverage. There is in full force and effect one or more policies of insurance issued by insurers of recognized responsibility insuring the Company and its properties, products and business against such losses and risks, and in such amounts, as are customary for corporations of established reputation engaged in the same or similar business and similarly situated. The Company has not been refused any insurance coverage sought or applied for, and the Company has no reason to believe that it will be unable to renew its existing insurance coverage as and when the same shall expire upon terms at least as favorable to those currently in effect, other than possible increases in premiums that do not result from any act or omission of the Company. No suit, proceeding or action or, to the knowledge of the Company, threat of suit, proceeding or action has been asserted or made against the Company due to alleged bodily injury, disease, medical condition, death or property damage arising out of the function or malfunction of a product, procedure or service designed, manufactured, sold or distributed by the Company.
Section 4.17 Environmental Matters.
(a) To the knowledge of the Company, the Company has never generated, used, handled, treated, released, stored or disposed of any Hazardous Materials on any real property on which it now has or previously had any leasehold or ownership interest, except in compliance with all applicable Environmental Laws.
(b) To the knowledge of the Company, the historical and present operations of the business of the Company are in compliance with all applicable Environmental Laws, except where any non-compliance has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(c) There are no material pending or, to the knowledge of the Company, threatened, demands, claims, information requests or notices of noncompliance or violation against or to the Company relating to any Environmental Law; and, to the knowledge of the Company, there are no conditions or occurrences on any of the real property used by the Company in connection with its business that would reasonably be expected to lead to any such demands, claims or notices against or to the Company, except such as have not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
(d) To the knowledge of the Company, (i) the Company has not, sent or disposed of, otherwise had taken or transported, arranged for the taking or disposal of (on behalf of itself, a customer or any other party) or in any other manner participated or been involved in the taking of or disposal or release of a Hazardous Material to or at a site that is contaminated by any Hazardous Material or that, pursuant to any Environmental Law, (A) has been placed on the “National Priorities List”, the “CERCLIS” list, or any similar state or federal list, or (B) is subject to or the source of a claim, an administrative order or other request to take “removal”, “remedial”, “corrective” or any other “response” action, as defined in any Environmental Law, or to pay for the costs of any such action at the site; (ii) the Company is not involved in (and has
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no basis to reasonably expect to be involved in) any suit or proceeding and has not received (and has no basis to reasonably expect to receive) any written notice, request for information or other communication from any governmental authority or other third party with respect to a release or threatened release of any Hazardous Material or a violation or alleged violation of any Environmental Law, and has not received (and has no basis to reasonably expect to receive) written notice of any claims from any Person relating to property damage, natural resource damage or to personal injuries from exposure to any Hazardous Material; and (iii) the Company has timely filed every report required to be filed, acquired all necessary certificates, approvals and permits, and generated and maintained all required data, documentation and records under all Environmental Laws, in all such instances except where the failure to do so would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Section 4.18 Disclosure. There is no fact relating to the Company that the Company has not disclosed to Parent in writing that has had or is currently having a Company Material Adverse Effect. No representation or warranty by the Company herein and no information disclosed in the exhibits hereto by the Company contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained herein or therein not misleading.
ARTICLE
V
REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB
Parent and Merger Sub hereby represent and warrant to the Company as follows:
Section 5.1 Organization. Each of Parent and Merger Sub (i) is duly organized, validly existing and in good standing under the laws of its State of incorporation or organization, (ii) has all licenses, permits, authorizations and other Consents necessary to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and (iii) has all requisite corporate or other applicable power and authority to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and presently proposed to be conducted, in each case except where such failures would not have, or be reasonably likely to have an apparent Material Adverse Effect. Each of Parent and Merger Sub is duly qualified or authorized to conduct business and is in good standing (or its equivalent) as a foreign corporation or other entity in all jurisdictions in which the ownership or use of its assets or nature of the business conducted by it makes such qualification or authorization necessary, except where the failure to be so duly qualified, authorized and in good standing would not have an apparent Material Adverse Effect.
Section 5.2 Authorization; Validity of Agreement. Each of Parent and Merger Sub has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby. The execution, delivery and performance by each of Parent and Merger Sub of this Agreement and all other agreements and instruments to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby and thereby, have been duly authorized by the Board of Directors of each of Parent and Merger Sub and the stockholder of Merger Sub, and no other action on the part of either of Parent or Merger Sub is necessary to authorize the execution and delivery of this Agreement and
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all other agreements and instruments to be executed pursuant to this Agreement and the consummation by either of Parent or Merger Sub of the transactions contemplated hereby and thereby. This Agreement has been duly executed and delivered by the Parent and Merger Sub and (assuming due and valid authorization, execution and delivery hereof by the Company) is a valid and binding obligation of each of Parent and Merger Sub, enforceable against each of them in accordance with its terms, except as such enforcement is limited by bankruptcy, insolvency and other similar laws affecting the enforcement of creditors’ rights generally and by general principles of equity.
Section 5.3 Consents and Approvals; No Violations. Except for filing of the certificate of merger with the Secretary of State of the State of Nevada, neither the execution, delivery or performance of this Agreement by either of Parent and Merger Sub nor the consummation of the transactions contemplated hereby will (i) violate any provision of the certificate of incorporation or by-laws of Parent or Merger Sub; (ii) violate, conflict with or result in a breach of any provision of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, require the consent of or result in the creation of any Lien upon any of the properties of Parent or Merger Sub under any Contract to which Parent or Merger Sub or any of their properties may be bound; (iii) require any Consent, approval or authorization of, or notice to, or declaration, filing or registration with, any governmental entity by or with respect to Parent or any subsidiary of Parent, or (iv) violate any order, writ, judgment, injunction, decree, law, statute, rule or regulation applicable to any of Parent or Merger Sub or any of their respective properties or assets; except, in the cases of clauses (ii), (iii) and (iv), any such violations, conflicts, breaches, defaults or encumbrances, or any failure to receive any such Consent, approval or authorization, or to make any such notice, declaration, filing or registration as will not result in, or could reasonably be expected to result in, a Parent Material Adverse Effect.
Section 5.4 Litigation. There is no Action pending or, to the knowledge of the Parent, threatened, involving Parent or Merger Sub or any subsidiary of Parent or affecting the officers, directors or employees of Parent or Merger Sub or any subsidiary of Parent with respect to Parent’s, Merger Sub’s, or any of Parent’s subsidiaries’, businesses by or before any governmental entity or by any third party and none of Parent, Merger Sub nor any subsidiary of Parent has received written notice that any such Action is threatened. None of Parent, Merger Sub nor any subsidiary of Parent is in default under any judgment, order or decree of any governmental entity applicable to its business which could reasonably be expected to have a Parent Material Adverse Effect.
Section 5.5 No Default; Compliance with Applicable Laws. Neither Parent nor any of Parent’s subsidiaries is in default or violation of any material term, condition or provision of (i) their respective certificate of incorporation, by-laws or similar organizational documents or (ii) any law applicable to Parent or any of Parent’s subsidiaries or its property and assets and neither Parent nor any of Parent’s subsidiaries has received written notice of any violation of or Liability under any of the foregoing (whether material or not).
Section 5.6 Broker’s and Finder’s Fees; Broker/Dealer Ownership. No person(s), firm, corporation or other entity is entitled by reason of any act or omission of Parent or Merger Sub to any broker’s or finder’s fees, commission or other similar compensation, nor, with respect
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to the execution, delivery and performance of this Agreement or with respect to the consummation of the transactions contemplated hereby will any such person have any right or valid claim against the Company, Parent or Merger Sub to any such payment.
Section 5.7 Capitalization of Parent. As of the date hereof, the authorized capital stock of Parent consists of 90,000,000 shares of Parent Common Stock and 10,000,000 shares of Parent Preferred Stock. As of the date hereof and immediately prior to the Effective Time, there are 9,635,000 shares of Parent Common Stock, par value $0.001, issued and outstanding. Other than as provided in Article III of this Agreement in connection with securities to be issued or to become issuable in connection with or as a result of the Merger, Parent has no outstanding options, warrants, rights or commitments to issue shares of Parent Common Stock or any capital stock or other securities of Parent or Merger Sub, and there are no outstanding securities convertible or exercisable into or exchangeable for shares of Parent Common Stock or any capital stock or other securities of Parent or Merger Sub There is no voting trust, agreement or arrangement among any of the beneficial holders of Parent Common Stock affecting the nomination or election of directors or the exercise of the voting rights of Parent Common Stock. There are no registration rights or similar rights applicable to any shares of Parent Common Stock or any capital stock or other securities of Parent or Merger Sub. All outstanding shares of the capital stock of Parent are validly issued and outstanding, fully paid and non-assessable, and none of such shares have been issued in violation of the preemptive rights of any person. All of the shares of Parent Common Stock issued and outstanding immediately prior to the Effective Time have been issued in compliance with the Securities Act and applicable state securities laws and (i) pursuant to effective registration statements filed with the Securities and Exchange Commission and/or (ii) in reliance on valid exemptions from registration or qualification thereunder.
Section 5.8 Merger Sub Merger Sub is a Delaware corporation and a wholly-owned subsidiary of Parent that was formed on December 11, 2015 specifically for the purpose of the Merger and that has not conducted any business or acquired any property, and will not conduct an business or acquire any property prior to the Closing Date, except in preparation for and otherwise in connection with the transactions contemplated by this Agreement. Parent owns all of the issued and outstanding capital stock of Merger Sub, has no outstanding options, warrants or rights to purchase capital stock or other securities of Merger Sub, other than the capital stock of Merger Sub owned by Parent. Except for Merger Sub, Parent has no subsidiaries. Merger Sub has no subsidiaries.
Section 5.9 Validity of Shares. The shares of Parent Common Stock to be issued in accordance with Article III hereof, when issued and delivered in accordance with the terms hereof, shall be duly authorized, validly issued, fully paid and non-assessable.
Section 5.10 SEC Reporting and Compliance.
(a) Parent filed a registration statement on Form S-11 under the Securities Act which became effective on January 22, 2013. Since that date, Parent has timely filed with the Commission all registration statements, proxy statements, information statements and reports required to be filed by Parent pursuant to the Exchange Act (collectively, the “Parent SEC
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Documents”). Parent has not filed with the Commission a certificate on Form 15 pursuant to the Exchange Act.
(b) None of the Parent SEC Documents, as of their respective dates, contained any untrue statement of a material fact or omitted to state a material fact necessary in order to make the statements contained therein not misleading. Each of the Parent SEC Documents complied, and each Parent SEC Document to be filed with the Commission prior to the Effective Date shall comply, in all material respects, with the applicable requirements of the Securities Act and the Securities Exchange, as the case may be. Each of the financial statements (including, in each case, any related notes), contained in the Parent SEC Documents, including any Parent SEC Documents filed after the date of this Agreement until the Closing, complied, as of its respective filing date, in all material respects with all applicable accounting requirements and the published rules and regulations of the Commission with respect thereto.
(c) Nothing has occurred with respect to which Parent would be required to file, any report on Form 8-K prior to the date hereof for which Parent has failed to file such report. Prior to and until the Closing, Parent will provide to the Company copies of any and all amendments or supplements to the Parent SEC Documents filed with the Commission and all subsequent registration statements and reports filed by Parent subsequent to the filing of the Parent SEC Documents with the Commission and any and all subsequent information statements, proxy statements, reports or notices filed by the Parent with the Commission or delivered to the stockholders of Parent.
(d) Parent is not an “investment company” within the meaning of Section 3 of the Investment Company Act.
(e) The Parent Common Stock is presently eligible for quotation and trading on the OTC Pink (SEC Reporting – Current) tier of the electronic quotation system operated by OTC Markets, Inc.
(f) Between the date hereof and the Closing Date, Parent shall continue to satisfy any applicable filing requirements of the Exchange Act or the Securities Act, as the case may be, and all other requirements of applicable securities laws.
(g) To the knowledge of Parent, Parent has complied with the Securities Act, Exchange Act and all other applicable federal and state securities laws.
Section 5.11 No General Solicitation. In issuing Parent Common Stock in the Merger hereunder, neither Parent nor anyone acting on its behalf has offered to sell Parent Common Stock by any form of general solicitation or advertising.
Section 5.12 Financial Statements. The balance sheets, and statements of income, stockholders’ equity and cash flows (including any notes thereto) contained in the Parent SEC Documents (the “Parent Financial Statements”) (i) have been prepared in accordance with GAAP, (ii) are in accordance with the books and records of the Parent, and (iii) present fairly in all material respects the financial condition of the Parent at the dates therein specified and the results of its operations and changes in financial position for the periods therein specified.
Section 5.13
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Absence of Undisclosed Liabilities. The Liabilities of the Parent as of the Effective Date shall be as set forth on Exhibit F hereto. The list set forth on Exhibit F contains a full a complete listing of all Liabilities of the Parent as of the Effective Date. Except as otherwise disclosed on Exhibit F, neither Parent nor Merger Sub has any Liability at or prior to the Closing. The Parent’s most recent audit-reviewed balance sheet is as of September 30, 2015 (the “Parent Balance Sheet” and such date, the “Parent Balance Sheet Date”).
Section 5.14 Changes. Except as otherwise set forth in Schedule F, Parent has not incurred any debts, obligations or Liabilities, absolute, accrued or, to the Parent’s knowledge, contingent, whether due or to become due, since the Parent Balance Sheet Date, (b) discharged or satisfied any Liens other than those securing, or paid any obligation or Liability other than, current liabilities shown on the Parent Balance Sheet and current Liabilities incurred since the Parent Balance Sheet Date, in each case in the usual and ordinary course of business, (c) mortgaged, pledged or subjected to Lien any of its assets, tangible or intangible, (d) sold, transferred or leased any of its assets, except in the usual and ordinary course of business, (e) cancelled or compromised any debt or claim, or waived or released any right of material value, (f) suffered any physical damage, destruction or loss (whether or not covered by insurance) that could reasonably be expected to have a Parent Material Adverse Effect, (g) entered into any transaction other than in the usual and ordinary course of business, (h) encountered any labor union difficulties, (i) made or granted any wage or salary increase or made any increase in the amounts payable under any profit sharing, bonus, deferred compensation, severance pay, insurance, pension, retirement or other employee benefit plan, agreement or arrangement, other than in the ordinary course of business consistent with past practice, or entered into any employment agreement, (j) issued or sold any shares of capital stock, bonds, notes, debentures or other securities or granted any options (including employee stock options), warrants or other rights with respect thereto, (k) declared or paid any dividends on or made any other distributions with respect to, or purchased or redeemed, any of its outstanding capital stock, (l) suffered or experienced any change in, or condition affecting, the financial condition of the Parent other than changes, events or conditions in the usual and ordinary course of its business, none of which (either by itself or in conjunction with all such other changes, events and conditions) could reasonably be expected to have a Parent Material Adverse Effect, (m) made any change in the accounting principles, methods or practices followed by it or depreciation or amortization policies or rates theretofore adopted, (n) made or permitted any amendment or termination of any material Contract, agreement or license to which it is a party, (o) suffered any material loss not reflected in the Parent Balance Sheet or its statement of income for the year ended on the Parent Balance Sheet Date, (p) paid, or made any accrual or arrangement for payment of, bonuses or special compensation of any kind or any severance or termination pay to any present or former officer, director, employee, stockholder or consultant, (q) made or agreed to make any charitable contributions or incurred any non-business expenses in excess of $1,000 in the aggregate, or (r) entered into any Contract, agreement or license, or otherwise obligated itself, to do any of the foregoing.
Section 5.15 Tax Returns and Audits. All required federal, state and local Tax Returns of the Parent have been accurately prepared in all material respects and duly and timely filed, and all federal, state and local Taxes required to be paid with respect to the periods covered by such returns have been paid to the extent that the same are material and have become due, except where the failure so to file or pay could not reasonably be expected to have a Parent Material
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Adverse Effect. The Parent is not and has not been delinquent in the payment of any Tax. The Parent has not had a Tax deficiency assessed against it. None of the Parent’s federal income Tax Returns nor any state or local income or franchise Tax Returns has been audited by governmental authorities. The reserves for Taxes reflected on the Parent Balance Sheet are sufficient for the payment of all unpaid Taxes payable by the Parent with respect to the period ended on the Parent Balance Sheet Date. There are no federal, state, local or foreign audits, actions, suits, proceedings, investigations, claims or administrative proceedings relating to Taxes or any Tax Returns of the Parent now pending, and the Parent has not received any notice of any proposed audits, investigations, claims or administrative proceedings relating to Taxes or any Tax Returns.
Section 5.16 Employee Benefit Plans; ERISA.
(a) Except as disclosed in the Parent SEC Documents, there are no “employee benefit plans” (within the meaning of Section 3(3) of ERISA) nor any other employee benefit or fringe benefit arrangements, practices, contracts, policies or programs other than programs merely involving the regular payment of wages, commissions, or bonuses established, maintained or contributed to by the Parent, whether written or unwritten and whether or not funded. Any plans listed in the Parent SEC Documents are hereinafter referred to as the “Parent Employee Benefit Plans.”
(b) Any current and prior material documents, including all amendments thereto, with respect to each Parent Employee Benefit Plan have been made available to the Company.
(c) All Parent Employee Benefit Plans are in material compliance with the applicable requirements of ERISA, the Code and any other applicable state, federal or foreign law.
(d) There are no pending, or to the knowledge of the Parent, threatened, claims or lawsuits that have been asserted or instituted against any Parent Employee Benefit Plan, the assets of any of the trusts or funds under the Parent Employee Benefit Plans, the plan sponsor or the plan administrator of any of the Parent Employee Benefit Plans or against any fiduciary of a Parent Employee Benefit Plan with respect to the operation of such plan.
(e) There is no pending, or to the knowledge of the Parent, threatened, investigation or pending or possible enforcement action by the Pension Benefit Guaranty Corporation, the Department of Labor, the Internal Revenue Service or any other government agency with respect to any Parent Employee Benefit Plan and Parent has no knowledge of any incident, transaction, occurrence or circumstance which might reasonably be expected to trigger such an investigation or enforcement action.
(f) No actual or, to the knowledge of Parent, contingent Liability exists with respect to the funding of any Parent Employee Benefit Plan or for any other expense or obligation of any Parent Employee Benefit Plan, except as disclosed on the Parent Financial Statements or the Parent SEC Documents, and to the knowledge of the Parent, no contingent
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Liability exists under ERISA with respect to any “multi-employer plan,” as defined in Section 3(37) or Section 4001(a)(3) of ERISA.
Section 5.17 Interested Party Transactions. Except as disclosed in the Parent SEC Documents, no officer, director or stockholder of the Parent or any Affiliate of any such Person or the Parent has or has had, either directly or indirectly, (a) an interest in any Person that (i) furnishes or sells services or products that are furnished or sold or are proposed to be furnished or sold by the Parent or (ii) purchases from or sells or furnishes to the Parent any goods or services, or (b) a beneficial interest in any Contract to which the Parent is a party or by which it may be bound or affected.
Section 5.18 Questionable Payments. Neither the Parent, Merger Sub nor to the knowledge of the Parent, any director, officer, agent, employee or other Person associated with or acting on behalf of the Parent or Merger Sub, has used any corporate funds for (a) unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity, (b) made any direct or indirect unlawful payments to government officials or employees from corporate funds, (c) established or maintained any unlawful or unrecorded fund of corporate monies or other assets, (d) made any false or fictitious entries on the books of record of any such corporations, or (e) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment.
Section 5.19 Obligations to or by Stockholders. Except as disclosed in the Parent SEC Documents, the Parent has no Liability or obligation or commitment to any stockholder of Parent or any Affiliate or “associate” (as such term is defined in Rule 405 under the Securities Act) of any stockholder of Parent, nor does any stockholder of Parent or any such Affiliate or associate have any Liability, obligation or commitment to the Parent.
Section 5.20 Schedule of Assets and Contracts. Except as expressly set forth in this Agreement, the Parent Balance Sheet or the notes thereto, the Parent is not a party to any Contract not made in the ordinary course of business that is material to the Parent. Parent does not own any real property. Parent is not a party to any Contract (a) with any labor union, (b) for the purchase of fixed assets or for the purchase of materials, supplies or equipment in excess of normal operating requirements, (c) for the employment of any officer, individual employee or other Person on a full-time basis or any contract with any Person for consulting services, (d) with respect to bonus, pension, profit sharing, retirement, stock purchase, stock option, deferred compensation, medical, hospitalization or life insurance or similar plan, contract or understanding with any or all of the employees of Parent or any other Person, (e) relating to or evidencing Indebtedness for Borrowed Money or subjecting any asset or property of Parent to any Lien or evidencing any Indebtedness, (f) guaranteeing of any Indebtedness, (g) under which Parent is lessee of or holds or operates any property, real or personal, owned by any other Person, (h) under which Parent is lessor or permits any Person to hold or operate any property, real or personal, owned or controlled by Parent, (i) granting any preemptive right, right of first refusal or similar right to any Person, (j) with any Affiliate of Parent or any present or former officer, director or stockholder of Parent, (k) obligating Parent to pay any royalty or similar charge for the use or exploitation of any tangible or intangible property, (1) containing a covenant not to compete or other restriction on the parent’s ability to conduct a business or engage in any other activity, (m) with respect to any distributor, dealer, manufacturer’s
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representative, sales agency, franchise or advertising contract or commitment, (n) regarding the registration of securities under the Securities Act, (o) characterized as a collective bargaining agreement, or (p) with any Person continuing for a period of more than three months from the Closing Date that involves an expenditure or receipt by Parent in excess of $1,000. The Parent maintains no insurance policies and insurance coverage of any kind with respect to Parent, its business, premises, properties, assets, employees and agents. Parent has furnished to the Company true and complete copies of all agreements and other documents requested by the Company.
Section 5.21 Environmental Matters.
(a) The Parent has never generated, used, handled, treated, released, stored or disposed of any Hazardous Materials on any real property on which it now has or previously had any leasehold or ownership interest, except in compliance with all applicable Environmental Laws.
(b) The historical and present operations of the business of the Parent compliance with all applicable Environmental Laws, except where any non-compliance has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(c) (i) The Parent has not, sent or disposed of, otherwise had taken or transported, arranged for the taking or disposal of (on behalf of itself, a customer or any other party) or in any other manner participated or been involved in the taking of or disposal or release of a Hazardous Material to or at a site that is contaminated by any Hazardous Material or that, pursuant to any Environmental Law, (A) has been placed on the “National Priorities List”, the “CERCLIS” list, or any similar state or federal list, or (B) is subject to or the source of a claim, an administrative order or other request to take “removal”, “remedial”, “corrective” or any other “response” action, as defined in any Environmental Law, or to pay for the costs of any such action at the site; (ii) the Parent is not involved in (and has no basis to reasonably expect to be involved in) any suit or proceeding and has not received (and has no basis to reasonably expect to receive) any written notice, request for information or other communication from any governmental authority or other third party with respect to a release or threatened release of any Hazardous Material or a violation or alleged violation of any Environmental Law, and has not received (and has no basis to reasonably expect to receive) written notice of any claims from any Person relating to property damage, natural resource damage or to personal injuries from exposure to any Hazardous Material; and (iii) the Parent has timely filed every report required to be filed, acquired all necessary certificates, approvals and permits, and generated and maintained all required data, documentation and records under all Environmental Laws, in all such instances except where the failure to do so would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(d) There are no material pending or, to the knowledge of Parent, threatened, demands, claims, information requests or notices of noncompliance or violation against or to the Parent relating to any Environmental Law; and, to the knowledge of Parent, there are no conditions or occurrences on any of the real property used by Parent in connection with its business that would reasonably be expected to lead to any such demands, claims or notices
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against or to Parent, except such as have not had, and would not reasonably be expected to have, a Parent Material Adverse Effect.
Section 5.22 Employees. Other than pursuant to ordinary arrangements of employment compensation, Parent is not under any obligation or liability to any officer, director, employee or Affiliate of Parent.
Section 5.23 Title to Property and Encumbrances. Parent has good and valid title to all properties and assets used in the conduct of its business (except for property held under valid and subsisting leases which are in full force and effect and which are not in default) free of all Liens except Permitted Liens and such ordinary and customary imperfections of title, restrictions and encumbrances as do not, individually or in the aggregate constitute a Parent Material Adverse Effect.
Section 5.24 Condition of Properties. All facilities, machinery, equipment, fixtures and other properties owned, leased or used by Parent are in operating condition, subject to ordinary wear and tear, and are adequate and sufficient for the Parent’s existing business.
Section 5.25 Insurance Coverage. Parent does not have in full force and effect any one or more policies of insurance issued by insurers of recognized responsibility insuring Parent and its properties, products and business against such losses and risks, and in such amounts, as are customary for corporations of established reputation engaged in the same or similar business and similarly situated. Parent has not been refused any insurance coverage sought or applied for, and Parent has no reason to believe that it will be unable to renew any existing insurance coverage as and when the same shall expire upon terms at least as favorable to those currently in effect, other than possible increases in premiums that do not result from any act or omission of Parent. No suit, proceeding or action or, to the best current actual knowledge of Parent, threat of suit, proceeding or action has been asserted or made against Parent due to alleged bodily injury, disease, medical condition, death or property damage arising out of the function or malfunction of a product, procedure or service designed, manufactured, sold or distributed by Parent.
Section 5.26 Disclosure. There is no fact relating to Parent or Merger Sub that Parent has not disclosed to the Company in writing that has had, is having or is reasonably likely to have a Parent Material Adverse Effect. No representation or warranty by Parent or Merger Sub herein and no information disclosed in the exhibits hereto by Parent or Merger Sub contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained herein or therein not misleading.
Section 5.27 No Liabilities. As of the Closing Date, there are no Liabilities or Indebtedness of the Parent or Merger Sub of any kind whatsoever, whether recorded on the Balance Sheet of Parent or Merger Sub or not, whether accrued, contingent, absolute, determined, determinable or otherwise, and there is no existing condition, situation or set of circumstances which could reasonably be expected to result in such Liability or Indebtedness. Neither the Parent nor the Merger Sub is a guarantor of any Indebtedness of any other person, firm or corporation.
ARTICLE VI
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CONDUCT OF BUSINESSES PENDING THE MERGER
Section 6.1 Conduct of Business by the Company Pending the Merger. Prior to the Effective Time, unless Parent or Merger Sub shall otherwise agree in writing or as otherwise contemplated by this Agreement:
(i) the business of the Company shall be conducted only in the ordinary course consistent with the past practice;
(ii) the Company shall not (A) directly or indirectly redeem, purchase or otherwise acquire or agree to redeem, purchase or otherwise acquire any shares of Company Capital Stock; (B) amend its certificate of incorporation or by-laws except to effectuate the transactions contemplated in this Agreement; or (C) split, combine or reclassify the outstanding Company Capital Stock or declare, set aside or pay any dividend payable in cash, stock or property or make any distribution with respect to any such stock;
(iii) the Company shall not (A) issue any additional shares of, or options, warrants or rights of any kind to acquire any shares of, Company Capital Stock; (B) acquire or dispose of any fixed assets or acquire or dispose of any other substantial assets other than in the ordinary course of business; (C) incur additional Indebtedness or any other Liabilities or enter into any other transaction other than in the ordinary course of business; (D) enter into any Contract, agreement, commitment or arrangement with respect to any of the foregoing except this Agreement; or (E) except as contemplated by this Agreement, enter into any Contract, agreement, commitment or arrangement to dissolve, merge, consolidate or enter into any other material business combination; and
(iv) the Company shall use its reasonable best efforts to preserve intact the business of the Company, to keep available the service of its present officers and key employees, and to preserve the good will of those having business relationships with it.
Section 6.2 Conduct of Business by Parent and Merger Sub Pending the Merger. Prior to the Effective Time, unless the Company shall otherwise agree in writing or as otherwise contemplated expressly permitted by this Agreement:
(i) the business of Parent and Merger Sub shall be conducted only in the ordinary course consistent with past practice;
(ii) neither Parent nor Merger Sub shall (A) directly or indirectly redeem, purchase or otherwise acquire or agree to redeem, purchase or otherwise acquire any shares of its capital stock; (B) amend its certificate of incorporation or by-laws; or (C) split, combine or reclassify its capital stock or declare, set aside or pay any dividend payable in cash, stock or property or make any distribution with respect to such stock; and
(iii) neither Parent nor Merger Sub shall (A) issue or agree to issue any additional shares of, or options, warrants or rights of any kind to acquire shares of, its
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capital stock; (B) acquire or dispose of any assets other than in the ordinary course of business; (C) incur additional Indebtedness or any other Liabilities or enter into any other transaction except in the ordinary course of business; (D) enter into any Contract, agreement, commitment or arrangement with respect to any of the foregoing except this Agreement, or (E) except as contemplated by this Agreement, enter into any Contract, agreement, commitment or arrangement to dissolve, merge; consolidate or enter into any other material business contract or enter into any negotiations in connection therewith.
(iv) Parent shall use its best efforts to preserve intact the business of Parent and Merger Sub, to keep available the service of its present officers and key employees, and to preserve the good will of those having business relationships with Parent and Merger Sub and to file all required SEC Reports under the Exchange Act;
(v) neither Parent nor Merger Sub will, nor will they authorize any director or authorize or permit any officer or employee or any attorney, accountant or other representative retained by them to, make, solicit, encourage any inquiries with respect to, or engage in any negotiations concerning, any Acquisition Proposal (as defined below). Parent will promptly advise the Company in writing of any such inquiries or Acquisition Proposal (or requests for information) and the substance thereof. As used in this paragraph, “Acquisition Proposal” shall mean any proposal for a merger or other business combination involving the Parent or Merger Sub or for the acquisition of a substantial equity interest in either of them or any material assets of either of them other than as contemplated by this Agreement. Parent will immediately cease and cause to be terminated any existing activities, discussions or negotiations with any Person conducted heretofore with respect to any of the foregoing; and
(vi) neither Parent nor Merger Sub will enter into any new employment agreements with any of their officers or employees or grant any increases in the compensation or benefits of their officers and employees.
ARTICLE
VII
ADDITIONAL AGREEMENTS
Section 7.1 Access and Information. The Company, Parent and Merger Sub shall each afford to the other and to the other’s accountants, counsel and other representatives reasonable access during normal business hours throughout the period prior to the Effective Time of all of its properties, books, contracts, commitments and records (including but not limited to Tax Returns) and during such period, each shall furnish promptly to the other all information concerning its business, properties and personnel as such other party may reasonably request, provided that no investigation pursuant to this Section 7.1 shall affect any representations or warranties made herein. Each party shall hold, and shall cause its employees and agents to hold, in confidence all such information (other than such information that (i) becomes generally available to the public other than as a result of a disclosure by such party or its directors, officers, managers, employees, agents or advisors, or (ii) becomes available to such party on a non-confidential basis from a source other than a party hereto or its advisors, provided that such source is not known by such party to be bound by a confidentiality agreement with or other obligation of secrecy to a party hereto or another party until such time as such information is
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otherwise publicly available; provided, however, that: (A) any such information may be disclosed to such party’s directors, officers, employees and representatives of such party’s advisors who need to know such information for the purpose of evaluating the transactions contemplated hereby (it being understood that such directors, officers, employees and representatives shall be informed by such party of the confidential nature of such information); (B) any disclosure of such information may be made as to which the party hereto furnishing such information has consented in writing; and (C) any such information may be disclosed pursuant to a judicial, administrative or governmental order or request provided, that the requested party will promptly so notify the other party so that the other party may seek a protective order or appropriate remedy and/or waive compliance with this Agreement and if such protective order or other remedy is not obtained or the other party waives compliance with this provision, the requested party will furnish only that portion of such information which is legally required and will exercise its best efforts to obtain a protective order or other reliable assurance that confidential treatment will be accorded the information furnished. If this Agreement is terminated, each party will deliver to the other all documents and other materials (including copies) obtained by such party or on its behalf from the other party as a result of this Agreement or in connection herewith, whether so obtained before or after the execution hereof.
Section 7.2 Additional Agreements. Subject to the terms and conditions herein provided, each of the parties hereto agrees to use its commercially reasonable best efforts to take, or cause to be taken, all action and to do, or cause to be done, all things necessary, proper or advisable under applicable laws and regulations to consummate and make effective the transactions contemplated by this Agreement, including using its commercially reasonable best efforts to satisfy the conditions precedent to the obligations of any of the parties hereto to obtain all necessary waivers, and to lift any injunction or other legal bar to the Merger (and, in such case, to proceed with the Merger as expeditiously as possible). In order to obtain any necessary governmental or regulatory action or non-action, waiver, Consent, extension or approval, each of Parent, Merger Sub and the Company agrees to take all reasonable actions and to enter into all reasonable agreements as may be necessary to obtain timely governmental or regulatory approvals and to take such further action in connection therewith as may be necessary. In case at any time after the Effective Time any further action is necessary or desirable to carry out the purposes of this Agreement, the proper officers and/or directors of Parent, Merger Sub and the Company shall take all such necessary action.
Section 7.3 Publicity. No party shall issue any press release or public announcement pertaining to the Merger that has not been agreed upon in advance by Parent and the Company, except as Parent reasonably determines to be necessary in order to comply with the rules of the Commission; provided that in such case Parent will use its best efforts to allow Company to review and reasonably approve any of the same prior to its release.
Section 7.4 Appointment of Directors. Immediately upon the Effective Time, Parent shall, in accordance with Section 2.3(d), require and accept the resignations of those officers and directors of Parent listed on Exhibit C hereto under the heading “Pre-Effective Time,” and shall immediately upon the Effective Time, cause the appointments of those officers and directors of Parent identified in Exhibit C hereto under the heading “Following Notice Filings”, subject to any notice and waiting period requirements of federal law. At the first annual meeting of
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Parent’s stockholders and thereafter, the election of members of Parent’s Board of Directors shall be accomplished in accordance with the by-laws of Parent.
Section 7.5 Stockholder Consent.
(a) So long as the Board of Directors of the Company shall not have withdrawn, modified or changed its recommendation in accordance with the provisions of Section 7.8(b) hereof, the Company, acting through its Board of Directors, shall, in accordance with Delaware law and its certificate of incorporation and by-laws, take all actions reasonably necessary to establish a record date for, duly call, give notice of, convene, and hold a stockholders meeting for the purpose of obtaining the requisite approval and adoption of this Agreement and the transactions contemplated hereby by the Stockholders, or in the alternative to obtain the written consent of a majority of the Shareholders of the Company to this merger. The Company shall notify each Stockholder, whether or not entitled to vote, of the proposed Company stockholders’ meeting or need for written consent. Such meeting notice shall state that the purpose, or one of the purposes, of the meeting is to consider the Merger and shall contain or be accompanied by a copy or summary of this Agreement. Notwithstanding the foregoing, the Board of Directors of the Company shall not be required to take all actions reasonably necessary to establish a record date for, duly call, give notice of, convene and hold a stockholders meeting for the purpose of obtaining the requisite approval and adoption of this Agreement and the transactions contemplated hereby by the Stockholders if the Company’s Board of Directors and the requisite Stockholders otherwise take all actions reasonably necessary to approve this Agreement and the transactions contemplated hereby by written consent in lieu of a meeting of the stockholders of the Company to the extent permitted by applicable law.
(b) The Board of Directors of the Company shall unanimously recommend such approval and shall use all reasonable efforts to solicit and obtain such approval; provided, however, that the Board of Directors of the Company may at any time prior to approval of the Stockholders (i) decline to make, withdraw, modify or change any recommendation or declaration regarding this Agreement or the Merger or (ii) recommend and declare advisable any other offer or proposal, to the extent the Board of Directors of the Company determines in good faith, based upon advice of legal counsel, that withdrawing, modifying, changing or declining to make its recommendation regarding this Agreement or the Merger or recommending and declaring advisable any other offer or proposal is necessary to comply with its fiduciary duties under applicable law (which declinations, withdrawal, modification or change shall not constitute a breach by the Company of this Agreement). The Company shall provide written notice to Parent promptly upon the Company taking any action referred to in the foregoing proviso.
(c) Pursuant to the NRS, at any time before the certificate of merger is filed with the Secretary of State of the State of Nevada, including any time after the Merger is authorized by the Stockholders, the Merger may be abandoned and this Agreement may be terminated in accordance with the terms hereof, without further action by the Stockholders.
ARTICLE VIII
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CONDITIONS OF PARTIES’ OBLIGATIONS
Section 8.1 Company Obligations. The obligations of Parent and Merger Sub under this Agreement are subject to the fulfillment by the Company at or prior to the Closing of the following conditions, any of which may be waived in whole or in part by Parent.
(a) No Errors, etc. The representations and warranties of the Company under this Agreement shall be deemed to have been made again on the Closing Date and shall then be true and correct in all material respects.
(b) Compliance with Agreement. The Company shall have performed and complied in all material respects with all agreements and conditions required by this Agreement to be performed or complied with by it on or before the Closing Date.
(c) No Company Material Adverse Effect. Since the date hereof, there shall not have been any event or circumstance that has resulted in a Company Material Adverse Effect, and no event has occurred or circumstance exists that would reasonably be expected to result in a Company Material Adverse Effect.
(d) Certificate of Officers. The Company shall have delivered to Parent and Merger Sub a certificate dated the Closing Date, executed on its behalf by the Chief Executive Officer of the Company, certifying the satisfaction of the conditions specified in paragraphs (a), (b) and (c) of this Section 8.1.
(e) No Restraining Action. No Action or proceeding before any court, governmental body or agency shall have been threatened, asserted or instituted to restrain or prohibit, or to obtain substantial damages in respect of, this Agreement or the carrying out of the transactions contemplated by this Agreement.
(f) Conversion of Company Preferred Stock. The Company shall have completed the conversion of all issued and outstanding Company Preferred Stock to Company Common Stock.
(g) Supporting Documents. Parent and Merger Sub shall have received the following:
(1) Copies of resolutions of the Board of Directors and the stockholders of the Company, certified by the President of the Company, authorizing and approving the Merger and the execution, delivery and performance of this Agreement and all other documents and instruments to be delivered pursuant hereto and thereto.
(2) A certificate of incumbency executed by the Secretary of the Company certifying the names, titles and signatures of the officers authorized to execute any documents referred to in this Agreement and further certifying that the certificate of incorporation and by-laws of the Company delivered to Parent and Merger Sub at the time of the execution of this Agreement have been validly adopted and have not been amended or modified since the date hereof.
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(3) Evidence as of a recent date of the good standing and corporate existence of the Company issued by the Secretary of State of the State of Delaware.
Section 8.2 Parent and Merger Sub Obligations. The obligations of the Company under this Agreement are subject to the fulfillment by Parent and Merger Sub at or prior to the Closing of the following conditions any of which may be waived in whole or in part by the Company:
(a) No Errors, etc. The representations and warranties of Parent and Merger Sub under this Agreement shall be deemed to have been made again on the Closing Date and shall then be true and correct in all material respects.
(b) Compliance with Agreement. Parent and Merger Sub shall have performed and complied in all material respects with all agreements and conditions required by this Agreement to be performed or complied with by them on or before the Closing Date.
(c) No Parent Material Adverse Effect. Since the date hereof, there shall not have been any event or circumstance that has resulted in a Parent Material Adverse Effect and no event has occurred or circumstance exists that would be reasonably expected to result in such a Parent Material Adverse Effect.
(d) Certificate of Officers. Parent and Merger Sub shall have delivered to the Company a certificate dated the Closing Date, executed on their behalf by their respective Presidents, certifying the satisfaction of the conditions specified in paragraphs (a), (b), and (c) of this Section 8.2.
(e) Assignment. Parent shall have completed, if necessary, an assignment of all assets and liabilities of the Parent immediately prior to the Effective Time (other than its ownership interest in Merger Sub) to an unrelated third party in a transaction satisfactory to the Company.
(f) Modification of Convertible Liabilities; Indemnity. To the extent that any of the Liabilities as set forth on Exhibit F are, by their terms, convertible into any capital stock of the Parent, the terms of all such Liabilities shall have been modified in writing to remove any such right to conversion. With regard to all Parent Liabilities in excess of $90,000, the President of the Parent, Reza Noorkayhani, shall have delivered an indemnity agreement in a form acceptable to the Company.
(g) Supporting Documents. The Company shall have received the following:
(1) Copies of resolutions of Parent’s and Merger Sub’s respective board of directors and the sole stockholder of Merger Sub, certified by their respective Secretaries, authorizing and approving the Merger and the execution, delivery and performance of this Agreement and all other documents and instruments to be delivered by them pursuant hereto.
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(2) A certificate of incumbency executed by the respective Secretaries of Parent and Merger Sub certifying the names, titles and signatures of the officers authorized to execute the documents referred to in paragraph (1) above and further certifying that the certificates of incorporation and by-laws of Parent and Merger Sub appended thereto have not been amended or modified.
(3) A certificate, dated the Closing Date, executed by the Secretary of each of the Parent and Merger Sub, certifying that, except for the filing of the certificate of merger with the Secretary of State of the State of Delaware: (i) all consents, authorizations, orders and approvals of, and filings and registrations with, any court, governmental body or instrumentality that are required to be obtained by Parent or Merger Sub for the execution and delivery of this Agreement and the consummation of the Merger shall have been duly made or obtained; and (ii) no action or proceeding before any court, governmental body or agency has been threatened, asserted or instituted against Parent or Merger Sub to restrain or prohibit, or to obtain substantial damages in respect of, this Agreement or the carrying out of the transactions contemplated by this Agreement.
(4) A certificate of Parent’s transfer agent and registrar, certifying as of the business day prior to the Closing Date, a true and complete list of the names and addresses of the record owners of all of the outstanding shares of Parent Common Stock, together with the number of shares of Parent Common Stock held by each record owner.
(5) The executed resignations of all directors and officers of Parent, with the director resignations to take effect following the notice period required by federal law, and (ii) executed releases from each such director and officer in the form and substance acceptable to the Company in its sole discretion.
(6) Evidence as of a recent date of the good standing and corporate existence of each of the Parent and Merger Sub issued by the Secretary of State of their respective states of incorporation.
(7) Such additional supporting documentation and other information with respect to the transactions contemplated hereby as the Company may reasonably request.
ARTICLE
IX
INDEMNIFICATION AND RELATED MATTERS
Section 9.1 Indemnification by Parent. Parent shall indemnify and hold harmless the Company and the Stockholders (collectively, the “Company Indemnified Parties”), and shall reimburse the Company Indemnified Parties for, any loss, liability, claim, damage, expense (including, but not limited to, costs of investigation and defense and reasonable attorneys’ fees) or diminution of value (collectively, “Damages”) arising from or in connection with (a) any inaccuracy, in any material respect, in any of the representations and warranties of Parent and Merger Sub in this Agreement or in any certificate delivered by Parent and Merger Sub to the
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Company pursuant to this Agreement, or any actions, omissions or statements of fact inconsistent with any such representation or warranty, (b) any failure by Parent or Merger Sub to perform or comply in any material respect with any covenant or agreement in this Agreement, (c) any claim for brokerage or finder’s fees or commissions or similar payments based upon any agreement or understanding alleged to have been made by any such party with Parent or Merger Sub in connection with any of the transactions contemplated by this Agreement, (d) Taxes attributable to any transaction or event occurring on or prior to the Closing, (e) any claim relating to or arising out of any Liabilities of either Parent or Merger Sub on or prior to Closing or with respect to accounting fees arising thereafter, or (f) any litigation, action, claim, proceeding or investigation by any third party relating to or arising out of the business or operations of Parent, or the actions of Parent or any holder of Parent capital stock prior to the Effective Time.
Section 9.2 Survival. All representations, warranties, covenants and agreements of Parent and Merger Sub contained in this Agreement or in any instrument delivered pursuant to this Agreement shall survive until twelve (12) months after the Effective Date. The representations and warranties of the Company contained in this Agreement or in any instrument delivered pursuant to this Agreement will terminate at, and have no further force and effect after, the Effective Time.
Section 9.3 Time Limitations. Neither Parent nor Merger Sub shall have any liability (for indemnification or otherwise) with respect to any representation or warranty, or covenant or agreement to be performed and complied with prior to the Effective Time, unless on or before the twelve month anniversary of the Effective Time (the “Claims Deadline”), Parent is given notice of a claim with respect thereto, in accordance with Section 9.5, specifying the factual basis therefore in reasonable detail to the extent then known by the Company Indemnified Parties.
Section 9.4 Limitation on Liability. The obligations of Parent and Merger Sub to the Company Indemnified Parties set forth in Section 9.1 shall be subject to the following limitations:
(a) The aggregate liability of Parent and Merger Sub to the Company shall not exceed $100,000.
(b) Other than claims based on fraud or for specific performance, injunctive or other equitable relief, the Company Indemnified Parties’ sole and exclusive remedy for any and all claims for Damages pursuant to Section 9.1 hereof shall be the indemnification provided under the terms and subject to the conditions of this Article IX.
Section 9.5 Notice of Claims.
(a) If, at any time on or prior to the Claims Deadline, Company Indemnified Parties shall assert a claim for indemnification pursuant to Section 9.1, such Company Indemnified Parties shall submit to Parent a written claim stating: (i) that a Company Indemnified Party incurred or reasonably believes it may incur Damages and the amount or reasonable estimate thereof of any such Damages; and (ii) in reasonable detail, the facts alleged as the basis for such claim and the section or sections of this Agreement alleged as the basis or bases for the claim.
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(b) In the event that any action, suit or proceeding is brought against any Company Indemnified Party with respect to which Parent may have liability under this Article IX, the Parent shall have the right, at its cost and expense, to defend such action, suit or proceeding in the name and on behalf of the Company Indemnified Party; provided, however, that a Company Indemnified Party shall have the right to retain its own counsel, with fees and expenses paid by Parent, if representation of the Company Indemnified Party by counsel retained by Parent would be inappropriate because of actual or potential differing interests between Parent and the Company Indemnified Party. In connection with any action, suit or proceeding subject to this Article IX, Parent and each Company Indemnified Party agree to render to each other such assistance as may reasonably be required in order to ensure proper and adequate defense of such action, suit or proceeding. Parent shall not, without the prior written consent of the applicable Company Indemnified Parties, which consent shall not be unreasonably withheld or delayed, settle or compromise any claim or demand if such settlement or compromise does not include an irrevocable and unconditional release of such Company Indemnified Parties for any liability arising out of such claim or demand.
ARTICLE
X
TERMINATION PRIOR TO CLOSING
Section 10.1 Termination of Agreement. This Agreement may be terminated at any time prior to the Closing:
(a) by the mutual written consent of the Company, Merger Sub and Parent;
(b) by the Company, if Parent or Merger Sub (i) fails to perform in any material respect any of its agreements contained herein required to be performed by it on or prior to the Effective Time, (ii) materially breaches any of its representations, warranties or covenants contained herein, which failure or breach is not cured within thirty (30) days after the Company has notified Parent and Merger Sub of its intent to terminate this Agreement pursuant to this paragraph (b);
(c) by Parent and Merger Sub, if the Company (i) fails to perform in any material respect any of its agreements contained herein required to be performed by it on or prior to the Closing Date, (ii) materially breaches any of its representations, warranties or covenants contained herein, which failure or breach is not cured within thirty (30) days after Parent or Merger Sub has notified the Company of its intent to terminate this Agreement pursuant to this paragraph (c);
(d) by either the Company, on the one hand, or Parent and Merger Sub, on the other hand, if there shall be any order, writ, injunction or decree of any court or governmental or regulatory agency binding on Parent, Merger Sub or the Company, which prohibits or materially restrains any of them from consummating the transactions contemplated hereby; provided that the parties hereto shall have used their best efforts to have any such order, writ, injunction or decree lifted and the same shall not have been lifted within ninety (90) days after entry, by any such court or governmental or regulatory agency;
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(e) by either the Company, on the one hand, or Parent and Merger Sub, on the other hand, if the Closing has not occurred on or prior to July 31, 2014, for any reason other than delay or nonperformance of the party seeking such termination;
(f) by the Company if the Board of Directors of the Company determines in good faith, based upon advice of legal counsel, that termination pursuant to this Section 10.1(f) is necessary to comply with its fiduciary duties under applicable law as provided in Section 7.8 hereof.
Section 10.2 Termination of Obligations. Termination of this Agreement pursuant to Section 10.1 hereof shall terminate all obligations of the parties hereunder, except for the obligations under Article IX, Article X, and Sections 11.4, 11.7, 11.14, 11.15 and 11.16 hereof; provided, however, that termination pursuant to paragraphs (b) or (c) of Section 10.1 shall not relieve the defaulting or breaching party or parties from any liability to the other parties hereto.
ARTICLE
XI
MISCELLANEOUS
Section 11.1 Amendments. Subject to applicable law, this Agreement may be amended or modified by the parties hereto by written agreement executed by each party to be bound thereby and delivered by duly authorized officers of the parties hereto at any time prior to the Effective Time; provided, however, that after the approval of the Merger by the requisite Stockholders, no amendment or modification of this Agreement shall be made that by law requires further approval from any Stockholders without such further approval.
Section 11.2 Notices. Any notice, request, instruction, other document or communications to be given hereunder by any party hereto to any other party hereto shall be in writing and shall be deemed to have been duly given (a) when delivered personally, (b) upon confirmation of delivery if by electronic mail, (c) upon receipt of a transmission confirmation (with a confirming copy delivered personally or sent by overnight courier) if sent by facsimile or like transmission, or (d) on the next business day when sent by Federal Express, United Parcel Service, U.S. Express Mail or other reputable overnight courier for guaranteed next day delivery, as follows:
If to Parent or Merger Sub, to: | American Boarding Company Attention: Reza Noorkayhani 358 Frankfort Street Daly City, CA, 94104 |
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If to the Company, to: | Microlin Bio, Inc. Attention: Joseph Hernandez 135 East 57th Street, 12th Floor New York, NY 10022
With a copy to:
Laxague Law, Inc. Attn: Joe Laxague, Esq. 1 East Liberty, Suite 600 Reno, NV 89501 |
or to such other persons or addresses as may be designated in writing by the party to receive such notice. Nothing in this Section 11.2 shall be deemed to constitute consent to the manner and address for service of process in connection with any legal proceeding (including arbitration arising in connection with this Agreement), which service shall be effected as required by applicable law.
Section 11.3 Entire Agreement. This Agreement and the exhibits attached hereto or referred to herein constitute the entire agreement of the parties hereto, and supersede all prior agreements and undertakings, both written and oral, among the parties hereto, with respect to the subject matter hereof and thereof.
Section 11.4 Expenses. Except as otherwise expressly provided herein, whether or not the Merger occurs, all expenses and fees incurred by Parent and Merger Sub on one hand, and the Company on the other, shall be borne solely and entirely by the party that has incurred the same; provided, that if the Merger occurs, Parent agrees to pay, and shall cause the Surviving Corporation to pay, any unpaid fees and expenses of the Company (including fees and expenses of its counsel and other advisors) in connection with the consummation of the transactions contemplated by this Agreement.
Section 11.5 Severability. If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any rule of law or public policy, all other conditions and provisions of this Agreement will nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto will negotiate in good faith to amend or modify this Agreement so as to effect the original intent of the parties as closely as possible in an acceptable manner to the end that transactions contemplated hereby are fulfilled to the extent possible.
Section 11.6 Successors and Assigns; Assignment. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned or delegated by any of the parties hereto without, in the case of Parent and Merger Sub, the prior
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written approval of the Company and, in the case of the Company, the prior written approval of Parent.
Section 11.7 No Third Party Beneficiaries. Except as set forth in Section 9.1 and Section 11.6, nothing herein expressed or implied shall be construed to give any person other than the parties hereto (and their successors and assigns as permitted herein) any legal or equitable rights hereunder.
Section 11.8 Counterparts; Delivery by Facsimile. This Agreement may be executed in multiple counterparts, and by the different parties hereto in separate counterparts, each of which when executed will be deemed to be an original but all of which taken together will constitute one and the same agreement. This Agreement and each other agreement or instrument entered into in connection herewith or therewith or contemplated hereby or thereby, and any amendments hereto or thereto, to the extent signed and delivered by means of a facsimile machine or by electronic mail, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. At the request of any party hereto or to any such agreement or instrument, each other party hereto or thereto shall re-execute original forms thereof and deliver them to all other parties. No party hereto or to any such agreement or instrument shall raise the use of a facsimile machine or electronic mail to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of a facsimile machine or electronic mail as a defense to the formation or enforceability of a contract and each such party forever waives any such defense.
Section 11.9 Waiver. At any time prior to the Effective Time, any party hereto may (a) extend the time for the performance of any of the obligations or other acts of the other party hereto; (b) waive any inaccuracies in the representations and breaches of the warranties of the other party contained herein or in any document delivered pursuant hereto; and (c) waive compliance by the other party with any of the agreements or conditions contained herein. Any such extension or waiver will be valid only if set forth in an instrument in writing signed by the party or parties to be bound thereby.
Section 11.10 No Constructive Waivers. No failure or delay on the part of any party hereto in the exercise of any right hereunder will impair such right or be construed to be a waiver of, or acquiescence in, any breach of any representation, warranty, agreement or covenant herein, nor will any single or partial exercise of any such right preclude other or further exercise thereof or of any other right. No waiver by any party of any default, misrepresentation, or breach of warranty or covenant hereunder, whether intentional or not, shall be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant hereunder or affect in any way any rights arising by virtue of any prior or subsequent such occurrence.
Section 11.11 Further Assurances. The parties hereto shall use their commercially reasonable efforts to do and perform or cause to be done and performed all such further acts and things and shall execute and deliver all such other agreements, certificates, instruments or documents as any other party hereto may reasonably request in order to carry out fully the intent and purposes of this Agreement and the consummation of the transactions contemplated hereby.
Section 11.12
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Recitals. The recitals set forth above are incorporated herein and, by this reference, are made part of this Agreement as if fully set forth herein.
Section 11.13 Headings. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
Section 11.14 Governing Law. This Agreement and the agreements, instruments and documents contemplated hereby shall be governed by and construed and enforced in accordance with the laws of the State of Delaware without regard to its conflicts of law principles.
Section 11.15 Dispute Resolution. The parties hereto shall initially attempt to resolve all claims, disputes or controversies arising under, out of or in connection with this Agreement by conducting good faith negotiations amongst themselves. If the parties hereto are unable to resolve the matter following good faith negotiations, the matter shall thereafter be resolved by binding arbitration and each party hereto hereby waives any right it may otherwise have to the resolution of such matter by any means other than binding arbitration pursuant to this Section 11.15. Whenever a party shall decide to institute arbitration proceedings, it shall provide written notice to that effect to the other parties hereto. The party giving such notice shall, however, refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice. During this period, the parties shall make good faith efforts to amicably resolve the claim, dispute or controversy without arbitration. Any arbitration hereunder shall be conducted in the English language under the commercial arbitration rules of the American Arbitration Association. Any such arbitration shall be conducted in New York City, New York by a panel of three arbitrators: one arbitrator shall be appointed by each of Parent and Company; and the third shall be appointed by the American Arbitration Association. The panel of arbitrators shall have the authority to grant specific performance. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based on the claim, dispute or controversy in question would be barred under this Agreement or by the applicable statute of limitations. The prevailing party in any arbitration in accordance with this Section 11.15 shall be entitled to recover from the other party, in addition to any other remedies specified in the award, all reasonable costs, attorneys’ fees and other expenses incurred by such prevailing party to arbitrate the claim, dispute or controversy.
Section 11.16 Interpretation.
(a) When a reference is made in this Agreement to a section or article, such reference shall be to a section or article of this Agreement unless otherwise clearly indicated to the contrary.
(b) Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”
(c) The words “hereof”, “hereby”, “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement, and article, section, paragraph, exhibit and
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schedule references are to the articles, sections, paragraphs, exhibits and schedules of this Agreement unless otherwise specified.
(d) The words “knowledge,” or “known to,” or similar terms, when used in this Agreement to qualify any representation or warranty, refer to the knowledge or awareness of certain specific facts or circumstances related to such representation or warranty of the persons in the Applicable Knowledge Group (as defined herein) which a prudent business person would have obtained after reasonable investigation or due diligence on the part of any such person. For the purposes hereof, the “Applicable Knowledge Group” with respect to the Company shall be Steven Cabouli. For the purposes hereof, the “Applicable Knowledge Group” with respect to Parent and the Merger Sub shall be Jerry Chatel.
(e) The word “subsidiary” shall mean any entity of which at least a majority of the outstanding shares or other equity interests having ordinary voting power for the election of directors or comparable managers of such entity is owned, directly or indirectly by another entity or person.
(f) For purposes of this Agreement, “ordinary course of business” means the ordinary course of business consistent with past custom and practice (including with respect to quantity and frequency).
(g) The plural of any defined term shall have a meaning correlative to such defined term, and words denoting any gender shall include all genders. Where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning.
(h) A reference to any legislation or to any provision of any legislation shall include any modification or re-enactment thereof, any legislative provision substituted therefor and all regulations and statutory instruments issued thereunder or pursuant thereto, unless the context requires otherwise.
(i) The parties hereto have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
[The remainder of this page is intentionally left blank]
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IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement to be executed as of the date first above written by their respective officers thereunto duly authorized.
COMPANY: | ||||
Microlin Bio, Inc. | ||||
By: | /s/ Joseph Hernandex | |||
Name: | Joseph Hernandez | |||
Title: | President &CEO | |||
PARENT: | ||||
American Boarding Company | ||||
By: | /s/ Reza Noorkayhani | |||
Name: | Reza Noorkayhani | |||
Title: | President & CEO | |||
MERGER SUB: | ||||
Microlin Merger Sub, Inc. | ||||
By: | /s/ Reza Noorkayhani | |||
Name: | Reza Noorkayhani | |||
Title: | President |
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Schedule 1
Issuances of Parent Common Stock to be made to Holders of
Company Common Stock at the Effective Time
Name | Shares of Parent Common Stock |
Joseph Hernandez | 17,537,000 |
Ohio State University Foundation, Inc. | 1,463,000 |
Total | 19,000,000 |
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Schedule 2
Company Stock Options
Name | Number of Shares | Exercise Price | Expiration Date |
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Exhibit A
Articles of Incorporation of Surviving Corporation
See attached.
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Exhibit B
By-Laws of Surviving Corporation
See attached.
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Exhibit C
Officers and Directors of Parent
— Pre-Effective Time and Post-Effective Time—
Pre-Effective Time:
Reza Noorkayhani – Chief Executive Officer, Chief Financial Officer, and Director
Joseph Marshall – Chief Operations Officer, Secretary, and Director
Following Notice Filings:
The following persons shall be appointed as Officers and Directors of Parent:
Name | Office(s) |
Joseph Hernandez | President, CEO, CFO, Executive Chairman, and Director |
Bruce Galton | Chief Operating Officer |
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Exhibit D
Articles of Incorporation of Parent
See attached.
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Exhibit E
Bylaws of Parent
See attached.
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Exhibit F
Parent Liabilities as of the Effective Time
Name of Creditor | Document | Date | Principal Amount |
Narguesse Nourkeyhani | Promissory Note | 5/22/14 | $12,000 |
Reza Noorkayhani | Promissory Note | 9/28/14 | $5,500 |
Reza Noorkayhani | Promissory Note | 11/24/14 | $3,975 |
Jenny Su | Promissory Note | 12/10/14 | $10,000 |
Reza Noorkayhani | Promissory Note | 6/30/15 | $8,750 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $17,619 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $30,000 |
Accounts Payable | Various | Various | $5,231 |
$93,075.00 |
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CERTIFICATE OF MERGER
OF
MICROLIN BIO, INC.
INTO
MICROLIN MERGER SUB, INC.
Pursuant to Title 8, Section 251 of the General Corporation Law of the State of Delaware, the undersigned corporation as the surviving corporation in a merger, hereby submits the following Certificate of Merger:
1. The name of the surviving corporation is Microlin Merger Sub, Inc., a corporation organized under the laws of the State of Delaware (the “Corporation”); the name of the non-surviving corporation is Microlin Bio, Inc., a corporation organized under the laws of the State of Delaware (the “Merged Corporation”).
2. The Agreement and Plan of Merger (the “Merger Agreement”) was duly approved, adopted, certified, executed and acknowledged in accord with Section 251 of the General Corporation Law of the State of Delaware by the Consent of the Board of Directors of the Corporation dated December 17, 2015 and the Consent of the Sole Shareholder of the Corporation dated December 17, 2015. The Merger Agreement was duly approved, adopted, certified, executed and acknowledged in accord with Section 251 of the General Corporation Law of the State of Delaware by the consent of the board of directors of the Merged Corporation on December 17, 2015 and by the requisite number of stockholders of the Merged Corporation on December 17, 2015.
3. The Corporation, which is the surviving corporation, shall hereby change its name to Microlin Bio, Inc.
4. The Merger Agreement provides that the merger herein certified shall be effective as prescribed by law (the “Effective Date”), insofar as the General Corporation Law of the State of Delaware shall govern the Effective Date.
5. The certificate of incorporation of the Corporation at the Effective Date of the merger shall be the certificate of incorporation of said surviving corporation, except that Article I of said certificate of incorporation shall be modified to read in its entirety as follows: “The name of the Corporation shall be Microlin Bio, Inc. (the “Corporation”).” and said certificate of incorporation shall continue in full force and effect until changed, altered, or amended in the manner prescribed by the provisions of the General Corporation Law of the State of Delaware.
6. The executed Merger Agreement is on file at an office of the Corporation located at 135 East 57th Street, 12th Floor, New York, NY 10022, the place of business of the Corporation.
7. A copy of the Merger Agreement shall be furnished by the Corporation, on request and without cost, to any stockholder of the Corporation or the Merged Corporation.
IN WITNESS WHEREOF, the surviving corporation has caused this certificate to be signed by an authorized officer on December 17, 2015.
MICROLIN MERGER SUB, INC., a Delaware corporation
By:/s/ Reza Noorkayhani
Reza Noorkayhani, President
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MICROLIN BIO INC.
EQUITY INCENTIVE PLAN
1. Establishment, Purpose, Duration.
a. Establishment. MicroLin Bio Inc. (the “Company”), hereby establishes an equity compensation plan to be known as the MicroLin Bio Inc. Equity Incentive Plan (the “Plan”). The Plan is effective as of December 30, 2013 (the “Effective Date”), subject to the approval of the Plan by the stockholders of the Company. Definitions of capitalized terms used in the Plan are contained in Section 2 of the Plan.
b. Purpose. The purpose of the Plan is to attract and retain Directors, Consultants and officers and other key Employees of the Company and its Subsidiaries and to provide to such persons incentives and rewards for superior performance.
c. Duration. No Award may be granted under the Plan after the day immediately preceding the tenth (10th) anniversary of the Effective Date, or such earlier date as the Board shall determine. The Plan will remain in effect with respect to outstanding Awards until no Awards remain outstanding.
2. Definitions. As used in the Plan, the following definitions shall apply.
“Applicable Law” means the applicable requirements relating to the administration of equity-based compensation plans under U.S. state corporate laws, U.S. federal and state securities laws, the Code, and the applicable laws of any other country or jurisdiction where Awards are granted under the Plan.
“Award” means an award of Nonqualified Stock Options, Incentive Stock Options, Stock Appreciation Rights, Restricted Shares, Restricted Share Units, or Other Share-Based Awards granted pursuant to the terms and conditions of the Plan.
“Award Agreement” means either: (a) an agreement, either in written or electronic format, entered into by the Company and a Participant setting forth the terms and provisions applicable to an Award granted under the Plan; or (b) a statement, either in written or electronic format, issued by the Company to a Participant describing the terms and provisions of such Award, which need not be signed by the Participant.
“Board” means the Board of Directors of the Company.
“Cause” shall have the meaning provided in the applicable employment agreement or consulting agreement between the Participant and the Company, if any, or if there is no such agreement that defines the term, “Cause” shall mean (a) the willful and continued failure of the Participant to perform substantially the Participant’s duties with the Company or any of its Subsidiaries (other than any such failure resulting from any medically determined physical or mental impairment), which failure is not cured by the Participant within 20 calendar days after a written demand for substantial performance is delivered to the Participant by the Board which specifically identifies the manner in which the Board believes that the Participant has not substantially performed the Participant’s duties; (b) the engaging by the Participant in illegal conduct, gross misconduct, gross insubordination or gross negligence that is materially and demonstrably injurious to the Company’s business or financial condition; (c) a conviction, guilty plea or plea of nolo contendere of the Participant for any crime involving dishonesty or for any felony; or (d) a material breach by the Participant of a fiduciary duty of loyalty or care to the Company or any of its Subsidiaries.
“Change in Control” means the occurrence of any of the following: (a) a sale of all or substantially all of the assets of the Company to an individual, entity or group thereof (“Person”) who is neither an affiliate of the Company nor an entity in which the stockholders of the Company immediately prior to such transaction control more than 50% of the voting power immediately following the transaction; (b) a sale resulting in more than 50% of the voting stock of the Company being held by a Person other than the Company or an affiliate of the Company at the time of such transaction; or (c) a merger or consolidation of the Company into another entity which is neither an affiliate of the Company at the time of such transaction nor an entity in which the stockholders of the Company immediately prior to such transaction control more than 50% of the voting power immediately following the transaction.
“Code” means the Internal Revenue Code of 1986, as amended.
“Company” has the meaning given such term in Section 1(a) and any successor thereto.
“Consultant” means an independent contractor who performs services for the Company or a Subsidiary in a capacity other than as an Employee or Director.
“Date of Grant” means the date as of which an Award is determined to be effective and designated in a resolution by the Board and is granted pursuant to the Plan. The Date of Grant shall not be earlier than the date of the resolution and action therein by the Board. In no event shall the Date of Grant be earlier than the Effective Date.
“Director” means any individual who is a member of the Board who is not an Employee.
“Effective Date” has the meaning given such term in Section 1(a).
“Employee” means any employee of the Company or a Subsidiary; provided, however, that for purposes of determining whether any person may be a Participant for purposes of any grant of Incentive Stock Options, the term “Employee” has the meaning given to such term in Section 3401(c) of the Code, as interpreted by the regulations thereunder and Applicable Law.
“Fair Market Value” means the value of one Share on any relevant date, determined under the following rules: (a) the closing sale price per Share on that date as reported on the principal exchange on which Shares are then trading, if any, or if there are no sales on that date, on the next preceding trading day during which a sale occurred; (b) if the Shares are not reported on a principal exchange or national market system, the average of the closing bid and asked prices last quoted on that date by an established quotation service for over-the-counter securities; or (c) if neither (a) nor (b) applies, (i) with respect to Stock Options, Stock Appreciation Rights and any Award of stock rights that is subject to Section 409A of the Code, the value as determined by the Board through the reasonable application of a reasonable valuation method, taking into account all information material to the value of the Company, within the meaning of Section 409A of the Code, and (ii) with respect to all other Awards, the fair market value as determined by the Board in good faith.
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“Incentive Stock Option” or “ISO” means a Stock Option that is designated as an Incentive Stock Option and that is intended to meet the requirements of Section 422 of the Code.
“Nonqualified Stock Option” means a Stock Option that is not intended to meet the requirements of Section 422 of the Code or otherwise does not meet such requirements.
“Other Share-Based Award” means an equity-based or equity-related Award not otherwise described by the terms of the Plan, granted in accordance with the terms and conditions set forth in Section 10.
“Participant” means any eligible individual as set forth in Section 5 who holds one or more outstanding Awards.
“Performance Objectives” means the performance objective or objectives established by the Board pursuant to the Plan. Any Performance Objectives may relate to the performance of the Company or one or more of its Subsidiaries, divisions, departments, units, functions, partnerships, joint ventures or minority investments, product lines or products, or the performance of the individual Participant.
“Plan” means this MicroLin Bio Inc. Equity Incentive Plan, as amended from time to time.
“Restricted Shares” means Shares granted or sold pursuant to Section 8 as to which neither the substantial risk of forfeiture nor the prohibition on transfers referred to in such Section 8 has expired.
“Restricted Share Unit” means a grant or sale of the right to receive Shares or cash at the end of a specified restriction period made pursuant to Section 9.
“Share” means a share of common stock of the Company, $0.000001 par value per share, or any security into which such Share may be changed by reason of any transaction or event of the type referred to in Section 13.
“Stock Appreciation Right” means a right granted pursuant to Section 7.
“Stock Option” means a right to purchase a Share granted to a Participant under the Plan in accordance with the terms and conditions set forth in Section 6. Stock Options may be either Incentive Stock Options or Nonqualified Stock Options.
“Subsidiary” means: (a) with respect to an Incentive Stock Option, a “subsidiary corporation” as defined under Section 424(f) of the Code; and (b) for all other purposes under the Plan, any corporation or other entity in which the Company owns, directly or indirectly, a proprietary interest of more than fifty percent (50%) by reason of stock ownership or otherwise.
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“Ten Percent Stockholder” means any Participant who owns more than 10% of the combined voting power of all classes of stock of the Company, within the meaning of Section 422 of the Code.
3. Shares Available Under the Plan.
a. Shares Available for Awards. The maximum number of Shares that may be issued or delivered pursuant to Awards under the Plan shall be 250,000 Shares, all of which may be granted with respect to Incentive Stock Options. Shares issued or delivered pursuant to an Award may be authorized but unissued Shares, treasury Shares, or a combination of the foregoing. The aggregate number of Shares available for issuance or delivery under the Plan shall be subject to adjustment as provided in Section 13.
b. Share Counting. The following Shares shall not count against the Share limit in Section 3(a): (i) Shares covered by an Award that expires or is forfeited, canceled, surrendered, or otherwise terminated without the issuance of such Shares; (ii) Shares covered by an Award that is settled only in cash; and (iii) Shares granted through the assumption of, or in substitution for, outstanding awards granted by a company to individuals who become Employees or Directors as the result of a merger, consolidation, acquisition or other corporate transaction involving such company and the Company or any of its Subsidiaries. This Section 3(b) shall apply to the number of Shares reserved and available for Incentive Stock Options only to the extent consistent with applicable Treasury Regulations relating to Incentive Stock Options under the Code.
4. Administration of the Plan.
a. In General. The Plan shall be administered by the Board. The Board shall have full and final authority in its discretion to take all actions determined by the Board to be necessary in the administration of the Plan, including, without limitation, discretion to: select Award recipients; determine the sizes and types of Awards; determine the terms and conditions of Awards in a manner consistent with the Plan; grant waivers of terms, conditions, restrictions and limitations applicable to any Award, or accelerate the vesting or exercisability of any Award, in a manner consistent with the Plan; construe and interpret the Plan and any Award Agreement or other agreement or instrument entered into under the Plan; establish, amend, or waive rules and regulations for the Plan’s administration; and take such other action, not inconsistent with the terms of the Plan, as the Board deems appropriate.
b. Delegation to Committees. To the extent permitted by Applicable Law, the Board may, in its discretion, delegate to one or more committees of the Board any of the Board’s authority under the Plan. With respect to any matters so delegated, the acts of any such committee shall be treated hereunder as acts of the Board, and all references in the Plan to the “Board” (except those in the immediately preceding sentence) shall mean any such committee.
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c. Delegation to Officers. To the extent permitted by Applicable Law, the Board may, in its discretion, delegate to one or more officers of the Company the authority to grant Awards and such other authority under the Plan as the Board may determine, provided that the Board shall fix the maximum number of Shares that may be subject to Awards granted by such officers under the Plan and the maximum number of Shares that may be subject to Awards granted to any one Participant by such officers. With respect to any matters so delegated, the acts of any such delegate shall be treated hereunder as acts of the Board, and all references in the Plan to the “Board” (except those in the immediately preceding sentence) shall mean any such delegate.
d. Determinations. The Board shall have no obligation to treat Participants or eligible Employees, Directors or Consultants uniformly, and the Board may make determinations under the Plan selectively among Participants who receive, or Employees, Directors or Consultants who are eligible to receive, Awards (whether or not such Participants or eligible Employees, Directors or Consultants are similarly situated). All determinations and decisions made by the Board pursuant to the provisions of the Plan and all related orders and resolutions of the Board shall be final, conclusive and binding on all persons, including the Company, its Subsidiaries, stockholders, Directors, Employees, Consultants, Participants and their estates and beneficiaries.
5. Eligibility and Participation. Each Employee, Director and Consultant is eligible to participate in the Plan. Subject to the provisions of the Plan, the Board may, from time to time, select from all eligible Employees, Directors and Consultants those to whom Awards shall be granted and shall determine, in its sole discretion, the nature of any and all terms permissible by Applicable Law and the amount of each Award.
6. Stock Options. Subject to the terms and conditions of the Plan, Stock Options may be granted to Participants in such number, and upon such terms and conditions, as shall be determined by the Board in its sole discretion.
a. Award Agreement. Each Stock Option shall be evidenced by an Award Agreement that shall specify the exercise price, the term of the Stock Option, the number of Shares covered by the Stock Option, the conditions upon which the Stock Option shall become vested and exercisable and such other terms and conditions as the Board shall determine and which are not inconsistent with the terms and conditions of the Plan. The Award Agreement also shall specify whether the Stock Option is intended to be an Incentive Stock Option or a Nonqualified Stock Option.
b. Exercise Price. The exercise price per Share of a Stock Option shall be determined by the Board at the time the Stock Option is granted and shall be specified in the related Award Agreement; provided, however, that in no event shall the exercise price per Share of any Stock Option be less than one hundred percent (100%) of the Fair Market Value of a Share on the Date of Grant.
c. Term. The term of a Stock Option shall be determined by the Board and set forth in the related Award Agreement; provided, however, that in no event shall the term of any Stock Option exceed ten (10) years from its Date of Grant.
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d. Exercisability. Stock Options shall become vested and exercisable at such times and upon such terms and conditions as shall be determined by the Board and set forth in the related Award Agreement. Such terms and conditions may include, without limitation, the satisfaction of (a) performance goals based on one or more Performance Objectives, and (b) time-based vesting requirements.
e. Exercise of Stock Options. Except as otherwise provided in the Plan or in a related Award Agreement, a Stock Option may be exercised for all or any portion of the Shares for which it is then exercisable. A Stock Option shall be exercised by the delivery of a notice of exercise to the Company or its designee in a form specified by the Company which sets forth the number of Shares with respect to which the Stock Option is to be exercised and full payment of the exercise price for such Shares. The exercise price of a Stock Option may be paid, in the discretion of the Board and as set forth in the applicable Award Agreement: (i) in cash or its equivalent; (ii) by tendering (either by actual delivery or attestation) previously acquired Shares having an aggregate Fair Market Value at the time of exercise equal to the aggregate exercise price; (iii) by a cashless exercise (including by withholding Shares deliverable upon exercise and through a broker-assisted arrangement to the extent permitted by Applicable Law); (iv) by a combination of the methods described in clauses (i), (ii) and/or (iii); or (v) through any other method approved by the Board in its sole discretion. As soon as practicable after receipt of the notification of exercise and full payment of the exercise price, the Company shall cause the appropriate number of Shares to be issued to the Participant.
f. Special Rules Applicable to Incentive Stock Options. Notwithstanding any other provision in the Plan to the contrary:
(i) Incentive Stock Options may be granted only to Employees of the Company and its Subsidiaries. The terms and conditions of Incentive Stock Options shall be subject to and comply with the requirements of Section 422 of the Code.
(ii) To the extent that the aggregate Fair Market Value of the Shares (determined as of the Date of Grant) with respect to which an Incentive Stock Option is exercisable for the first time by any Participant during any calendar year (under all plans of the Company and its Subsidiaries) is greater than $100,000 (or such other amount specified in Section 422 of the Code), as calculated under Section 422 of the Code, then the Stock Option shall be treated as a Nonqualified Stock Option.
(iii) No Incentive Stock Option shall be granted to any Participant who, on the Date of Grant, is a Ten Percent Stockholder, unless (x) the exercise price per Share of such Incentive Stock Option is at least one hundred and ten percent (110%) of the Fair Market Value of a Share on the Date of Grant, and (y) the term of such Incentive Stock Option shall not exceed five (5) years from the Date of Grant.
7. Stock Appreciation Rights. Subject to the terms and conditions of the Plan, Stock Appreciation Rights may be granted to Participants in such number, and upon such terms and conditions, as shall be determined by the Board in its sole discretion.
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a. Award Agreement. Each Stock Appreciation Right shall be evidenced by an Award Agreement that shall specify the exercise price, the term of the Stock Appreciation Right, the number of Shares covered by the Stock Appreciation Right, the conditions upon which the Stock Appreciation Right shall become vested and exercisable and such other terms and conditions as the Board shall determine and which are not inconsistent with the terms and conditions of the Plan.
b. Exercise Price. The exercise price per Share of a Stock Appreciation Right shall be determined by the Board at the time the Stock Appreciation Right is granted and shall be specified in the related Award Agreement; provided, however, that in no event shall the exercise price per Share of any Stock Appreciation Right be less than one hundred percent (100%) of the Fair Market Value of a Share on the Date of Grant.
c. Term. The term of a Stock Appreciation Right shall be determined by the Board and set forth in the related Award Agreement; provided, however, that in no event shall the term of any Stock Appreciation Right exceed ten (10) years from its Date of Grant.
d. Exercisability of Stock Appreciation Rights. A Stock Appreciation Right shall become vested and exercisable at such times and upon such terms and conditions as may be determined by the Board and set forth in the related Award Agreement. Such terms and conditions may include, without limitation, the satisfaction of (i) performance goals based on one or more Performance Objectives, and (ii) time-based vesting requirements.
e. Exercise of Stock Appreciation Rights. Except as otherwise provided in the Plan or in a related Award Agreement, a Stock Appreciation Right may be exercised for all or any portion of the Shares for which it is then exercisable. A Stock Appreciation Right shall be exercised by the delivery of a notice of exercise to the Company or its designee in a form specified by the Company which sets forth the number of Shares with respect to which the Stock Appreciation Right is to be exercised. Upon exercise, a Stock Appreciation Right shall entitle a Participant to an amount equal to (i) the excess of the Fair Market Value of a Share on the exercise date over the exercise price per Share, multiplied by (ii) the number of Shares with respect to which the Stock Appreciation Right is exercised. A Stock Appreciation Right may be settled in whole Shares, cash or a combination thereof, as specified by the Board in the related Award Agreement.
8. Restricted Shares. Subject to the terms and conditions of the Plan, Restricted Shares may be granted or sold to Participants in such number, and upon such terms and conditions, as shall be determined by the Board in its sole discretion.
a. Award Agreement. Each Restricted Shares Award shall be evidenced by an Award Agreement that shall specify the number of Restricted Shares, the restriction period(s) applicable to the Restricted Shares, the conditions upon which the restrictions on the Restricted Shares will lapse and such other terms and conditions as the Board shall determine and which are not inconsistent with the terms and conditions of the Plan.
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b. Terms, Conditions and Restrictions. The Board shall impose such other terms, conditions and/or restrictions on any Restricted Shares as it may deem advisable, including, without limitation, a requirement that the Participant pay a purchase price for each Restricted Share, restrictions based on the achievement of specific Performance Objectives, time-based restrictions or holding requirements or sale restrictions placed on the Shares by the Company upon vesting of such Restricted Shares. Unless otherwise provided in the related Award Agreement or required by Applicable Law, the restrictions imposed on Restricted Shares shall lapse upon the expiration or termination of the applicable restriction period and the satisfaction of any other applicable terms and conditions.
c. Custody of Certificates. To the extent deemed appropriate by the Board, the Company may retain the certificates representing Restricted Shares in the Company’s possession until such time as all terms, conditions and/or restrictions applicable to such Shares have been satisfied or lapse.
d. Rights Associated with Restricted Shares during Restriction Period. During any restriction period applicable to Restricted Shares: (i) the Restricted Shares may not be sold, transferred, pledged, assigned or otherwise alienated or hypothecated; (ii) unless otherwise provided in the related Award Agreement, the Participant shall be entitled to exercise full voting rights associated with such Restricted Shares; and (iii) the Participant shall be entitled to all dividends and other distributions paid with respect to such Restricted Shares during the restriction period. The Award Agreement may require that receipt of any dividends or other distributions with respect to the Restricted Shares shall be subject to the same terms and conditions as the Restricted Shares with respect to which they are paid.
9. Restricted Share Units. Subject to the terms and conditions of the Plan, Restricted Share Units may be granted or sold to Participants in such number, and upon such terms and conditions, as shall be determined by the Board in its sole discretion.
a. Award Agreement. Each Restricted Share Unit Award shall be evidenced by an Award Agreement that shall specify the number of units, the restriction period(s) applicable to the Restricted Share Units, the conditions upon which the restrictions on the Restricted Share Units will lapse, the time and method of payment of the Restricted Share Units, and such other terms and conditions as the Board shall determine and which are not inconsistent with the terms and conditions of the Plan.
b. Terms, Conditions and Restrictions. The Board shall impose such other terms, conditions and/or restrictions on any Restricted Share Units as it may deem advisable, including, without limitation, a requirement that the Participant pay a purchase price for each Restricted Share Unit, restrictions based on the achievement of specific Performance Objectives or time-based restrictions or holding requirements.
c. Form of Settlement. Restricted Share Units may be settled in whole Shares, cash or a combination thereof, as specified by the Board in the related Award Agreement.
d. Dividend Equivalents. Restricted Share Units may provide the Participant with dividend equivalents, on either a current or deferred or contingent basis, and either in cash or in additional Shares, as determined by the Board in its sole discretion and set forth in the related Award Agreement.
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10. Other Share-Based Awards. Subject to the terms and conditions of the Plan, Other Share-Based Awards may be granted to Participants in such number, and upon such terms and conditions, as shall be determined by the Board in its sole discretion. Other Share-Based Awards are Awards that are valued in whole or in part by reference to, or otherwise based on the Fair Market Value of, Shares, and shall be in such form as the Board shall determine, including without limitation, unrestricted Shares or time-based or performance-based units that are settled in Shares and/or cash.
a. Award Agreement. Each Other Share-Based Award shall be evidenced by an Award Agreement that shall specify the terms and conditions upon which the Other Share-Based Award shall become vested, if applicable, the time and method of settlement, the form of settlement and such other terms and conditions as the Board shall determine and which are not inconsistent with the terms and conditions of the Plan.
b. Form of Settlement. An Other Share-Based Award may be settled in whole Shares, cash or a combination thereof, as specified by the Board in the related Award Agreement.
c. Dividend Equivalents. Other Share-Based Awards may provide the Participant with dividend equivalents, on either a current or deferred or contingent basis, and either in cash or in additional Shares, as determined by the Board in its sole discretion and set forth in the related Award Agreement.
11. Compliance with Section 409A. Awards granted under the Plan shall be designed and administered in such a manner that they are either exempt from the application of, or comply with, the requirements of Section 409A of the Code. To the extent that the Board determines that any award granted under the Plan is subject to Section 409A of the Code, the Award Agreement shall incorporate the terms and conditions necessary to avoid the imposition of an additional tax under Section 409A of the Code upon a Participant. Notwithstanding any other provision of the Plan or any Award Agreement (unless the Award Agreement provides otherwise with specific reference to this Section): (a) an Award shall not be granted, deferred, accelerated, extended, paid out, settled, substituted or modified under the Plan in a manner that would result in the imposition of an additional tax under Section 409A of the Code upon a Participant; and (b) if an Award is subject to Section 409A of the Code, and if the Participant holding the award is a “specified employee” (as defined in Section 409A of the Code, with such classification to be determined in accordance with the methodology established by the Company), then, to the extent required to avoid the imposition of an additional tax under Section 409A of the Code upon a Participant, no distribution or payment of any amount shall be made before the date that is six (6) months following the date of such Participant’s “separation from service” (as defined in Section 409A of the Code) or, if earlier, the date of the Participant’s death. Although the Company intends to administer the Plan so that Awards will be exempt from, or will comply with, the requirements of Section 409A of the Code, the Company does not warrant that any Award under the Plan will qualify for favorable tax treatment under Section 409A of the Code or any other provision of federal, state, local, or non-United States law. The Company shall not be liable to any Participant for any tax, interest, or penalties the Participant might owe as a result of the grant, holding, vesting, exercise, or payment of any Award under the Plan.
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12. Transferability. Except as otherwise determined by the Board, no Award or dividend equivalents paid with respect to any Award shall be transferable by the Participant except by will or the laws of descent and distribution; provided, that if so determined by the Board, each Participant may, in a manner established by the Board, designate a beneficiary to exercise the rights of the Participant with respect to any Award upon the death of the Participant and to receive Shares or other property issued or delivered under such Award. Except as otherwise determined by the Board, Stock Options and Stock Appreciation Rights will be exercisable during a Participant’s lifetime only by the Participant or, in the event of the Participant’s legal incapacity to do so, by the Participant’s guardian or legal representative acting on behalf of the Participant in a fiduciary capacity under state law and/or court supervision.
13. Adjustments. In the event of any equity restructuring (within the meaning of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation – Stock Compensation), such as a stock dividend, stock split, reverse stock split, spinoff, rights offering, or recapitalization through a large, nonrecurring cash dividend, the Board shall cause there to be an equitable adjustment in the numbers of Shares specified in Section 3 of the Plan and, with respect to outstanding Awards, in the number and kind of Shares subject to outstanding Awards and the exercise price or other price of Shares subject to outstanding Awards, in each case to prevent dilution or enlargement of the rights of Participants. In the event of any other change in corporate capitalization, or in the event of a merger, consolidation, liquidation, or similar transaction, the Board may, in its sole discretion, cause there to be an equitable adjustment as described in the foregoing sentence, to prevent dilution or enlargement of rights; provided, however, that, unless otherwise determined by the Board, the number of Shares subject to any Award shall always be rounded down to a whole number. Notwithstanding the foregoing, the Board shall not make any adjustment pursuant to this Section 13 that would (i) cause any Stock Option intended to qualify as an ISO to fail to so qualify, (ii) cause an Award that is otherwise exempt from Section 409A of the Code to become subject to Section 409A, or (iii) cause an Award that is subject to Section 409A of the Code to fail to satisfy the requirements of Section 409A. The determination of the Board as to the foregoing adjustments, if any, shall be conclusive and binding on all Participants and any other persons claiming under or through any Participant.
14. Fractional Shares. The Company shall not be required to issue or deliver any fractional Shares pursuant to the Plan and, unless otherwise provided by the Board, fractional Shares shall be settled in cash.
15. Withholding Taxes. To the extent required by Applicable Law, a Participant shall be required to satisfy, in a manner satisfactory to the Company or Subsidiary, as applicable, any withholding tax obligations that arise by reason of a Stock Option or Stock Appreciation Right exercise, the vesting of or settlement of Shares under an Award, an election pursuant to Section 83(b) of the Code or otherwise with respect to an Award. The Company and its Subsidiaries shall not be required to issue or deliver Shares, make any payment or to recognize the transfer or disposition of Shares until such obligations are satisfied. The Board may permit or require these obligations to be satisfied by having the Company withhold a portion of the Shares that otherwise would be issued or delivered to a Participant upon exercise of a Stock Option or Stock Appreciation Right or upon the vesting or settlement of an Award, or by tendering Shares previously acquired, in each case having a Fair Market Value equal to the minimum amount required to be withheld or paid. Any such elections are subject to such conditions or procedures as may be established by the Board and may be subject to disapproval by the Board.
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16. Foreign Employees. Without amending the Plan, the Board may grant Awards to Participants who are foreign nationals, or who are subject to Applicable Law of one or more non-United States jurisdictions, on such terms and conditions different from those specified in the Plan as may in the judgment of the Board be necessary or desirable to foster and promote achievement of the purposes of the Plan, and, in furtherance of such purposes, the Board may make such modifications, amendments, procedures, and the like as may be necessary or advisable to comply with provisions of Applicable Law of other countries in which the Company or its Subsidiaries operate or have employees.
17. Termination for Cause; Forfeiture of Awards.
a. Termination for Cause. If a Participant's employment or service is terminated by the Company or a Subsidiary for Cause, as determined by the Board in its sole discretion, then, promptly upon receiving notice of the Board’s determination, the Participant shall: (i) forfeit all Awards granted under the Plan to the extent then held by the Participant; (ii) return to the Company or the Subsidiary all Shares that the Participant has not disposed of that had been acquired pursuant to all Awards granted under the Plan, in exchange for payment by the Company or the Subsidiary of any amount actually paid therefor by the Participant; and (iii) with respect to any Shares acquired pursuant to an Award granted under the Plan that were disposed of, pay to the Company or the Subsidiary, in cash, the excess, if any, of: (A) the Fair Market Value of the Shares on the date acquired, over (B) any amount actually paid by the Participant for the Shares.
b. Compensation Recovery Policy. Any Award granted to a Participant shall be subject to forfeiture or repayment pursuant to the terms of any applicable compensation recovery policy adopted by the Company, including any such policy that may be adopted to comply with Applicable Law.
c. Set-Off and Other Remedies. To the extent that amounts are not immediately returned or paid to the Company as provided in this Section 17, the Company may, to the extent permitted by Applicable Law, seek other remedies, including a set off of the amounts so payable to it against any amounts that may be owing from time to time by the Company or a Subsidiary to the Participant for any reason, including, without limitation, wages, or vacation pay or other benefits; provided, however, that, except to the extent permitted by Treasury Regulation Section 1.409A-3(j)(4), such offset shall not apply to amounts that are “deferred compensation” within the meaning of Section 409A of the Code.
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18. Change in Control. In the event of a Change in Control, the Board, in its sole discretion, may take such actions, if any, as it deems necessary or desirable with respect to any Award that is outstanding as of the date of the consummation of the Change in Control. Such actions may include, without limitation: (a) the acceleration of the vesting, settlement and/or exercisability of an Award; (b) the payment of a cash amount in exchange for the cancellation of an Award; (c) the cancellation of Stock Options and/or Stock Appreciation Rights without payment therefor if the Fair Market Value of a Share on the date of the Change in Control does not exceed the exercise price per Share of the applicable Awards; and/or (d) the issuance of substitute Awards that substantially preserve the value, rights and benefits of any affected Awards.
19. Amendment, Modification and Termination.
a. In General. The Board may at any time and from time to time, alter, amend, suspend or terminate the Plan in whole or in part.
b. Adjustments to Outstanding Awards. The Board may in its sole discretion at any time (i) provide that all or a portion of a Participant’s Stock Options, Stock Appreciation Rights and other Awards in the nature of rights that may be exercised shall become fully or partially exercisable; (ii) provide that all or a part of the time-based vesting restrictions on all or a portion of the outstanding Awards shall lapse, and/or that any Performance Objectives or other performance-based criteria with respect to any Awards shall be deemed to be wholly or partially satisfied; or (iii) waive any other limitation or requirement under any such Award, in each case, as of such date as the Board may, in its sole discretion, declare. Additionally, the Board shall not make any adjustment pursuant to this Section 19(b) that would cause an Award that is otherwise exempt from Section 409A of the Code to become subject to Section 409A, or that would cause an Award that is subject to Section 409A of the Code to fail to satisfy the requirements of Section 409A.
c. Effect on Outstanding Awards. Notwithstanding any other provision of the Plan to the contrary (other than Sections 13, 18, 19(b) and 21(d)), no termination, amendment, suspension, or modification of the Plan or an Award Agreement shall adversely affect in any material way any Award previously granted under the Plan, without the written consent of the Participant holding such Award; provided that the Board may modify an ISO held by a Participant to disqualify such Stock Option from treatment as an “incentive stock option” under Section 422 of the Code without the Participant’s consent.
20. Applicable Law. The obligations of the Company with respect to Awards under the Plan shall be subject to Applicable Law and such approvals by any governmental agencies as the Board determines may be required. The Plan and each Award Agreement shall be governed by the laws of the State of Delaware, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of the Plan to the substantive law of another jurisdiction.
12 |
21. Miscellaneous.
a. Conditions on Delivery of Shares. The Company will not be obligated to deliver any Shares pursuant to the Plan or to remove restrictions from Shares previously delivered under the Plan until (i) all conditions of the Award have been met or removed to the satisfaction of the Company, (ii) in the opinion of the Company’s counsel, all other legal matters in connection with the issuance and delivery of such Shares have been satisfied, including any applicable securities laws and any applicable stock exchange or stock market rules and regulations, and (iii) the Participant has executed and delivered to the Company such representations or agreements as the Company may consider appropriate to satisfy the requirements of Applicable Law. Unless and until the Shares have been registered under the Securities Act of 1933, as amended, each certificate evidencing any Shares delivered pursuant to the Plan shall bear a restrictive legend specified by the Company.
b. No Right of Continued Employment or Service. The Plan shall not confer upon any Participant any right with respect to continuance of employment or other service with the Company or any Subsidiary, nor shall it interfere in any way with any right the Company or any Subsidiary would otherwise have to terminate such Participant’s employment or other service at any time. No Employee, Director or Consultant shall have the right to be selected to receive an Award under the Plan, or, having been so selected, to be selected to receive future Awards.
c. Unfunded, Unsecured Plan. Neither a Participant nor any other person shall, by reason of participation in the Plan, acquire any right or title to any assets, funds or property of the Company or any Subsidiary, including without limitation, any specific funds, assets or other property which the Company or any Subsidiary may set aside in anticipation of any liability under the Plan. A Participant shall have only a contractual right to an Award or the amounts, if any, payable under the Plan, unsecured by any assets of the Company or any Subsidiary, and nothing contained in the Plan shall constitute a guarantee that the assets of the Company or any Subsidiary shall be sufficient to pay any benefits to any person.
d. Severability. If any provision of the Plan is or becomes invalid, illegal or unenforceable in any jurisdiction, or would disqualify the Plan or any Award under any law deemed applicable by the Board, such provision shall be construed or deemed amended or limited in scope to conform to Applicable Law or, in the discretion of the Board, it shall be stricken and the remainder of the Plan shall remain in full force and effect.
e. Acceptance of the Plan. By accepting any benefit under the Plan, each Participant and each person claiming under or through any such Participant shall be conclusively deemed to have indicated their acceptance and ratification of, and consent to, all of the terms and conditions of the Plan and any action taken under the Plan by the Board or the Company, in any case in accordance with the terms and conditions of the Plan.
f. Successors. All obligations of the Company under the Plan and with respect to Awards shall be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or other event, or a sale or disposition of all or substantially all of the business and/or assets of the Company and references to the “Company” herein and in any Award Agreements shall be deemed to refer to such successors.
[END OF DOCUMENT]
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***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
PATENT & Technology LICENSE AGREEMENT
AGT. No. A2014-0165
This Patent & Technology License Agreement is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).
No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.
Background
Licensor owns, controls and/or has the right to sublicense the Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:
The Terms and Conditions of Patent & Technology License attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). The Commercialization Plan attached hereto as Exhibit B is incorporated herein by reference in its entirety (the “Commercialization Plan”). In the event of a conflict between provisions of this Patent & Technology License Agreement and the Terms and Conditions, the provisions in this Patent & Technology License Agreement shall govern. Unless defined in this Patent & Technology License Agreement, capitalized terms used in this Patent & Technology License Agreement shall have the meanings given to them in the Terms and Conditions.
The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.
1. Definitions |
Effective Date | September 6, 2013 | |
Licensor | Ohio State Innovation Foundation, with an address at 1524 North High Street, Columbus, OH 43201. | |
Licensee
|
MicroLin Bio, Inc., a corporation, with its principle place of business at 302A West 12th Suite 114, New York, NY 10014 | |
Contract Year and Contract Quarters |
x Contract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31
| |
Territory | Worldwide |
Field of Use
|
Exclusive Field of Use for the diagnosis, prognosis and therapy/treatment of colon cancer. | |
Patent Rights/Technology Rights [See Exhibit C for individual patent application and patent information] |
App. No./ Date of Filing |
Title | Inventor(s) | Jointly Owned? (Y/N; if Y, with whom?) |
Countries |
Prosecution Counsel | |
PCT/US2007/000159 03/03/2007 [2006-138]
|
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | C. Croce S. Volinia G. Calin
|
x No | US CA AU CN JP HK EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2006/035100 09/11/2006 [2006-009] |
Compositions and Methods for the Diagnosis and Therapy of BCL2-Associated Cancers | C. Croce G. Calin |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2007/15892 07/12/2007 [2007-019] |
MicroRNA Based Methods and Compositions for the Diagnosis and Treatment of Colon Related Diseases | C. Croce C. Harris A. Schetter |
x Yes, w/ The National Institutes of Health
[See section 20.1] |
US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/072081 08/04/2008 [2007-028] |
Ultraconserved Regions Encoding ncRNAs | C. Croce
|
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/081294 10/27/2008 [2007-030] |
Methods for Identifying Fragile Histidine Triad (Fhit) Interaction and Uses Thereof | C. Croce F. Trapasso |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC |
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PCT/US2011/029348 03/22/2011 [2010-126] |
Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | C. Croce N. Valeri |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | ||
PCT/US2011/060349 11/11/2011 [2011-085] |
Materials and Methods Related to MicroRNA-21. Mismatch Repair, And Colorectal Cancer | C. Croce N. Valeri |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | ||
PCT/US2012/028016 03/07/2012 [2011-137] |
Mutator activity induced by microRNA-155 (miR-155) Links Inflammation and Cancer | C. Croce |
x No | US PCT |
MacMillan, Sobanski, and Todd LLC | ||
PCT/US2012/069484 12/13/2012 [2012-066] |
Methods and Compositions Related to miR-21 & miR-29a and Cancer Metastasis | C. Croce M. Fabbri |
x No | PCT | MacMillan, Sobanski, and Todd LLC | ||
PCT/US2012/067651 12/03/2012 [2012-104] |
Mechanism of NSAID Chemoprevention in Colorectal Cancer | R. Fishel C. Croce L. Kopelovich B. Aronow |
x No | PCT | MacMillan, Sobanski, and Todd LLC | ||
USPTO Entity Status as of Effective Date
|
Check one box: x Small | ||||||
2.4. Diligence Milestones |
|
Milestones and deadlines | Milestone Events | Deadlines |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of colon cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** |
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5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for colon cancer therapeutics. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of colon cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
9. First Sale in any country outside of the United States of America of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** |
3. Compensation |
3.1(a) | Patent expenses due upon Effective Date
(See Section 20.1)
|
Amount | based on invoices received as of: | |
Tech ID 2006-138 | $66,014.47 | 09/06/13 | ||
Tech ID 2006-009 | Costs already accounted for in an Agreement having an Effective Date of September 6, 2013 between the parties. | 09/06/13 | ||
Tech ID 2007-019 | $377,022.70 | 09/06/13 | ||
Tech ID 2007-028 | Costs already accounted for in an Agreement having an Effective Date of September 6, 2013 between the parties. | 09/06/13 | ||
Tech ID 2007-030 | $72,345.30 | 09/06/13 |
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Tech ID 2010-126 | Costs already accounted for in an Agreement having an Effective Date of September 6, 2013 between the parties. | 09/06/13 | ||
Tech ID 2011-085 | $50,991.53 | 09/06/13 | ||
Tech ID 2011-137 | $16,866.45 | 09/06/13 | ||
Tech ID 2012-066 | $26,326.50 | 09/06/13 | ||
Tech ID 2012-104 | $12,986.50 | 09/06/13 | ||
Total | $622,553.45 | 09/06/13 | ||
3.1(b) | Milestone fees
|
Milestone Events | Milestone Fees | |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of colon cancer. | *** | |||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | |||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | |||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. | *** | |||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for colon cancer therapeutics. | ***
(Associated fees referenced in Sections 3.1e and 20.4) | |||
6. Complete financing in which Licensee receives $10,000,000 or greater for the for the purpose of advancing Licensed Product and/or Licensed Service. | *** | |||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of colon cancer. | *** | |||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. | *** | |||
9. First Sale in any country outside of the United States of America of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer. | *** | |||
3.1(c) | Upfront Fee | $5,000 due on Effective Date $95,000 due on or before May 31, 2014 | ||
3.1(d) | License Maintenance Fees |
$25,000 due on May 31, 2015 | ||
3.1(e) | Sublicense Fees | *** of Non-Royalty Sublicensing Consideration for diagnostics and prognostics. *** of Non-Royalty Sublicensing Consideration for therapeutics. |
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3.1(f) | Assignment fee | For the Contract Year ending ***, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement.
For any Contract Year thereafter, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement. Assignments shall include assignments or transfers of the Agreement as part of a corporate reorganization, consolidation, merger or sale of substantially all of the assets or any other change of control |
3.2 | Running royalty rate (applies to Sales by Licensee, Affiliates and Sublicensees) | (a) Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights | *** |
(b) Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights
|
*** | ||
3.3 | Minimum royalty | *** for Contract Year ending *** *** for Contract Year ending *** *** per each subsequent Contract Year thereafter |
18. Contact Information | ||
Licensee Contacts | Licensor Contacts | |
Contact for Notice: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Accounting contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
|
Contact for Notice: Attn: President 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: techlicensing@osu.edu
Payment and reporting contact: Checks payable to “Ohio State Innovation Foundation” Attn: Accounting/Compliance 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 Email: OSIFCompliance@osu.edu
|
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Patent prosecution contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
|
Patent prosecution contact: Attn: Catherine Martineau MacMillan, Sobanski , & Todd, LLC ; Patent, Trademark, Copyright and Intellectual Property Law One Maritime Plaza, Fifth Floor 720 Water Street Toledo, Ohio 43604-1853 419-255-5900 (voice) 419-255-9639 (fax) E-mail: martineau@mstfirm.com Internet: http//www.mstfirm.com
|
For Licensor Administrative Purposes Only | ||
Changes to Standard Form Terms and Conditions | There have not been any revisions to Licensor’s standard form Terms and Conditions , except for revisions to the following sections: 7
| |
20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent & Technology License Agreement.
Section 20.1 Inter-Institutional Agreement. Pursuant to an Inter-Institutional Agreement (NIH reference number L-003-2009) having an effective date of October 23, 2008 between Licensor and National Institutes of Health (NIH), NIH has granted Licensor the ability to grant license rights in the patent indicated in Section 1 as jointly owned by Licensor and NIH.
Section 20.2 Payment Schedule for Past Patent Expenses. Licensee will repay the past patent expenses referenced in Section 3.1(a) above upon the earlier of: (1) the payment due dates on the following schedule (shown below); or (2) Licensee has cumulative external funding (any combination of government grant, government contract, or private equity) of at least $10,000,000. In the event that $10,000,000 of external funding is obtained by Licensee, all unpaid amounts of past patent expenses shall become immediately due and payable to Licensor. The payments below include interest at the rate of 3.50% per annum. Should this Agreement be terminated, all patent expenses are immediately due and payable by Licensee to Licensor.
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Pmt. No. | Payment Date | Beginning Balance | Scheduled Payment | Principal | Interest | Ending Balance | ||||||||||||||||
1 | 10/31/2013 | $ | 622,553.45 | $ | 25,000 | $ | 14,105.31 | $ | 10,894.69 | $ | 608,448.14 | |||||||||||
2 | 12/31/2013 | $ | 608,448.14 | $ | 25,000 | $ | 14,352.16 | $ | 10,647.84 | $ | 594,095.98 | |||||||||||
3 | 7/31/2014 | $ | 594,095.98 | $ | 25,000 | $ | 14,603.32 | $ | 10,396.68 | $ | 579,492.66 | |||||||||||
4 | 12/31/2014 | $ | 579,492.66 | $ | 25,000 | $ | 14,858.88 | $ | 10,141.12 | $ | 564,633.78 | |||||||||||
5 | 6/30/2015 | $ | 564,633.78 | $ | 73,386.52 | $ | 68,445.98 | $ | 4,940.55 | $ | 496,187.80 | |||||||||||
6 | 9/30/2015 | $ | 496,187.80 | $ | 73,386.52 | $ | 69,044.88 | $ | 4,341.64 | $ | 427,142.92 | |||||||||||
7 | 12/31/2015 | $ | 427,142.92 | $ | 73,386.52 | $ | 69,649.02 | $ | 3,737.50 | $ | 357,493.90 | |||||||||||
8 | 3/31/2016 | $ | 357,493.90 | $ | 73,386.52 | $ | 70,258.45 | $ | 3,128.07 | $ | 287,235.45 | |||||||||||
9 | 6/30/2016 | $ | 287,235.45 | $ | 73,386.52 | $ | 70,873.21 | $ | 2,513.31 | $ | 216,362.24 | |||||||||||
10 | 9/30/2016 | $ | 216,362.24 | $ | 73,386.52 | $ | 71,493.35 | $ | 1,893.17 | $ | 144,868.88 | |||||||||||
11 | 12/31/2016 | $ | 144,868.88 | $ | 73,386.52 | $ | 72,118.92 | $ | 1,267.60 | $ | 72,749.96 | |||||||||||
12 | 3/31/2017 | $ | 72,749.96 | $ | 72,749.96 | $ | 72,113.40 | $ | 636.56 | $ | 0.00 |
Each of the Licensed Patents listed in a separate row in Section 1 shall constitute a single patent family. The past patent expenses set forth in Section 3.1(a) are separated out and each entry corresponds to a particular single patent family identified in Section 1. Certain of the past patent expenses for a single patent family may also be covered by one or more separate agreements between Licensor and Licensee (a “Multi-Covered Patent Expense”). Licensor does not intend for Licensee to pay double for Multi-Covered Patent Expense.
Section 20.3 Milestone Extension Option. Licensee shall have the one-time option to extend the deadlines for those Milestone Events specified in said Section 2.4 by three (3) months by paying a milestone extension fee of *** for each such extension. This option may only be exercised at a time when Licensee is in compliance with all of its obligations under the Agreement, including having met all milestones with deadlines prior to the date such notice is given (without giving effect to the extension resulting from the exercise of such option). In order to exercise this option, Licensee must provide Licensor written notice of its exercise of this option accompanied by payment of the milestone extension fee. Such notice must contain an affirmation from the Licensee that it is in compliance with all of its obligations under the Agreement, that it has and is currently using commercially reasonable efforts to implement the Commercialization Plan and Actively Commercialize Licensed Products or Licensed Services and that it reasonably expects to meet the milestone deadlines as extended by the exercise of such option.
Section 20.4 Therapeutic Research and Development. Licensee shall launch a research and development program for the licensed therapeutic rights pursuant to the therapeutic milestone events and fees outlined below, unless Licensee executes a Sublicense Agreement as set forth in Milestone 5 in section 2.4 above. Should Licensee not execute a Sublicense Agreement as set forth in Milestone 5, Licensee shall pay a fee of *** to the Licensor and provide a detailed Commercialization Plan for the licensed therapeutic rights to Licensor within forty-five days of the Deadline for Diligence Milestone 5 above.
Therapeutic Milestone Events | Deadlines | Therapeutic Milestone Fees |
1. In-license acquisition and/or development of therapeutic delivery platform. | *** | *** |
2. Regulatory Approval of IND filing by Regulatory Authority. | *** | *** |
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3. Dosing of first patient by a Regulatory Authority approved Phase I Clinical Trial of Licensed Product. | *** | *** |
4. Dosing of first patient by a Regulatory Authority approved Phase II Clinical Trial of Licensed Product. | *** | *** |
5. Dosing of first patient by a Regulatory Authority approved Phase III Clinical Trial of Licensed Product. | *** | *** |
6. Regulatory Approval of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
7. Launch of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
8. Regulatory Approval of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
9. Launch of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
Section 20.5 Therapeutic Research and Development Sublicense. Should Licensee sublicense the licensed therapeutic and/or treatment rights, Licensee shall require milestones and fees at least as stringent as those outlined in section 20.4 above.
Section 20.6 Additional CLIA Product Launch. For each subsequent CLIA validation of Licensed Product or Licensed Service for diagnosis and/or prognosis of colon cancer, launched after ***, Licensee shall pay Licensor *** dollars.
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Section 20.7 First Sale of Additional Products in United States of America. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer, Sold or launched after *** in any country outside of the United States, Licensee shall pay Licensor a fee of *** dollars.
Section 20.8 First Sale of Additional Products in any Non-U.S.A. Country. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of colon cancer, which are Sold or launched after *** in the United States, Licensee shall pay Licensor a fee of *** dollars.
Section 20.9 Identification of Sublicense Partners. For each Sublicensee brought to Licensee by Licensor that results in a successful negotiation of a Sublicense Agreement, Licensee shall pay to Licensor *** within thirty (30) days of the execution of said Sublicense Agreement.
Section 20.10 Termination Penalty. Should Licensee terminate this Agreement within two years of the Effective Date, Licensee shall pay Licensor two million five hundred thousand ($2,500,000) dollars in addition to the requirements of section 7 below.
Section 20.11 Diagnostic & Prognostic Sublicense. Licensee agrees to sublicense, nonexclusively and under reasonable terms, the diagnostic and/or prognostic field of use covered only by the Patent Rights/Technology Rights identified in Section 1 as jointly owned with the NIH and as referenced in section 20.1 above, to non-profit and commercial entities requesting such a sublicense or referred by Licensor or NIH to Licensee.
21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly represents and warrants and does hereby state and represent that no promise or agreement which is not herein expressed has been made to Licensee in executing this Patent & Technology License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby represents and warrants that Licensee understands and agrees to all terms and conditions set forth in this Patent & Technology License Agreement and said Terms and Conditions.
22. Deadline for Execution by Licensee. If this Patent & Technology License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent & Technology License Agreement shall be null and void and of no further effect.
IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent & Technology License Agreement.
LICENSOR: Ohio State INNOVATION FOUNDATION | LICENSEE: MICROLIN BIO, INC. | |||
By | /s/ Timothy R. Wright | By | /s/ Joseph Hernandez | |
Timothy R. Wright | Joseph Hernandez | |||
Interim President | Chairman |
Date | 9/10/13 | Date | 9/10/13 |
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EXHIBIT A
Terms and Conditions of Patent & Technology License
These Terms and Conditions of Patent & Technology License (“Terms and Conditions”) are incorporated by reference into the Patent & Technology License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.
1. | Definitions |
“Actively Commercialize” means having a commercially effective, reasonably funded (as compared to other similarly situated companies), ongoing and active research, development, manufacturing, marketing and/or sales program directed toward obtaining regulatory approval, production and/or Sales of Licensed Product(s) in a Field of Use in the Licensed Territory.
“Affiliate” means any business entity more than 50% owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee.
“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.
“CLIA” means Clinical Laboratory Improvement Amendments
“Commercialization Plan” means the written commercialization plan attached as Appendix B of the Patent & Technology License Agreement.
“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“…Covered By…” means a claim or claims within any pending or issued patent included in the Patent Rights claiming all, a portion, or a component or step of a Licensed Process, Licensed Product, or Licensed Service.
“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent & Technology License Agreement.
“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.
“FDA” means United States Food and Drug Administration.
“Field of Use” means the field indicated as the Field of Use identified in Section 1 of the Patent & Technology License Agreement.
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“Government” means any agency, department or other unit of the United States of America or the State of Ohio.
“Gross Consideration” means all cash and non-cash consideration (e.g., securities).
“IND” means investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights/Technology Rights in Section 1 of the Patent & Technology License Agreement.
“Licensed Process” means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.
“Licensed Product” means any product, apparatus, kit, test having a panel of either a single nucleotide or two or more nucleotides in combination or component thereof (i) whose manufacture, use, sale, offer for sale or import is Covered By any claim or claims included within the Patent Rights or incorporates any Technology Rights, or (ii) which is made using a Licensed Process or another Licensed Product.
“Licensed Service” means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.
“Licensed Subject Matter” means Patent Rights and/or Technology Rights
“Licensee” means the Party identified as the Licensee in Section 1 of the Patent & Technology License Agreement.
“Licensor” means the Party identified as the Licensor in Section 1 of the Patent & Technology License Agreement.
“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent & Technology License Agreement.
“Net Sales” means the Gross Consideration from the Sale of Licensed Products, Licensed Processes, or Licensed Services less the following items directly attributable to the Sale of such Licensed Products that are specifically identified on the invoice for such Sale and borne by the Licensee, Affiliates, or Sublicensees as the seller: (a) discounts and rebates actually granted; (b) sales, value added, use and other taxes and government charges actually paid, excluding income taxes; (c) import and export duties actually paid; (d) freight, transport, packing and transit insurance charges actually paid or allowed; and (e) other amounts actually refunded, allowed or credited due to rejections or returns, but not exceeding the original invoiced amount.
“Non-Royalty Sublicensing Consideration" means the Gross Consideration received by the Licensee or its Affiliate from a Sublicensee in consideration of the grant of a sublicense under the Licensed Subject Matter (including, without limitation, license or option or distribution fees, fees to maintain license rights, and bonus/milestone payments), but excluding amounts received as running royalties, a profit share, or other revenue sharing based on Net Sales for which Licensor receives a running royalty under Section 3.2. For the avoidance of doubt, Non-Royalty Sublicensing Consideration shall not include bona fide: (a) running royalties received by Licensee or an Affiliate based on Net Sales that are royalty-bearing to Licensor under Section 3.2, (b) purchase price for Licensee’s stock or other securities not in excess of Fair Market Value, and (iii) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by Licensee.
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“Patent & Technology License Agreement” means the particular Patent & Technology License Agreement to which these Terms and Conditions are attached and incorporated into by reference.
“Patent Rights” means the Licensor’s rights in: (a) the patents and patent applications listed in Section 1 of the Patent & Technology License Agreement; (b) all non-provisional patent applications that claim priority to any of the provisional applications listed in Section 1 of the Patent & Technology License Agreement to the extent the claims of such non-provisional applications are entitled to claim priority to such provisional applications; (c) all divisionals, continuations and continuations-in-part (excluding new matter and claims containing new matter) of the non-provisional patent applications identified in (a) and (b), above to the extent that claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above; (d) all reissues, reexaminations, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and (e) any patents that issue with respect to any of the patent applications listed in (a), (b) , (c) or (d), above. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.
"Phase I Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
"Phase II Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
"Phase IIA Clinical Trial" means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.
"Phase IIB Clinical Trial" means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.
"Phase III Clinical Trial" means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent & Technology License Agreement.
“Quarterly Payment Deadline” means the day that is thirty (30) days after the last day of any particular Contract Quarter.
“Regulatory Approval” means the approval needed by the Regulatory Authority for a particular national jurisdiction to market, Sell and use a Licensed Product or Licensed Service in that national jurisdiction.
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“Regulatory Authority” means the governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product or Licensed Service in a particular national jurisdiction, including without limitation FDA, European Medicines Agency or Koseisho (i.e., the Japanese Ministry of Health and Welfare).
“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products or Licensed Services for which consideration is received by Licensee, its Affiliates or Sublicensees. A Sale of Licensed Products or Licensed Services will be deemed completed at the time Licensee or its Affiliate or its Sublicensee receives such consideration.
“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.
“Sublicense Fee” means the fee specified in Section 3.1(e) of the Patent & Technology License Agreement.
“Sublicensee” means any entity to which an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product or Licensed Services within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee or an Affiliate for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.
“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at The Ohio State University (“OSU”) and within the Field of Use which are not Covered By any claim or claims included within the Patent Rights, but which are either (1) directly related to the Tech ID listed in Section 1 of the Patent & Technology License Agreement or (2) necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.
“Territory” means the territory so indicated as the Territory in Section 1 of the Patent & Technology License Agreement.
2. | License Grant and Commercialization |
2.1 | Grant |
(a) | Licensor grants to Licensee a royalty-bearing exclusive license under Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(b) | Licensor grants to Licensee a royalty-bearing non- exclusive sublicense under Technology Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
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(c) | This grant is subject to (i) the payment by Licensee to Licensor of all consideration required under the Agreement, (ii) any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights), and (iii) rights retained by Licensor to: |
(1) | Publish the scientific findings from research related to the Patent Rights; and |
(2) | Use the Licensed Subject Matter for teaching, research, patient care, education, and other educationally-related purposes; and |
(3) | Grant rights to, and transfer material embodiments of, the Licensed Subject Matter to other academic institutions or non-profit research institutions for the purposes identified in clauses (1) and (2) above. |
(d) Licensor reserves all rights not expressly granted in the Agreement including, but not limited to, any other licenses, implied or otherwise, to any patents or other rights of Licensor, regardless of whether such patents or other rights are dominant or subordinate to any rights expressly granted in the Agreement, or are required to exploit any rights expressly granted in the Agreement.
2.2 | Affiliates |
Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” herein shall include such Affiliate regardless of whether a specific reference to an “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution.
2.3 | Sublicensing |
Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:
(a) | A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by the applicable terms and conditions of the Agreement and shall indicate that Licensor is a third party beneficiary of the Sublicense Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Licensee has no right to grant a Sublicensee the right to grant further sub-Sublicense Agreements. |
(b) | Licensee shall deliver to Licensor a true, complete, and correct copy of each Sublicense Agreement granted by Licensee, Affiliate or Sublicensee, and any modification or termination thereof, within thirty (30) days following the applicable execution, modification, or termination of such Sublicense Agreement. All Sublicense Agreements will be in English. |
(c) | Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2 whether or not paid to Licensee by a Sublicensee. Any act or omission of a Sublicensee that would be a breach of the Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Licensor or any other terms and conditions of the Sublicense Agreement that would constitute a breach of the Agreement if such acts were performed by Licensee. |
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2.4 | Diligent Commercialization |
Licensee by itself or through its Affiliates and Sublicensees will use diligent and commercially reasonable efforts to implement the Commercialization Plan and to Actively Commercialize Licensed Products and/or Licensed Services (as applicable) in the Field of Use within the Territory. Without limiting the foregoing, Licensee will
(a) | maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make License Products and/or Licensed Services commercially available to the public as soon as commercially practicable, and |
(b) | fulfill the milestone events specified in Section 2.4 of the Patent & Technology License Agreement by the deadlines indicated therein. |
If the obligations under this Section 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b).
3. | Compensation |
In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent & Technology License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
3.1 | Non-Royalty Payments due from Licensee |
(a) | Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) and Section 20.1 of the Patent & Technology License Agreement within fifteen (15) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount. |
(b) | Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved. |
(c) | Upfront Fee. Licensee will pay the amount of the Upfront Fee set forth in Section 3.1(c) of the Patent & Technology License Agreement on the Effective Date. |
(d) | License Maintenance Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(d) of the Patent & Technology License Agreement in accordance with the stated schedule. |
(e) | Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter. |
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(f) | Assignment Fee. Licensee will pay the assignment fee set forth in Section 3.1(f) of the Patent & Technology License Agreement within fifteen (15) days of the assignment of the Agreement. |
3.2 | Royalties |
Licensee will pay running royalties on Net Sales in each Contract Quarter on or before the Quarterly Payment Deadline for such Contract Quarter, as follows: (a) at the rate set forth in Section 3.2(a) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights; and (b) at the rate set forth in Section 3.2(b) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights. No royalty shall be payable under this Section 3.2 with respect to (i) Sales to an Affiliate or Sublicensee of a particular unit of Licensed Product that is used by such Affiliate or Sublicensee to perform a Licensed Service if Licensor is paid a royalty on the Sale of such Licensed Service, (ii) the Sale of Licensed Products between or among Licensee, its Affiliates, and Sublicensees for re-sale purposes, provided Licensor is paid a royalty with respect to the re-sale, or (iii) payments that constitute Non-Royalty Sublicensing Consideration.
3.3 | Minimum Royalties |
If royalties paid to Licensor do not reach the minimum royalty amounts stated in Section 3.3 of the Patent & Technology License Agreement for the specified periods, Licensee will pay Licensor on or before the Quarterly Payment Deadline for the last Contract Quarter in the stated period an additional amount equal to the difference between the stated minimum royalty amount and the actual royalties paid to Licensor.
3.4 | Non-cash Consideration |
If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.
4. | Reports and Plans |
The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent & Technology License Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.
4.1 | Quarterly Payment and Milestone Reports |
On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall include:
(a) | The name of the Licensee, the Patent & Technology License Agreement number, and the period covered by the report; |
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(b) | The name of any Affiliates and Sublicensees whose activities
are also covered by the report; |
(c) | Identification of each Licensed Product and Licensed Service
for which any royalty payments have become payable; |
(d) | Net Sales segregated on a product-by-product basis, and a
country-by-country basis, or an affirmative statement that no Sales were made. The report
shall also itemize the permitted deductions from the Gross Consideration used to arrive
at the resulting Net Sales, on a product-by-product and country-by-country basis; |
(e) | The applicable royalty rate; |
(f) | An affirmative statement of whether any milestones with deadlines
in that Contract Quarter under Section 2.4 and any milestones under Section 3.1(b) were
met or not, and the resulting Milestone Fee payable; |
(g) | Non-Royalty Sublicensing Consideration received by Licensee
segregated on a Sublicense-by-Sublicense basis, or an affirmative statement that none
was received; |
(h) | If any consideration was received in currencies other than
U.S. dollars, the report shall describe the currency exchange calculations; and |
(i) | Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report. |
4.2 | Annual Written Progress Report and Commercialization Plan |
Within forty five (45) days following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products and Licensed Services, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products and Licensed Services for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:
(a) | The name of the Licensee, the Patent & Technology License
Agreement number, the names of any Affiliates and Sublicensees, and the products and
services being developed and/or commercialized; |
(b) | The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b); and |
(c) | The research and development activities, including status and plans for obtaining any necessary Regulatory Approvals, performed during the past year, and the plans for research and development activities for the next year. |
4.3 | Government and Economic Development Reporting |
If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:
(a) | Number and geographic location of new full-time employees created during the past Contract Year; total number and geographic location of full-time employees of Licensee at the end of such Contract Year; |
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(b) | Dollar amount of new equity financing received by Licensee
during the past Contract Year, and current capitalization, including number and class
of outstanding securities; |
(c) | Location and square footage of facilities; and |
(d) | Other information required under Federal and state law. |
This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than two hundred (200) full-time employees, then no further economic development reports will be required from Licensee.
5. | Payment, Records, and Audits |
5.1 | Payments |
All amounts referred to in the Patent & Technology License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent & Technology License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent & Technology License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
5.2 | Sales Outside the U.S. |
If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business day of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.
5.3 | Late Payments |
Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).
5.4 | Records |
For a period of six (6) years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Sales, Net Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.
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5.5 | Auditing |
Licensee and its Affiliates will permit Licensor or its representatives, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.
6. | Patent Expenses and Prosecution |
6.1 | Patent Expenses |
Licensee shall pay for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent & Technology License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a)), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Patent & Technology License Agreement and future expenses, within thirty (30) days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counselor to Licensor) will be considered a payment default under Section 7.3(a).
6.2 | Direction of Prosecution |
Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.
6.3 | Ownership |
All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent & Technology License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.
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6.4 | Foreign Filings |
In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.
6.5 | Withdrawal from Paying Patent Costs |
If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.
6.6 | U.S. Patent and Trademark Office Entity Size Status |
Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent & Technology License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.
7. | Term and Termination |
7.1 | Term |
Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue until the last date of expiration or termination of the Patent Rights, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of 20 years.
7.2 | Termination by Licensee |
Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.
7.3 | Termination by Licensor |
Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field of Use, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:
(a) | Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or |
(b) | Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within ninety (90) days after delivery of written notice from Licensor; |
(c) | Licensor delivers notice to Licensee of three or more actual breaches of the Agreement in any 12-month period, even in the event that Licensee cures such breaches in the allowed period; or |
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(d) | Licensee or its Affiliate or Sublicensee initiates any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights, or assist a third party in pursuing such a proceeding or action. |
7.4 | Other Conditions of Termination |
The Agreement will terminate:
(a) | Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files a bankruptcy action or becomes bankrupt or insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee ceases its business operations, or (iv) Licensee makes an assignment for the benefit of creditors, or (v) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee or trustee, whether by voluntary act of Licensee or otherwise; or |
(b) At any time by mutual written agreement between Licensee and Licensor.
7.5 | Effect of Termination |
If the Agreement is terminated for any reason:
(a) | All rights and licenses of Sublicensees shall terminate upon termination of the Agreement; provided however, if the Sublicense Agreement is for all of the Field of Use for all of the Territory, and the Sublicensee is in good standing and agrees in writing to assume all of the obligations of Licensee and provides Licensor with written notice thereof within thirty (30) days after termination of the Agreement, then such Sublicense Agreement shall survive; and |
(b) | Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products and performing Licensed Services by the effective date of termination; and |
(c) | Licensee shall tender payment of all accrued royalties and other payments due to Licensor as of the effective date of termination; and |
(d) | Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and |
(e) | The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses), and 20.2 (Payment Schedule for Past Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement. |
8. | Confidentiality |
8.1 | Definition |
“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.
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8.2 | Protection and Marking |
Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.
8.3 | Confidentiality of Terms of Agreement |
Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, Ohio Public Records laws, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If the Agreement is not for all fields of use, then Licensor may disclose the Field of Use to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.
8.4 | Disclosure Required by Court Order or Law |
If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.
8.5 | Copies |
Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.
8.6 | Continuing Obligations |
Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of three (3) years thereafter.
8.6 | Exclusions |
Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:
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(a) | Was in the public domain at the time of disclosure; or |
(b) | Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or |
(c) | Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or |
(d) | Was already known by the recipient Party at the time of disclosure; or |
(e) | Was independently developed by the recipient Party without use of the disclosing Party’s Confidential Information. |
8.8 | Copyright Notice |
The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.
9. | Infringement and Litigation |
9.1 | Notification |
If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.
9.2 | Licensee’s Enforcement Rights |
Licensee shall enforce the Patent Rights against any infringement by a third party in the Field in the Territory. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by Licensor in providing cooperation or joining as a party as provided in Section 9.4. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.
9.3 | Licensor’s Enforcement Rights |
If Licensee does not file suit within six (6) months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement. If Licensor pursues such infringement action, Licensor may, as part of the resolution of such efforts, grant non-exclusive license rights to the alleged infringer notwithstanding Licensee’s exclusive license rights.
9.4 | Cooperation between Licensor and Licensee |
In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.
If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s and the Ohio Attorney General’s prior written permission, which permission shall not be unreasonably withheld, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Ohio Attorney General regarding retention of outside counsel for state entities.
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9.5 | Contest of Validity |
(a) In the event Licensee or its Sublicensee(s) (or a third party on its behalf) files any action contesting the validity or enforceability of any Patent Rights and the provision in Section 7.3(d) is unenforceable, the Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall pay a royalty rate of one and a half (1.5) times the royalty rate specified in Section 3.2 for all Net Sales. Moreover, should the outcome of such contest determine that any claim of the Patent Rights challenged is both valid and would be infringed by a Licensed Product, Licensed Process, or Licensed Service sold by Licensee (or its Sublicensee(s) if such Sublicensee filed the action), if not for the license granted by this Agreement, Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall thereafter, and for the remaining term of this Agreement, pay a royalty rate of two (2) times the royalty rate specified in Section 3.2 for all Net Sales.
(b) In the event that Licensee or its Sublicensee(s) contests the validity or enforceability of any Patent Rights during the term of this Agreement, Licensee agrees (and shall require its Sublicensee(s) to agree) to pay to Licensor all royalties due under the Agreement during the period of challenge. For the sake of clarity, such amounts shall not be paid into any escrow or other account, but directly to Licensor, and shall not be refunded.
(c) In the event that a validity or non-infringement challenge of any Patent Rights brought by Licensee is successful, Licensee shall have no right to recoup any royalties paid before or during the period challenge.
10. | Export Compliance |
10.1 Licensee shall observe all applicable United States and foreign laws and regulations with respect to the research, development, manufacture, marketing and transfer of Licensed Products and related technical data, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulation (collectively, the “Export Laws”). To this end, Licensee shall take all actions necessary to comply with the Export Laws. Licensee hereby represents and covenants that Licensee:
(i) | Is neither a national of nor controlled by a national of any country to which the United States prohibits the export or re-export of goods, services, or technology; |
(ii) | Is not a person specifically designated as ineligible to export from the United States or deal in U.S.-origin goods, services, or technologies; |
(iii) | Shall not export or re-export, directly or indirectly, any goods, services, or technology, to any country or person (including juridical persons) to which the United States prohibits the export of goods, technology or services; and |
(iv) | In the event that a United States government license or authorization is required for an export or re-export of goods, services, or technology (including technical information acquired from Licensor under this Agreement and/or any products created by using such technical information or any part thereof), the Licensee shall obtain any necessary United States government license or other authorization prior to undertaking the export or re-export. |
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Licensee shall include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable export laws and regulations and other applicable laws and regulations.
11. | Representations and Disclaimers |
11.1 | Licensor Representations |
Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or agent of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent & Technology License Agreement), (ii) Licensor has the right to grant the license and sublicense hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.
11.2 | Government Rights |
Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement (NIH reference number L-003-2009) and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.
11.3 | Licensor Disclaimers |
EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, NONINFRINGEMENT, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY CLAIM OR PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD OF USE. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN.
11.4 | Licensee Representation |
By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (c) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent & Technology License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent & Technology License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.
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12. | Limit of Liability |
IN NO EVENT SHALL LICENSOR, OSU, OR THEIR INVENTORS, OFFICERS, EMPLOYEES, STUDENTS, TRUSTEES, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
13. | Indemnification |
13.1 | Indemnification Obligation |
Licensee agrees to hold harmless, defend and indemnify Licensor, OSU, and their officers, employees, students, inventors, trustees, agents, and consultants (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Licensee shall have no responsibility or obligation under the section for any Liabilities to the extent caused by the gross negligence or willful misconduct by Licensor.
14. | Insurance |
14.1 | Insurance Requirements |
Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, its officers, and employees named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.
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14.2 | Evidence of Insurance and Notice of Changes |
Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least sixty (60) days prior to Licensee cancelling, not renewing, or materially changing such insurance.
15. | Assignment |
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld. For any permitted assignment to be effective, (a) Licensee must be in good standing under this Agreement, (b) the Licensee must pay Licensor the assignment fee pursuant to Section 3.1(f), and (c) the assignee must assume in writing (a copy of which shall be promptly provided to Licensor) all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if assignee were an original Party to the Agreement.
16. | Governmental Markings |
16.1 | Patent Markings |
Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.
16.2 | Governmental Approvals and Marketing of Licensed Products and or Licensed Services |
Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.
16.3 | Foreign Registration and Laws |
Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products and Licensed Services to the extent there is no conflict with United States law, in which case United States law will control.
17. | Use of Name |
Licensee will not use the name, trademarks or other marks of Licensor or OSU without the advance written consent of Licensor or OSU. Licensor and OSU may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent.
18. | Notices |
Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Patent & Technology License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.
Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent & Technology License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.
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19. | General Provisions |
19.1 | Binding Effect |
The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.
19.2 | Construction of Agreement |
Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.
19.3 | Counterparts and Signatures |
The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.
19.4 | Compliance with Laws |
Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.
19.5 | Governing Law |
The Agreement will be construed and enforced in accordance with laws of the State of Ohio, without regard to choice of law and conflicts of law principles.
19.6 | Modification |
Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.
19.7 | Severability |
If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.
19.8 | Third Party Beneficiaries |
Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties, OSU and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent & Technology License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).
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19.9 | Waiver |
Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.
19.10 | Sovereign Immunity |
Nothing in the Agreement shall be deemed or treated as any waiver of OSU’s sovereign immunity.
19.11 | Entire Agreement |
The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.
19.12 | Claims Against Licensor for Breach of Agreement |
Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be brought in a court of competent jurisdiction in Ohio and this is Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor.
19.13 | Grant of Security Interest |
Licensee hereby grants to Licensor a security interest in and to Licensee's rights under the Patent & Technology License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.
— END OF EXHIBIT A —
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EXHIBIT B
COMMERCIALIZATION PLAN
EXHIBIT C
PATENT APPLICATIONS
Tech ID | App. Title | Terr. | Patent or App. No. |
Filing Date |
2006-138 | MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | Au | 2007205163 | 07/03/08 |
2006-138-1 | Ca |
2633754 (Allowed claims) |
01/03/07 | |
2006-138-58 | Ca | wAITING ON APPLICATION NUMBER | 03/29/13 | |
2006-138 | CN | 2007-80005821.2 | 07/03/08 | |
2006-138-2 | Ep | 12154246.8 | 03/05/12 | |
2006-138-4 | Ep | 12154300.3 | 01/03/07 | |
2006-138-5 | ep | 12154301.1 | 01/03/07 | |
2006-138-6 | ep | 12154304.5 | 01/03/07 | |
2006-138-7 | ep | 12154307.8 | 01/03/07 | |
2006-138-8 | ep | 12154315.1 | 01/03/07 | |
2006-138-9 | ep | 12154321.9 | 01/03/07 |
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2006-138-11 | ep | 12154326.8 | 03/05/12 | |
2006-138-13 | ep | 12154329.2 | 03/05/12 | |
2006-138-14 | ep | 12154332.6 | 03/05/12 | |
2006-138-15 | ep | 12154334.2 | 03/05/12 | |
2006-138-18 | ep | 12154341.7 | 03/05/12 | |
2006-138-19 | ep | 12154342.5 | 01/03/07 | |
2006-138-20 | EP | 12154343.3 | 01/03/07 | |
2006-138-23 | ep | 12154346.6 | 03/01/12 | |
2006-138-27 | ep | 12154350.8 | 03/01/12 | |
2006-138 | hk | 09108431.1 | 01/03/07 | |
2006-138 | JP | 2008-549555 | 01/03/07 | |
2006-138 | jp | 2012-183280 | 09/08/12 | |
2006-138-1 | us | 8,148,069 | 07/03/08 | |
2006-138-2 | US | 13/405,517 | 02/27/12 | |
2006-138-4 | us | 13/405,543 | 02/27/12 | |
2006-138-8 | US | 13/406,615 | 02/28/12 | |
2006-138-14 | us | 13/407,890 | 02/29/12 |
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2006-009 | Compositions and Methods for the Diagnosis and Therapy of BCL-2 Associated Cancers | au |
2006291165 ALLOWED |
09/11/06 |
2006-009 | ca | 2,621,441 | 09/11/06 | |
2006-009 | cn |
ZL200680039776.8 ISSUED |
09/11/06 | |
2006-009 | cn | 2012-10380806.9 | 10/10/12 | |
2006-009 | ep | 06814375.9 | 09/11/06 | |
2006-009 | jp | 2008-531200 | 09/11/06 | |
2006-009 | jp | 2013-081761 | 09/11/06 | |
2006-009 | us |
11/991,773 allowed |
05/14/08 | |
2007-019 Joint with NIh |
microRNA Based Methods and Compositions for the Diagnosis and Treatment of Colon Related Diseases | AU | 2007272947 | 07/12/07 |
2007-019 Joint with NIh |
CA | 2,657,030 | 07/12/07 | |
2007-019 Joint with NIh |
CN | 2007-8033066.9 | 07/12/07 | |
2007-019 Joint with NIh |
EP | 11170608.1 | 07/12/07 | |
2007-019-2 Joint with NIh |
EP | 11196190.0 | 07/12/07 |
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2007-019-3 Joint with NIh |
EP | 11196250.2 | 07/12/07 | |
2007-019-4 Joint with NIh |
EP | 11196253.6 | 07/12/07 | |
2007-019-5 Joint with NIh |
EP |
11196254.4 allowed |
07/12/07 | |
2007-019-6 Joint with NIh |
EP |
11196256.9 allowed |
07/12/07 | |
2007-019-7 Joint with NIh |
EP |
11196261.9 allowed |
07/12/07 | |
2007-019-8 Joint with NIh |
EP |
11196262.7 allowed |
07/12/07 | |
2007-019-9 Joint with NIh |
EP | 11170608.1 | 07/12/07 | |
2007-019-10 Joint with NIh |
EP | 11196265.0 | 07/12/07 | |
2007-019 Joint with NIh |
JP |
5230619 issued |
07/12/07 | |
2007-019 Joint with NIh |
JP | 2013-056596 | 04/09/13 |
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 34 of 37 |
2007-019-1 Joint with NIh |
US |
8,084,199 ISSUED |
01/12/09 | |
2007-019-2 Joint with NIh |
US |
8,338,102 ISSUED |
11/14/11 | |
2007-019-3 Joint with NIh |
US |
8,349,568 ISSUED |
11/14/11 | |
2007-019-4 Joint with NIh |
US |
13/295,440 ALLOWED |
11/14/11 | |
2007-019-5 Joint with NIh |
US |
8,338,103 ISSUED |
11/14/11 | |
2007-019-6 Joint with NIh |
US |
8,338,104 ISSUED |
11/15/11 | |
2007-019-7 Joint with NIh |
US |
8,338,105 ISSUED |
11/15/11 | |
2007-019-8 Joint with NIh |
US |
8,338,106 ISSUED |
11/15/11 | |
2007-019-9 Joint with NIh |
US |
8,343,725 ISSUED |
11/15/11 | |
2007-019-10 Joint with NIh |
US | 13/296,545 | 11/15/11 | |
2007-028 | Ultraconserved Regions Encoding ncRNAs | AU | 2008283997 | 02/11/10 |
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 35 of 37 |
2007-028 | CA | 2,695,514 | 02/03/10 | |
2007-028 | CN | 2008-80108689.2 | 08/04/08 | |
2007-028 | EP | 08782609.5 | 02/04/10 | |
2007-028 | JP | 2010-519269 | 01/28/10 | |
2007-028 | US |
12/672,014 ALLOWED |
02/03/10 | |
2007-030 |
Methods for Identifying Fragile Histidine Triad (Fhit) Interaction and Uses Thereof (this application has broad claims that could be amended to include lung and colon) |
AU | 2008316577 | 04/27/10 |
2007-030 | CA | 2,703,707 | 04/23/10 | |
2007-030 | CN | 200880119206.9 | 10/27/08 | |
2007-030 | EP | 08841700.1 | 04/26/10 | |
2007-030 | JP | 2010-531311 | 04/26/10 | |
2007-030 | US | 12/739,541 | 02/25/11 | |
2010-126 | Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | au | 2011232669 | 09/24/12 |
2010-126 | CA | 2,794,142 | 09/24/12 |
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 36 of 37 |
2010-126 | CN | 2011-80022637.5 | 09/24/12 | |
2010-126 | EP | 11760035.3 | 09/24/12 | |
2010-126 | JP | 2013-502642 | 09/26/12 | |
2010-126 | US | 13/637,490 | 11/15/12 | |
2011-085 | Materials and Methods Related to microRNA-21 Mismatch Repair and Colorectal Cancer | PCT | PCT/US2011/060349 | 11/11/11 |
2011-085 | US | 13/884,668 | 05/10/13 | |
2011-137 | Mutator activity induced by microRNA-155 links inflammation and cancer | PCT | PCT/US2012/028016 | 03/07/12 |
2011-137 | US | 13/414,084 | 03/07/12 | |
2012-066 | Methods and Compositions Related to miR-21 & miR-29a and Cancer Metastasis | PCT | PCT/US2012/069484 | 12/13/12 |
2012-104 |
Mechanism of NSAID Chemoprevention in Colorectal Cancer (Croce is not the lead on this) |
pct | pct/us2012/067651 | 12/3/12 |
Provisional | 61/732,906 | 12/3/12 |
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 37 of 37 |
INDEMNITY AGREEMENT
THIS INDEMNITY AGREEMENT (this "Agreement") is entered into as of December 17, 2015 by and between Reza Noorkayhani, an individual (the "Indemnitor"), and American Boarding Company, a Delaware corporation (“AMIB”), and Microlin Bio, Inc., a Delaware corporation (“Microlin”) (AMIB and Microlin are, collectively, the "Indemnitees").
RECITALS
WHEREAS, Microlin, AMIB, and Microlin Merger Sub, Inc. have entered into that certain Agreement and Plan of Merger and Reorganization (the "Merger Agreement"), dated as of the date hereof, and
WHEREAS, the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby are required in connection with the Merger Agreement,
NOW, THEREFORE, in consideration of the premises and the covenants, promises and agreements herein set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending legally to be bound, agree as follows:
1. Liabilities of AMIB. Indemnitor represents and warrants to Indemnitees that Schedule A hereto contains a complete and accurate listing of all Liabilities of AMIB as of the Effective Time as defined in the Merger Agreement. Other than as set forth on Schedule A hereto, as of the Effective Time, AMIB is not liable for any other liability, debt, obligation, deficiency, tax, penalty, fine, claim, cause of action or other loss, cost or expense of any kind or nature whatsoever, whether asserted or unasserted, absolute or contingent, accrued or unaccrued, liquidated or unliquidated, and whether due or to become due.
2. Indemnification. In connection with the Merger Agreement, as of the Effective Time as defined therein, Indemnitor shall assume and pay, honor and discharge when due, and shall indemnify Indemnitors and their affiliates against, all debts, adverse claims, liabilities, judgments and obligations, including tax obligations, of AMIB which are in excess of a total amount of $90,000.00, whether accrued, contingent or otherwise and whether known or unknown, including those arising under any law (including common law) or any rule or regulation of any governmental authority or imposed by any court or any arbitrator in a binding arbitration resulting from, arising out of or relating to the assets, activities, operations, actions or omissions of AMIB, or products manufactured or sold thereby or services provided thereby, or under contracts, agreements (whether written or oral), leases, commitments or undertakings thereof (the “Liabilities”).
3. Assistance With Modification of Terms. To the extent that any of the Liabilities of AMIB, whether set forth on Schedule A or otherwise, are, by their terms, convertible into any capital stock of AMIB, Indemnitor shall assist with and facilitate the written modification of the terms of such Liabilities to remove any such right to conversion. In addition to the indemnification provided under Section 2, above, Indemnitor shall defend and indemnify the Indemnitees against any claim by any person or entity that their Liability is or was convertible to capital stock of AMIB.
4. Release. Indemnitor, on behalf of Indemnitor and Indemnitor’s heirs, personal representatives, successors and assigns (collectively, the "Releasors"), hereby forever fully and irrevocably releases and discharges the Indemnitees and each of thier affiliates, and each of their respective predecessors, successors, direct or indirect subsidiaries, directors, officers, employees, agents and other representatives (collectively, the "Released Parties"), from any and all actions, suits, claims, demands, debts, agreements, obligations, promises, judgments and liabilities of any kind whatsoever in law or equity and causes of action of every kind and nature or otherwise (including, claims for damages, costs, expenses, and attorneys’, brokers’ and accountants’ fees and expenses) arising out of or related to events, facts, conditions or circumstances existing or arising prior to or after the date hereof or the Effective Date, which the Releasors can, shall or may have against the Released Parties, whether known or unknown, suspected or unsuspected, anticipated or unanticipated (collectively, the "Released Claims"). The Releasors irrevocably agree to refrain from instituting any suit, action or proceeding of any kind, in any court or before any tribunal, against any Released Party based upon, arising out of, or relating to any Released Claim, participating, assisting or cooperating in any such suit, action or proceeding or encouraging or soliciting any third party to institute any such suit, action or proceeding. Notwithstanding the preceding sentences of this Section 4, "Released Claims" does not include, and the provisions of this Section 4 shall not release, the Indemnitee’s commitment to pay certain Liabilities of AMIB, up to a total maximum amount of $90,000.00, as set forth in Section 3.5 of the Merger Agreement.
5. Miscellaneous.
5.1 Assignment; Beneficiaries. This Agreement shall be binding upon and inure to the benefit of the successors and assigns of the parties hereto, and none of the rights or obligations herein may be assigned or delegated without the prior written consent of the other party hereto. Except as expressly set forth herein, the covenants and agreements set forth in this Agreement are for the sole benefit of the parties hereto and their successors and permitted assigns and shall not be construed as conferring any rights on any other Persons.
5.2 Entire Agreement and Amendment. This Agreement (including Schedule A hereto) constitutes the entire agreement of the parties hereto and supersedes any and all prior negotiations, correspondence, understandings and agreements between the parties hereto with respect to the subject matter hereof. This Agreement may only be amended by written instrument signed by both parties hereto.
5.3 Governing Law; Jurisdiction and Venue. This Agreement, and any matter or dispute arising hereunder or in connection with this Agreement, will be governed by and construed in accordance with the laws of the state of Delaware without giving effect to conflict of laws principles thereof. Each party hereto irrevocably consents to the exclusive jurisdiction of the state and federal courts located in New York City, New York, as well as to the jurisdiction of all courts to which an appeal may be taken from such courts, for the purpose of any suit, action or other proceeding arising out of, or in connection with, this agreement or any of the transactions contemplated hereby. Each party hereby expressly waives any and all rights to bring any suit, action or other proceeding in or before any court or tribunal other than those located in New York City, New York.
2 |
5.4 Severability. If any provision of this Agreement is held to be unenforceable for any reason, it shall be adjusted rather than voided, if possible, in order to achieve the intent of the parties to the extent possible. In any event, all other provisions of this Agreement shall be deemed valid and enforceable to the fullest extent practicable.
5.5 Counterparts. This Agreement may be executed and delivered (including by facsimile transmission) in counterparts, both of which will be considered one and the same agreement.
[SIGNATURE PAGES TO FOLLOW]
3 |
IN WITNESS WHEREOF, the parties hereto have caused this Indemnity Agreement to be executed as of the date first written above.
INDEMNITOR:
/s/ Reza Noorkayhani
Reza Noorkayhani
INDEMNITEES:
AMERICAN BOARDING COMPANY
By: /s/ Reza Noorkayhani
Reza Noorkayhani
Chief Executive Officer
MICROLIN BIO, INC.
By: /s/ Joseph Hernandez
Joseph Hernandez
Chief Executive Officer
4 |
Schedule A
Name of Creditor | Document | Date | Principal Amount |
Narguesse Nourkeyhani | Promissory Note | 5/22/14 | $12,000 |
Reza Noorkayhani | Promissory Note | 9/28/14 | $5,500 |
Reza Noorkayhani | Promissory Note | 11/24/14 | $3,975 |
Jenny Su | Promissory Note | 12/10/14 | $10,000 |
Reza Noorkayhani | Promissory Note | 6/30/15 | $8,750 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $17,619 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $30,000 |
Accounts Payable | Various | Various | $5,231 |
$93,075.00 |
5 |
AMENDMENT TO PROMISSORY NOTES
WHEREAS, American Boarding Company, a Delaware corporation, (“Maker”) has issued certain Promissory Notes to Reza Noorkayhani in the principal amounts, and on the dates, set forth below (collectively, the “Notes”):
Name of Creditor | Document | Date | Principal Amount |
Reza Noorkayhani | Promissory Note | 9/28/14 | $5,500 |
Reza Noorkayhani | Promissory Note | 11/24/14 | $3,975 |
Reza Noorkayhani | Promissory Note | 6/30/15 | $8,750 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $17,619 |
Reza Noorkayhani | Promissory Note | 12/1/15 | $30,000 |
$65,844.00 |
NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:
/s/ Reza Noorkayhani
Reza Noorkayhani
American Board Company
By: /s/ Reza Noorkayhani
Reza Noorkayhani, President and CEO
AMENDMENT TO PROMISSORY NOTE
WHEREAS, American Boarding Company, a Delaware corporation, (“Maker”) has issued that certain Promissory Note to Narguesse Nourkeyhani in the principal amount of $12,000 on May 22, 2014 (the “Note”),
NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:
/s/ Narguesse Nourkeyhani
Narguesse Nourkeyhani
American Board Company
By: /s/ Reza Noorkayhani
Reza Noorkayhani, President and CEO
AMENDMENT TO PROMISSORY NOTE
WHEREAS, American Boarding Company, a Delaware corporation, (“Maker”) has issued that certain Promissory Note to Jenny Su in the principal amount of $10,000 on December 10, 2014 (the “Note”),
NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:
/s/ Jenny Su
Jenny Su
American Board Company
By: /s/ Reza Noorkayhani
Reza Noorkayhani, President and CEO
***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
PATENT & Technology LICENSE AGREEMENT
AGT. No. A2013-2080
This Patent & Technology License Agreement is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).
No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.
Background
Licensor owns, controls and/or has the right to sublicense the Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:
The Terms and Conditions of Patent & Technology License attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). The Commercialization Plan attached hereto as Exhibit B is incorporated herein by reference in its entirety (the “Commercialization Plan”). In the event of a conflict between provisions of this Patent & Technology License Agreement and the Terms and Conditions, the provisions in this Patent & Technology License Agreement shall govern. Unless defined in this Patent & Technology License Agreement, capitalized terms used in this Patent & Technology License Agreement shall have the meanings given to them in the Terms and Conditions.
The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.
1. Definitions |
Effective Date | September 6 , 2013 | |
Licensor | Ohio State Innovation Foundation, with an address at 1524 North High Street, Columbus, OH 43201. | |
Licensee |
MicroLin Bio, Inc., a corporation, with its principle place of business at 302A West 12th Suite 114, New York, NY 10014 | |
Contract Year and Contract Quarters |
x Cntract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31
| |
Territory | Worldwide |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 1 of 39 |
Exhibit 10.4 |
Field of Use
|
Exclusive Field of use for the diagnosis, prognosis and therapy/treatment of lung cancer.
|
Patent Rights/Technology Rights [See Exhibit C for individual patent application and patent information] |
App. No./ Date of Filing |
Title | Inventor(s) | Jointly Owned? (Y/N; if Y, with whom?) |
Countries | Prosecution Counsel | |
PCT/US2007/000159 03/03/2007 [2006-138]
|
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | C. Croce S. Volinia G. Calin |
x No | US CA AU CN JP HK EU |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2007/000103 01/03/2007 [2006-008] |
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis, and Treatment of Lung Cancer | C. Croce G. Calin C. Harris |
x Yes w/ the National Institutes of Health
[See section 20.1]
|
US CA JP AU CN EU |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2010/057758 11/23/2010 [2010-079] |
Material and Methods Useful for Affecting Tumor Cell Growth, Migration, and Invasion | C. Croce G. Nuovo F. Pichiorri G. Romano P. Secchiero S. Suh C. Taccioli M. Acunzo H. Alder G. Condorelli G. Di Leva P. Gasparini M. Garofalo A. Gonelli A. Ngankeu |
x NO
|
US CA JP AU CN EU |
MacMillan, Sobanski, and Todd LLC |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 2 of 39 |
Exhibit 10.4 |
PCT/US2008/072081 08/04/2008 [2007-028] |
Ultraconserved Regions Encoding ncRNAs | C. Croce |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2011/029348 03/22/2011 [2010-126] |
Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | C. Croce N. Valeri |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/071532 07/30/2008 [2007-159] |
Methods for Reverting Methylation by Targeting DNMT3A and DNMT3B | C. Croce | x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/081294 10/27/2008 [2007-030] |
Methods of Identifying Fragile Histidine Triad (FHIT) Interaction and Uses Thereof | C. Croce | x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2012/069484 12/13/2012 [2012-066] |
Methods and Compositions Related to miR-21 and miR-29a, Exosome Inhibition and Cancer Mestastsis | C. Croce M. Fabbri |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2012/068736 12/10/2012 [2012-111] |
miRNAs Useful to Reduce Lung Cancer Turmorigenesis and Chemotherpay Resistance and Related Compositions and Methods | C. Croce M. Garofalo |
x No | US National Phase Approaching
|
MacMillan, Sobanski, and Todd LLC |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 3 of 39 |
Exhibit 10.4 |
PCT/US2012/028016 03/07/2012 [2011-137] |
Mutator Activity Induced by microRNA-155 (miR-155) Links Inflammation and Cancer | C. Croce S. Costinean H. Alder J. Michaille E. Tili S. Volinia D. Wernicke-Jameson |
x No | US National Phase Approaching |
MacMillan, Sobanski, and Todd LLC | ||
61/704,542 09/23/2012 [2013-072] |
Use of miR-494 to Modulate TRAIL-induced Apoptosis through BIM Down-regulation | C. Croce G. Romano |
x No | US CA |
MacMillan, Sobanski, and Todd LLC | ||
USPTO Entity Status as of Effective Date
|
Check one box: x Small
| ||||||
2.4. Diligence Milestones |
|
Milestones and deadlines | Milestone Events | Deadlines |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of lung cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for lung cancer therapeutics. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. |
*** |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 4 of 39 |
Exhibit 10.4 |
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of lung cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancers. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
9. First Sale in any country outside of the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone.
|
*** |
3. Compensation |
3.1(a) | Patent expenses due upon Effective Date
(See Section 20.1)
|
Amount | based on invoices received as of: | |
Tech ID 2006-138 | $355,066.061 | August 29, 2013 | ||
Tech ID 2006-008 | $238,745.45 | August 29, 2013 | ||
Tech ID 2007-159 | $116,113.80 | August 29, 2013 | ||
Tech ID 2007-028 | Costs already accounted for in Agreement# A2013-2069 having an Effective Date of September 6, 2013 between the parties. | August 296, 2013, 2013 | ||
Tech ID 2010-126 | Costs already accounted for in Agreement# A2013-2069 having an Effective Date of September 6, 2013 between the parties. | August 29, 2013, 2013 | ||
Tech ID 2010-079 | $66,105.78 | August 29, 2013 | ||
Tech ID 2007-030 | Costs already accounted for in Agreement# A2014-0165 having an Effective Date of September 6,2013between the parties. | August 29, 2013 | ||
Tech ID 2012-066 | Costs already accounted for in Agreement# A2014-0165 having an Effective Date of September 6, 2013 between the parties. | August 29, 2013 | ||
Tech ID 2011-137 | Costs already accounted for in Agreement# A2014-0165 having an Effective Date of September 6, 2013between the parties. | August 29, 2013 |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 5 of 39 |
Exhibit 10.4 |
Tech ID 2006-009 | Costs already accounted for in Agreement# A2014-064 having an Effective Date of September 6, 2013 between the parties. | August 29, 2013 | ||
Tech ID 2012-111 | $12,109.00 | August 29, 2013 | ||
Tech ID 2013-072 | $3,835.00 | August 29, 2013 | ||
Total | $791,975.09 |
3.1(b) | Milestone fees
|
Milestone Events | Milestone Fees |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of lung cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for lung cancer therapeutics. | (Associated fees referenced in Sections 3.1(e) and/or 20.4) | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of lung cancer. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancers. | *** | ||
9. First Sale in any country outside of the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer. | *** |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 6 of 39 |
Exhibit 10.4 |
3.1(c) | Upfront Fee | $5,000 due on Effective Date $95,000 due on or before May 31, 2014 | |
3.1(d) | License Maintenance Fees
|
$10,000 due on May 31, 2015 $25,000 due on May 31, 2016 $50,000 due on May 31, 2017 | |
3.1(e) | Sublicense Fees | *** of Non-Royalty Sublicensing Consideration for diagnostics and prognostics.
*** of Non-Royalty Sublicensing Consideration for therapeutics.
| |
3.1(f) | Assignment fee | For the Contract Year ending ***, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement.
For any Contract Year thereafter, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement. Assignments shall include assignments or transfers of the Agreement as part of a corporate reorganization, consolidation, merger or sale of substantially all of the assets or any other change of control | |
3.2 | Running royalty rate (applies to Sales by Licensee, Affiliates and Sublicensees) | (a) Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights | *** |
(b) Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights
|
*** | ||
3.3 | Minimum royalty | *** for Contract Year ending *** *** for Contract Year ending *** *** per each subsequent Contract Year thereafter. |
{00182041-1}Licensee: MicroLin Bio, Inc. Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 7 of 39 |
Exhibit 10.4 |
18. Contact Information |
Licensee Contacts | Licensor Contacts | |
Contact for Notice: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Accounting contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Patent prosecution contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com |
Contact for Notice: Attn: President
1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: techlicensing@osu.edu
Payment and reporting contact: Checks payable to “Ohio State Innovation Foundation” Attn: Accounting/Compliance 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 Email: OSIFCompliance@osu.edu
Patent prosecution contact: Attn: Catherine Martineau MacMillan, Sobanski , & Todd, LLC ; Patent, Trademark, Copyright and Intellectual Property Law One Maritime Plaza, Fifth Floor 720 Water Street Toledo, Ohio 43604-1853 419-255-5900 (voice) 419-255-9639 (fax) E-mail: martineau@mstfirm.com Internet: http//www.mstfirm.com
|
For Licensor Administrative Purposes Only |
Changes to Standard Form Terms and Conditions | There have not been any revisions to Licensor’s standard form Terms and Conditions , except for revisions to the following sections: 7
|
20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent & Technology License Agreement.
Section 20.1 Inter-Institutional Agreement. Pursuant to an Inter-Institutional Agreement (NIH reference number L-003-2009) having an effective date of October 23, 2008 between Licensor and National Institutes of Health (NIH), NIH has granted Licensor the ability to grant license rights in the patent indicated in Section 1 as jointly owned by Licensor and NIH.
Section 20.2 Payment Schedule for Past Patent Expenses. Licensee will repay the past patent expenses referenced in Section 3.1(a) above upon the earlier of: (1) the payment due dates on the following schedule (shown below); or (2) Licensee has cumulative external funding (any combination of government grant, government contract, or private equity) of at least $10,000,000. In the event that $10,000,000 of external funding is obtained by Licensee, all unpaid amounts of past patent expenses shall become immediately due and payable to Licensor. The payments below include interest at the rate of 3.50% per annum. Should this Agreement be terminated, all patent expenses are immediately due and payable by Licensee to Licensor.
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Exhibit 10.4 |
Pmt No. | Payment Date | Beginning Balance | Scheduled Payment | Total Payment | Principal | Interest | Ending Balance | |||||||||||||||||||
1 | 10/31/2013 | $ | 791,975.09 | $ | 25,000.00 | $ | 25,000.00 | $ | 11,140.44 | $ | 13,859.56 | $ | 780,534.65 | |||||||||||||
2 | 12/31/2013 | $ | 780,534.65 | $ | 25,000.00 | $ | 25,000.00 | $ | 11,335.39 | $ | 13,664.61 | $ | 769,199.21 | |||||||||||||
3 | 7/31/2014 | $ | 769,199.21 | $ | 25,000.00 | $ | 25,000.00 | $ | 11,539.01 | $ | 13,460.99 | $ | 757,660.20 | |||||||||||||
4 | 12/31/2014 | $ | 757,660,20 | $ | 25,000.00 | $ | 25,000.00 | $ | 11,740.94 | $ | 13,259.05 | $ | 745,919.26 | |||||||||||||
5 | 6/30/2015 | $ | 745,919.26 | 95,084.92 | 95,084.92 | $ | 91,821.52 | $ | 3,263.40 | $ | 654,097.74 | |||||||||||||||
6 | 9/30/2015 | $ | 654,097.74 | $ | 95,084.92 | $ | 95,084.92 | $ | 92,223.24 | $ | 2,861.68 | $ | 561,874.50 | |||||||||||||
7 | 12/31/2015 | $ | 561,874.50 | $ | 95,084.92 | $ | 95,084.92 | $ | 92,626.72 | $ | 2,458.20 | $ | 469,247.78 | |||||||||||||
8 | 3/31/2016 | $ | 469,247.78 | $ | 95,084.92 | $ | 95,084.92 | $ | 93,031.96 | $ | 2,052.96 | $ | 376,215.83 | |||||||||||||
9 | 6/30/2016 | $ | 376,215.83 | $ | 95,084.92 | $ | 95,084.92 | $ | 93,438.97 | $ | 1,645.94 | $ | 282,776.85 | |||||||||||||
10 | 9/30/2016 | $ | 282,776.85 | $ | 95,084.92 | $ | 95,084.92 | $ | 93,847.77 | $ | 1,237.15 | $ | 188,929.08 | |||||||||||||
11 | 12/31/2016 | $ | 188,929.08 | $ | 95,084.92 | $ | 95,084.92 | $ | 94,258.35 | $ | 826.56 | $ | 94,670.73 | |||||||||||||
12 | 3/31/2017 | $ | 94,670.73 | $ | 95,084.92 | $ | 94,670.73 | $ | 94,256.55 | $ | 414.18 | $ | 0.00 |
Each of the Licensed Patents listed in a separate row in Section 1 shall constitute a single patent family. The past patent expenses set forth in Section 3.1(a) are separated out and each entry corresponds to a particular single patent family identified in Section 1. Certain of the past patent expenses for a single patent family may also be covered by one or more separate agreements between Licensor and Licensee (a “Multi-Covered Patent Expense”). Licensor does not intend for Licensee to pay double for Multi-Covered Patent Expenses.
Section 20.3 Milestone Extension Option. Licensee shall have the one-time option to extend the deadlines for those Milestone Events specified in said Section 2.4 by three (3) months by paying a milestone extension fee of *** for each such extension. This option may only be exercised at a time when Licensee is in compliance with all of its obligations under the Agreement, including having met all milestones with deadlines prior to the date such notice is given (without giving effect to the extension resulting from the exercise of such option). In order to exercise this option, Licensee must provide Licensor written notice of its exercise of this option accompanied by payment of the milestone extension fee. Such notice must contain an affirmation from the Licensee that it is in compliance with all of its obligations under the Agreement, that it has and is currently using commercially reasonable efforts to implement the Commercialization Plan and Actively Commercialize Licensed Products or Licensed Services and that it reasonably expects to meet the milestone deadlines as extended by the exercise of such option.
Section 20.4 Therapeutic Research and Development. Licensee shall launch a research and development program for the licensed therapeutic rights pursuant to the therapeutic milestone events and fees outlined below, unless Licensee executes a Sublicense Agreement as set forth in Milestone 5 in section 2.4 above. Should Licensee not execute a Sublicense Agreement as set forth in Milestone 5, Licensee shall pay a fee of *** to the Licensor and provide a detailed Commercialization Plan for the licensed therapeutic rights to Licensor within forty-five days of the Deadline for Milestone 5.
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Exhibit 10.4 |
Therapeutic Milestone Events | Deadlines | Therapeutic Milestone Fees |
1. In-license acquisition and/or development of therapeutic delivery platform | *** | *** |
2. Regulatory Approval of IND filing by Regulatory Authority. | *** | *** |
3. Dosing of first patient in a Regulatory Authority-approved Phase I Clinical Trial of Licensed Product | *** | *** |
4. Dosing of first patient in an Regulatory Authority-approved Phase II Clinical Trial of Licensed Product | *** | *** |
5. Dosing of first patient in a Regulatory Authority-approved Phase III Clinical Trial of Licensed Product | *** | *** |
6. Regulatory Approval of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
7. Launch of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
8. Regulatory Approval of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
9. Launch of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
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Exhibit 10.4 |
Section 20.5 Therapeutic Research and Development Sublicense. Should Licensee sublicense the licensed therapeutic and/or treatment rights, Licensee shall require milestones at least as stringent as those outlined in section 20.4 above.
Section 20.6 Additional CLIA Product Launch. For each subsequent CLIA validation of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer, which is launched after ***, Licensee shall pay Licensor ***.
Section 20.7 First Sale of Additional Products In United States of America. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer, which are Sold or launched after *** in the United States, Licensee shall pay Licensor a fee of ***.
Section 20.8 First Sale of Additional Products in any Non-U.S.A. Country For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of lung cancer, Sold or launched after *** in any country outside of the United States, Licensee shall pay Licensor a fee of ***.
Section 20.9 Identification of Sublicense Partners. For each Sublicensee brought to Licensee by Licensor that results in a successful negotiation of a Sublicense Agreement, Licensee shall pay to Licensor *** within thirty (30) days of the execution of said Sublicense Agreement.
Section 20.10 Termination Penalty. Should Licensee terminate this Agreement within two years of the Effective Date, Licensee shall pay Licensor two million five hundred thousand ($2,500,000) dollars in addition to the requirements of section 7 below.
Section 20.11 Diagnostic & Prognostic Sublicense. Licensee agrees to sublicense, nonexclusively and under reasonable terms, the diagnostic and/or prognostic field of use covered only by the Patent Rights/Technology Rights identified in Section 1 as jointly owned with the NIH and as referenced in section 20.1 above, to non-profit and commercial entities requesting such a sublicense or referred by Licensor or NIH to Licensee.
21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly represents and warrants and does hereby state and represent that no promise or agreement which is not herein expressed has been made to Licensee in executing this Patent & Technology License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby represents and warrants that Licensee understands and agrees to all terms and conditions set forth in this Patent & Technology License Agreement and said Terms and Conditions.
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Exhibit 10.4 |
22. Deadline for Execution by Licensee. If this Patent & Technology License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent & Technology License Agreement shall be null and void and of no further effect.
IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent & Technology License Agreement.
LICENSOR: Ohio State Innovation Foundation | LICENSEE: MICROLIN BIO, INC. | |||
By | /s/ Timothy R. Wright | By | /s/ Joseph Hernandez | |
Timothy R. Wright | Joseph Hernandez | |||
Interim President | CEO and President | |||
Date | 9/10/13 | Date | 9/10/13 |
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EXHIBIT A
Terms and Conditions of Patent & Technology License
These Terms and Conditions of Patent & Technology License (“Terms and Conditions”) are incorporated by reference into the Patent & Technology License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.
1. | Definitions |
“Actively Commercialize” means having a commercially effective, reasonably funded (as compared to other similarly situated companies), ongoing and active research, development, manufacturing, marketing and/or sales program directed toward obtaining regulatory approval, production and/or Sales of Licensed Product(s) in a Field of Use in the Licensed Territory.
“Affiliate” means any business entity more than 50% owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee.
“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.
“CLIA” means Clinical Laboratory Improvement Amendments.
“Commercialization Plan” means the written commercialization plan attached as Appendix B of the Patent & Technology License Agreement.
“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“…Covered By…” means a claim or claims within any pending or issued patent included in the Patent Rights claiming all, a portion, or a component or step of a Licensed Process, Licensed Product, or Licensed Service.
“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent & Technology License Agreement.
“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.
“FDA” means United States Food and Drug Administration.
“Field of Use” means the field indicated as the Field of Use identified in Section 1 of the Patent & Technology License Agreement.
Licensee: [Company name] Licensor: [Name] | CONFIDENTIAL EXHIBIT A | Exclusive PLA (Physical Sciences) Page 13 of 39 |
Exhibit 10.4 |
“Government” means any agency, department or other unit of the United States of America or the State of Ohio.
“Gross Consideration” means all cash and non-cash consideration (e.g., securities).
“IND” means investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights/Technology Rights in Section 1 of the Patent & Technology License Agreement.
“Licensed Process” means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.
“Licensed Product” means any product, apparatus, kit, test having a panel of either a single nucleotide or two or more nucleotides in combination or component thereof (i) whose manufacture, use, sale, offer for sale or import is Covered By any claim or claims included within the Patent Rights or incorporates any Technology Rights, or (ii) which is made using a Licensed Process or another Licensed Product.
“Licensed Service” means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.
“Licensed Subject Matter” means Patent Rights and/or Technology Rights
“Licensee” means the Party identified as the Licensee in Section 1 of the Patent & Technology License Agreement.
“Licensor” means the Party identified as the Licensor in Section 1 of the Patent & Technology License Agreement.
“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent & Technology License Agreement.
“Net Sales” means the Gross Consideration from the Sale of Licensed Products, Licensed Processes, or Licensed Services less the following items directly attributable to the Sale of such Licensed Products that are specifically identified on the invoice for such Sale and borne by the Licensee, Affiliates, or Sublicensees as the seller: (a) discounts and rebates actually granted; (b) sales, value added, use and other taxes and government charges actually paid, excluding income taxes; (c) import and export duties actually paid; (d) freight, transport, packing and transit insurance charges actually paid or allowed; and (e) other amounts actually refunded, allowed or credited due to rejections or returns, but not exceeding the original invoiced amount.
“Non-Royalty Sublicensing Consideration" means the Gross Consideration received by the Licensee or its Affiliate from a Sublicensee in consideration of the grant of a sublicense under the Licensed Subject Matter (including, without limitation, license or option or distribution fees, fees to maintain license rights, and bonus/milestone payments), but excluding amounts received as running royalties, a profit share, or other revenue sharing based on Net Sales for which Licensor receives a running royalty under Section 3.2. For the avoidance of doubt, Non-Royalty Sublicensing Consideration shall not include bona fide: (a) running royalties received by Licensee or an Affiliate based on Net Sales that are royalty-bearing to Licensor under Section 3.2, (b) purchase price for Licensee’s stock or other securities not in excess of Fair Market Value, and (iii) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by Licensee.
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Exhibit 10.4 |
“Patent & Technology License Agreement” means the particular Patent & Technology License Agreement to which these Terms and Conditions are attached and incorporated into by reference.
“Patent Rights” means the Licensor’s rights in: (a) the patents and patent applications listed in Section 1 of the Patent & Technology License Agreement; (b) all non-provisional patent applications that claim priority to any of the provisional applications listed in Section 1 of the Patent & Technology License Agreement to the extent the claims of such non-provisional applications are entitled to claim priority to such provisional applications; (c) all divisionals, continuations and continuations-in-part (excluding new matter and claims containing new matter) of the non-provisional patent applications identified in (a) and (b), above to the extent that claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above; (d) all reissues, reexaminations, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and (e) any patents that issue with respect to any of the patent applications listed in (a), (b) , (c) or (d), above. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.
"Phase I Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
"Phase II Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
"Phase IIA Clinical Trial" means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.
"Phase IIB Clinical Trial" means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.
"Phase III Clinical Trial" means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent & Technology License Agreement.
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Exhibit 10.4 |
“Quarterly Payment Deadline” means the day that is thirty (30) days after the last day of any particular Contract Quarter.
“Regulatory Approval” means the approval needed by the Regulatory Authority for a particular national jurisdiction to market, Sell and use a Licensed Product or Licensed Service in that national jurisdiction.
“Regulatory Authority” means the governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product or Licensed Service in a particular national jurisdiction, including without limitation FDA, European Medicines Agency or Koseisho (i.e., the Japanese Ministry of Health and Welfare).
“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products or Licensed Services for which consideration is received by Licensee, its Affiliates or Sublicensees. A Sale of Licensed Products or Licensed Services will be deemed completed at the time Licensee or its Affiliate or its Sublicensee receives such consideration.
“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.
“Sublicense Fee” means the fee specified in Section 3.1(e) of the Patent & Technology License Agreement.
“Sublicensee” means any entity to which an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product or Licensed Services within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee or an Affiliate for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.
“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at The Ohio State University (“OSU”) and within the Field of Use which are not Covered By any claim or claims included within the Patent Rights, but which are either (1) directly related to the Tech ID listed in Section 1 of the Patent & Technology License Agreement or (2) necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.
“Territory” means the territory so indicated as the Territory in Section 1 of the Patent & Technology License Agreement.
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Exhibit 10.4 |
2. | License Grant and Commercialization |
2.1 | Grant |
(a) | Licensor grants to Licensee a royalty-bearing exclusive license under Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(b) | Licensor grants to Licensee a royalty-bearing non- exclusive sublicense under Technology Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(c) | This grant is subject to (i) the payment by Licensee to Licensor of all consideration required under the Agreement, (ii) any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights), and (iii) rights retained by Licensor to: |
(1) | Publish the scientific findings from research related to the Patent Rights; and |
(2) | Use the Licensed Subject Matter for teaching, research, patient care, education, and other educationally-related purposes; and |
(3) | Grant rights to, and transfer material embodiments of, the Licensed Subject Matter to other academic institutions or non-profit research institutions for the purposes identified in clauses (1) and (2) above. |
(d) Licensor reserves all rights not expressly granted in the Agreement including, but not limited to, any other licenses, implied or otherwise, to any patents or other rights of Licensor, regardless of whether such patents or other rights are dominant or subordinate to any rights expressly granted in the Agreement, or are required to exploit any rights expressly granted in the Agreement.
2.2 | Affiliates |
Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” herein shall include such Affiliate regardless of whether a specific reference to an “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution.
2.3 | Sublicensing |
Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:
(a) | A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by the applicable terms and conditions of the Agreement and shall indicate that Licensor is a third party beneficiary of the Sublicense Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Licensee has no right to grant a Sublicensee the right to grant further sub-Sublicense Agreements. |
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Exhibit 10.4 |
(b) | Licensee shall deliver to Licensor a true, complete, and correct copy of each Sublicense Agreement granted by Licensee, Affiliate or Sublicensee, and any modification or termination thereof, within thirty (30) days following the applicable execution, modification, or termination of such Sublicense Agreement. All Sublicense Agreements will be in English. |
(c) | Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2 whether or not paid to Licensee by a Sublicensee. Any act or omission of a Sublicensee that would be a breach of the Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Licensor or any other terms and conditions of the Sublicense Agreement that would constitute a breach of the Agreement if such acts were performed by Licensee. |
2.4 | Diligent Commercialization |
Licensee by itself or through its Affiliates and Sublicensees will use diligent and commercially reasonable efforts to implement the Commercialization Plan and to Actively Commercialize Licensed Products and/or Licensed Services (as applicable) in the Field of Use within the Territory. Without limiting the foregoing, Licensee will
(a) | maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make License Products and/or Licensed Services commercially available to the public as soon as commercially practicable, and |
(b) | fulfill the milestone events specified in Section 2.4 of the Patent & Technology License Agreement by the deadlines indicated therein. |
If the obligations under this Section 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b).
3. | Compensation |
In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent & Technology License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
3.1 | Non-Royalty Payments due from Licensee |
(a) | Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) and Section 20.1 of the Patent & Technology License Agreement within fifteen (15) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount. |
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Exhibit 10.4 |
(b) | Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved. |
(c) | Upfront Fee. Licensee will pay the amount of the Upfront Fee set forth in Section 3.1(c) of the Patent & Technology License Agreement on the Effective Date. |
(d) | License Maintenance Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(d) of the Patent & Technology License Agreement in accordance with the stated schedule. |
(e) | Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter. |
(f) | Assignment Fee. Licensee will pay the assignment fee set forth in Section 3.1(f) of the Patent & Technology License Agreement within fifteen (15) days of the assignment of the Agreement. |
3.2 | Royalties |
Licensee will pay running royalties on Net Sales in each Contract Quarter on or before the Quarterly Payment Deadline for such Contract Quarter, as follows: (a) at the rate set forth in Section 3.2(a) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights; and (b) at the rate set forth in Section 3.2(b) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights. No royalty shall be payable under this Section 3.2 with respect to (i) Sales to an Affiliate or Sublicensee of a particular unit of Licensed Product that is used by such Affiliate or Sublicensee to perform a Licensed Service if Licensor is paid a royalty on the Sale of such Licensed Service, (ii) the Sale of Licensed Products between or among Licensee, its Affiliates, and Sublicensees for re-sale purposes, provided Licensor is paid a royalty with respect to the re-sale, or (iii) payments that constitute Non-Royalty Sublicensing Consideration.
3.3 | Minimum Royalties |
If royalties paid to Licensor do not reach the minimum royalty amounts stated in Section 3.3 of the Patent & Technology License Agreement for the specified periods, Licensee will pay Licensor on or before the Quarterly Payment Deadline for the last Contract Quarter in the stated period an additional amount equal to the difference between the stated minimum royalty amount and the actual royalties paid to Licensor.
3.4 | Non-cash Consideration |
If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.
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Exhibit 10.4 |
4. | Reports and Plans |
The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent & Technology License Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.
4.1 | Quarterly Payment and Milestone Reports |
On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall include:
(a) | The name of the Licensee, the Patent & Technology License Agreement number, and the period covered by the report; |
(b) | The name of any Affiliates and Sublicensees whose activities are also covered by the report; |
(c) | Identification of each Licensed Product and Licensed Service for which any royalty payments have become payable; |
(d) | Net Sales segregated on a product-by-product basis, and a country-by-country basis, or an affirmative statement that no Sales were made. The report shall also itemize the permitted deductions from the Gross Consideration used to arrive at the resulting Net Sales, on a product-by-product and country-by-country basis; |
(e) | The applicable royalty rate; |
(f) | An affirmative statement of whether any milestones with deadlines in that Contract Quarter under Section 2.4 and any milestones under Section 3.1(b) were met or not, and the resulting Milestone Fee payable; |
(g) | Non-Royalty Sublicensing Consideration received by Licensee segregated on a Sublicense-by-Sublicense basis, or an affirmative statement that none was received; |
(h) | If any consideration was received in currencies other than U.S. dollars, the report shall describe the currency exchange calculations; and |
(i) | Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report. |
4.2 | Annual Written Progress Report and Commercialization Plan |
Within forty five (45) days following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products and Licensed Services, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products and Licensed Services for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:
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Exhibit 10.4 |
(a) | The name of the Licensee, the Patent & Technology License Agreement number, the names of any Affiliates and Sublicensees, and the products and services being developed and/or commercialized; |
(b) | The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b); and |
(c) | The research and development activities, including status and plans for obtaining any necessary Regulatory Approvals, performed during the past year, and the plans for research and development activities for the next year. |
4.3 | Government and Economic Development Reporting |
If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:
(a) | Number and geographic location of new full-time employees created during the past Contract Year; total number and geographic location of full-time employees of Licensee at the end of such Contract Year; |
(b) | Dollar amount of new equity financing received by Licensee during the past Contract Year, and current capitalization, including number and class of outstanding securities; |
(c) | Location and square footage of facilities; and |
(d) | Other information required under Federal and state law. |
This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than two hundred (200) full-time employees, then no further economic development reports will be required from Licensee.
5. | Payment, Records, and Audits |
5.1 | Payments |
All amounts referred to in the Patent & Technology License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent & Technology License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent & Technology License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
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Exhibit 10.4 |
5.2 | Sales Outside the U.S. |
If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business day of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.
5.3 | Late Payments |
Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).
5.4 | Records |
For a period of six (6) years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Sales, Net Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.
5.5 | Auditing |
Licensee and its Affiliates will permit Licensor or its representatives, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.
6. | Patent Expenses and Prosecution |
6.1 | Patent Expenses |
Licensee shall pay for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent & Technology License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a)), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Patent & Technology License Agreement and future expenses, within thirty (30) days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) will be considered a payment default under Section 7.3(a).
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Exhibit 10.4 |
6.2 | Direction of Prosecution |
Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.
6.3 | Ownership |
All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent & Technology License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.
6.4 | Foreign Filings |
In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.
6.5 | Withdrawal from Paying Patent Costs |
If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.
6.6 | U.S. Patent and Trademark Office Entity Size Status |
Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent & Technology License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.
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Exhibit 10.4 |
7. | Term and Termination |
7.1 | Term |
Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue until the last date of expiration or termination of the Patent Rights, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of 20 years.
7.2 | Termination by Licensee |
Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.
7.3 | Termination by Licensor |
Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field of Use, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:
(a) | Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or |
(b) | Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within ninety (90) days after delivery of written notice from Licensor; |
(c) | Licensor delivers notice to Licensee of three or more actual breaches of the Agreement in any 12-month period, even in the event that Licensee cures such breaches in the allowed period; or |
(d) | Licensee or its Affiliate or Sublicensee initiates any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights, or assist a third party in pursuing such a proceeding or action. |
7.4 | Other Conditions of Termination |
The Agreement will terminate:
(a) | Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files a bankruptcy action or becomes bankrupt or insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee ceases its business operations, or (iv) Licensee makes an assignment for the benefit of creditors, or (v) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee or trustee, whether by voluntary act of Licensee or otherwise; or |
(b) | At any time by mutual written agreement between Licensee and Licensor. |
7.5 | Effect of Termination |
If the Agreement is terminated for any reason:
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Exhibit 10.4 |
(a) | All rights and licenses of Sublicensees shall terminate upon termination of the Agreement; provided however, if the Sublicense Agreement is for all of the Field of Use for all of the Territory, and the Sublicensee is in good standing and agrees in writing to assume all of the obligations of Licensee and provides Licensor with written notice thereof within thirty (30) days after termination of the Agreement, then such Sublicense Agreement shall survive; and |
(b) | Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products and performing Licensed Services by the effective date of termination; and |
(c) | Licensee shall tender payment of all accrued royalties and other payments due to Licensor as of the effective date of termination; and |
(d) | Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and |
(e) | The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses), and 20.2 (Payment Schedule for Past Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement. |
8. | Confidentiality |
8.1 | Definition |
“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.
8.2 | Protection and Marking |
Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.
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Exhibit 10.4 |
8.3 | Confidentiality of Terms of Agreement |
Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, Ohio Public Records laws, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If the Agreement is not for all fields of use, then Licensor may disclose the Field of Use to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.
8.4 | Disclosure Required by Court Order or Law |
If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.
8.5 | Copies |
Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.
8.6 | Continuing Obligations |
Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of three (3) years thereafter.
8.6 | Exclusions |
Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:
(a) | Was in the public domain at the time of disclosure; or |
(b) | Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or |
(c) | Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or |
(d) | Was already known by the recipient Party at the time of disclosure; or |
(e) | Was independently developed by the recipient Party without use of the disclosing Party’s Confidential Information. |
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Exhibit 10.4 |
8.8 | Copyright Notice |
The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.
9. | Infringement and Litigation |
9.1 | Notification |
If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.
9.2 | Licensee’s Enforcement Rights |
Licensee shall enforce the Patent Rights against any infringement by a third party in the Field in the Territory. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by Licensor in providing cooperation or joining as a party as provided in Section 9.4. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.
9.3 | Licensor’s Enforcement Rights |
If Licensee does not file suit within six (6) months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement. If Licensor pursues such infringement action, Licensor may, as part of the resolution of such efforts, grant non-exclusive license rights to the alleged infringer notwithstanding Licensee’s exclusive license rights.
9.4 | Cooperation between Licensor and Licensee |
In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.
If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s and the Ohio Attorney General’s prior written permission, which permission shall not be unreasonably withheld, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Ohio Attorney General regarding retention of outside counsel for state entities.
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Exhibit 10.4 |
9.5 | Contest of Validity |
(a) In the event Licensee or its Sublicensee(s) (or a third party on its behalf) files any action contesting the validity or enforceability of any Patent Rights and the provision in Section 7.3(d) is unenforceable, the Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall pay a royalty rate of one and a half (1.5) times the royalty rate specified in Section 3.2 for all Net Sales. Moreover, should the outcome of such contest determine that any claim of the Patent Rights challenged is both valid and would be infringed by a Licensed Product, Licensed Process, or Licensed Service sold by Licensee (or its Sublicensee(s) if such Sublicensee filed the action), if not for the license granted by this Agreement, Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall thereafter, and for the remaining term of this Agreement, pay a royalty rate of two (2) times the royalty rate specified in Section 3.2 for all Net Sales.
(b) In the event that Licensee or its Sublicensee(s) contests the validity or enforceability of any Patent Rights during the term of this Agreement, Licensee agrees (and shall require its Sublicensee(s) to agree) to pay to Licensor all royalties due under the Agreement during the period of challenge. For the sake of clarity, such amounts shall not be paid into any escrow or other account, but directly to Licensor, and shall not be refunded.
(c) In the event that a validity or non-infringement challenge of any Patent Rights brought by Licensee is successful, Licensee shall have no right to recoup any royalties paid before or during the period challenge.
10. | Export Compliance |
10.1 Licensee shall observe all applicable United States and foreign laws and regulations with respect to the research, development, manufacture, marketing and transfer of Licensed Products and related technical data, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulation (collectively, the “Export Laws”). To this end, Licensee shall take all actions necessary to comply with the Export Laws. Licensee hereby represents and covenants that Licensee:
(i) | Is neither a national of nor controlled by a national of any country to which the United States prohibits the export or re-export of goods, services, or technology; |
(ii) | Is not a person specifically designated as ineligible to export from the United States or deal in U.S.-origin goods, services, or technologies; |
(iii) | Shall not export or re-export, directly or indirectly, any goods, services, or technology, to any country or person (including juridical persons) to which the United States prohibits the export of goods, technology or services; and |
(iv) | In the event that a United States government license or authorization is required for an export or re-export of goods, services, or technology (including technical information acquired from Licensor under this Agreement and/or any products created by using such technical information or any part thereof), the Licensee shall obtain any necessary United States government license or other authorization prior to undertaking the export or re-export. |
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Exhibit 10.4 |
Licensee shall include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable export laws and regulations and other applicable laws and regulations.
11. | Representations and Disclaimers |
11.1 | Licensor Representations |
Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or agent of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent & Technology License Agreement), (ii) Licensor has the right to grant the license and sublicense hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.
11.2 | Government Rights |
Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement (NIH reference number L-003-2009) and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.
11.3 | Licensor Disclaimers |
EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, NONINFRINGEMENT, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY CLAIM OR PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD OF USE. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN.
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Exhibit 10.4 |
11.4 | Licensee Representation |
By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (c) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent & Technology License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent & Technology License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.
12. | Limit of Liability |
IN NO EVENT SHALL LICENSOR, OSU, OR THEIR INVENTORS, OFFICERS, EMPLOYEES, STUDENTS, TRUSTEES, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
13. | Indemnification |
13.1 | Indemnification Obligation |
Licensee agrees to hold harmless, defend and indemnify Licensor, OSU, and their officers, employees, students, inventors, trustees, agents, and consultants (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Licensee shall have no responsibility or obligation under the section for any Liabilities to the extent caused by the gross negligence or willful misconduct by Licensor.
14. | Insurance |
14.1 | Insurance Requirements |
Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, its officers, employees named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 30 of 39 |
Exhibit 10.4 |
14.2 | Evidence of Insurance and Notice of Changes |
Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least sixty (60) days prior to Licensee cancelling, not renewing, or materially changing such insurance.
15. | Assignment |
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld. For any permitted assignment to be effective, (a) Licensee must be in good standing under this Agreement, (b) the Licensee must pay Licensor the assignment fee pursuant to Section 3.1(f), and (c) the assignee must assume in writing (a copy of which shall be promptly provided to Licensor) all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if assignee were an original Party to the Agreement.
16. | Governmental Markings |
16.1 | Patent Markings |
Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.
16.2 | Governmental Approvals and Marketing of Licensed Products and or Licensed Services |
Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.
16.3 | Foreign Registration and Laws |
Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products and Licensed Services to the extent there is no conflict with United States law, in which case United States law will control.
17. | Use of Name |
Licensee will not use the name, trademarks or other marks of Licensor or OSU without the advance written consent of Licensor or OSU. Licensor or OSU may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent.
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 31 of 39 |
Exhibit 10.4 |
18. | Notices |
Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Patent & Technology License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.
Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent & Technology License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.
19. | General Provisions |
19.1 | Binding Effect |
The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.
19.2 | Construction of Agreement |
Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.
19.3 | Counterparts and Signatures |
The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.
19.4 | Compliance with Laws |
Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.
19.5 | Governing Law |
The Agreement will be construed and enforced in accordance with laws of the State of Ohio, without regard to choice of law and conflicts of law principles.
19.6 | Modification |
Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.
19.7 | Severability |
If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 32 of 39 |
Exhibit 10.4 |
19.8 | Third Party Beneficiaries |
Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties, OSU and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent & Technology License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).
19.9 | Waiver |
Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.
19.10 | Sovereign Immunity |
Nothing in the Agreement shall be deemed or treated as any waiver of OSU’s sovereign immunity.
19.11 | Entire Agreement |
The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.
19.12 | Claims Against Licensor for Breach of Agreement |
Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be brought in a court of competent jurisdiction in Ohio and this is Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor.
19.13 | Grant of Security Interest |
Licensee hereby grants to Licensor a security interest in and to Licensee's rights under the Patent & Technology License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.
— END OF EXHIBIT A —
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 33 of 39 |
Exhibit 10.4 |
EXHIBIT B
COMMERCIALIZATION PLAN
EXIHIBIT C
PATENT APPLICATIONS
TECH ID | APP. Title | TERR. | PAT. APP# | Filing Date |
2006-008 Joint with NIH |
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Lung Cancer | PCT | PCT/US2007/000103 | 01/03/2007 |
2006-008-06 Joint with NIH |
US | 7,943,318 ISSUED |
07/03/2008 | |
2006-008-03 Joint with NIH |
AU | 2007205234 ISSUED |
07/03/2008 | |
2006-008-04 Joint with NIH |
CA | 2,633,674 | 06/18/2008 | |
2006-008-05 Joint with NIH |
EU | 07717734.3 | 07/03/2008 | |
2006-008-07 Joint with NIH |
CN | ZL200780006750.8 ISSUED |
08/26/2008 | |
2006-008-08 Joint with NIH |
JP | 2008-549549 | 07/07/2008 | |
2006-008-10 Joint with NIH |
JP | 59-3172050 | 09/08/2008 | |
2006-008-12 Joint with NIH |
US | 8,367,710 ISSUED |
03/30/2011 | |
2006-008-13 Joint with NIH |
US | 8,377,637 ISSUED |
03/30/2011
| |
2006-008-16 Joint with NIH |
EU | 12165748.0 ALLOWED |
04/26/2012 | |
2006-008-17 Joint with NIH |
EU | 12165740.7 | 04/26/2012 | |
2006-008-18 Joint with NIH |
12165478.0 | 04/26/2012 | ||
2006-008-19 Joint with NIH |
AU | 2012-238336 | 12/18/2012 | |
2006-008-020 Joint with NIH |
AU | 2007-205234 | 10/11/2012 |
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Exhibit 10.4 |
2006-008-021 Joint with NIH |
CN | CN1210312507.1 | 03/21/2013 | |
2006-008-33 Joint with NIH |
2011-552098 | |||
2006-009 | Compositions and Methods for the Diagnosis and Therapy of BCL-2 Associated Cancers | au | 2006291165
ALLOWED
|
09/11/06 |
2006-009 | ca | 2,621,441 | 09/11/06 | |
2006-009 | cn | ZL200680039776.8
ISSUED
|
09/11/06 | |
2006-009 | cn | 2012-10380806.9 | 10/10/12 | |
2006-009 | ep | 06814375.9 | 09/11/06 | |
2006-009 | jp | 2008-531200 | 09/11/06 | |
2006-009 | jp | 2013-081761 | 09/11/06 | |
2006-009 | us | 11/991,773
allowed
|
05/14/08 | |
2006-138 | MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | PCT | PCT/US2007/00159 | 01/03/2007 |
2006-138-03 | CA | 2,633,754
ALLOWED
|
01/03/2007 | |
2006-138-58 | CA | 2811486 | 03/29/2013 | |
2006-138-07 | JP | 2008-549555 | 01/03/2007 | |
2006-138-50 | JP | 2012-183280 | 09/08/2012 |
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Exhibit 10.4 |
2006-138-04 | AU | 2007-205163
|
07/03/2008 | |
2006-138-09 | HK | 09108431.1 | 01/03/2007 | |
2006-138-12 | CN | 2007-80005821.2 | 01/03/2007 | |
2006-138-06 | US | 8,148,069
ISSUEd
|
07/03/2008 | |
2006-138-11 | US | 13/405,517 | 02//27/2012 | |
2006-138-12 | US | 13/405,533 | 02//27/2012 | |
2006-138-13 | US | 13,/405,543 | 02/27/2012 | |
2006-138-18 | US | 13/406,618 | 02/28/2012 | |
2006-138-24 | US | 13/407,894 | 02/29/2012 | |
2006-138-05 | EU | 07717903.4 | 01/03/2007 | |
2006-138-57 | EU | 12151246.8 | 03/05/2012 | |
2006-138-55 | EU | 12154298.9 | 01/03/2007 | |
2006-138-56 | EU | 12154300.3 | 01/03/2007 | |
2006-138-47 | EU | 12154307.8 | 01/03/2007 | |
2006-138-45 | EU | 12154326.8
******
|
03/05/2012 | |
2006-138-27 | EU | 12154345.8 | 03/01/2012 | |
2006-138-33 | EU | 12154351.6 | 03/01/2012 | |
2007-028 | Ultraconserved Regions Encoding ncRNAs | AU | 2008283997 | 02/11/10 |
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Exhibit 10.4 |
2007-028 | CA | 2,695,514 | 02/03/10 | |
2002007-028 | CN | 2008-80108689.2 | 08/04/08 | |
2007-028 | EP | 08782609.5 | 02/04/10 | |
2007-028 | JP | 2010-519269 | 01/28/10 | |
2007-028 | US | 12/672,014 ALLOWED
|
02/03/10 | |
2007-030 | Methods for Identifying Fragile Histidine Triad (Fhit) Interaction and Uses Thereof (this application has broad claims that could be amended to include lung and colon) |
AU | 2008316577 *****
|
04/27/10 |
2007-030 | CA | 2,703,707 *****
|
04/23/10 | |
2007-030 | CN | 200880119206.9 *****
|
10/27/08 | |
2007-030 | EP | 08841700.1 ***** |
04/26/10 | |
2007-030 | JP | 2010-531311 *****
|
04/26/10 | |
2007-030 | US | 12/739,541 *****
|
02/25/11 | |
2007-159-06 | METHODS FOR REVERTING METHYLATION BY TARGETING DNMT3A AND DNMT3B | AU | 2008282318 | 07/30/2008 |
2007-159-03 | US | 8,367,632 ISSUED
|
02/01/2012 |
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Exhibit 10.4 |
2007-159-08 | EU | 08796821.0 | 07/30/2008 | |
2007-159-09 | CA | 2695184 | 01/29/2010 | |
2007-159-10 | CN | 200880108625.2 | 03/25/2010 | |
2007-159-11 | JP
|
2010-520,144 | 01/28/2010 | |
2007-159-12 | US | 13/740,345 | 01/14/2013 | |
2010-079-02 | Materials and methods useful for affecting tumor cell growth, migration and invasion | AU | 2010321555 | 05/15/2012 |
2010-079-04 | CA | 2781547 | 05/22/2012 | |
2010-079-06 | US | 13/511,474 | 05/23/2012 | |
2010-079-07 | CN | 201080059339.9 | 07/12/2012 | |
2010-079-08 | JP | 2012-541156 | 09/26/2012 | |
2010-079-08 | EU | 10832355.1 | 08/21/2012 | |
2010-126 | Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | au | 2011232669 | 09/24/12 |
2010-126 | CA | 2,794,142 | 09/24/12 | |
2010-126 | CN | 2011-80022637.5 | 09/24/12 | |
2010-126 | EP | 11760035.3 | 09/24/12 |
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Exhibit 10.4 |
2010-126 | JP | 2013-502642 | 09/26/12 | |
2010-126 | US | 13/637,490 | 11/15/12 | |
2011-137 | Mutator activity induced by microRNA-155 links inflammation and cancer | PCT | PCT/US2012/028016 ******
|
03/07/12 |
2011-137 | US | 13/414,084 ******
|
03/07/12 | |
2012-066 | Methods and Compositions Related to miR-21 & miR-29a and Cancer Metastasis | PCT | PCT/US2012/069484 *****
|
12/13/12 |
2012-111 | miRNAs USEFUL TO REDUCE LUNG CANCER TUMORIGENESIS AND CHEMOTHERAPY RESISTANCE AND RELATED COMPOSITIONS AND METHODS | PCT | PCT/US2012/068736 | 12/10/2012 |
2013-072 | Use of miR-494 to Modulate TRAIL-induced Apoptosis through BIM Down-regulation | Prov. | 61/704,542 | 09/23/2012 |
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL EXHIBIT A | Exclusive License (Life Sciences) Page 39 of 39 |
***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
PATENT & Technology LICENSE AGREEMENT
AGT. No. A2013-2069
This Patent & Technology License Agreement is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).
No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.
Background
Licensor owns, controls and/or has the right to sublicense the Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:
The Terms and Conditions of Patent & Technology License attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). The Commercialization Plan attached hereto as Exhibit B is incorporated herein by reference in its entirety (the “Commercialization Plan”). In the event of a conflict between provisions of this Patent & Technology License Agreement and the Terms and Conditions, the provisions in this Patent & Technology License Agreement shall govern. Unless defined in this Patent & Technology License Agreement, capitalized terms used in this Patent & Technology License Agreement shall have the meanings given to them in the Terms and Conditions.
The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.
1. Definitions |
Effective Date | September 6, 2013, 2013 | |
Licensor | Ohio State Innovation Foundation, with an address at 1524 North High Street, Columbus, OH 43201. | |
Licensee
|
MicroLin Bio, Inc., a corporation, with its principle place of business at 302A West 12th Suite 114, New York, NY 10014 | |
Contract Year and Contract Quarters |
x Contract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31
| |
Territory | Worldwide |
Field of Use
|
Exclusive Field of Use for the diagnosis, prognosis and therapy/treatment of ovarian cancer.
|
Patent Rights/Technology Rights [See Exhibit C for individual patent application and patent information] |
App. No./ Date of Filing |
Title | Inventor(s) | Jointly Owned? (Y/N; if Y, with whom?) |
Countries
|
Prosecution Counsel | |
PCT/US09/38214 Mar. 25, 2009 [2009-034]
|
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis, and Treatment of Ovarian Cancer using a Real-Time PCR Platform | D.E. Cohn K. Resnick A. Hansjuerg C. Croce |
x No | US CA EU JP AU |
MacMillan, Sobanski, and Todd LLC | |
PCT/US08/075565 Sep. 08, 2008 [2008-008]
|
MicroRNA Signatures in Human Ovarian Cancer | C. Croce |
x No |
US CA EU JP AU CN |
MacMillan, Sobanski, and Todd LLC | |
PCT/US12/060225 Oct 15, 2012 [2012-030]
|
Methods and Materials Related to Ovarian Cancer | C. Croce A. Vecchione |
x No |
US (National Phase Decision on Apr 4, 2014) |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2011/029348 Mar 3, 2011 [2010-126]
|
Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | C. Croce N. Valerii |
x No |
US CN EU CA AU JP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/072081 Aug 4, 2008 [2007-028]
|
Ultra conserved Regions encoding ncRNAs | C. Croce |
x No |
US CN CA EU AU JP |
MacMillan, Sobanski, and Todd LLC |
USPTO Entity Status as of Effective Date
|
Check one box: x Small
|
{00182041-1}Licensee: MicroLin Bio Licensor: Ohio State Innovation Foundation | CONFIDENTIAL | Exclusive License (Life Sciences) Page 2 of 34 |
2.4. Diligence Milestones |
|
Milestones and deadlines | Milestone Events | Deadlines |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of ovarian cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for ovarian cancer therapeutics. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of ovarian cancer. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancers. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** | ||
9. First Sale in any country outside of the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer. Milestone extension option and fees referenced in Section 20.2 may be applied to this Milestone. | *** |
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3. Compensation |
3.1(a) | Patent expenses due upon Effective Date
(See Section 20.1) |
Amount | based on invoices received as of: | |
Tech ID# 2008-008 | $109,000 | August 29, 2013 | ||
Tech ID# 2009-034 | Costs already accounted for in Agreement# A2013-0887 having an Effective Date of May 7, 2013 between the parties. | August 29, 2013 | ||
Tech ID# 2012-030 | $28,260.95 | August 29, 2013 | ||
Tech ID# 2010-126 | $64,415.21 | August 29, 2013 | ||
Tech ID# 2007-028 | $195,348.81 | August 29, 2013 | ||
Total | $397,024.97 |
3.1(b) | Milestone fees
|
Milestone Events | Milestone Fees |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of ovarian cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for ovarian cancer therapeutics. |
(Associated fees referenced in Sections 3.1(e) and/or 20.4) | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of ovarian cancer. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancers. | *** |
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9. First Sale in any country outside of the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer. | *** |
3.1(c) | Upfront Fee | $5,000 due on Effective Date $95,000 due on or before May 31, 2014 |
3.1(d) | License Maintenance Fees
|
$25,000 due on May 31, 2015 |
3.1(e) | Sublicense Fees | *** of Non-Royalty Sublicensing Consideration for diagnostics and prognostics.
*** of Non-Royalty Sublicensing Consideration for therapeutics. |
3.1(f) | Assignment fee | For the Contract Year ending *** the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement.
For any Contract Year thereafter, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement. Assignments shall include assignments or transfers of the Agreement as part of a corporate reorganization, consolidation, merger or sale of substantially all of the assets or any other change of control |
3.2 | Running royalty rate (applies to Sales by Licensee, Affiliates and Sublicensees) | (a) Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights | *** |
(b) Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights
|
*** |
3.3 | Minimum royalty | *** for Contract Year ending *** *** for Contract Year ending *** *** per each subsequent Contract Year thereafter. |
3.5 | Equity Consideration |
(a) Capitalization table at Effective Date on a fully-diluted basis | Shareholder | No.
of Shares |
%
on fully- diluted basis | ||
Ohio State Innovation Foundation | 7.0 | ||||
Joe Hernandez | 93.00 | ||||
Carlo Croce | Issued options (vesting) | 50000 | 2.50 | ||
TOTAL | 100% |
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(b) Anti-dilution | Licensor’s minimum equity on a fully-diluted basis shall be 7 % until Licensee raises at least ten million ($10,000,000) dollars in a single transactions or a series of transactions of Equity Financing (“Equity Financing Threshold”) |
18. Contact Information |
Licensee Contacts | Licensor Contacts | |
Contact for Notice: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Accounting contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Patent prosecution contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com |
Contact for Notice: Attn: President 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: techlicensing@osu.edu
Payment and reporting contact: Checks payable to “Ohio State Innovation Foundation” Attn: Accounting/Compliance 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 Email: OSIFCompliance@osu.edu
Patent prosecution contact: Attn: Catherine Martineau MacMillan, Sobanski , & Todd, LLC ; Patent, Trademark, Copyright and Intellectual Property Law One Maritime Plaza, Fifth Floor 720 Water Street Toledo, Ohio 43604-1853 419-255-5900 (voice) 419-255-9639 (fax) E-mail: martineau@mstfirm.com Internet: http//www.mstfirm.com
|
For Licensor Administrative Purposes Only |
Changes to Standard Form Terms and Conditions | There have not been any revisions to Licensor’s standard form Terms and Conditions , except for revisions to the following sections: 7
|
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20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent & Technology License Agreement.
Section 20.1 Payment Schedule for Past Patent Expenses. Licensee will repay the past patent expenses referenced in Section 3.1(a) above upon the earlier of: (1) the payment due dates on the following schedule (shown below); or (2) Licensee has cumulative external funding (any combination of government grant, government contract, or private equity) of at least $10,000,000. In the event that $10,000,000 of external funding is obtained by Licensee, all unpaid amounts of past patent expenses shall become immediately due and payable to Licensor. The payments below include interest at the rate of 3.50% per annum. Should this Agreement be terminated, all patent expenses are immediately due and payable by Licensee to Licensor.
PmtNo. | Payment Date | Beginning Balance | Scheduled Payment | Total Payment | Principal | Interest | Ending Balance | |||||||||||||||||||||
1 | 10/31/2013 | $ | 397,024.97 | $ | 25,000.00 | $ | 25,000.00 | $ | 18,052.06 | $ | 6,947.94 | $ | 378,972.91 | |||||||||||||||
2 | 12/31/2013 | $ | 378,972.91 | $ | 25,000.00 | $ | 25,000.00 | $ | 18,367.97 | $ | 6,632.03 | $ | 360,604.94 | |||||||||||||||
3 | 7/31/2014 | $ | 360,604.94 | $ | 25,000.00 | $ | 25,000.00 | $ | 18,689.41 | $ | 6,310.59 | $ | 341,915.53 | |||||||||||||||
4 | 12/31/2014 | $ | 341,915.53 | $ | 25,000.00 | $ | 25,000.00 | $ | 19,016.48 | $ | 5,983.52 | $ | 322,899.05 | |||||||||||||||
5 | 6/30/2015 | $ | 322,899.05 | 41,967.80 | $ | 41,967.80 | $ | 39,142.44 | $ | 2,825.37 | $ | 283,756.61 | ||||||||||||||||
6 | 9/30/2015 | 283,756.61 | 41,967.80 | 41,967.80 | 39,484.93 | 2,482.87 | 244,271.68 | |||||||||||||||||||||
7 | 12/31/2015 | 244,271.68 | 41,967.80 | 41,967.80 | 39,830.42 | 2,137.38 | 204,441.26 | |||||||||||||||||||||
8 | 3/31/2016 | 204,441.26 | 41,967.80 | 41,967.80 | 40,178.94 | 1,788.86 | 164,262.32 | |||||||||||||||||||||
9 | 6/30/2016 | 164,262.32 | 41,967.80 | 41,967.80 | 40,530.51 | 1,437.30 | 123,731.81 | |||||||||||||||||||||
10 | 9/30/2016 | 123,731.81 | 41,967.80 | 41,967.80 | 40,885.15 | 1,082.65 | 82,846.66 | |||||||||||||||||||||
11 | 12/31/2016 | 82,846.66 | 41,967.80 | 41,967.80 | 41,242.89 | 724.91 | 41,603.77 | |||||||||||||||||||||
12 | 3/31/2017 | 41,603.77 | 41,967.80 | 41,603.77 | 41,239.74 | 364.03 | 0.00 |
Each of the Licensed Patents listed in a separate row in Section 1 shall constitute a single patent family. The past patent expenses set forth in Section 3.1(a) are separated out and each entry corresponds to a particular single patent family identified in Section 1. Certain of the past patent expenses for a single patent family may also be covered by one or more separate agreements between Licensor and Licensee (a “Multi-Covered Patent Expense”). Licensor does not intend for Licensee to pay double for Multi-Covered Patent Expenses.
Section 20.2 Milestone Extension Option. Licensee shall have the one-time option to extend the dates for those Milestone Events specified in Section 2.4 by three (3) months by paying a milestone extension fee of *** for each such extension. The exercise of this option shall not modify any subsequent Milestone Dates. This option may only be exercised at a time when Licensee is in compliance with all of its obligations under the Agreement, including having met all milestones with deadlines prior to the date such notice is given (without giving effect to the extension resulting from the exercise of such option). In order to exercise this option, Licensee must provide Licensor written notice of its exercise of this option accompanied by payment of the milestone extension fee. Such notice must contain an affirmation from the Licensee that it is in compliance with all of its obligations under the Agreement, that it has and is currently using commercially reasonable efforts to implement the Commercialization Plan and Actively Commercialize Licensed Products or Licensed Services and that it reasonably expects to meet the milestone deadlines as extended by the exercise of such option.
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Section 20.3 Therapeutic Research and Development. Licensee shall launch a research and development program for the licensed therapeutic rights pursuant to the therapeutic milestone events and fees outlined below, unless Licensee executes a Sublicense Agreement as set forth in Milestone 5 in section 2.4 above. Should Licensee not execute a Sublicense Agreement as set forth in Milestone 5, Licensee shall pay a fee of *** to the Licensor and provide a detailed Commercialization Plan for the licensed therapeutic rights to Licensor within forty-five days of the Deadline for Milestone 5.
Therapeutic Milestone Events | Deadlines | Therapeutic Milestone Fees |
1. In-license acquisition and/or development of therapeutic delivery platform | *** | *** |
2. Regulatory Approval of IND filing by Regulatory Authority. | *** | *** |
3. Dosing of first patient in a Regulatory Authority-approved Phase I Clinical Trial of Licensed Product | *** | *** |
4. Dosing of first patient in an Regulatory Authority-approved Phase II Clinical Trial of Licensed Product | *** | *** |
5. Dosing of first patient in a Regulatory Authority-approved Phase III Clinical Trial of Licensed Product | *** | *** |
6. Regulatory Approval of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
7. Launch of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
8. Regulatory Approval of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
9. Launch of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
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Section 20.4 Therapeutic Research and Development Sublicense. Should Licensee sublicense the licensed therapeutic and/or treatment rights, Licensee shall require milestones and fees at least as stringent as those outlined in section 20.3 above.
Section 20.5 Additional CLIA Product Launch. For each subsequent CLIA validation of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer, which is launched after ***, Licensee shall pay Licensor ***.
Section 20.6 First Sale of Additional Products In United States of America. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer, which are Sold or launched after *** in the United States, Licensee shall pay Licensor a fee of ***.
Section 20.7 First Sale of Additional Products in any Non-U.S.A. Country For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of ovarian cancer, Sold or launched after *** in any country outside of the United States, Licensee shall pay Licensor a fee of ***.
Section 20.8 Identification of Sublicense Partners. For each Sublicensee brought to Licensee by Licensor that results in a successful negotiation of a Sublicense Agreement, Licensee shall pay to Licensor *** within thirty (30) days of the execution of said Sublicense Agreement.
Section 20.9 Termination Penalty. Should Licensee terminate this Agreement within two years of the Effective Date, Licensee shall pay Licensor two million five hundred thousand ($2,500,000) dollars in addition to the requirements of section 7 below.
21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly represents and warrants and does hereby state and represent that no promise or agreement which is not herein expressed has; been made to Licensee in executing this Patent & Technology License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby represents and warrants that Licensee understands and agrees to all terms and conditions set forth in this Patent & Technology License Agreement and said Terms and Conditions.
22. Deadline for Execution by Licensee. If this Patent & Technology License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent & Technology License Agreement shall be null and void and of no further effect.
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IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent & Technology License Agreement.
LICENSOR: Ohio State INNOVATION FOUNDATION | LICENSEE: MICROLIN BIO, INC. | |||
By | /s/ Timothy R. Wright | By | /s/ Joseph Hernandez | |
Timothy R. Wright | Joseph Hernandez | |||
Interim President | CEO and President | |||
Date | 9/10/13 | Date | 9/10/13 |
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EXHIBIT A
Terms and Conditions of Patent & Technology License
These Terms and Conditions of Patent & Technology License (“Terms and Conditions”) are incorporated by reference into the Patent & Technology License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.
1. | Definitions |
“Actively Commercialize” means having a commercially effective, reasonably funded (as compared to other similarly situated companies), ongoing and active research, development, manufacturing, marketing and/or sales program directed toward obtaining regulatory approval, production and/or Sales of Licensed Product(s) in a Field of Use in the Licensed Territory.
“Affiliate” means any business entity more than 50% owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee.
“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.
“CLIA” means Clinical Laboratory Improvement Amendments.
“Commercialization Plan” means the written commercialization plan attached as Appendix B of the Patent & Technology License Agreement.
“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“…Covered By…” means a claim or claims within any pending or issued patent included in the Patent Rights claiming all, a portion, or a component or step of a Licensed Process, Licensed Product, or Licensed Service.
“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent & Technology License Agreement.
“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.
“FDA” means United States Food and Drug Administration.
“Field of Use” means the field indicated as the Field of Use identified in Section 1 of the Patent & Technology License Agreement.
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“Government” means any agency, department or other unit of the United States of America or the State of Ohio.
“Gross Consideration” means all cash and non-cash consideration (e.g., securities).
“IND” means investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights/Technology Rights in Section 1 of the Patent & Technology License Agreement.
“Licensed Process” means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.
“Licensed Product” means any product, apparatus, kit, test having a panel of either a single nucleotide or two or more nucleotides in combination or component thereof (i) whose manufacture, use, sale, offer for sale or import is Covered By any claim or claims included within the Patent Rights or incorporates any Technology Rights, or (ii) which is made using a Licensed Process or another Licensed Product.
“Licensed Service” means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.
“Licensed Subject Matter” means Patent Rights and/or Technology Rights
“Licensee” means the Party identified as the Licensee in Section 1 of the Patent & Technology License Agreement.
“Licensor” means the Party identified as the Licensor in Section 1 of the Patent & Technology License Agreement.
“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent & Technology License Agreement.
“Net Sales” means the Gross Consideration from the Sale of Licensed Products, Licensed Processes, or Licensed Services less the following items directly attributable to the Sale of such Licensed Products that are specifically identified on the invoice for such Sale and borne by the Licensee, Affiliates, or Sublicensees as the seller: (a) discounts and rebates actually granted; (b) sales, value added, use and other taxes and government charges actually paid, excluding income taxes; (c) import and export duties actually paid; (d) freight, transport, packing and transit insurance charges actually paid or allowed; and (e) other amounts actually refunded, allowed or credited due to rejections or returns, but not exceeding the original invoiced amount.
“Non-Royalty Sublicensing Consideration" means the Gross Consideration received by the Licensee or its Affiliate from a Sublicensee in consideration of the grant of a sublicense under the Licensed Subject Matter (including, without limitation, license or option or distribution fees, fees to maintain license rights, and bonus/milestone payments), but excluding amounts received as running royalties, a profit share, or other revenue sharing based on Net Sales for which Licensor receives a running royalty under Section 3.2. For the avoidance of doubt, Non-Royalty Sublicensing Consideration shall not include bona fide: (a) running royalties received by Licensee or an Affiliate based on Net Sales that are royalty-bearing to Licensor under Section 3.2, (b) purchase price for Licensee’s stock or other securities not in excess of Fair Market Value, and (iii) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by Licensee.
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“Patent & Technology License Agreement” means the particular Patent & Technology License Agreement to which these Terms and Conditions are attached and incorporated into by reference.
“Patent Rights” means the Licensor’s rights in: (a) the patents and patent applications listed in Section 1 of the Patent & Technology License Agreement; (b) all non-provisional patent applications that claim priority to any of the provisional applications listed in Section 1 of the Patent & Technology License Agreement to the extent the claims of such non-provisional applications are entitled to claim priority to such provisional applications; (c) all divisionals, continuations and continuations-in-part (excluding new matter and claims containing new matter) of the non-provisional patent applications identified in (a) and (b), above to the extent that claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above; (d) all reissues, reexaminations, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and (e) any patents that issue with respect to any of the patent applications listed in (a), (b) , (c) or (d), above. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.
"Phase I Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
"Phase II Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
"Phase IIA Clinical Trial" means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.
"Phase IIB Clinical Trial" means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.
"Phase III Clinical Trial" means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent & Technology License Agreement.
“Quarterly Payment Deadline” means the day that is thirty (30) days after the last day of any particular Contract Quarter.
“Regulatory Approval” means the approval needed by the Regulatory Authority for a particular national jurisdiction to market, Sell and use a Licensed Product or Licensed Service in that national jurisdiction.
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“Regulatory Authority” means the governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product or Licensed Service in a particular national jurisdiction, including without limitation FDA, European Medicines Agency or Koseisho (i.e., the Japanese Ministry of Health and Welfare).
“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products or Licensed Services for which consideration is received by Licensee, its Affiliates or Sublicensees. A Sale of Licensed Products or Licensed Services will be deemed completed at the time Licensee or its Affiliate or its Sublicensee receives such consideration.
“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.
“Sublicense Fee” means the fee specified in Section 3.1(e) of the Patent & Technology License Agreement.
“Sublicensee” means any entity to which an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product or Licensed Services within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee or an Affiliate for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.
“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at The Ohio State University (“OSU”) and within the Field of Use which are not Covered By any claim or claims included within the Patent Rights, but which are either (1) directly related to the Tech ID listed in Section 1 of the Patent & Technology License Agreement or (2) necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.
“Territory” means the territory so indicated as the Territory in Section 1 of the Patent & Technology License Agreement.
2. | License Grant and Commercialization |
2.1 | Grant |
(a) | Licensor grants to Licensee a royalty-bearing exclusive license under Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(b) | Licensor grants to Licensee a royalty-bearing non- exclusive sublicense under Technology Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
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(c) | This grant is subject to (i) the payment by Licensee to Licensor of all consideration required under the Agreement, (ii) any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights), and (iii) rights retained by Licensor to: |
(1) | Publish the scientific findings from research related to the Patent Rights; and |
(2) | Use the Licensed Subject Matter for teaching, research, patient care, education, and other educationally-related purposes; and |
(3) | Grant rights to, and transfer material embodiments of, the Licensed Subject Matter to other academic institutions or non-profit research institutions for the purposes identified in clauses (1) and (2) above. |
(d) | Licensor reserves all rights not expressly granted in the Agreement including, but not limited to, any other licenses, implied or otherwise, to any patents or other rights of Licensor, regardless of whether such patents or other rights are dominant or subordinate to any rights expressly granted in the Agreement, or are required to exploit any rights expressly granted in the Agreement. |
2.2 | Affiliates |
Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” herein shall include such Affiliate regardless of whether a specific reference to an “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution.
2.3 | Sublicensing |
Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:
(a) | A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by the applicable terms and conditions of the Agreement and shall indicate that Licensor is a third party beneficiary of the Sublicense Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Licensee has no right to grant a Sublicensee the right to grant further sub-Sublicense Agreements. |
(b) | Licensee shall deliver to Licensor a true, complete, and correct copy of each Sublicense Agreement granted by Licensee, Affiliate or Sublicensee, and any modification or termination thereof, within thirty (30) days following the applicable execution, modification, or termination of such Sublicense Agreement. All Sublicense Agreements will be in English. |
(c) | Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2 whether or not paid to Licensee by a Sublicensee. Any act or omission of a Sublicensee that would be a breach of the Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Licensor or any other terms and conditions of the Sublicense Agreement that would constitute a breach of the Agreement if such acts were performed by Licensee. |
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2.4 | Diligent Commercialization |
Licensee by itself or through its Affiliates and Sublicensees will use diligent and commercially reasonable efforts to implement the Commercialization Plan and to Actively Commercialize Licensed Products and/or Licensed Services (as applicable) in the Field of Use within the Territory. Without limiting the foregoing, Licensee will
(a) | maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make License Products and/or Licensed Services commercially available to the public as soon as commercially practicable, and |
(b) | fulfill the milestone events specified in Section 2.4 of the Patent & Technology License Agreement by the deadlines indicated therein. |
If the obligations under this Section 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b).
3. | Compensation |
In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent & Technology License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
3.1 | Non-Royalty Payments due from Licensee |
(a) | Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) and Section 20.1 of the Patent & Technology License Agreement within fifteen (15) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount. |
(b) | Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved. |
(c) | Upfront Fee. Licensee will pay the amount of the Upfront Fee set forth in Section 3.1(c) of the Patent & Technology License Agreement on the Effective Date. |
(d) | License Maintenance Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(d) of the Patent & Technology License Agreement in accordance with the stated schedule. |
(e) | Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter. |
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(f) | Assignment Fee. Licensee will pay the assignment fee set forth in Section 3.1(f) of the Patent & Technology License Agreement within fifteen (15) days of the assignment of the Agreement. |
3.2 | Royalties |
Licensee will pay running royalties on Net Sales in each Contract Quarter on or before the Quarterly Payment Deadline for such Contract Quarter, as follows: (a) at the rate set forth in Section 3.2(a) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights; and (b) at the rate set forth in Section 3.2(b) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights. No royalty shall be payable under this Section 3.2 with respect to (i) Sales to an Affiliate or Sublicensee of a particular unit of Licensed Product that is used by such Affiliate or Sublicensee to perform a Licensed Service if Licensor is paid a royalty on the Sale of such Licensed Service, (ii) the Sale of Licensed Products between or among Licensee, its Affiliates, and Sublicensees for re-sale purposes, provided Licensor is paid a royalty with respect to the re-sale, or (iii) payments that constitute Non-Royalty Sublicensing Consideration.
3.3 | Minimum Royalties |
If royalties paid to Licensor do not reach the minimum royalty amounts stated in Section 3.3 of the Patent & Technology License Agreement for the specified periods, Licensee will pay Licensor on or before the Quarterly Payment Deadline for the last Contract Quarter in the stated period an additional amount equal to the difference between the stated minimum royalty amount and the actual royalties paid to Licensor.
3.4 | Non-cash Consideration |
If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.
3.5 | Equity Consideration for License Grant |
(a) | In partial consideration of the rights granted to Licensee by Licensor in the Agreement, Licensee will, within thirty (30) days after Effective Date, issue to Licensor the number of shares of capital stock set forth the name of the Licensor in Section 3.5(a) of the Patent & Technology License Agreement. This capital stock shall be of the same character and have the same rights as that capital stock issued to the other major holders of capital stock in the Licensee as of the Effective Date. The capitalization table in Section 3.5(a) of the Patent & Technology License Agreement shows all outstanding, committed, and reserved equity securities of Licensee as of the Effective Date on a fully diluted basis. Upon the Licensor’s request, Licensee shall provide, from time to time, an updated capitalization table along with a certification from the Licensee’s Chief Financial Officer certifying the table’s completeness and accuracy and identifying any shareholders who are employees of Licensor. |
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(b) | Licensee agrees that Licensor’s percentage threshold set forth in Section 3.5(b) of the Patent License Agreement on a fully-diluted basis shall be maintained thereat until Licensee receives, in the aggregate, in a single transaction or a series of transactions, the amount set forth in Section 3.5(b) of the Patent License Agreement of Equity Financing (the “Equity Financing Threshold”); provided that for purposes of this Section 3.5(b) only, a cash investment in exchange for convertible securities shall not constitute an Equity Financing at the time of issuance of such convertible securities but instead shall constitute an Equity Financing only at the time that the convertible securities are convertible or exchangeable into the equity securities received by Licensor; and provided, further, in the event the Licensee receives Equity Financing in a certain transaction, a portion of which (the “Applicable Portion”), when added to the prior aggregate amount of Equity Financing received by Licensee, brings the total amount of Equity Financing received by the Licensee up to the Equity Financing Threshold and a portion of which (the “Excess Portion”), when added to the aggregate amount of Equity Financing received by Licensee (inclusive of the Applicable Portion), brings the total amount of Equity Financing received by the Licensee above the Equity Financing Threshold, the anti-dilution provisions contained in this Section 3.5(b) shall only apply to the Applicable Portion and not to the Excess Portion. An “Equity Financing” shall mean a cash investment in exchange for any equity securities. Simultaneous with the closing of any Equity Financing, the Licensee shall issue to Licensor for no additional consideration that additional number of equity securities necessary to increase Licensor’s equity interest to an amount equal to the percentage threshold set forth in Section 3.5(b) of the Patent and License Agreement. Once Licensee meets the Equity Financing Threshold, Licensor shall have the right to participate in any sales of equity securities on the same terms as other purchasers so as to maintain its percentage ownership interest in Licensee. The foregoing right of participation may be assigned by Licensor to a third party. The term “fully diluted basis” will be calculated to include conversion of all issued and outstanding securities convertible into capital stock, and the exercise of all then outstanding options, warrants and other rights to acquire capital stock, whether or not then exercisable. |
(c) If Licensee, prior to meeting the Equity Financing Threshold, issues any shares having rights and preferences superior to those issued to the Licensor under Sections 3.5(a) or 3.5(b), then the Licensor shall have the right and option to convert all of its shares of capital stock into such shares with superior rights and preferences and the Licensor shall have the same rights, preferences and privileges afforded the other holders thereof (including all contractual rights granted to such holders). The number of shares of capital stock issued to Licensor upon such conversion shall maintain the Licensor’s percentage equity ownership interest in Licensee, calculated on a fully diluted basis prior to such conversion.
(b)
(d) | All shares issued to Licensor under this Section 3.5 will be considered fully paid, non-assessable, and have no requirement of contribution of any kind to Licensee. Stock certificates shall be issued in the name of Licensor indicated in Section 3.5(a) of the Patent & Technology License Agreement. The address of record shall be the payment and reporting contact address set forth in Section 18 (Notices) of the Patent & Technology License Agreement. |
(e) | Licensor shall be entitled to receive all financial statements, budgets and business plans of Licensee that Licensee provides to any other shareholder, lender or prospective investor of Licensee, at the same time and in the same format as provided to such other parties. Licensor shall be entitled to access to such other financial information and books and records of Licensee as Licensor may reasonably request from time to time and in any event, annually. |
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(f) | If Licensee transacts any business with an Affiliate of Licensee, including, without limitation, any contract for service or license or transfer of any intellectual property rights or other asset, then either (i) the terms of such business transaction must be no less favorable to the Licensee than those that could be commercially obtained by the Licensee in an arms-length transaction negotiated with an unrelated party, or (ii) the transaction must not affect the interests of Licensor in an adverse manner relative to the effect of the transaction on other shareholders of Licensee, taking into account all interests of such shareholders, including those in capacities other than as shareholders of Licensee. A transaction shall be deemed to satisfy (i) or (ii) if the independent members of Licensee’s board of directors who have no interest in such transaction unanimously determine prior to such transaction that (i) or (ii) is met. |
4. | Reports and Plans |
The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent & Technology License Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.
4.1 | Quarterly Payment and Milestone Reports |
On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall include:
(a) | The name of the Licensee, the
Patent & Technology License Agreement number, and the period covered by the report; |
(b) | The name of any Affiliates and
Sublicensees whose activities are also covered by the report; |
(c) | Identification of each Licensed
Product and Licensed Service for which any royalty payments have become payable; |
(d) | Net Sales segregated on a product-by-product
basis, and a country-by-country basis, or an affirmative statement that no Sales were
made. The report shall also itemize the permitted deductions from the Gross Consideration
used to arrive at the resulting Net Sales, on a product-by-product and country-by-country
basis; |
(e) | The applicable royalty rate; |
(f) | An affirmative statement of whether
any milestones with deadlines in that Contract Quarter under Section 2.4 and any milestones
under Section 3.1(b) were met or not, and the resulting Milestone Fee payable; |
(g) | Non-Royalty Sublicensing Consideration
received by Licensee segregated on a Sublicense-by-Sublicense basis, or an affirmative
statement that none was received; |
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(h) | If any consideration was received
in currencies other than U.S. dollars, the report shall describe the currency exchange
calculations; and |
(i) | Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report. |
4.2 | Annual Written Progress Report and Commercialization Plan |
Within forty five (45) days following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products and Licensed Services, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products and Licensed Services for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:
(a) | The name of the Licensee, the
Patent & Technology License Agreement number, the names of any Affiliates and Sublicensees,
and the products and services being developed and/or commercialized; |
(b) | The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b); and |
(c) | The research and development activities, including status and plans for obtaining any necessary Regulatory Approvals, performed during the past year, and the plans for research and development activities for the next year. |
4.3 | Government and Economic Development Reporting |
If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:
(a) | Number and geographic location of new full-time employees created during the past Contract Year; total number and geographic location of full-time employees of Licensee at the end of such Contract Year; |
(b) | Dollar amount of new equity financing
received by Licensee during the past Contract Year, and current capitalization, including
number and class of outstanding securities; |
(c) | Location and square footage of
facilities; and |
(d) | Other information required under Federal and state law. |
This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than two hundred (200) full-time employees, then no further economic development reports will be required from Licensee.
5. | Payment, Records, and Audits |
5.1 | Payments |
All amounts referred to in the Patent & Technology License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent & Technology License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent & Technology License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
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5.2 | Sales Outside the U.S. |
If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business day of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.
5.3 | Late Payments |
Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).
5.4 | Records |
For a period of six (6) years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Sales, Net Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.
5.5 | Auditing |
Licensee and its Affiliates will permit Licensor or its representatives, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.
6. | Patent Expenses and Prosecution |
6.1 | Patent Expenses |
Licensee shall pay for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent & Technology License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a)), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Patent & Technology License Agreement and future expenses, within thirty (30) days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) will be considered a payment default under Section 7.3(a).
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6.2 | Direction of Prosecution |
Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.
6.3 | Ownership |
All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent & Technology License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.
6.4 | Foreign Filings |
In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.
6.5 | Withdrawal from Paying Patent Costs |
If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.
6.6 | U.S. Patent and Trademark Office Entity Size Status |
Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent & Technology License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.
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7. | Term and Termination |
7.1 | Term |
Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue until the last date of expiration or termination of the Patent Rights, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of 20 years.
7.2 | Termination by Licensee |
Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.
7.3 | Termination by Licensor |
Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field of Use, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:
(a) | Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or |
(b) | Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within ninety (90) days after delivery of written notice from Licensor; |
(c) | Licensor delivers notice to Licensee of three or more actual breaches of the Agreement in any 12-month period, even in the event that Licensee cures such breaches in the allowed period; or |
(d) | Licensee or its Affiliate or Sublicensee initiates any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights, or assist a third party in pursuing such a proceeding or action. |
7.4 | Other Conditions of Termination |
The Agreement will terminate:
(a) | Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files a bankruptcy action or becomes bankrupt or insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee ceases its business operations, or (iv) Licensee makes an assignment for the benefit of creditors, or (v) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee or trustee, whether by voluntary act of Licensee or otherwise; or |
(b) | At any time by mutual written agreement between Licensee and Licensor. |
7.5 | Effect of Termination |
If the Agreement is terminated for any reason:
(a) | All rights and licenses of Sublicensees shall terminate upon termination of the Agreement; provided however, if the Sublicense Agreement is for all of the Field of Use for all of the Territory, and the Sublicensee is in good standing and agrees in writing to assume all of the obligations of Licensee and provides Licensor with written notice thereof within thirty (30) days after termination of the Agreement, then such Sublicense Agreement shall survive; and |
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(b) | Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products and performing Licensed Services by the effective date of termination; and |
(c) | Licensee shall tender payment of all accrued royalties and other payments due to Licensor as of the effective date of termination; and |
(d) | Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and |
(e) | The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses), and 20.1 (Payment Schedule for Past Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement. |
8. | Confidentiality |
8.1 | Definition |
“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.
8.2 | Protection and Marking |
Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.
8.3 | Confidentiality of Terms of Agreement |
Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, Ohio Public Records laws, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If the Agreement is not for all fields of use, then Licensor may disclose the Field of Use to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.
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8.4 | Disclosure Required by Court Order or Law |
If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.
8.5 | Copies |
Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.
8.6 | Continuing Obligations |
Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of three (3) years thereafter.
8.6 | Exclusions |
Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:
(a) | Was in the public domain at the time of disclosure; or |
(b) | Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or |
(c) | Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or |
(d) | Was already known by the recipient Party at the time of disclosure; or |
(e) | Was independently developed by the recipient Party without use of the disclosing Party’s Confidential Information. |
8.8 | Copyright Notice |
The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.
9. | Infringement and Litigation |
9.1 | Notification |
If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.
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9.2 | Licensee’s Enforcement Rights |
Licensee shall enforce the Patent Rights against any infringement by a third party in the Field in the Territory. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by Licensor in providing cooperation or joining as a party as provided in Section 9.4. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.
9.3 | Licensor’s Enforcement Rights |
If Licensee does not file suit within six (6) months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement. If Licensor pursues such infringement action, Licensor may, as part of the resolution of such efforts, grant non-exclusive license rights to the alleged infringer notwithstanding Licensee’s exclusive license rights.
9.4 | Cooperation between Licensor and Licensee |
In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.
If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s and the Ohio Attorney General’s prior written permission, which permission shall not be unreasonably withheld, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Ohio Attorney General regarding retention of outside counsel for state entities.
9.5 | Contest of Validity |
(a) In the event Licensee or its Sublicensee(s) (or a third party on its behalf) files any action contesting the validity or enforceability of any Patent Rights and the provision in Section 7.3(d) is unenforceable, the Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall pay a royalty rate of one and a half (1.5) times the royalty rate specified in Section 3.2 for all Net Sales. Moreover, should the outcome of such contest determine that any claim of the Patent Rights challenged is both valid and would be infringed by a Licensed Product, Licensed Process, or Licensed Service sold by Licensee (or its Sublicensee(s) if such Sublicensee filed the action), if not for the license granted by this Agreement, Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall thereafter, and for the remaining term of this Agreement, pay a royalty rate of two (2) times the royalty rate specified in Section 3.2 for all Net Sales.
(b) In the event that Licensee or its Sublicensee(s) contests the validity or enforceability of any Patent Rights during the term of this Agreement, Licensee agrees (and shall require its Sublicensee(s) to agree) to pay to Licensor all royalties due under the Agreement during the period of challenge. For the sake of clarity, such amounts shall not be paid into any escrow or other account, but directly to Licensor, and shall not be refunded.
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(c) In the event that a validity or non-infringement challenge of any Patent Rights brought by Licensee is successful, Licensee shall have no right to recoup any royalties paid before or during the period challenge.
10. | Export Compliance |
10.1 Licensee shall observe all applicable United States and foreign laws and regulations with respect to the research, development, manufacture, marketing and transfer of Licensed Products and related technical data, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulation (collectively, the “Export Laws”). To this end, Licensee shall take all actions necessary to comply with the Export Laws. Licensee hereby represents and covenants that Licensee:
(i) | Is neither a national of nor controlled by a national of any country to which the United States prohibits the export or re-export of goods, services, or technology; |
(ii) | Is not a person specifically designated as ineligible to export from the United States or deal in U.S.-origin goods, services, or technologies; |
(iii) | Shall not export or re-export, directly or indirectly, any goods, services, or technology, to any country or person (including juridical persons) to which the United States prohibits the export of goods, technology or services; and |
(iv) | In the event that a United States government license or authorization is required for an export or re-export of goods, services, or technology (including technical information acquired from Licensor under this Agreement and/or any products created by using such technical information or any part thereof), the Licensee shall obtain any necessary United States government license or other authorization prior to undertaking the export or re-export. |
Licensee shall include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable export laws and regulations and other applicable laws and regulations.
11. | Representations and Disclaimers |
11.1 | Licensor Representations |
Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or agent of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent & Technology License Agreement), (ii) Licensor has the right to grant the license and sublicense hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.
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11.2 | Government Rights |
Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.
11.3 | Licensor Disclaimers |
EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, NONINFRINGEMENT, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY CLAIM OR PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD OF USE. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN.
11.4 | Licensee Representation |
By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (c) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent & Technology License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent & Technology License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.
12. | Limit of Liability |
IN NO EVENT SHALL LICENSOR, OSU, OR THEIR INVENTORS, OFFICERS, EMPLOYEES, STUDENTS, TRUSTEES, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
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13. | Indemnification |
13.1 | Indemnification Obligation |
Licensee agrees to hold harmless, defend and indemnify Licensor, OSU, and their officers, employees, students, inventors, trustees, agents, and consultants (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Licensee shall have no responsibility or obligation under the section for any Liabilities to the extent caused by the gross negligence or willful misconduct by Licensor.
14. | Insurance |
14.1 | Insurance Requirements |
Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, its officers, and employees named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.
14.2 | Evidence of Insurance and Notice of Changes |
Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least sixty (60) days prior to Licensee cancelling, not renewing, or materially changing such insurance.
15. | Assignment |
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld. For any permitted assignment to be effective, (a) Licensee must be in good standing under this Agreement, (b) the Licensee must pay Licensor the assignment fee pursuant to Section 3.1(f), and (c) the assignee must assume in writing (a copy of which shall be promptly provided to Licensor) all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if assignee were an original Party to the Agreement.
16. | Governmental Markings |
16.1 | Patent Markings |
Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.
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16.2 | Governmental Approvals and Marketing of Licensed Products and or Licensed Services |
Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.
16.3 | Foreign Registration and Laws |
Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products and Licensed Services to the extent there is no conflict with United States law, in which case United States law will control.
17. | Use of Name |
Licensee will not use the name, trademarks or other marks of Licensor or OSU without the advance written consent of Licensor and OSU. Licensor and OSU may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent.
18. | Notices |
Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Patent & Technology License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.
Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent & Technology License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.
19. | General Provisions |
19.1 | Binding Effect |
The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.
19.2 | Construction of Agreement |
Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.
19.3 | Counterparts and Signatures |
The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.
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19.4 | Compliance with Laws |
Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.
19.5 | Governing Law |
The Agreement will be construed and enforced in accordance with laws of the State of Ohio, without regard to choice of law and conflicts of law principles.
19.6 | Modification |
Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.
19.7 | Severability |
If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.
19.8 | Third Party Beneficiaries |
Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties, OSU and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent & Technology License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).
19.9 | Waiver |
Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.
19.10 | Sovereign Immunity |
Nothing in the Agreement shall be deemed or treated as any waiver of OSU’s sovereign immunity.
19.11 | Entire Agreement |
The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.
19.12 | Claims Against Licensor for Breach of Agreement |
Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be brought in a court of competent jurisdiction in Ohio and this is Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor.
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19.13 | Grant of Security Interest |
Licensee hereby grants to Licensor a security interest in and to Licensee's rights under the Patent & Technology License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.
— END OF EXHIBIT A —
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EXHIBIT B
COMMERCIALIZATION PLAN
EXIHIBIT C
PATENT APPLICATIONS
Tech ID |
App. Title | Terr. | App. No. | Filing Date |
Pub. No. | Pub. Date |
2008-008 | Micro-RNA Signatures in Human Ovarian Cancer | Au | 2008296022 | 2/25/2010 | WO2009/033140 | 3/25/2010 |
2008-008 | Ca | 2698771 | 3/5/2010 | |||
2008-008 | CN | 2008-80112585.9 | 4/21/2010 | 101939446 | 1/12/2011 | |
2008-008 | Eu | 8799295.4 | 2/26/2010 | 2183393 | 3/12/2009 | |
2008-008 | JP | 2010-538610 | 4/30/2010 | |||
2008-008 | US | 12/676,670 | 3/31/2010 | 20100249213 | 9/30/2010 | |
2009-034 | Micro-RNA Based Methods and Compositions for the Diagnosis and Treatment of Ovarian Cancer | CA | 2745746 | 6/3/2011 | ||
2009-034 | CN | 200980155340.9 | 7/26/2011 | 102292456 | 12/21/2011 | |
2009-034 | EU | 9830750.7 | 6/23/2011 | 2373815 | 10/12/2011 | |
2009-034 | JP | 2011-539528 | 6/6/2011 | 2012-510813 | ||
2009-034 | US | 13/132,583 | 6/29/2011 | 2011-0275534 | 11/10/2011 | |
2012-030 | Methods and Materials Related to Ovarian Cancer | US | 13/651,679 | 10/15/2012 |
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2007-028 | Ultraconserved Regions encoding ncRNAs | AU | 2008283997 | |||
2007-028 | CA | 2,695,514 | ||||
2007-028 | CN | 2008-80108689.2 | ||||
2007-028 | EU | 08782609.5 | ||||
2007-028 | JP | 2010-519269 | ||||
2007-028 | US | 12/672,014 ALLOWED |
||||
2010-126 | Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | AU | 2011232669 | 09/24/12 | ||
2010-126 | CA | 2,794,142 | 09/24/12 | |||
2010-126 | EU | 11760035.3 | 09/24/12 | |||
2010-126 | JP | 2013-502642 | 09/26/12 | |||
2010-126 | US | 13/637,490 | 11/15/12 |
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AMENDMENT NO. 1 TO LICENSE AGREEMENT
This Amendment No. 1 to License Agreement (“Amendment”), having an effective date of January 15, 2014 (“Amendment Effective Date”), is made and entered by and between Ohio State Innovation Foundation, located at 1524 North High Street, Columbus, Ohio 43201 (“OSIF”) and MicroLin Bio, Inc., a New York corporation located at 302A W. 12th Street, Suite 114, New York, NY 10014 (“Licensee”).
BACKGROUND
OSIF and Licensee entered into a Patent & Technology License Agreement dated September 6, 2013 (“License Agreement”) with respect to Ohio State # A2013-2069; and
OSIF and Licensee would like to amend and modify the License Agreement as identified below and such amendment shall be incorporated as part of the License Agreement.
The parties agree as follows:
1. | Definitions. All capitalized terms used herein and not otherwise defined herein shall have the meanings assigned to such terms in the License Agreement. |
2. | In Section 3.1(a) for Tech ID# 2009-034, delete “Costs already accounted for in Agreement# A2013-0887 having an Effective Date of May 7, 2013 between the parties” and replace it with: $82,895.82. |
3. | In Section 3.1(a) for Tech ID# 2009-034, delete “August 29, 2013” and replace it with: January 15, 2014. |
4. | In Section 3.1(a) for Total, delete “$397,024.97” and replace it with: $479,920.79 |
5. | In Section 3.1(c) for Upfront Fee, delete “$95,000” and replace it with: $120,000. |
6. | In Exhibit C for Patent Applications for Tech ID 2009-034, Australian (AU) PCT application #2009322907; filing date of 03/25/2009 shall be amended into the exhibit. |
7. | Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which together shall constitute an agreement, notwithstanding that all parties are not signatories to the same counterpart. |
8. | Continued Force and Effect. Except as provided in this Amendment, all terms, conditions, and provisions of the License Agreement shall remain and continue in full force and effect as provided therein. |
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IN WITNESS WHEREOF, the parties hereto have entered into this Amendment effective as of the Amendment Effective Date.
[AUTHORIZED SIGNATURES APPEAR ON THE FOLLOWING PAGE]
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OHIO STATE INNOVATION FOUNDATION | Microlin bio, inc | |||
By: | /s/ Timothy R. Wright | By: | /s/ Joseph Hernandez | |
Name: | Timothy R. Wright | Name: | Joseph Hernandez | |
Title: | President | Title: | CEO and President | |
Date: | January 15, 2014 | Date: | January 15, 2014 |
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***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
PATENT & Technology LICENSE AGREEMENT
AGT. No. A2014-0164
This Patent & Technology License Agreement is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).
No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.
Background
Licensor owns, controls and/or has the right to sublicense the Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:
The Terms and Conditions of Patent & Technology License attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). The Commercialization Plan attached hereto as Exhibit B is incorporated herein by reference in its entirety (the “Commercialization Plan”). In the event of a conflict between provisions of this Patent & Technology License Agreement and the Terms and Conditions, the provisions in this Patent & Technology License Agreement shall govern. Unless defined in this Patent & Technology License Agreement, capitalized terms used in this Patent & Technology License Agreement shall have the meanings given to them in the Terms and Conditions.
The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.
1. Definitions |
Effective Date | September 6, 2013 | |
Licensor | Ohio State Innovation Foundation, with an address at 1524 North High Street, Columbus, OH 43201. | |
Licensee
|
MicroLin Bio, Inc., a corporation, with its principle place of business at 302A West 12th Suite 114, New York, NY 10014 | |
Contract Year and Contract Quarters |
x Contract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31
| |
Territory | Worldwide |
Field of Use
|
Exclusive Field of Use for the diagnosis, prognosis and therapy/treatment of prostate cancer. |
Patent Rights/Technology Rights [See Exhibit C for individual patent application and patent information] |
App. No./ Date of Filing |
Title | Inventor(s) |
Jointly Owned? (Y/N; if Y, with whom?) |
Countries | Prosecution Counsel | |
PCT/US2007/000159 03/03/2007 [2006-138]
|
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | C. Croce S. Volinia G. Calin |
x No | US CA AU CN JP HK EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2006/035100 09/11/2006 [2006-009] |
Compositions and Methods for the Diagnosis and Therapy of BCL2-Associated Cancers | C. Croce G. Calin |
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2009/035470 02/27/2009 [2008-074] |
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Prostate Related Disorders | C. Croce S. Ambs |
x Yes, w/ The National Institutes of Health
[See section 20.1] |
US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC | |
PCT/US2008/072081 08/04/2008 [2007-028] |
Ultraconserved Regions Encoding ncRNAs | C. Croce
|
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC |
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PCT/US2011/029348 03/22/2011 [2010-126] |
Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | C. Croce N. Valeri
|
x No | US CA JP AU CN EP |
MacMillan, Sobanski, and Todd LLC |
USPTO Entity Status as of Effective Date
|
Check one box: x Small |
2.4. Diligence Milestones |
|
Milestones and deadlines | Milestone Events | Deadlines |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of prostate cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for prostate cancer therapeutics. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of prostate cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** |
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| Exclusive License (Life Sciences) Page 3 of 34 |
9. First Sale in any country outside of the United States of America of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. Milestone extension option and fees referenced in Section 20.3 may be applied to this Milestone. | *** |
3. Compensation |
3.1(a) | Patent expenses due upon Effective Date
(See Section 20.2) |
Amount | based
on invoices received as of: | |
Tech ID 2006-138 | $280,268.65 | 09/06/13 | ||
Tech ID 2006-009 | $171,536.27 | 09/06/13 | ||
Tech ID 2008-074 | $94,006.76 | 09/06/13 | ||
Tech ID 2007-028 | Costs already accounted for in an Agreement having an Effective Date of September 6, 2013 between the parties. | 09/06/13 | ||
Tech ID 2010-126 | Costs already accounted for in an Agreement having an Effective Date of September 6, 2013 between the parties. | 09/06/13 | ||
Total | $545,811.68 | 09/06/13 |
3.1(b) | Milestone fees
|
Milestone Events | Milestone Fees |
1. Completion of Commercialization Plan for use of Licensed Product or Licensed Service for early diagnosis of prostate cancer. | *** | ||
2. Hiring of experienced executive management, sales, and research team for the commercialization of Licensed Product or Licensed Service. | *** | ||
3. External funding or equity financing of greater than or equal to $500,000 received by Licensee for the purpose of advancing Licensed Products and/or Licensed Service. | *** | ||
4. CLIA validation of first Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. | *** | ||
5. Execute a Sublicense Agreement for the development and/or establishment of a research development program for prostate cancer therapeutics. | *** (Associated fees referenced in Sections 3.1e and 20.4) |
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| Exclusive License (Life Sciences) Page 4 of 34 |
6. Complete financing in which Licensee receives $10,000,000 or greater for the purpose of advancing Licensed Product and/or Licensed Service. | *** | ||
7. Establishment of clinical insurance reimbursement for the diagnosis and/or prognosis of prostate cancer. | *** | ||
8. First Sale in the United States of America of the first Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. | *** | ||
9. First Sale in any country outside of the United States of America of a Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer. | *** |
3.1(c) | Upfront Fee | $5,000 due on Effective Date $95,000 due on or before May 31, 2014 |
3.1(d) | License Maintenance Fees
|
$25,000 due on May 31, 2015
|
3.1(e) | Sublicense Fees | *** of Non-Royalty Sublicensing Consideration for diagnostics and prognostics.
*** of Non-Royalty Sublicensing Consideration for therapeutics. |
3.1(f) | Assignment fee | For the Contract Year ending ***, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement.
For any Contract Year thereafter, the greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement. Assignments shall include assignments or transfers of the Agreement as part of a corporate reorganization, consolidation, merger or sale of substantially all of the assets or any other change of control
|
3.2 | Running royalty rate (applies to Sales by Licensee, Affiliates and Sublicensees) | (a) Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights | *** |
(b) Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights
|
*** |
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3.3 | Minimum royalty | *** for Contract Year ending *** *** for Contract Year ending *** *** per each subsequent Contract Year thereafter |
18. Contact Information |
Licensee Contacts | Licensor Contacts | |
Contact for Notice: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Accounting contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Patent prosecution contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
|
Contact for Notice: Attn: President 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: techlicensing@osu.edu
Payment and reporting contact: Checks payable to “Ohio State Innovation Foundation” Attn: Accounting/Compliance 1524 North High Street Columbus, Ohio 43201 Fax: 614-292-8907 Phone: 614-292-1315 Email: OSIFCompliance@osu.edu
Patent prosecution contact: Attn: Catherine Martineau MacMillan, Sobanski , & Todd, LLC ; Patent, Trademark, Copyright and Intellectual Property Law One Maritime Plaza, Fifth Floor 720 Water Street Toledo, Ohio 43604-1853 419-255-5900 (voice) 419-255-9639 (fax) E-mail: martineau@mstfirm.com Internet: http//www.mstfirm.com |
For Licensor Administrative Purposes Only |
Changes to Standard Form Terms and Conditions | There have not been any revisions to Licensor’s standard form Terms and Conditions , except for revisions to the following sections: 7
|
20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent & Technology License Agreement.
Section 20.1 Inter-Institutional Agreement. Pursuant to an Inter-Institutional Agreement (NIH reference number L-003-2009) having an effective date of October 23, 2008 between Licensor and National Institutes of Health (NIH), NIH has granted Licensor the ability to grant license rights in the patent indicated in Section 1 as jointly owned by Licensor and NIH.
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Section 20.2 Payment Schedule for Past Patent Expenses. Licensee will repay the past patent expenses referenced in Section 3.1(a) above upon the earlier of: (1) the payment due dates on the following schedule (shown below); or (2) Licensee has cumulative external funding (any combination of government grant, government contract, or private equity) of at least $10,000,000. In the event that $10,000,000 of external funding is obtained by Licensee, all unpaid amounts of past patent expenses shall become immediately due and payable to Licensor. The payments below include interest at the rate of 3.50% per annum. Should this Agreement be terminated, all patent expenses are immediately due and payable by Licensee to Licensor.
Pmt. No. | Payment Date | Beginning Balance | Scheduled Payment | Principal | Interest | Ending Balance | ||||||||||||||||
1 | 10/31/2013 | $ | 545,811.68 | $ | 25,000 | $ | 15,448.30 | $ | 9,551.70 | $ | 530,363.38 | |||||||||||
2 | 12/31/2013 | $ | 530,363.38 | $ | 25,000 | $ | 15,718.64 | $ | 9,281.36 | $ | 514,644.74 | |||||||||||
3 | 7/31/2014 | $ | 514,644.74 | $ | 25,000 | $ | 15,993.72 | $ | 9,006.28 | $ | 498,651.02 | |||||||||||
4 | 12/31/2014 | $ | 498,651.02 | $ | 25,000 | $ | 16,273.61 | $ | 8,726.39 | $ | 482,377.41 | |||||||||||
5 | 6/30/2015 | $ | 482,377.41 | $ | 62,695.51 | $ | 58,474.70 | $ | 4,220.80 | $ | 423,902.71 | |||||||||||
6 | 9/30/2015 | $ | 423,902.71 | $ | 62,695.51 | $ | 58,986.36 | $ | 3,709.15 | $ | 364,916.35 | |||||||||||
7 | 12/31/2015 | $ | 364,916.35 | $ | 62,695.51 | $ | 59,502.49 | $ | 3,193.02 | $ | 305,413.86 | |||||||||||
8 | 3/31/2016 | $ | 305,413.86 | $ | 62,695.51 | $ | 60,023.14 | $ | 2,672.37 | $ | 245,390.72 | |||||||||||
9 | 6/30/2016 | $ | 245,390.72 | $ | 62,695.51 | $ | 60,548.34 | $ | 2,147.17 | $ | 184,842.39 | |||||||||||
10 | 9/30/2016 | $ | 184,842.39 | $ | 62,695.51 | $ | 61,078.14 | $ | 1,617.37 | $ | 123,764.25 | |||||||||||
11 | 12/31/2016 | $ | 123,764.25 | $ | 62,695.51 | $ | 61,612.57 | $ | 1,082.94 | $ | 62,151.68 | |||||||||||
12 | 3/31/2017 | $ | 62,151.68 | $ | 62,151.68 | $ | 61,607.85 | $ | 543.83 | $ | 0.00 |
Each of the Licensed Patents listed in a separate row in Section 1 shall constitute a single patent family. The past patent expenses set forth in Section 3.1(a) are separated out and each entry corresponds to a particular single patent family identified in Section 1. Certain of the past patent expenses for a single patent family may also be covered by one or more separate agreements between Licensor and Licensee (a “Multi-Covered Patent Expense”). Licensor does not intend for Licensee to pay double for Multi-Covered Patent Expense.
Section 20.3 Milestone Extension Option. Licensee shall have the one-time option to extend the deadlines for those Milestone Events specified in said Section 2.4 by three (3) months by paying a milestone extension fee of *** for each such extension. This option may only be exercised at a time when Licensee is in compliance with all of its obligations under the Agreement, including having met all milestones with deadlines prior to the date such notice is given (without giving effect to the extension resulting from the exercise of such option). In order to exercise this option, Licensee must provide Licensor written notice of its exercise of this option accompanied by payment of the milestone extension fee. Such notice must contain an affirmation from the Licensee that it is in compliance with all of its obligations under the Agreement, that it has and is currently using commercially reasonable efforts to implement the Commercialization Plan and Actively Commercialize Licensed Products or Licensed Services and that it reasonably expects to meet the milestone deadlines as extended by the exercise of such option.
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Section 20.4 Therapeutic Research and Development. Licensee shall launch a research and development program for the licensed therapeutic rights pursuant to the therapeutic milestone events and fees outlined below, unless Licensee executes a Sublicense Agreement as set forth in Milestone 5 in section 2.4 above. Should Licensee not execute a Sublicense Agreement as set forth in Milestone 5, Licensee shall pay a fee of *** to the Licensor and provide a detailed Commercialization Plan for the licensed therapeutic rights to Licensor within forty-five days of the Deadline for Milestone 5.
Therapeutic Milestone Events | Deadlines | Therapeutic Milestone Fees |
1. In-license acquisition and/or development of therapeutic delivery platform. | *** | *** |
2. Regulatory Approval of IND filing by Regulatory Authority. | *** | *** |
3. Dosing of first patient by a Regulatory Authority approved Phase I Clinical Trial of Licensed Product. | *** | *** |
4. Dosing of first patient by a Regulatory Authority approved Phase II Clinical Trial of Licensed Product. | *** | *** |
5. Dosing of first patient by a Regulatory Authority approved Phase III Clinical Trial of Licensed Product. | *** | *** |
6. Regulatory Approval of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
7. Launch of Licensed Product in a major licensed country (e.g. US, EU country, or JP). | *** | *** |
8. Regulatory Approval of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
9. Launch of Licensed Product in a non-major licensed country. (e.g. CA, CN, or AU) | *** | *** |
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Section 20.5 Therapeutic Research and Development Sublicense. Should Licensee sublicense the licensed therapeutic and/or treatment rights, Licensee shall require milestones and fees at least as stringent as those outlined in section 20.4 above.
Section 20.6 Additional CLIA Product Launch. For each subsequent CLIA validation of Licensed Product or Licensed Service for diagnosis and/or prognosis of prostate cancer, launched after ***, Licensee shall pay Licensor ***.
Section 20.7 First Sale of Additional Products in United States of America. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer, Sold or launched after *** in any country outside of the United States, Licensee shall pay Licensor a fee of ***.
Section 20.8 First Sale of Additional Products in any Non-U.S.A. Country. For each subsequent first Sale of any new Licensed Product or Licensed Service for the diagnosis and/or prognosis of prostate cancer, which are Sold or launched after *** in the United States, Licensee shall pay Licensor a fee of ***.
Section 20.9 Identification of Sublicense Partners. For each Sublicensee brought to Licensee by Licensor that results in a successful negotiation of a Sublicense Agreement, Licensee shall pay to Licensor *** within thirty (30) days of the execution of said Sublicense Agreement.
Section 20.10 Termination Penalty. Should Licensee terminate this Agreement within two years of the Effective Date, Licensee shall pay Licensor two million five hundred thousand ($2,500,000) dollars in addition to the requirements of section 7 below.
Section 20.11 Diagnostic & Prognostic Sublicense. Licensee agrees to sublicense, nonexclusively and under reasonable terms, the diagnostic and/or prognostic field of use covered only by the Patent Rights/Technology Rights identified in Section 1 as jointly owned with the NIH and as referenced in section 20.1 above, to non-profit and commercial entities requesting such a sublicense or referred by Licensor or NIH to Licensee.
21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly represents and warrants and does hereby state and represent that no promise or agreement which is not herein expressed has been made to Licensee in executing this Patent & Technology License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby represents and warrants that Licensee understands and agrees to all terms and conditions set forth in this Patent & Technology License Agreement and said Terms and Conditions.
22. Deadline for Execution by Licensee. If this Patent & Technology License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent & Technology License Agreement shall be null and void and of no further effect.
IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent & Technology License Agreement.
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LICENSOR: Ohio State INNOVATION FOUNDATION | LICENSEE: MICROLIN BIO, INC. | |||
By | /s/ Timothy R. Wright | By | /s/ Joseph Hernandez | |
Timothy R. Wright | Joseph Hernandez | |||
Interim President | Chairman | |||
Date | 9/10/13 | Date | 9/10/2013 |
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EXHIBIT A
Terms and Conditions of Patent & Technology License
These Terms and Conditions of Patent & Technology License (“Terms and Conditions”) are incorporated by reference into the Patent & Technology License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.
1. | Definitions |
“Actively Commercialize” means having a commercially effective, reasonably funded (as compared to other similarly situated companies), ongoing and active research, development, manufacturing, marketing and/or sales program directed toward obtaining regulatory approval, production and/or Sales of Licensed Product(s) in a Field of Use in the Licensed Territory.
“Affiliate” means any business entity more than 50% owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee.
“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.
“CLIA” means Clinical Laboratory Improvement Amendments
“Commercialization Plan” means the written commercialization plan attached as Appendix B of the Patent & Technology License Agreement.
“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“…Covered By…” means a claim or claims within any pending or issued patent included in the Patent Rights claiming all, a portion, or a component or step of a Licensed Process, Licensed Product, or Licensed Service.
“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent & Technology License Agreement.
“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.
“FDA” means United States Food and Drug Administration.
“Field of Use” means the field indicated as the Field of Use identified in Section 1 of the Patent & Technology License Agreement.
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“Government” means any agency, department or other unit of the United States of America or the State of Ohio.
“Gross Consideration” means all cash and non-cash consideration (e.g., securities).
“IND” means investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights/Technology Rights in Section 1 of the Patent & Technology License Agreement.
“Licensed Process” means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.
“Licensed Product” means any product, apparatus, kit, test having a panel of either a single nucleotide or two or more nucleotides in combination or component thereof (i) whose manufacture, use, sale, offer for sale or import is Covered By any claim or claims included within the Patent Rights or incorporates any Technology Rights, or (ii) which is made using a Licensed Process or another Licensed Product.
“Licensed Service” means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.
“Licensed Subject Matter” means Patent Rights and/or Technology Rights
“Licensee” means the Party identified as the Licensee in Section 1 of the Patent & Technology License Agreement.
“Licensor” means the Party identified as the Licensor in Section 1 of the Patent & Technology License Agreement.
“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent & Technology License Agreement.
“Net Sales” means the Gross Consideration from the Sale of Licensed Products, Licensed Processes, or Licensed Services less the following items directly attributable to the Sale of such Licensed Products that are specifically identified on the invoice for such Sale and borne by the Licensee, Affiliates, or Sublicensees as the seller: (a) discounts and rebates actually granted; (b) sales, value added, use and other taxes and government charges actually paid, excluding income taxes; (c) import and export duties actually paid; (d) freight, transport, packing and transit insurance charges actually paid or allowed; and (e) other amounts actually refunded, allowed or credited due to rejections or returns, but not exceeding the original invoiced amount.
“Non-Royalty Sublicensing Consideration" means the Gross Consideration received by the Licensee or its Affiliate from a Sublicensee in consideration of the grant of a sublicense under the Licensed Subject Matter (including, without limitation, license or option or distribution fees, fees to maintain license rights, and bonus/milestone payments), but excluding amounts received as running royalties, a profit share, or other revenue sharing based on Net Sales for which Licensor receives a running royalty under Section 3.2. For the avoidance of doubt, Non-Royalty Sublicensing Consideration shall not include bona fide: (a) running royalties received by Licensee or an Affiliate based on Net Sales that are royalty-bearing to Licensor under Section 3.2, (b) purchase price for Licensee’s stock or other securities not in excess of Fair Market Value, and (iii) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by Licensee.
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“Patent & Technology License Agreement” means the particular Patent & Technology License Agreement to which these Terms and Conditions are attached and incorporated into by reference.
“Patent Rights” means the Licensor’s rights in: (a) the patents and patent applications listed in Section 1 of the Patent & Technology License Agreement; (b) all non-provisional patent applications that claim priority to any of the provisional applications listed in Section 1 of the Patent & Technology License Agreement to the extent the claims of such non-provisional applications are entitled to claim priority to such provisional applications; (c) all divisionals, continuations and continuations-in-part (excluding new matter and claims containing new matter) of the non-provisional patent applications identified in (a) and (b), above to the extent that claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above; (d) all reissues, reexaminations, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and (e) any patents that issue with respect to any of the patent applications listed in (a), (b) , (c) or (d), above. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.
"Phase I Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
"Phase II Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
"Phase IIA Clinical Trial" means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.
"Phase IIB Clinical Trial" means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.
"Phase III Clinical Trial" means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent & Technology License Agreement.
“Quarterly Payment Deadline” means the day that is thirty (30) days after the last day of any particular Contract Quarter.
“Regulatory Approval” means the approval needed by the Regulatory Authority for a particular national jurisdiction to market, Sell and use a Licensed Product or Licensed Service in that national jurisdiction.
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“Regulatory Authority” means the governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product or Licensed Service in a particular national jurisdiction, including without limitation FDA, European Medicines Agency or Koseisho (i.e., the Japanese Ministry of Health and Welfare).
“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products or Licensed Services for which consideration is received by Licensee, its Affiliates or Sublicensees. A Sale of Licensed Products or Licensed Services will be deemed completed at the time Licensee or its Affiliate or its Sublicensee receives such consideration.
“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.
“Sublicense Fee” means the fee specified in Section 3.1(e) of the Patent & Technology License Agreement.
“Sublicensee” means any entity to which an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product or Licensed Services within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee or an Affiliate for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.
“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at The Ohio State University (“OSU”) and within the Field of Use which are not Covered By any claim or claims included within the Patent Rights, but which are either (1) directly related to the Tech ID listed in Section 1 of the Patent & Technology License Agreement or (2) necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.
“Territory” means the territory so indicated as the Territory in Section 1 of the Patent & Technology License Agreement.
2. | License Grant and Commercialization |
2.1 | Grant |
(a) | Licensor grants to Licensee a royalty-bearing exclusive license under Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(b) | Licensor grants to Licensee a royalty-bearing non- exclusive sublicense under Technology Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
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(c) | This grant is subject to (i) the payment by Licensee to Licensor of all consideration required under the Agreement, (ii) any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights), and (iii) rights retained by Licensor to: |
(1) | Publish the scientific findings from research related to the Patent Rights; and |
(2) | Use the Licensed Subject Matter for teaching, research, patient care, education, and other educationally-related purposes; and |
(3) | Grant rights to, and transfer material embodiments of, the Licensed Subject Matter to other academic institutions or non-profit research institutions for the purposes identified in clauses (1) and (2) above. |
(d) Licensor reserves all rights not expressly granted in the Agreement including, but not limited to, any other licenses, implied or otherwise, to any patents or other rights of Licensor, regardless of whether such patents or other rights are dominant or subordinate to any rights expressly granted in the Agreement, or are required to exploit any rights expressly granted in the Agreement.
2.2 | Affiliates |
Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” herein shall include such Affiliate regardless of whether a specific reference to an “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution.
2.3 | Sublicensing |
Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:
(a) | A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by the applicable terms and conditions of the Agreement and shall indicate that Licensor is a third party beneficiary of the Sublicense Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Licensee has no right to grant a Sublicensee the right to grant further sub-Sublicense Agreements. |
(b) | Licensee shall deliver to Licensor a true, complete, and correct copy of each Sublicense Agreement granted by Licensee, Affiliate or Sublicensee, and any modification or termination thereof, within thirty (30) days following the applicable execution, modification, or termination of such Sublicense Agreement. All Sublicense Agreements will be in English. |
(c) | Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2 whether or not paid to Licensee by a Sublicensee. Any act or omission of a Sublicensee that would be a breach of the Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Licensor or any other terms and conditions of the Sublicense Agreement that would constitute a breach of the Agreement if such acts were performed by Licensee. |
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2.4 | Diligent Commercialization |
Licensee by itself or through its Affiliates and Sublicensees will use diligent and commercially reasonable efforts to implement the Commercialization Plan and to Actively Commercialize Licensed Products and/or Licensed Services (as applicable) in the Field of Use within the Territory. Without limiting the foregoing, Licensee will
(a) | maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make License Products and/or Licensed Services commercially available to the public as soon as commercially practicable, and |
(b) | fulfill the milestone events specified in Section 2.4 of the Patent & Technology License Agreement by the deadlines indicated therein. |
If the obligations under this Section 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b).
3. | Compensation |
In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent & Technology License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
3.1 | Non-Royalty Payments due from Licensee |
(a) | Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) and Section 20.1 of the Patent & Technology License Agreement within fifteen (15) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount. |
(b) | Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved. |
(c) | Upfront Fee. Licensee will pay the amount of the Upfront Fee set forth in Section 3.1(c) of the Patent & Technology License Agreement on the Effective Date. |
(d) | License Maintenance Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(d) of the Patent & Technology License Agreement in accordance with the stated schedule. |
(e) | Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter. |
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(f) | Assignment Fee. Licensee will pay the assignment fee set forth in Section 3.1(f) of the Patent & Technology License Agreement within fifteen (15) days of the assignment of the Agreement. |
3.2 | Royalties |
Licensee will pay running royalties on Net Sales in each Contract Quarter on or before the Quarterly Payment Deadline for such Contract Quarter, as follows: (a) at the rate set forth in Section 3.2(a) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights; and (b) at the rate set forth in Section 3.2(b) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights. No royalty shall be payable under this Section 3.2 with respect to (i) Sales to an Affiliate or Sublicensee of a particular unit of Licensed Product that is used by such Affiliate or Sublicensee to perform a Licensed Service if Licensor is paid a royalty on the Sale of such Licensed Service, (ii) the Sale of Licensed Products between or among Licensee, its Affiliates, and Sublicensees for re-sale purposes, provided Licensor is paid a royalty with respect to the re-sale, or (iii) payments that constitute Non-Royalty Sublicensing Consideration.
3.3 | Minimum Royalties |
If royalties paid to Licensor do not reach the minimum royalty amounts stated in Section 3.3 of the Patent & Technology License Agreement for the specified periods, Licensee will pay Licensor on or before the Quarterly Payment Deadline for the last Contract Quarter in the stated period an additional amount equal to the difference between the stated minimum royalty amount and the actual royalties paid to Licensor.
3.4 | Non-cash Consideration |
If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.
4. | Reports and Plans |
The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent & Technology License Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.
4.1 | Quarterly Payment and Milestone Reports |
On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall include:
(a) | The name of the Licensee, the Patent & Technology License Agreement number, and the period covered by the report; |
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(b) | The name of any Affiliates and Sublicensees whose activities are also covered by the report; |
(c) | Identification of each Licensed Product and Licensed Service for which any royalty payments have become payable; |
(d) | Net Sales segregated on a product-by-product basis, and a country-by-country basis, or an affirmative statement that no Sales were made. The report shall also itemize the permitted deductions from the Gross Consideration used to arrive at the resulting Net Sales, on a product-by-product and country-by-country basis; |
(e) | The applicable royalty rate; |
(f) | An affirmative statement of whether any milestones with deadlines in that Contract Quarter under Section 2.4 and any milestones under Section 3.1(b) were met or not, and the resulting Milestone Fee payable; |
(g) | Non-Royalty Sublicensing Consideration received by Licensee segregated on a Sublicense-by-Sublicense basis, or an affirmative statement that none was received; |
(h) | If any consideration was received in currencies other than U.S. dollars, the report shall describe the currency exchange calculations; and |
(i) | Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report. |
4.2 | Annual Written Progress Report and Commercialization Plan |
Within forty five (45) days following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products and Licensed Services, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products and Licensed Services for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:
(a) | The name of the Licensee, the Patent & Technology License Agreement number, the names of any Affiliates and Sublicensees, and the products and services being developed and/or commercialized; |
(b) | The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b); and |
(c) | The research and development activities, including status and plans for obtaining any necessary Regulatory Approvals, performed during the past year, and the plans for research and development activities for the next year. |
4.3 | Government and Economic Development Reporting |
If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:
(a) | Number and geographic location of new full-time employees created during the past Contract Year; total number and geographic location of full-time employees of Licensee at the end of such Contract Year; |
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(b) | Dollar amount of new equity financing received by Licensee during the past Contract Year, and current capitalization, including number and class of outstanding securities; |
(c) | Location and square footage of facilities; and |
(d) | Other information required under Federal and state law. |
This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than two hundred (200) full-time employees, then no further economic development reports will be required from Licensee.
5. | Payment, Records, and Audits |
5.1 | Payments |
All amounts referred to in the Patent & Technology License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent & Technology License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent & Technology License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
5.2 | Sales Outside the U.S. |
If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business day of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.
5.3 | Late Payments |
Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).
5.4 | Records |
For a period of six (6) years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Sales, Net Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.
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5.5 | Auditing |
Licensee and its Affiliates will permit Licensor or its representatives, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.
6. | Patent Expenses and Prosecution |
6.1 | Patent Expenses |
Licensee shall pay for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent & Technology License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a)), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Patent & Technology License Agreement and future expenses, within thirty (30) days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) will be considered a payment default under Section 7.3(a).
6.2 | Direction of Prosecution |
Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.
6.3 | Ownership |
All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent & Technology License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.
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6.4 | Foreign Filings |
In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.
6.5 | Withdrawal from Paying Patent Costs |
If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.
6.6 | U.S. Patent and Trademark Office Entity Size Status |
Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent & Technology License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.
7. | Term and Termination |
7.1 | Term |
Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue until the last date of expiration or termination of the Patent Rights, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of 20 years.
7.2 | Termination by Licensee |
Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.
7.3 | Termination by Licensor |
Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field of Use, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:
(a) | Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or |
(b) | Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within ninety (90) days after delivery of written notice from Licensor; |
(c) | Licensor delivers notice to Licensee of three or more actual breaches of the Agreement in any 12-month period, even in the event that Licensee cures such breaches in the allowed period; or |
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(d) | Licensee or its Affiliate or Sublicensee initiates any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights, or assist a third party in pursuing such a proceeding or action. |
7.4 | Other Conditions of Termination |
The Agreement will terminate:
(a) | Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files a bankruptcy action or becomes bankrupt or insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee ceases its business operations, or (iv) Licensee makes an assignment for the benefit of creditors, or (v) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee or trustee, whether by voluntary act of Licensee or otherwise; or |
(b) | At any time by mutual written agreement between Licensee and Licensor. |
7.5 | Effect of Termination |
If the Agreement is terminated for any reason:
(a) | All rights and licenses of Sublicensees shall terminate upon termination of the Agreement; provided however, if the Sublicense Agreement is for all of the Field of Use for all of the Territory, and the Sublicensee is in good standing and agrees in writing to assume all of the obligations of Licensee and provides Licensor with written notice thereof within thirty (30) days after termination of the Agreement, then such Sublicense Agreement shall survive; and |
(b) | Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products and performing Licensed Services by the effective date of termination; and |
(c) | Licensee shall tender payment of all accrued royalties and other payments due to Licensor as of the effective date of termination; and |
(d) | Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and |
(e) | The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses), and 20.2 (Payment Schedule for Past Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement. |
8. | Confidentiality |
8.1 | Definition |
“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.
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8.2 | Protection and Marking |
Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.
8.3 | Confidentiality of Terms of Agreement |
Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, Ohio Public Records laws, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If the Agreement is not for all fields of use, then Licensor may disclose the Field of Use to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.
8.4 | Disclosure Required by Court Order or Law |
If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.
8.5 | Copies |
Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.
8.6 | Continuing Obligations |
Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of three (3) years thereafter.
8.6 | Exclusions |
Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:
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(a) | Was in the public domain at the time of disclosure; or |
(b) | Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or |
(c) | Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or |
(d) | Was already known by the recipient Party at the time of disclosure; or |
(e) | Was independently developed by the recipient Party without use of the disclosing Party’s Confidential Information. |
8.8 | Copyright Notice |
The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.
9. | Infringement and Litigation |
9.1 | Notification |
If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.
9.2 | Licensee’s Enforcement Rights |
Licensee shall enforce the Patent Rights against any infringement by a third party in the Field in the Territory. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by Licensor in providing cooperation or joining as a party as provided in Section 9.4. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.
9.3 | Licensor’s Enforcement Rights |
If Licensee does not file suit within six (6) months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement. If Licensor pursues such infringement action, Licensor may, as part of the resolution of such efforts, grant non-exclusive license rights to the alleged infringer notwithstanding Licensee’s exclusive license rights.
9.4 | Cooperation between Licensor and Licensee |
In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.
If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s and the Ohio Attorney General’s prior written permission, which permission shall not be unreasonably withheld, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Ohio Attorney General regarding retention of outside counsel for state entities.
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9.5 | Contest of Validity |
(a) In the event Licensee or its Sublicensee(s) (or a third party on its behalf) files any action contesting the validity or enforceability of any Patent Rights and the provision in Section 7.3(d) is unenforceable, the Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall pay a royalty rate of one and a half (1.5) times the royalty rate specified in Section 3.2 for all Net Sales. Moreover, should the outcome of such contest determine that any claim of the Patent Rights challenged is both valid and would be infringed by a Licensed Product, Licensed Process, or Licensed Service sold by Licensee (or its Sublicensee(s) if such Sublicensee filed the action), if not for the license granted by this Agreement, Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall thereafter, and for the remaining term of this Agreement, pay a royalty rate of two (2) times the royalty rate specified in Section 3.2 for all Net Sales.
(b) In the event that Licensee or its Sublicensee(s) contests the validity or enforceability of any Patent Rights during the term of this Agreement, Licensee agrees (and shall require its Sublicensee(s) to agree) to pay to Licensor all royalties due under the Agreement during the period of challenge. For the sake of clarity, such amounts shall not be paid into any escrow or other account, but directly to Licensor, and shall not be refunded.
(c) In the event that a validity or non-infringement challenge of any Patent Rights brought by Licensee is successful, Licensee shall have no right to recoup any royalties paid before or during the period challenge.
10. | Export Compliance |
10.1 Licensee shall observe all applicable United States and foreign laws and regulations with respect to the research, development, manufacture, marketing and transfer of Licensed Products and related technical data, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulation (collectively, the “Export Laws”). To this end, Licensee shall take all actions necessary to comply with the Export Laws. Licensee hereby represents and covenants that Licensee:
(i) | Is neither a national of nor controlled by a national of any country to which the United States prohibits the export or re-export of goods, services, or technology; |
(ii) | Is not a person specifically designated as ineligible to export from the United States or deal in U.S.-origin goods, services, or technologies; |
(iii) | Shall not export or re-export, directly or indirectly, any goods, services, or technology, to any country or person (including juridical persons) to which the United States prohibits the export of goods, technology or services; and |
(iv) | In the event that a United States government license or authorization is required for an export or re-export of goods, services, or technology (including technical information acquired from Licensor under this Agreement and/or any products created by using such technical information or any part thereof), the Licensee shall obtain any necessary United States government license or other authorization prior to undertaking the export or re-export. |
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Licensee shall include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable export laws and regulations and other applicable laws and regulations.
11. | Representations and Disclaimers |
11.1 | Licensor Representations |
Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or agent of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent & Technology License Agreement), (ii) Licensor has the right to grant the license and sublicense hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.
11.2 | Government Rights |
Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement (NIH reference number L-003-2009) and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.
11.3 | Licensor Disclaimers |
EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, NONINFRINGEMENT, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY CLAIM OR PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD OF USE. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN.
11.4 | Licensee Representation |
By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (c) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent & Technology License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent & Technology License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.
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12. | Limit of Liability |
IN NO EVENT SHALL LICENSOR, OSU, OR THEIR INVENTORS, OFFICERS, EMPLOYEES, STUDENTS, TRUSTEES, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
13. | Indemnification |
13.1 | Indemnification Obligation |
Licensee agrees to hold harmless, defend and indemnify Licensor, OSU and their officers, employees, students, inventors, trustees, agents, and consultants (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Licensee shall have no responsibility or obligation under the section for any Liabilities to the extent caused by the gross negligence or willful misconduct by Licensor.
14. | Insurance |
14.1 | Insurance Requirements |
Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, its officers, and employees named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.
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14.2 | Evidence of Insurance and Notice of Changes |
Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least sixty (60) days prior to Licensee cancelling, not renewing, or materially changing such insurance.
15. | Assignment |
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld. For any permitted assignment to be effective, (a) Licensee must be in good standing under this Agreement, (b) the Licensee must pay Licensor the assignment fee pursuant to Section 3.1(f), and (c) the assignee must assume in writing (a copy of which shall be promptly provided to Licensor) all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if assignee were an original Party to the Agreement.
16. | Governmental Markings |
16.1 | Patent Markings |
Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.
16.2 | Governmental Approvals and Marketing of Licensed Products and or Licensed Services |
Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.
16.3 | Foreign Registration and Laws |
Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products and Licensed Services to the extent there is no conflict with United States law, in which case United States law will control.
17. | Use of Name |
Licensee will not use the name, trademarks or other marks of Licensor or OSU without the advance written consent of Licensor and OSU. Licensor and OSU may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent.
18. | Notices |
Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Patent & Technology License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.
Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent & Technology License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.
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19. | General Provisions |
19.1 | Binding Effect |
The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.
19.2 | Construction of Agreement |
Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.
19.3 | Counterparts and Signatures |
The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.
19.4 | Compliance with Laws |
Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.
19.5 | Governing Law |
The Agreement will be construed and enforced in accordance with laws of the State of Ohio, without regard to choice of law and conflicts of law principles.
19.6 | Modification |
Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.
19.7 | Severability |
If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.
19.8 | Third Party Beneficiaries |
Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties, OSU and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent & Technology License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).
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19.9 | Waiver |
Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.
19.10 | Sovereign Immunity |
Nothing in the Agreement shall be deemed or treated as any waiver of OSU’s sovereign immunity.
19.11 | Entire Agreement |
The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.
19.12 | Claims Against Licensor for Breach of Agreement |
Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be brought in a court of competent jurisdiction in Ohio and this is Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor.
19.13 | Grant of Security Interest |
Licensee hereby grants to Licensor a security interest in and to Licensee's rights under the Patent & Technology License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.
— END OF EXHIBIT A —
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EXHIBIT B
COMMERCIALIZATION PLAN
EXIHIBIT C
PATENT APPLICATIONS
Tech ID | App. Title | Terr. | Patent or App. No. |
Filing Date |
2006-138 | MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Solid Cancers | Au | 2007205163 | 07/03/08 |
2006-138-1 | Ca |
2633754 (Allowed claims) |
01/03/07 | |
2006-138-58 | Ca | wAITING ON APPLICATION NUMBER | 03/29/13 | |
2006-138 | CN | 2007-80005821.2 | 07/03/08 | |
2006-138-2 | Ep | 12154246.8 | 03/05/12 | |
2006-138-3 | Ep | 12154298.9 | 01/03/07 | |
2006-138-5 | ep | 12154301.1 | 01/03/07 | |
2006-138-6 | ep | 12154304.5 | 01/03/07 | |
2006-138-7 | ep | 12154307.8 | 01/03/07 | |
2006-138-10 | ep | 12154322.7 | 03/05/12 | |
2006-138-12 | ep | 12154327.6 | 03/05/12 |
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2006-138-13 | ep | 12154329.2 | 03/05/12 | |
2006-138-16 | ep | 12154337.5 | 03/05/12 | |
2006-138-17 | ep | 12154339.1 | 03/05/12 | |
2006-138-18 | ep | 12154341.7 | 03/05/12 | |
2006-138-19 | ep | 12154342.5 | 01/03/07 | |
2006-138-23 | ep | 12154346.6 | 03/01/12 | |
2006-138-29 | ep | 12154352.4 | 03/01/12 | |
2006-138 | hk | 09108431.1 | 01/03/07 | |
2006-138 | JP | 2008-549555 | 01/03/07 | |
2006-138 | jp | 2012-183280 | 09/08/12 | |
2006-138-1 | us | 8,148,069 | 07/03/08 | |
2006-138-2 | US | 13/405,517 | 02/27/12 | |
2006-138-4 | us | 13/405,543 | 02/27/12 | |
2006-138-11 | us | 13/406,630 | 02/28/12 | |
2006-138-17 | us | 13/407,898 | 02/29/12 | |
2006-009 | Compositions and Methods for the Diagnosis and Therapy of BCL-2 Associated Cancers | au |
2006291165 ALLOWED |
09/11/06 |
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2006-009 | ca | 2,621,441 | 09/11/06 | |
2006-009 | cn |
ZL200680039776.8 ISSUED |
09/11/06 | |
2006-009 | cn | 2012-10380806.9 | 10/10/12 | |
2006-009 | ep | 06814375.9 | 09/11/06 | |
2006-009 | jp | 2008-531200 | 09/11/06 | |
2006-009 | jp | 2013-081761 | 09/11/06 | |
2006-009 | us |
11/991,773 allowed |
05/14/08 | |
2008-074 Joint with NIh |
MicroRNA-Based Methods and Compositions for the Diagnosis, Prognosis and Treatment of Prostate Related Disorders | au | 2009219197 | 02/27/09 |
2008-074 Joint with NIh |
ca | 2,716,938 | 02/27/09 | |
2008-074 Joint with NIh |
cn | 2009-80111708.1 | 02/27/09 | |
2008-074 Joint with NIh |
ep | 09715064.3 | 02/27/09 | |
2008-074 Joint with NIh |
jp | 2010-548904 | 02/27/09 |
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2008-074 Joint with NIh |
us | 13/622,487 | 09/19/12 | |
2007-028 | Ultraconserved Regions Encoding ncRNAs | AU | 2008283997 | 02/11/10 |
2007-028 | CA | 2,695,514 | 02/03/10 | |
2007-028 | CN | 2008-80108689.2 | 08/04/08 | |
2007-028 | EP | 08782609.5 | 02/04/10 | |
2007-028 | JP | 2010-519269 | 01/28/10 | |
2007-028 | US |
12/672,014 ALLOWED |
02/03/10 | |
2010-126 | Materials and Methods Related to Modulation of Mismatch Repair and Genomic Stability by miR-155 | au | 2011232669 | 09/24/12 |
2010-126 | CA | 2,794,142 | 09/24/12 | |
2010-126 | CN | 2011-80022637.5 | 09/24/12 | |
2010-126 | EP | 11760035.3 | 09/24/12 | |
2010-126 | JP | 2013-502642 | 09/26/12 | |
2010-126 | US | 13/637,490 | 11/15/12 |
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***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
PATENT & Technology LICENSE AGREEMENT
AGT. No. A2014-0294
This Patent & Technology License Agreement is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).
No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.
Background
Licensor owns, controls, and/or has the right to sublicense the Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:
The Terms and Conditions of Patent & Technology License attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). The Commercialization Plan attached hereto as Exhibit B is incorporated herein by reference in its entirety (the “Commercialization Plan”). In the event of a conflict between provisions of this Patent & Technology License Agreement and the Terms and Conditions, the provisions in this Patent & Technology License Agreement shall govern. Unless defined in this Patent & Technology License Agreement, capitalized terms used in this Patent & Technology License Agreement shall have the meanings given to them in the Terms and Conditions.
The section numbers used in the left hand column in the table below correspond to the section numbers in the Terms and Conditions.
1. Definitions | ||
Effective Date | September 6, 2013 | |
Licensor | Ohio State Innovation Foundation, with an address at 1524 North High Street, Columbus, Ohio 43201. | |
Licensee |
MicroLin Bio, Inc., a corporation, with its principal place of business at 302A West 12th Suite 114, New York, NY 10014 | |
Contract Year and Contract Quarters | Contract Year is 12-month period ending on December 31 and Contract Quarters are 3-month periods ending on March 31, June 30, Sept. 30, Dec. 31 | |
Territory | Worldwide |
Licensee: [Company name] Licensor: [Name] | CONFIDENTIAL EXHIBIT A | Exclusive PLA (Physical Sciences) Page 1 of 29 |
Field of Use | Field of Use: Exclusive use of lipid nanoparticles (also referred to as quaternary and tertiary amine-cationic lipids “QTsome”, small peptide lipid nanoparticle-gramicidin and/or JTS-1 “SPLN-G”, and proteinase K-coated liposome “PrKsome”), as more particularly defined in Patent Rights/Technology Rights for the diagnosis, treatment, prevention and amelioration of human diseases and conditions.
Excluded Fields of Use include but are not limited to: (1) Use of the following technology described in Patent Rights/Technology Rights: L-CAN” – lipid-coated albumin nanoparticles (also referred to as “Hyper-cationized albumin-polycation conjugates”, “APC”, and “L-CAN”). | |
Patent Rights/Technology Rights |
App. No./ Date of Filing |
Title | Inventor(s) | Jointly Owned? (Y/N; if Y, with whom?) |
Prosecution Counsel | |
61/650,729 May 23, 2012 [2012-284] |
Novel Liposomal Formulation for Drug Delivery | R. Lee
|
x No | Michael Steffensmeier (Ohio State) | |
61/784,892 March 14, 2013 [2013-246] |
Nanoparticle Compositions for Nucleic Acid Delivery | R. Lee | x No | MacMillan, Sobanski, and Todd LLC | |
PCT/US2013/042458 May 23, 2013 [2012-284] [2013-246] |
Lipid Nanoparticle Compositions and Methods of Making and Methods of Using the Same | R. Lee
|
x No | MacMillan, Sobanski, and Todd LLC |
2.4. Diligence Milestones | |||
|
Milestones and deadlines | Milestone Events | Deadlines |
1. Enter into a Sponsored Research Agreement (SRA) with Licensor with Dr. Robert Lee as the principal investigator for at least *** cash | *** | ||
2. Initiation of cGMP manufacturing and GLP-toxicity studies for first Licensed Product | *** | ||
3. Filing of IND (or an equivalent regulatory application, if filed outside of the United States) for first Licensed Product(s) | *** | ||
4. Dosing of first patient in any Phase II Clinical Trial of first Licensed Product(s) | *** | ||
5. Dosing of first patient in any Phase III Clinical Trial of first Licensed Product(s) | *** |
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6. Filing of Marketing Application with FDA (or an equivalent regulatory agency, if filed outside the United States) for first Licensed Product | *** | ||
7. Regulatory approval of Marketing Application for first Licensed Product in a Major Territory (US, Europe, Japan) | *** | ||
8. First sale of first Licensed Product(s) in a Major Territory (US, Europe, Japan) | *** | ||
9. Regulatory approval of Marketing Application for first Licensed Product in each BRICS Territory (Brazil, Russia, China, India, South Korea) | *** | ||
10. First sale of first Licensed Product in a BRICS Territory (Brazil, Russia, China, India, South Korea) | *** |
3. Compensation | |||
3.1(a) | Patent expenses due upon Effective Date | Amount | based on invoices received as of: |
$5,952.50 | June 30, 2013 |
3.1(b) | Milestone fees | Milestone Events | Milestone Fees |
1. Enter into a Sponsored Research Agreement (SRA) with Licensor with Dr. Robert Lee as the principal investigator for *** cash | *** as funding for the SRA | ||
2. Initiation of cGMP manufacturing and GLP-toxicity studies for first Licensed Product | *** for first Non-OSU Product | ||
3. Filing of IND (or an equivalent regulatory application, if filed outside the United States) for each Major Disease Area for each Licensed Product | *** for each Major Disease Area for each Non-OSU Product; *** for each Major Disease Area for each OSU Product | ||
4. Dosing of first patient in any Phase II Clinical Trial for each Major Disease Area for each Licensed Product | *** for each Major Disease Area for each Non-OSU Product; *** for each Major Disease Area for each OSU Product | ||
5. Dosing of first patient in any Phase III Clinical Trial for each Major Disease Area for each Licensed Product | *** for each Major Disease Area for each Non-OSU Product; *** for each Major Disease Area for each OSU Product |
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6. Filing of Marketing Application with FDA (or an equivalent regulatory agency, if filed outside the United States) for each Major Disease Area for each Licensed Product | *** for each Major Disease Area for each Non-OSU Product; *** for each Major Disease Area for each OSU Product | ||
7. Regulatory approval of Marketing Application for each Licensed Product in each Major Territory (US, Europe, Japan) | *** for each Major Disease Area for each Non-OSU Product in each Major Territory; *** for each Major Disease Area for each OSU Product in each Major Territory | ||
8. First sale of each Licensed Product for each Major Disease Area in each Major Territory (US, Europe, Japan) | *** for each Major Disease Area for each Non-OSU Product in each Major Territory; *** for each Major Disease Area for each OSU Product in each Major Territory | ||
9. Regulatory approval of each Marketing Application for each Licensed Product in each BRICS Territory (Brazil, Russia, China, India, South Korea) | *** for each Major Disease Area for each Non-OSU Product in each BRICS territory; *** for each Major Disease Area for each OSU Product in each BRICS territory | ||
10. First sale of each Licensed Product for each Major Disease Area in each BRICS Territory (Brazil, Russia, India, China, S. Korea) | *** for each Major Disease Area for each Non-OSU Product in each BRICS Territory; *** for each Major Disease Area for each OSU Product in each BRICS Territory | ||
3.1(c) | Upfront Fee | $5,000 due upon Effective Date $95,000 due May 31, 2014 | |
3.1(d) | License Maintenance Fees |
$10,000 due on May 31st of every Contract Year beginning in 2015. | |
3.1(e) | Sublicense Fees | *** of Non-Royalty Sublicensing Consideration | |
3.1(f) | Assignment fee | The greater of *** (USD) or *** of Gross Consideration of the total transaction value received by Licensee for any transaction that includes the assignment or transfer of any portion of this Agreement. |
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3.2 | Running royalty rate (applies to Sales by Licensee, Affiliates and Sublicensees) | (a) Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights | *** for Non-OSU Products; *** for OSU Products |
(b) Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights | *** for Non-OSU Products; *** for OSU Products |
3.3 | Minimum royalty | *** |
3.1(g) | Sales Milestones | *** upon first Licensed Product with cumulative Net Sales equal to ***. *** upon first Licensed Product with cumulative Net Sales equal to *** *** |
18. Contact Information |
Licensee Contacts | Licensor Contacts | |
Contact for Notice: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Accounting contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
Patent prosecution contact: Attn: Joseph Hernandez 302A West 12th Suite 114 New York, NY 10014 Phone: 646-707-2937 Email: hernandez_joe@yahoo.com
|
Contact for Notice: Attn: President 1524 North High Street Columbus, OH 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: techlicensing@osu.edu
Payment and reporting contact: Checks payable to “Ohio State Innovation Foundation” Attn: Accounting/Compliance 1524 North High Street Columbus, OH 43201 Fax: 614-292-8907 Phone: 614-292-1315 E-mail: OSIFcompliance@osu.edu
Patent prosecution contact: Attn: Catherine Martineau MacMillan, Sobanski , & Todd, LLC ; Patent, Trademark, Copyright and Intellectual Property Law One Maritime Plaza, Fifth Floor 720 Water Street Toledo, Ohio 43604-1853 419-255-5900 (voice) 419-255-9639 (fax) E-mail: martineau@mstfirm.com Internet: http//www.mstfirm.com |
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For Licensor Administrative Purposes Only |
Changes to Standard Form Terms and Conditions | There have not been any revisions to Licensor’s standard form Terms and Conditions , except for revisions to the following sections: 7 |
20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Patent & Technology License Agreement.
20.1 Identification of Sublicense Partners. For each Sublicensee brought to Licensee by Licensor that results in a successful negotiation of a Sublicense Agreement, Licensee shall pay to Licensor *** dollars within thirty (30) days of the execution of said Sublicense Agreement.
20.2 Milestone Definitions
“Marketing Application” means the application or submission for marketing authorization of a Licensed Product filed with the United Sates Food and Administrations, or equivalent regulatory agency if filed in a country other than the United States.
“Major Disease Area” means a primary and distinct disease area, each with commercially reasonable market potential - to be further defined in the Terms and Conditions. For example, Major Disease Area may include but are not limited to Brain Cancer, Bladder Cancer, Lung Cancer, Breast Cancer, Melanoma, Colon and Rectal Cancer, Non-Hodgkin Lymphoma, Endometrial Cancer, Pancreatic Cancer, Kidney (Renal Cell) Cancer, Prostate Cancer, Leukemia Thyroid Cancer, Head and Neck Cancer, Ovarian Cancer, Hepatocellular Cancer, Cervical Cancer, Sarcomas, Gastric Cancers, Multiple Myeloma, Lymphomas, Gastrointestinal Cancer, and Uterine Cancer.
“cGMP” means the Current Good Manufacturing Practice regulations enforced by the FDA to assure the proper design, monitoring, and control of pharmaceutical-grade manufacturing processes and facilities for a Licensed Product.
“Major Territory” means the following: United States of America, Japan (JP), and Europe (EU).
“BRICS” means the means the following countries: Brazil, Russia, India, China, and South Korea.
“OSU Product(s)” means Licensed Product(s) and/or Licensed Service(s) that also qualify as “Licensed Products” and/or “Licensed Services” under a separate patent and technology license agreement (as defined as such under said separate license agreement) with Licensor.
“Non-OSU Product(s)” means Licensed Product(s) and/or Licensed Service(s) that do not also qualify as “Licensed Products” and/or “Licensed Services” under a separate patent and technology license agreement (as defined as such under said separate license agreement) with Licensor.
20.3 Cross Default. In the event that Licensee is a party to any other agreement with Licensor, a default by Licensee of this or any other agreement shall be deemed a default under all other agreements with Licensor.
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21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly represents and warrants and does hereby state and represent that no promise or agreement which is not herein expressed has been made to Licensee in executing this Patent & Technology License Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby represents and warrants that Licensee understands and agrees to all terms and conditions set forth in this Patent & Technology License Agreement and said Terms and Conditions.
22. Deadline for Execution by Licensee. If this Patent & Technology License Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within thirty (30) days of the date of signature set forth under the Licensor’s signature below, then this Patent & Technology License Agreement shall be null and void and of no further effect.
IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Patent & Technology License Agreement.
LICENSOR: Ohio State INNOVATION FOUNDATION | LICENSEE: MICROLIN BIO, INC. | |||
By | /s/ Timothy R. Wright | By | /s/ Joseph Hernandez | |
Timothy R. Wright | Joseph Hernandez | |||
Interim President | CEO and President | |||
Date | 9/10/13 | Date | 9/10/13 |
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EXHIBIT A
Terms and Conditions of Patent & Technology License
These Terms and Conditions of Patent & Technology License (“Terms and Conditions”) are incorporated by reference into the Patent & Technology License Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.
1. | Definitions |
“Affiliate” means any business entity more than 50% owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee.
“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.
“Commercialization Plan” means the written commercialization plan attached as Appendix B of the Patent & Technology License Agreement.
“Contract Quarter” means the three-month periods indicated as the Contract Quarter in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“Contract Year” means the 12-month periods indicated as the Contract Year in Section 1 of the Patent & Technology License Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.
“…Covered By…” means a claim or claims within any pending or issued patent included in the Patent Rights claiming all, a portion, or a component or step of a Licensed Process, Licensed Product, or Licensed Service.
“Effective Date” means the date indicated as the Effective Date in Section 1 of the Patent & Technology License Agreement.
“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.
“FDA” means United States Food and Drug Administration.
“Field of Use” means the field indicated as the Field of Use identified in Section 1 of the Patent & Technology License Agreement.
“Government” means any agency, department or other unit of the United States of America or the State of Ohio.
“Gross Consideration” means all cash and non-cash consideration (e.g., securities).
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“IND” means investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights/Technology Rights in Section 1 of the Patent & Technology License Agreement.
“Licensed Process” means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.
“Licensed Product” means any product, apparatus, kit, or component thereof (i) whose manufacture, use, sale, offer for sale or import is Covered By any claim or claims included within the Patent Rights or incorporates any Technology Rights, or (ii) which is made using a Licensed Process or another Licensed Product.
“Licensed Service” means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.
“Licensed Subject Matter” means Patent Rights and/or Technology Rights
“Licensee” means the Party identified as the Licensee in Section 1 of the Patent & Technology License Agreement.
“Licensor” means the Party identified as the Licensor in Section 1 of the Patent & Technology License Agreement.
“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Patent & Technology License Agreement.
“Net Sales” means the Gross Consideration from the Sale of Licensed Products, Licensed Processes, or Licensed Services less the following items directly attributable to the Sale of such Licensed Products that are specifically identified on the invoice for such Sale and borne by the Licensee, Affiliates, or Sublicensees as the seller: (a) discounts and rebates actually granted; (b) sales, value added, use and other taxes and government charges actually paid, excluding income taxes; (c) import and export duties actually paid; (d) freight, transport, packing and transit insurance charges actually paid or allowed; and (e) other amounts actually refunded, allowed or credited due to rejections or returns, but not exceeding the original invoiced amount.
“Non-Royalty Sublicensing Consideration" means the Gross Consideration received by the Licensee or its Affiliate from a Sublicensee in consideration of the grant of a sublicense under the Licensed Subject Matter (including, without limitation, license or option or distribution fees, fees to maintain license rights, and bonus/milestone payments), but excluding amounts received as running royalties, a profit share, or other revenue sharing based on Net Sales for which Licensor receives a running royalty under Section 3.2. For the avoidance of doubt, Non-Royalty Sublicensing Consideration shall not include bona fide: (a) running royalties received by Licensee or an Affiliate based on Net Sales that are royalty-bearing to Licensor under Section 3.2, (b) purchase price for Licensee’s stock or other securities not in excess of Fair Market Value, and (iii) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by Licensee.
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“Patent & Technology License Agreement” means the particular Patent & Technology License Agreement to which these Terms and Conditions are attached and incorporated into by reference.
“Patent Rights” means the Licensor’s rights in: (a) the patents and patent applications listed in Section 1 of the Patent & Technology License Agreement; (b) all non-provisional patent applications that claim priority to any of the provisional applications listed in Section 1 of the Patent & Technology License Agreement to the extent the claims of such non-provisional applications are entitled to claim priority to such provisional applications; (c) all divisionals, continuations and continuations-in-part (excluding new matter and claims containing new matter) of the non-provisional patent applications identified in (a) and (b), above to the extent that claims of such continuations-in-part are entitled to claim priority to at least one of the patent applications identified in (a) or (b), above; (d) all reissues, reexaminations, extensions, and foreign counterparts of any of the patents or patent applications identified in (a), (b) or (c), above; and (e) any patents that issue with respect to any of the patent applications listed in (a), (b) , (c) or (d), above. From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.
"Phase I Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
"Phase II Clinical Trial" means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.
"Phase IIA Clinical Trial" means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.
"Phase IIB Clinical Trial" means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.
"Phase III Clinical Trial" means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
“Prosecution Counsel” means the law firm or attorney who is handling the prosecution of the Patent Rights. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Patent & Technology License Agreement.
“Quarterly Payment Deadline” means the day that is thirty (30) days after the last day of any particular Contract Quarter.
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“Regulatory Approval” means the approval needed by the Regulatory Authority for a particular national jurisdiction to market, Sell and use a Licensed Product or Licensed Service in that national jurisdiction.
“Regulatory Authority” means the governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product or Licensed Service in a particular national jurisdiction, including without limitation FDA, European Medicines Agency or Koseisho (i.e., the Japanese Ministry of Health and Welfare).
“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products or Licensed Services for which consideration is received by Licensee, its Affiliates or Sublicensees. A Sale of Licensed Products or Licensed Services will be deemed completed at the time Licensee or its Affiliate or its Sublicensee receives such consideration.
“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.
“Sublicense Fee” means the fee specified in Section 3.1(e) of the Patent & Technology License Agreement.
“Sublicensee” means any entity to which an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product or Licensed Services within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee or an Affiliate for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.
“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at The Ohio State University (“OSU”) and within the Field of Use which are not Covered By any claim or claims included within the Patent Rights, but which are either (1) directly related to the Tech ID listed in Section 1 of the Patent & Technology License Agreement or (2) necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.
“Territory” means the territory so indicated as the Territory in Section 1 of the Patent & Technology License Agreement.
2. | License Grant and Commercialization |
2.1 | Grant |
(a) | Licensor grants to Licensee a royalty-bearing exclusive license under Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
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(b) | Licensor grants to Licensee a royalty-bearing non- exclusive sublicense under Technology Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field of Use in the Territory and to perform Licensed Services in the Field of Use in the Territory. |
(c) | This grant is subject to (i) the payment by Licensee to Licensor of all consideration required under the Agreement, (ii) any rights of, or obligations to, the Government as set forth in Section 11.2 (Government Rights), and (iii) rights retained by Licensor to: |
(1) | Publish the scientific findings from research related to the Patent Rights; and |
(2) | Use the Licensed Subject Matter for teaching, research, patient care, education, and other educationally-related purposes; and |
(3) | Grant rights to, and transfer material embodiments of, the Licensed Subject Matter to other academic institutions or non-profit research institutions for the purposes identified in clauses (1) and (2) above. |
(d) Licensor reserves all rights not expressly granted in the Agreement including, but not limited to, any other licenses, implied or otherwise, to any patents or other rights of Licensor, regardless of whether such patents or other rights are dominant or subordinate to any rights expressly granted in the Agreement, or are required to exploit any rights expressly granted in the Agreement.
2.2 | Affiliates |
Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” herein shall include such Affiliate regardless of whether a specific reference to an “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within thirty (30) calendar days following execution.
2.3 | Sublicensing |
Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:
(a) | A Sublicense Agreement shall not exceed the scope and rights granted to Licensee hereunder. Sublicensee must agree in writing to be bound by the applicable terms and conditions of the Agreement and shall indicate that Licensor is a third party beneficiary of the Sublicense Agreement. In the event of termination of this Agreement, continued sublicense rights shall be governed by Section 7.5(a) (Effect of Termination). Licensee has no right to grant a Sublicensee the right to grant further sub-Sublicense Agreements. |
(b) | Licensee shall deliver to Licensor a true, complete, and correct copy of each Sublicense Agreement granted by Licensee, Affiliate or Sublicensee, and any modification or termination thereof, within thirty (30) days following the applicable execution, modification, or termination of such Sublicense Agreement. All Sublicense Agreements will be in English. |
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(c) | Notwithstanding any such Sublicense Agreement, Licensee will remain primarily liable to Licensor for all of the Licensee’s duties and obligations contained in the Agreement, including without limitation the payment of running royalties due under Section 3.2 whether or not paid to Licensee by a Sublicensee. Any act or omission of a Sublicensee that would be a breach of the Agreement if performed by Licensee will be deemed to be a breach by Licensee. Each Sublicense Agreement will contain a right of termination by Licensee in the event that the Sublicensee breaches the payment or reporting obligations affecting Licensor or any other terms and conditions of the Sublicense Agreement that would constitute a breach of the Agreement if such acts were performed by Licensee. |
2.4 | Diligent Commercialization |
Licensee by itself or through its Affiliates and Sublicensees will use diligent efforts to implement the Commercialization Plan and make Licensed Products and/or Licensed Services (as applicable) commercially available in the Field of Use within the Territory. Without limiting the foregoing, Licensee will
(a) | maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make License Products and/or Licensed Services commercially available to the public as soon as commercially practicable, and |
(b) | fulfill the milestone events specified in Section 2.4 of the Patent & Technology License Agreement by the deadlines indicated therein. |
If the obligations under this Section 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b).
3. | Compensation |
In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. All fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Patent & Technology License Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
3.1 | Non-Royalty Payments due from Licensee |
(a) | Patent Expenses. Licensee will reimburse Licensor for the past patent expenses stated in Section 3.1(a) of the Patent & Technology License Agreement within fifteen (15) days after the Effective Date. The stated amount is the current estimate for past patent expenses based on invoices received by the Licensor through the stated date. Licensee’s obligations to pay all past and future patent expenses pursuant to Section 6 (Patent Expenses and Prosecution) will not be limited by such amount. |
(b) | Milestone Fees. Licensee will pay Milestone Fees indicated in Section 3.1(b) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(b) of the Patent & Technology License Agreement are achieved. |
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(c) | Upfront Fee. Licensee will pay the amount of the Upfront Fee set forth in Section 3.1(c) of the Patent & Technology License Agreement on the dates indicated in Section 3.1(c) of the Patent & Technology License Agreement. |
(d) | License Maintenance Fees. Licensee will pay license fees in the amounts set forth in Sections 3.1(d) of the Patent & Technology License Agreement in accordance with the stated schedule. |
(e) | Sublicense Fees. Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter. |
(f) | Assignment Fee. Licensee will pay the assignment fee set forth in Section 3.1(f) of the Patent & Technology License Agreement within fifteen (15) days of the assignment of the Agreement. |
(g) | Sales Milestones. Licensee will pay the Sales Milestone fees set forth in Section 3.1(g) of the Patent & Technology License Agreement in accordance with the sales milestone events set forth in Section 3.1(g) of the Patent & Technology License Agreement by the Quarterly Payment Deadline for the Contract Quarter in which the milestone events set forth in Section 3.1(g) of the Patent & Technology License Agreement are achieved. |
3.2 | Royalties |
Licensee will pay running royalties on Net Sales in each Contract Quarter on or before the Quarterly Payment Deadline for such Contract Quarter, as follows: (a) at the rate set forth in Section 3.2(a) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services Covered By any claim or claims included within the Patent Rights; and (b) at the rate set forth in Section 3.2(b) of the Patent & Technology License Agreement on Net Sales in each Contract Quarter for Licensed Products and Licensed Services not Covered By any claim or claims included within the Patent Rights. No royalty shall be payable under this Section 3.2 with respect to (i) Sales to an Affiliate or Sublicensee of a particular unit of Licensed Product that is used by such Affiliate or Sublicensee to perform a Licensed Service if Licensor is paid a royalty on the Sale of such Licensed Service, (ii) the Sale of Licensed Products between or among Licensee, its Affiliates, and Sublicensees for re-sale purposes, provided Licensor is paid a royalty with respect to the re-sale, or (iii) payments that constitute Non-Royalty Sublicensing Consideration.
3.3 | Minimum Royalties |
If royalties paid to Licensor do not reach the minimum royalty amounts stated in Section 3.3 of the Patent & Technology License Agreement for the specified periods, Licensee will pay Licensor on or before the Quarterly Payment Deadline for the last Contract Quarter in the stated period an additional amount equal to the difference between the stated minimum royalty amount and the actual royalties paid to Licensor.
3.4 | Non-cash Consideration |
If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to by the Parties.
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4. | Reports and Plans |
The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Patent & Technology License Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.
4.1 | Quarterly Payment and Milestone Reports |
On or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees (including copies of reports provided by Sublicensees and Affiliates to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall include:
(a) | The name of the Licensee, the Patent & Technology License Agreement number, and the period covered by the report; |
(b) | The name of any Affiliates and Sublicensees whose activities are also covered by the report; |
(c) | Identification of each Licensed Product and Licensed Service for which any royalty payments have become payable; |
(d) | Net Sales segregated on a
product-by-product basis, and a country-by-country basis, or an affirmative statement that no Sales were made. The report shall
also itemize the permitted deductions from the Gross Consideration used to arrive at the resulting Net Sales, on a product-by-product
and country-by-country basis; |
(e) | The applicable royalty rate; |
(f) | An affirmative statement of whether any milestones with deadlines in that Contract Quarter under Section 2.4 and any milestones under Section 3.1(b) were met or not, and the resulting Milestone Fee payable; |
(g) | Non-Royalty Sublicensing Consideration received by Licensee segregated on a Sublicense-by-Sublicense basis, or an affirmative statement that none was received; |
(h) | If any consideration was received in currencies other than U.S. dollars, the report shall describe the currency exchange calculations; and |
(i) | Any changes in accounting methodologies used to account for and calculate the items included in the report since the previous report. |
4.2 | Annual Written Progress Report and Commercialization Plan |
Within forty five (45) days following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year to diligently commercialize Licensed Products and Licensed Services, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products and Licensed Services for the next Contract Year. The report shall also cover such activities by Affiliates and Sublicensees. The report shall contain the following information to the extent relevant to the activities under the Agreement:
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(a) | The name of the Licensee, the Patent & Technology License Agreement number, the names of any Affiliates and Sublicensees, and the products and services being developed and/or commercialized; |
(b) | The progress toward completing and the plans for completing the applicable milestone events pursuant to Sections 2.4 and 3.1(b); and |
(c) | The research and development activities, including status and plans for obtaining any necessary Regulatory Approvals, performed during the past year, and the plans for research and development activities for the next year. |
4.3 | Government and Economic Development Reporting |
If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:
(a) | Number and geographic location of new full-time employees created during the past Contract Year; total number and geographic location of full-time employees of Licensee at the end of such Contract Year; |
(b) | Dollar amount of new equity financing received by Licensee during the past Contract Year, and current capitalization, including number and class of outstanding securities; |
(c) | Location and square footage of facilities; and |
(d) | Other information required under Federal and state law. |
This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than two hundred (200) full-time employees, then no further economic development reports will be required from Licensee.
5. | Payment, Records, and Audits |
5.1 | Payments |
All amounts referred to in the Patent & Technology License Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Patent & Technology License Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Patent & Technology License Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Patent & Technology License Agreement.
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5.2 | Sales Outside the U.S. |
If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business day of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.
5.3 | Late Payments |
Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to 1.0% per month (or the maximum allowed by law, if less).
5.4 | Records |
For a period of six (6) years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Affiliates and Sublicensees will each keep complete and accurate records of their Sales, Net Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.
5.5 | Auditing |
Licensee and its Affiliates will permit Licensor or its representatives, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least thirty (30) days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request, and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts due Licensor have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3. If the amount of underpayment is equal to or greater than 5% of the total amount due for the records so examined, Licensee will pay the cost of such audit. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.
6. | Patent Expenses and Prosecution |
6.1 | Patent Expenses |
Licensee shall pay for all past documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches through the Effective Date of the Agreement, including those identified in Section 3.1(a) of the Patent & Technology License Agreement, and all such future expenses incurred by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a)), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Patent & Technology License Agreement and future expenses, within thirty (30) days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) will be considered a payment default under Section 7.3(a).
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6.2 | Direction of Prosecution |
Licensor will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensor will request that copies of all documents prepared by the Prosecution Counsel for submission to governmental patent offices be provided to Licensee for review and comment prior to filing, to the extent practicable under the circumstances. At its discretion, Licensor may allow Licensee to instruct Prosecution Counsel directly, provided, that (a) Licensor will maintain final authority in all decisions regarding the prosecution and maintenance of the Patent Rights, (b) Licensor may revoke this authorization to instruct Prosecution Counsel directly at any time, and (c) the Prosecution Counsel remains counsel to the Licensor with an appropriate contract (and shall not jointly represent Licensee unless requested by Licensee and approved by Licensor, and an appropriate engagement letter and conflict waiver are in effect). If Licensee wishes to instruct Prosecution Counsel directly or change Prosecution Counsel, Licensee may request to do so by following the Licensor’s procedures for such. Licensor reserves in its sole discretion the ability to change Prosecution Counsel and to approve or disapprove any requested changes by Licensee. The Parties agree that they share a common legal interest to get valid enforceable patents and that Licensee will maintain as privileged all information received pursuant to this Section.
6.3 | Ownership |
All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Patent & Technology License Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.
6.4 | Foreign Filings |
In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.
6.5 | Withdrawal from Paying Patent Costs |
If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least ninety (90) days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.
6.6 | U.S. Patent and Trademark Office Entity Size Status |
Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Patent & Technology License Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.
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7. | Term and Termination |
7.1 | Term |
Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue until the last date of expiration or termination of the Patent Rights, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of 20 years.
7.2 | Termination by Licensee |
Licensee, at its option, may terminate the Agreement by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.
7.3 | Termination by Licensor |
Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field of Use, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:
(a) | Licensee becomes in arrears in any payments due under the Agreement, and Licensee fails to make the required payment within thirty (30) days after delivery of written notice from Licensor; or |
(b) | Licensee is in breach of any non-payment provision of the Agreement, and does not cure such breach within ninety (90) days after delivery of written notice from Licensor; or |
(c) | Licensor delivers notice to Licensee of three or more actual breaches of the Agreement in any 12-month period, even in the event that Licensee cures such breaches in the allowed period; or |
(d) | Licensee or its Affiliate or Sublicensee initiates any proceeding or action to challenge the validity, enforceability, or scope of one or more of the Patent Rights, or assist a third party in pursuing such a proceeding or action. |
7.4 | Other Conditions of Termination |
The Agreement will terminate:
(a) | Immediately without the necessity of any action being taken by Licensor or Licensee, (i) if Licensee files a bankruptcy action or becomes bankrupt or insolvent, or (ii) Licensee’s Board of Directors elects to liquidate its assets or dissolve its business, or (iii) Licensee ceases its business operations, or (iv) Licensee makes an assignment for the benefit of creditors, or (v) if the business or assets of Licensee are otherwise placed in the hands of a receiver, assignee or trustee, whether by voluntary act of Licensee or otherwise; or |
(b) | At any time by mutual written agreement between Licensee and Licensor. |
7.5 | Effect of Termination |
If the Agreement is terminated for any reason:
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(a) | All rights and licenses of Sublicensees shall terminate upon termination of the Agreement; provided however, if the Sublicense Agreement is for all of the Field of Use for all of the Territory, and the Sublicensee is in good standing and agrees in writing to assume all of the obligations of Licensee and provides Licensor with written notice thereof within thirty (30) days after termination of the Agreement, then such Sublicense Agreement shall survive; and |
(b) | Licensee shall cease making, having made, distributing, having distributed, using, selling, offering to sell, leasing, loaning and importing any Licensed Products and performing Licensed Services by the effective date of termination; and |
(c) | Licensee shall tender payment of all accrued royalties and other payments due to Licensor as of the effective date of termination; and |
(d) | Nothing in the Agreement will be construed to release either Party from any obligation that matured prior to the effective date of termination; and |
(e) | The provisions of Sections 8 (Confidentiality), 9 (Infringement and Litigation), 11 (Representations and Disclaimers), 12 (Limit of Liability), 13 (Indemnification), 14 (Insurance), 17 (Use of Name), 18 (Notices), and 19 (General Provisions) will survive any termination or expiration of the Agreement. In addition, the provisions of Sections 3 (Compensation), 4.1 (Quarterly Payment and Milestone Reports), 5 (Payment, Records and Audits), and 6.1 (Patent Expenses) shall survive with respect to all activities and payment obligations accruing prior to the termination or expiration of the Agreement. |
8. | Confidentiality |
8.1 | Definition |
“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.
8.2 | Protection and Marking |
Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents or employees without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Affiliates, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.
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8.3 | Confidentiality of Terms of Agreement |
Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, Ohio Public Records laws, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If the Agreement is not for all fields of use, then Licensor may disclose the Field of Use to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.
8.4 | Disclosure Required by Court Order or Law |
If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.
8.5 | Copies |
Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.
8.6 | Continuing Obligations |
Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of three (3) years thereafter.
8.6 | Exclusions |
Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:
(a) | Was in the public domain at the time of disclosure; or |
(b) | Later became part of the public domain through no act or omission of the recipient Party, its employees, agents, successors or assigns in breach of the Agreement; or |
(c) | Was lawfully disclosed to the recipient Party by a third party having the right to disclose it not under an obligation of confidentiality; or |
(d) | Was already known by the recipient Party at the time of disclosure; or |
(e) | Was independently developed by the recipient Party without use of the disclosing Party’s Confidential Information. |
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8.8 | Copyright Notice |
The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder.
9. | Infringement and Litigation |
9.1 | Notification |
If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.
9.2 | Licensee’s Enforcement Rights |
Licensee shall enforce the Patent Rights against any infringement by a third party in the Field in the Territory. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by Licensee and incurred by Licensor in providing cooperation or joining as a party as provided in Section 9.4. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.
9.3 | Licensor’s Enforcement Rights |
If Licensee does not file suit within six (6) months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement. If Licensor pursues such infringement action, Licensor may, as part of the resolution of such efforts, grant non-exclusive license rights to the alleged infringer notwithstanding Licensee’s exclusive license rights.
9.4 | Cooperation between Licensor and Licensee |
In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.
If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s and the Ohio Attorney General’s prior written permission, which permission shall not be unreasonably withheld, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Ohio Attorney General regarding retention of outside counsel for state entities.
9.5 | Contest of Validity |
(a) In the event Licensee or its Sublicensee(s) (or a third party on its behalf) files any action contesting the validity or enforceability of any Patent Rights and the provision in Section 7.3(d) is unenforceable, the Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall pay a royalty rate of one and a half (1.5) times the royalty rate specified in Section 3.2 for all Net Sales. Moreover, should the outcome of such contest determine that any claim of the Patent Rights challenged is both valid and would be infringed by a Licensed Product, Licensed Process, or Licensed Service sold by Licensee (or its Sublicensee(s) if such Sublicensee filed the action), if not for the license granted by this Agreement, Licensee (or its Sublicensee(s), if such Sublicensee filed the action) shall thereafter, and for the remaining term of this Agreement, pay a royalty rate of two (2) times the royalty rate specified in Section 3.2 for all Net Sales.
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(b) In the event that Licensee or its Sublicensee(s) contests the validity or enforceability of any Patent Rights during the term of this Agreement, Licensee agrees (and shall require its Sublicensee(s) to agree) to pay to Licensor all royalties due under the Agreement during the period of challenge. For the sake of clarity, such amounts shall not be paid into any escrow or other account, but directly to Licensor, and shall not be refunded.
(c) In the event that a validity or non-infringement challenge of any Patent Rights brought by Licensee is successful, Licensee shall have no right to recoup any royalties paid before or during the period challenge.
10. | Export Compliance |
10.1 Licensee shall observe all applicable United States and foreign laws and regulations with respect to the research, development, manufacture, marketing and transfer of Licensed Products and related technical data, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulation (collectively, the “Export Laws”). To this end, Licensee shall take all actions necessary to comply with the Export Laws. Licensee hereby represents and covenants that Licensee:
(i) | Is neither a national of nor controlled by a national of any country to which the United States prohibits the export or re-export of goods, services, or technology; |
(ii) | Is not a person specifically designated as ineligible to export from the United States or deal in U.S.-origin goods, services, or technologies; |
(iii) | Shall not export or re-export, directly or indirectly, any goods, services, or technology, to any country or person (including juridical persons) to which the United States prohibits the export of goods, technology or services; and |
(iv) | In the event that a United States government license or authorization is required for an export or re-export of goods, services, or technology (including technical information acquired from Licensor under this Agreement and/or any products created by using such technical information or any part thereof), the Licensee shall obtain any necessary United States government license or other authorization prior to undertaking the export or re-export. |
Licensee shall include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable export laws and regulations and other applicable laws and regulations.
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11. | Representations and Disclaimers |
11.1 | Licensor Representations |
Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or agent of the entire right, title, and interest in and to Patent Rights (other than the right, title and interest of any joint owner identified in Section 1 of the Patent & Technology License Agreement), (ii) Licensor has the right to grant the license and sublicense hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.
11.2 | Government Rights |
Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.
11.3 | Licensor Disclaimers |
EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS OR LICENSED SERVICES, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, NONINFRINGEMENT, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY CLAIM OR PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD OF USE. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN.
11.4 | Licensee Representation |
By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (c) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Patent & Technology License Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Patent & Technology License Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.
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12. | Limit of Liability |
IN NO EVENT SHALL LICENSOR, OSU, OR THEIR INVENTORS, OFFICERS, EMPLOYEES, STUDENTS, TRUSTEES, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
13. | Indemnification |
13.1 | Indemnification Obligation |
Licensee agrees to hold harmless, defend and indemnify Licensor, OSU, and their officers, employees, students, inventors, trustees, agents, and consultants (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Affiliates or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Licensee shall have no responsibility or obligation under the section for any Liabilities to the extent caused by the gross negligence or willful misconduct by Licensor.
14. | Insurance |
14.1 | Insurance Requirements |
Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, , officers, and employees, named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.
14.2 | Evidence of Insurance and Notice of Changes |
Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least sixty (60) days prior to Licensee cancelling, not renewing, or materially changing such insurance.
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15. | Assignment |
The Agreement may not be assigned by Licensee without the prior written consent of Licensor, which consent will not be unreasonably withheld. For any permitted assignment to be effective, (a) Licensee must be in good standing under this Agreement, (b) the Licensee must pay Licensor the assignment fee pursuant to Section 3.1(f), and (c) the assignee must assume in writing (a copy of which shall be promptly provided to Licensor) all of Licensee’s interests, rights, duties and obligations under the Agreement and agree to comply with all terms and conditions of the Agreement as if assignee were an original Party to the Agreement.
16. | Governmental Markings |
16.1 | Patent Markings |
Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.
16.2 | Governmental Approvals and Marketing of Licensed Products and or Licensed Services |
Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.
16.3 | Foreign Registration and Laws |
Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products and Licensed Services to the extent there is no conflict with United States law, in which case United States law will control.
17. | Use of Name |
Licensee will not use the name, trademarks or other marks of Licensor or OSU without the advance written consent of Licensor and OSU. Licensor and OSU may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent.
18. | Notices |
Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Patent & Technology License Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.
Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Patent & Technology License Agreement. Each Party shall update the other Party in writing with any changes in such contact information.
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19. | General Provisions |
19.1 | Binding Effect |
The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.
19.2 | Construction of Agreement |
Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.
19.3 | Counterparts and Signatures |
The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.
19.4 | Compliance with Laws |
Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.
19.5 | Governing Law |
The Parties agree to remain silent in regard to Governing Law.
19.6 | Modification |
Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.
19.7 | Severability |
If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.
19.8 | Third Party Beneficiaries |
Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties, OSU, and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Patent & Technology License Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).
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19.9 | Waiver |
Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.
19.10 | Sovereign Immunity |
Nothing in the Agreement shall be deemed or treated as any waiver of OSU’s sovereign immunity.
19.11 | Entire Agreement |
The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.
19.12 | Claims Against Licensor for Breach of Agreement |
Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be brought in a competent jurisdiction in Ohio and this is Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor.
19.13 | Grant of Security Interest |
Licensee hereby grants to Licensor a security interest in and to Licensee's rights under the Patent & Technology License Agreement, as collateral security for the payment by Licensee of any and all sums which may be owed from time to time by Licensee to Licensor. Licensor shall have all rights of a secured party as specified in the Uniform Commercial Code relative to this security interest and the enforcement thereof. Licensee hereby authorizes Licensor to file with the appropriate governmental agencies appropriate UCC-1 financing statements to evidence this security interest.
— END OF EXHIBIT A —
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EXHIBIT B
COMMERCIALIZATION PLAN
1. Enter into a Sponsored Research Agreement (SRA) with Licensor with Dr. Robert Lee as the principal investigator at least $100,000 cash total | January 31, 2014 |
2. Initiation of cGMP manufacturing and GLP-toxicity studies for first Licensed Product | December 31, 2014 |
3. Filing of IND (or an equivalent regulatory application, if filed outside of the United States) for first Licensed Product(s) | December 31, 2015 |
4. Dosing of first patient in any Phase II Clinical Trial of first Licensed Product(s) | December 31, 2017 |
5. Dosing of first patient in any Phase III Clinical Trial of first Licensed Product(s) | March 31, 2019 |
6. Filing of Marketing Application with FDA (or an equivalent regulatory agency, if filed outside the United States) for first Licensed Product | January 31, 2022 |
7. Regulatory approval of Marketing Application for first Licensed Product in a Major Territory (US, Europe, Japan) | March 31, 2023 |
8. First sale of first Licensed Product(s) in a Major Territory (US, Europe, Japan) | March 31, 2024 |
9. Regulatory approval of Marketing Application for first Licensed Product in each BRICS Territory (Brazil, Russia, China, India, South Korea) | June 30, 2024 |
10. First sale of first Licensed Product in a BRICS Territory (Brazil, Russia, China, India, South Korea) | June 30, 2025 |
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AMENDMENT NO. 1 TO LICENSE AGREEMENT
This Amendment No. 1 to the License Agreement (“Amendment”), having an effective , date of April 7, 2014 (“Amendment Effective Date”), is made and entered by and between Ohio State Innovation Foundation, located at 1524 North High Street, Columbus, Ohio 43201 (“OSIF”) and Microlin Bio, Inc., a New York based corporation located at 302A West 12th, New York, NY 10014 (“Licensee”).
BACKGROUND
OSIF and Licensee entered into a Patent & Technology License Agreement dated September 6, 2013 (“License Agreement”) with respect to OSIF # A2014-0294; and
OSIF and Licensee would like to amend and modify the License Agreement as identified below and such amendment shall be incorporated as part of the License Agreement.
The parties agree as follows:
1. | Definitions. All capitalized terms used herein and not otherwise defined herein shall have the meanings assigned to such terms in the License Agreement. |
2. | In Section 1, Patent Rights/Technology Rights shall be amended to include the information below: | |
App. No./ Date of Filing [Tech ID#] |
Title | Inventor(s) |
Jointly Owned? (Y/N; if Y, with whom?) |
Prosecution Counsel | ||||
61/975,366 April 4, 2014 [2014-218] |
Lipid Nanoparticle Compositions and Methods of Making and Methods of Using the Same | R. Lee | x No | MacMillan, Sobanski, and Todd LLC |
3. | In Section 3.1(a), “Patent expenses due upon Effective Date” shall be amended to include the information below: | |
Patent expenses due upon Effective Date |
Amount |
based on invoices received as of: | ||
Tech ID#2014-218 | Current Estimate: $8,500 – invoice for 4/04/14 filing not yet received | Reimbursement of past patent cost and future patent cost due upon Licensee receipt of invoice from OSIF |
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4. | Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which together shall constitute an agreement, notwithstanding that all parties are not signatories to the same counterpart. |
5. | Continued Force and Effect. Except as provided in this Amendment, all terms, conditions, and provisions of the License Agreement shall remain and continue in full force and effect as provided therein. |
IN WITNESS WHEREOF, the parties hereto have entered into this Amendment effective as of the Amendment Effective Date.
[AUTHORIZED SIGNATURES APPEAR ON THE FOLLOWING PAGE]
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OHIO STATE INNOVATION FOUNDATION | MICROLIN BIO, INC. | |||
By: | /s/ Timothy R. Wright | By: | /s/ Joseph Hernandez | |
Name: | Timothy R. Wright | Name: | Joseph Hernandez | |
Title: | President | Title: | CEO & President | |
Date: | 4-8-14 | Date: | 4-10-14 |
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May 22, 2014
Ohio State Innovation Foundation Attn: Timothy R. Wright, President 1524 North High Street
Columbus, Ohio 43201
Re: License Agreements/Upfront Fees
Dear Mr.Wright:
Reference is made to (1 ) the Patent & Technology License Agreement, Agt. No. A2014-0165, entered into as of September 6, 2013, by and between Microlin Bio, Inc. ("Microlin") and Ohio State Innovation Foundation ("OSIF'), as amended, (2) the Patent & Technology License Agreement, Agt. No. A2013- 2080, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (3) the Patent & Technology License Agreement, Agt. No. A2013-2069, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (4) the Patent & Technology License Agreement, Agt. No.A2014-0164, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, and (5) the Patent & Technology License Agreement. Agt. No.A2014-0294, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended (collectively, the "Agreements ").
Each of the Agreements provide that Microlin is to pay an upfront fee to OSIF on or before May 31, 2014 for the patents licensed from OSIF under the Agreements. The upfront fees payable to OSIF on or before May 31, 2014 total $500,000 in the aggregate (the "May 2014 Fee").
This letter serves to confirm our agreement regarding Microlin's obligations with respect to the May 2014 Fee. Mkrolin acknowledges that it owes OSIF $500,000 on or before May 31, 2014 pursuant to the Agreements and OSIF agrees to defer Microlin's obligation to pay such amount on or before May 31, 2014 as set forth below. Microlin and OSIF agree that the May 2014 Fee will be paid in full from Microlin to OSIF via wire transfer no later than three (3) calendar days after the day on which Microlin delivers its registered securities to its underwriter(s) and receives payment for these securities (the "Closing Date"). In the event that the Closing Date does not occur or occurs after June 30, 2014, the parties will agree to a commercially reasonable alternati ve payment schedule.
Sincerely,
/s/ Joseph Hernandez Joseph Hernandez Executive Chairman |
[Acknowledgement page follows]
ACKNOWLEDGED AND AGREED TO BY:
OHIO STATE INNOVATJON FOUNDATION
By: /s/ Erin Bender
Name: Erin Bender
Title: Vice President
2 |
July 1, 2014
Ohio State Innovation Foundation
Attn: Timothy R. Wright, President
1524 North High Street
Columbus, Ohio 43201
Re: License Agreements/Upfront Fees/Equity
Dear Mr. Wright:
Reference is made to (1) the Patent & Technology License Agreement, Agt. No. A2014-0165, entered into as of September 6, 2013, by and between Microlin Bio, Inc. ("Microlin") and Ohio State Innovation Foundation ("OSIF"), as amended, (2) the Patent & Technology License Agreement, Agt. No. A2013- 2080, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (3) the Patent & Technology License Agreement, Agt. No. A2013-2069, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (4) the Patent & Technology License Agreement, Agt. No. A2014-0164, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (5) the Patent & Technology License Agreement, Agt. No. A2014-0294, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended (collectively, the "Agreements"), and (6) the letter agreement, entered into as of May 22, 2014, by and between Microlin and OSIF (the "May Letter Agreement").
This letter serves to confirm our agreement regarding Microlin's obligations with respect to the fees and expenses due to OSIF for the patents licensed from OSIF under the Agreements. The Agreements provide that Microlin is to pay OSIF an upfront fee (the "Upfront Fee") for the licensed patents and to repay OSIF for past patent expenses (the "Patent Expenses"). The Agreements further provide that the Patent Expenses become immediately due and payable to OSIF in the event that $I 0,000,000 of external funding is obtained by Microlin.
Microlin and OSIF agree that the entire unpaid balance of the Upfront Fee, which totals $500,000 in the aggregate, will be paid in full by Microlin on or before August 1, 2014, $300,000 of which will be paid by Microlin to OSIF via wire transfer no later than three (3) calendar days after the day on which Microlin delivers its registered securities to its underwriter(s) and receives payment for such securities (the "Closing Date"), and $200,000 of which shall, on the date Microlin's registration statement on Form S-1 filed in connection with the initial public offering of its common shares (the "Initial Public Offering") is deemed effective (the "Effective Date"), automatically convert in whole, without any further action by OSIF, into shares of common stock of Microlin (the "Common Stock"), with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the "Upfront Fee Conversion"). Upon the Upfront Fee Conversion, OSIF shall receive (1) the number of shares of Common Stock equal to the quotient of (x) $200,000 divided by (y) the initial public offering price of the Common Stock and (2) warrants in the same proportion as issued to other investors in the initial public offering. Microlin shall, promptly after the Upfront Fee Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be entitled. OSIF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Upfront Fee Conversion. In the event that the Effective Date does not occur or occurs after August 1, 2014, the parties will agree to a commercially reasonable alternative payment schedule for the Upfront Fee. Microlin and OSIF acknowledge that the foregoing agreement with respect to the Upfront Fee supersedes the May Letter Agreement.
In the event Microlin raises in excess of $10,000,000 in its Initial Public Offering on or before August 1, 2014, the entire unpaid balance of the Patent Expenses, which totals $2,446,000 in the aggregate, shall, on the Effective Date, automatically convert in whole, without any further action by OSIF, into shares of Common Stock with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the "Patent Expense Conversion"). Upon the Patent Expense Conversion, OSIF shall receive ( 1) the number of shares of Common Stock equal to the quotient of (x) $2,446,000 divided by (y) the initial public offering price of the Common Stock and (2) warrants in the same proportion as issued to other investors in the initial public offering. Microlin shall, promptly after the Patent Expense Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be entitled. OSIF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Patent Expense Conversion. In the event that the Effective Date does not occur or occurs after August 1, 2014, the parties will agree to a commercially reasonable alternative payment schedule for the Patent Expenses.
Sincerely,
/s/ Joseph Hernandez Executive Chairman |
[Acknowledgement page follows]
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ACKNOWLEDGED AND AGREED TO BY:
OHIO STATE INNOVATION FOUNDATION
By: /s/ Timothy R. Wright
Name: Timothy R. Wright
Title: President
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July 28, 2014
Ohio State Innovation Foundation
Attn: Timothy R. Wright, President
1524 North High Street
Columbus, Ohio 43201
Re: License Agreements/Upfront Fees/Extension Fees/Equity
Dear Mr. Wright:
Reference is made to (1) the Patent & Technology License Agreement, Agt. No. A2014-0165, entered into as of September 6, 2013, by and between Microlin Bio, Inc. ("Microlin") and Ohio State Innovation Foundation ("OSIF"), as amended, (2) the Patent & Technology License Agreement, Agt. No. A2013- 2080, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (3) the Patent & Technology License Agreement, Agt. No. A2013-2069, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (4) the Patent & Technology License Agreement, Agt. No. A2014-0164, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (5) the Patent & Technology License Agreement, Agt. No. A2014-0294, entered into as of September 6, 2013, by and between Microlin and OSIF, as amended (collectively, the "Agreements"), (6) the letter agreement, entered into as of May 22, 2014, by and between Microlin and OSIF (the "May Letter Agreement") and the letter agreement, entered into as of July 1, 2014, by and between Microlin and OSIF (the "July Letter Agreement").
This letter serves to confirm our agreement regarding Microlin's obligations with respect to the fees and expenses due to OSIF for the patents licensed from OSIF under the Agreements. The Agreements provide that Microlin is to pay OSIF an upfront fee (the "Upfront Fee") for the licensed patents and to repay OSIF for past patent expenses (the "Patent Expenses"). The Agreements further provide that the Patent Expenses become immediately due and payable to OSIF in the event that $10,000,000 of external funding is obtained by Microlin.
Microlin and OSIF agree that the entire unpaid balance of the Upfront Fee, which totals $500,000 in the aggregate, will be paid in full by Microlin on or before September 30, 2014 $300,000 of which will be paid by Microlin to OSIF via wire transfer no later than three (3) calendar days after the day on which Microlin delivers its registered securities to its underwriter(s) and receives payment for such securities (the "Closing Date"), and $200,000 of which shall, on the date Microlin's registration statement on Form S-1 filed in connection with the initial public offering of its common shares (the "Initial Public Offering") is deemed effective (the "Effective Date"), automatically convert in whole, without any further action by OSIF, into shares of common stock of Microlin (the "Common Stock"), with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the "Upfront Fee Conversion"). Upon the Upfront Fee Conversion, OSIF shall receive (1) the number of shares of Common Stock equal to the quotient of (x) $200,000 divided by (y) the initial public offering price of the Common Stock and (2) warrants in the same proportion as issued to other investors in the initial public offering. Microlin shall, promptly after the Upfront Fee Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be entitled. OSIF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Upfront Fee Conversion. In addition to paying the Upfront Fee as described above, and in exchange for OSIF providing Microlin the extension herein, Microlin shall also pay OSIF a non-refundable fee of fifteen thousand dollars ($15,000) on or before September 30, 2014 (the "July Extension Fee"). In the event that the Effective Date does not occur or occurs after September 30, 2014, the parties will agree to a commercially reasonable alternative payment schedule for the Upfront Fee. Microlin and OSIF acknowledge that the foregoing agreement with respect to the Upfront Fee supersedes the May Letter Agreement and the July Letter Agreement.
In the event Microlin raises in excess of $10,000,000 in its Initial Public Offering on or before September 30, 2014, the entire unpaid balance of the Patent Expenses, which totals $3,005,000 in the aggregate, shall, on the Effective Date, automatically convert in whole, without any further action by OSIF, into shares of Common Stock with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the "Patent Expense Conversion"). Upon the Patent Expense Conversion, OSIF shall receive (1) the number of shares of Common Stock equal to the quotient of (x) $3,005,000 divided by (y) the initial public offering price of the Common Stock and (2) warrants in the same proportion as issued to other investors in the initial public offering. Microlin shall, promptly after the Patent Expense Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be entitled. OSIF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Patent Expense Conversion. In the event that the Effective Date does not occur or occurs after September 30, 2014, the parties will agree to a commercially reasonable alternative payment schedule for the Patent Expenses.
Sincerely,
/s/ Joseph Hernandez Executive Chairman |
ACKNOWLEDGED AND AGREED TO BY:
OHIO STATE INNOVATION FOUNDATION
By:/s/ Stan Micek
Name: Stan Micek
Title: Vice President
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May 6, 2015
Ohio State Innovation Foundation
Attn: Stan Micek, Interim Vice President 1524 North High Street
Columbus, Ohio 43201
Re: | License Agreements/Upfront Fees/Equitv |
Dear Mr. Micek:
Reference is made to (I) the Patent & Technology License Agreement, Agt. No. A2014-0165, entered into as of September 6, 2013, by and between Microlin Bio, I nc. ("Microlin") and Ohio State Innovation Foundation ("OSIF"), as amended, (2) the Patent & Technology License Agreement, Agt. No. A2013- 2080. entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (3) the Patent & Technology License Agreement Agt. No. A2013-2069. entered into as of September 6, 2013, by and between Microlin and OSIF, as amended, (4) the Patent & Technology License Agreement Agt. No. A2014-0 l 64, entered into as of September 6, 2013, by and between Microlin and OSlF, as amended, (5) the Patent & Technology License Agreement, Agt. No. A2014--0294. entered into as of September 6. 2013, by and between Microlin and OSIF, as amended (collectively, The “Agreements''), (6) the letter agreement. entered into as of May 22, 2014, by and between Microlin and OSIF, and (7) the letter agreement, entered into as of July 28. 2014, by and between Microli n and OSIF (the “July Agreement").
This letter serves to confirm our agreement regarding Microlin's obligations with respect to the fees and expenses due to OSIF for the patents licensed from OSIF under the Agreements. The Agreements provide that Microlin is to pay OSIF an upfront fee (the “Upfront Fee"') for the licensed patents and to repay OSIF for past patent expenses (the "Patent Expenses"). The Agreements further provide that the Patent Expenses become immediately due and payable to OSIF in the event that $10,000,000 of external funding is obtained by Microlin.
Microlin and OSIF agree that the entire unpaid balance of the Upfront Fee, which totals $515,000 in the aggregate which includes the $15,000 ··July Extension Fee'', will be paid in full by Microlin on or before August 1st, 2015, $315,000 of which will be paid by Microlin to OSIF via wire transfer no later than three (3) calendar days after the day on which Microlin delivers its registered securities to its underwriter(s) and receives payment for such securities (the “Closing Date"), and $200,000 of which shall, on the date Microlin’s registration statement on Form S-1 filed in connection with the initial public offering of its common shares (the --Initial Public Offering'') is deemed effective (the "Effective Date"), automatically convert in whole, without any further action by OSIF, into shares of common stock of Microlin (the Common Stock"), with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the --upfront Fee Conversion..). Upon the Upfront Fee Conversion. 0 IF shall receive the number of shares of Common Stock equal to the quotient of (x) $200,000 divided by (y) the initial public offering price of the Common Stock. Microlin shall, promptly after the Upfront Fee Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be entitled. OSIF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Upfront Fee Conversion. In the event that the Effective Date does not occur or occurs after August 1st 2015, the parties will agree to a commercially reasonable alternative payment schedule for the Upfront Fee. Microlin and OS1F acknowledge that the foregoing agreement with respect to the Upfront Fee supersedes the July Letter Agreement.
In the event Microlin raises in excess of $10,000.000 in its Initial Public Offering on or before August 1st, 20 l5, the entire unpaid balance of the past Patent Expenses, which totals $4,096,800.21 in the aggregate, shall, on the Effective Date, automatically convert in whole, without any further action by OSIF, into shares of Common Stock with the same rights, obligations, preferences and privileges as are received by the other holders of Common Stock (the “Patent Expense Conversion"). Upon the Patent Expense Conversion, OSIF shall receive the number of shares of Common Stock equal to the quotient of (x) $4,096,800.21 divided by (y) the initial public offering price of the Common Stock. Microlin shall, promptly after the Patent Expense Conversion, issue and deliver to OSIF a certificate or certificates evidencing the shares of Common Stock to which OSIF shall be enti tled. OSLF shall be treated for all purposes as the record holder of such shares of Common Stock as of the date of the Patent Expense Conversion. In the event that the Effective Date does not occur or occurs after August t •\ 2015. the parties will agree to a commercially reasonable alternative payment schedule for the Patent Expenses.
Sincerely,
/s/ Joseph Hernandez Executive Chairman |
[Acknowledgement page follows]
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ACKNOWLEDGED AND AGREED TO BY:
OHIO STATE INNOVATION FOUNDATION
By:/s/ Stan Micek
Name: Stan Micek
Title: Vice President
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EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT (the “Agreement”) is entered into by Microlin Bio, Inc., a Delaware corporation with its principal business address at 302A West 12th Street Suite 114 New York, NY 10014 (the “Company”), and Joseph Hernandez, an individual residing at 635 West 42nd Street Apt. 11K (the “Executive”) July 15th, 2013 (the “Commencement Date”).
The Company desires to employ the Executive, and the Executive desires to be employed by the Company. In consideration of the mutual covenants and promises contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by the parties hereto, the parties agree as follows:
1. Employment. The Company hereby agrees to employ the Executive, and the Executive hereby accepts employment with the Company, subject to the terms and conditions herein set forth.
2. Term of Employment. The term of the Executive’s employment hereunder shall commence on the Commencement Date and, unless sooner terminated in accordance with the provisions of Section 5 hereof, end four 4) years after the Commencement Date (such four (4) year term being referred to as the “Initial Term”). Notwithstanding anything to the contrary contained in the preceding sentence, this Agreement shall be automatically renewed for successive one-year terms (each such one-year term a “Renewal Term”), unless sooner terminated in accordance with the provisions of Section 5 hereof, or unless either party gives to the other party written notice of intent not to renew the Agreement at least sixty (60) days prior to the end of the Initial Term or any Renewal Term. For the purposes of this Agreement, the Initial Term and each Renewal Term shall collectively be referred to as the “Employment Period.”
3. Title and Capacity.
3.1 During the Employment Period, the Executive shall serve as Executive Chairman and Chief Executive Officer and Board Member of the Company. The Executive shall be subject to the supervision of, and shall have such authority as is delegated to the Executive by, the Board of Directors of the Company (the “Board”).
3.2 The Executive hereby accepts such employment and agrees to undertake the duties and responsibilities inherent in such position and such other duties and responsibilities as the Board shall from time to time reasonably assign to the Executive. The Executive agrees to devote substantially all the Executive’s working time and business attention to the business and interests of the Company during the Employment Period. Notwithstanding the forgoing, the Executive may continue to serve in existing board positions, including as Chairmanship roles for the companies listed in Annex A provided that the time Executive spends on such obligations does not interfere with his role at the Company The Executive agrees to abide by all reasonable rules, regulations, instructions, personnel practices and policies of the Company and changes therein which may be adopted from time to time by the Company, once the Company provides written copies of all such rules, regulations, instructions, personnel practices and policies to the Executive.
4. Compensation and Benefits.
4.1 Salary. The Company shall pay the Executive an annual salary of $460,000, to be paid in accordance with the Company’s payroll practices commencing immediately at the Commencement Date and continuing for the duration of the Employment Period (“Annual Salary”). The Executive shall be subject to Annual Salary review by the Board.
4.2 Incentive Unit Awards. The Executive shall receive a grant of [______]1 Units in the Company (the “Units”) in accordance with an Incentive Units Agreement to be entered into by the Company and Executive in substantially the form attached hereto as Annex B (the “Incentive Units Agreement”). The Units will be subject to the terms and conditions of the Incentive Units Agreement.
4.3 Yearly Bonus. Each calendar year during the Employment Period, the Executive shall be eligible to receive a performance-based cash bonus as determined by the Board in good faith (the “Annual Bonus”) and estimated to be equivalent to fifty percent (50%) of the Executive’s Annual Salary. The amount, if any, of such Annual Bonus for each such calendar year shall be determined based upon the Company’s attainment of reasonable performance goals approved by the Board in its sole discretion. Each such Annual Bonus shall be payable in a lump sum cash amount during the calendar year following the year for which such Annual Bonus is earned.
4.4 Fringe Benefits. The Executive shall be entitled to Life and Disability insurance coverage and participate in all benefit programs that the Company establishes and makes available to its employees to the extent that Executive’s position, tenure, salary, age, health and other qualifications make the Executive eligible to participate. In addition, the Company will reimburse the Executive for the out of pocket cost for supplemental Life and Disability Insurance premiums in an amount not to exceed $10,000 per year.
4.5 Vacation and Leave. Each calendar year during the Employment Period, the Executive shall be entitled to eight (8) weeks paid vacation time pursuant to the Company’s policies applicable to senior executives of the Company, as in effect from time to time. Any vacation shall be taken at the reasonable and mutual convenience of the Company and the Executive.
4.6 Reimbursement of Expenses. The Company shall reimburse the Executive for all reasonable travel, entertainment and other expenses incurred or paid by the Executive in connection with, or related to, the performance of the Executive’s duties, responsibilities or services under this Agreement, upon presentation by the Executive of documentation, expense statements, vouchers, and such other supporting information as the Company may request, or as may be consistent with standard Company practices.
1 Note: Number is intended to represent 1.5% of the outstanding equity interests of the Company on the date of this Agreement
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5. Employment Termination. The employment of the Executive by the Company pursuant to this Agreement shall terminate upon the occurrence of any of the following:
5.1 Expiration of the Employment Period in accordance with Section 2;
5.2 At the election of the Company, for Cause, immediately upon written notice by the Company to the Executive. For the purposes of this Section 5.2, “Cause” for termination shall be deemed to exist upon the occurrence of one or more of the following events:
(a) | a material breach of fiduciary duty or material breach of the terms of this Agreement or any other agreement between the Executive and the Company (including without limitation any agreements regarding confidentiality, inventions assignment and non-competition), which, in the case of a material breach of the terms of this Agreement or any other agreement, remains uncured for a period of sixty (60) days following receipt of written notice from the Board specifying the nature of such breach; |
(b) | the commission by the Executive of any act of embezzlement, fraud, larceny or theft on or from the Company; |
(c) | substantial and continuing neglect or inattention by the Executive of the duties of the Executive’s employment, refusal to perform the lawful and reasonable directives of the Board or the willful misconduct or gross negligence of the Executive in connection with the performance of such duties which remains uncured for a period of sixty (60) days following receipt of written notice from the Board specifying the nature of such breach; |
(d) | the commission by the Executive of any crime involving moral turpitude or a felony; and |
(e) | the Executive’s performance or omission of any act which, in the judgment of the Board, if known to the customers, clients, stockholders or any regulators of the Company, would have a material and adverse impact on the business of the Company. |
5.3 Upon the death or disability of the Executive. As used in this Agreement, the term “disability” shall mean the inability of the Executive, due to a physical or mental disability, to perform the essential functions contemplated under this Agreement. A determination of disability shall be made by a physician satisfactory to both the Executive and the Company, provided that if the Executive and the Company do not agree on a physician, the Executive and the Company shall each select a physician and these two together shall select a third physician, whose determination as to disability shall be binding on all parties. In the event the Executive experiences a disability, the Executive’s employment with the Company shall terminate effective on the later of the 30th day after receipt of such notice by the Executive, the date specified in such notice, or such longer period required by law, if later, provided that within the 30 days after such receipt, the Executive shall not have returned to full-time performance of his duties.
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5.4 At the election of the Executive, upon not less than thirty (30) days prior written notice of termination for Good Reason (as defined below). For purposes of this Agreement, “Good Reason” shall mean any of the following:
(a) | a material breach of this Agreement by the Company; |
(b) | a material and substantial reduction of the Executive’s responsibilities that is inconsistent with the Executive’s status as a senior executive of the Company; or |
(c) | the requirement by the Company that the Executive perform any act or refrain from performing any act that would be in violation of applicable law. |
However, none of the foregoing events or conditions will constitute Good Reason unless: (x) the Executive provides the Company with written objection to the event or condition within 90 days following the occurrence thereof, (y) the Company does not reverse or otherwise cure the event or condition within 30 days of receiving that written objection, and (z) the Executive resigns his employment within 30 days following the expiration of that cure period.
5.5 At the election of the Executive, upon not less than thirty (30) days prior written notice of termination other than for Good Reason; or
5.6 At the election of the Company, otherwise than for Cause as set forth in Section 5.2 above, upon written notice of termination.
6. Effect of Termination.
6.1 Termination by the Company for Cause or at the Election of the Executive Other than for Good Reason. If the Executive’s employment is terminated for Cause pursuant to Section 5.2, or at the election of the Executive other than for Good Reason pursuant to Section 5.5, the Company shall pay to the Executive the Annual Salary through the date of such termination not theretofore paid and any amount arising from the Executive’s participation in, or benefits under, any employee benefit plans, programs or arrangements under Sections 4.4, which amounts shall be payable in accordance with the terms and conditions of such employee benefit plans, programs or arrangements.
6.2 Termination for Death or Disability. If the Executive’s employment is terminated by death or because of disability as determined pursuant to Section 5.3, then the Executive or, as applicable, his estate or other legal representative, shall be entitled to receive the amounts described in Section 6.1, including any amount arising from the Executive’s participation in, or benefits under, any employee benefit plans, programs or arrangements provided pursuant to Section 4.4 (including without limitation any disability or life insurance benefit plans, programs or arrangements), which amounts shall be payable in accordance with the terms and conditions of such employee benefit plans, programs or arrangements.
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6.3 Termination at the Election of the Company Other Than For Cause or the Executive for Good Reason. If on or after the effective date, the Executive’s employment is terminated pursuant to Section 5.6 at the election of the Company other than for Cause, or pursuant to Section 5.4 by the Executive for Good Reason (but not by reason of the Executive’s death, disability, termination by the Company for Cause or termination by the Executive without Good Reason), then, in addition to the payments described in Section 6.1, and subject to Sections 6.4 and 6.5, on or before the 60th day following the date of termination, the Company shall continue to pay to the Executive severance payment in the amount equal to twenty four (24) months ofthe Executive’s Annual Salary as in effect immediately prior to the date of termination, payable in a lump sum.
6.4 Section 409A. (a) Notwithstanding any provision to the contrary in this Agreement: (i) no amount shall be payable pursuant to Section 6.3 unless the Executive’s termination of employment constitutes a “separation from service” within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended, (the “Code”) and U.S. Department of Treasury regulations and other interpretive guidance thereunder (“Section 409A”) and unless, on or prior to the 60th day following Executive’s date of termination (A) the Executive executes a waiver and release of claims agreement in the Company’s customary form which is reasonably satisfactory to both the Company and the Executive and (B) such waiver and release of claims agreement shall become effective prior to such 60th day; and (ii) if the Executive is deemed at the time of his separation from service to be a “specified employee” for purposes of Section 409A(a)(2)(B)(i) of the Code, to the extent delayed commencement of any portion of the termination benefits to which Executive is entitled under this Agreement is required in order to avoid a prohibited distribution under Section 409A(a)(2)(B)(i) of the Code, such portion of Executive’s termination benefits shall not be provided to Executive prior to the earlier of (A) the expiration of the six-month period measured from the date of the Executive’s “separation from service” with the Company (as such term is defined in the Treasury Regulations issued under Section 409A of the Code) or (B) the date of Executive’s death. Upon the earlier of such dates, all payments deferred pursuant to this Section 6.4(ii) shall be paid in a lump sum to the Executive, and any remaining payments due under the Agreement shall be paid as otherwise provided herein.
(b) To the extent that any reimbursement of any expense under Sections 4.6, or 6.1 or in-kind benefits provided under this Agreement are: (1) deemed to constitute taxable compensation to the Executive and (2) otherwise deductible under Section 162 or 167 as business expenses incurred in connection with the performance of Executive’s services, such amounts will be reimbursed or provided no later than December 31 of the year following the year in which the expense was incurred. The amount of any such expenses reimbursed or in-kind benefits provided in one year shall not affect the expenses or in-kind benefits eligible for reimbursement or payment in any subsequent year, the Executive’s right to such reimbursement or payment of any such expenses will not be subject to liquidation or exchange for any other benefit, and the Executive may not, directly or indirectly, designate the calendar year of payment. No acceleration of the time and form of payment of any nonqualified deferred compensation to the Executive shall occur unless and to the extent permitted by Section 409A. The determination of whether the Executive is a “specified employee” for purposes of Section 409A(a)(2)(B)(i) of the Code as of the time of his separation from service shall made by the Company in accordance with the terms of Section 409A of the Code and applicable guidance thereunder (including without limitation Treasury Regulation Section 1.409A-1(i) and any successor provision thereto).
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7. Restrictive Covenants.
7.1 Confidentiality. The Executive agrees that he will not during the Employment Period or for a period of twelve (12) months thereafter divulge to anyone (other than the Company or any persons designated by the Company) any knowledge or information of any type whatsoever of a confidential nature relating to the business of the Company, including, without limitation, trade secrets, business strategies, marketing and distribution plans as well as ideas, proposals, and plans described in Section 7.2 below. The Executive further agrees that he will not disclose, publish or make use of any such knowledge or information of a confidential nature (other than in the performance of the Executive’s duties hereunder) without the prior written consent of the Company. This provision does not apply to information which becomes available publicly without the fault of the Executive or information which the Executive is required to disclose in legal proceedings, provided the Executive gives advance written notice to the Board and an opportunity to for the Company to resist such disclosure.
7.2 Intellectual Property. During the Employment Period, the Executive will disclose to the Company all ideas, proposals, and plans invented or developed by the Executive which relate directly or indirectly to the business of the Company or any of its subsidiaries or affiliates including, without limitation, any ideas, proposals and plans which may be copyrightable, trademarkable, patentable or otherwise exploitable. The Executive agrees that all such ideas, proposals, and plans are and will be the property of the Company. The Executive further agrees, at the Company’s request, to do whatever is necessary or desirable to secure for the Company the rights to said ideas, proposals, and plans, whether by copyright, trademark, patent or otherwise and to assign, transfer and convey the rights thereto to the Company.
7.3 Non-Solicitation. The Executive further agrees that during the Employment Period and for a period of twelve (12) months thereafter, the Executive will not (i) encourage, induce, attempt to induce, solicit, attempt to solicit or hire any employee, consultant or contractor to leave his or his employment or engagement with Company or any affiliate of Company or (ii) intentionally divert or take advantage of any actual or potential business opportunities of Company or its affiliates in which the Company or its affiliates have a current interest or expectancy, or solicit or induce any customer, client, subscriber or supplier of the Company or its affiliates to change its relationship with the Company or its affiliates, or establish any relationship with the Executive for any business purpose related to the Restricted Business, or otherwise interfere with the Company’s business or its relationship or prospective relationship with any person or entity that is, was or is expected to become a customer or client of the Company or its affiliates.
7.4 Non-Compete. In consideration of the Company’s agreements herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Executive agrees, in addition to any other obligation imposed by this Section 7, that he will not, during the Employment Period and for a period of twelve (12) months thereafter (the “Non-Compete Period”), engage directly or indirectly, whether as an employee, independent contractor, consultant, partner, shareholder or otherwise, in any business directly or indirectly that competes with the Restricted Business, anywhere in the United States or Canada where the Company is engaged in business as of the date of termination. The Executive specifically acknowledges that he is of special, unique and extraordinary value to the Company and that as a key executive of the Company, he has access to all confidential information, trade secrets, and the like, of the Company, and that in view of the foregoing, the restrictions imposed by this Section 7.5 are reasonably necessary to protect the Company against unfair competition by the Executive and are not unduly burdensome to the Executive.
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7.5 Non-Disparagement. At all times during the Employment Period and thereafter (regardless of how the Executive’s employment was terminated), both the Executive and Company shall not, directly or indirectly, make (or cause to be made) to any person any disparaging, derogatory or other negative or false statement about the Executive or Company (including its products, services, policies, practices, operations, employees, sales representatives, agents, officers, members, managers, partners or directors).
7.6 Injunctive Relief. The Executive and the Company recognizes and acknowledges that a breach of the covenants contained in Section 7 will cause irreparable damage to Company or Executive and its goodwill, the exact amount of which will be difficult or impossible to ascertain, and that the remedies at law for any such breach will be inadequate. Accordingly, the Executive and Company agrees that in the event of a breach of any of the covenants contained in Section 7, in addition to any other remedy which may be available at law or in equity, the Company or Executive will be entitled to specific performance and injunctive relief.
7.7 Interpretation. In the event the terms of this Section 7 shall be determined by any court of competent jurisdiction to be unenforceable by reason of its extending for too great a period of time or over too great a geographical area or by reason of its being too extensive in any other respect, it will be interpreted to extend only over the maximum period of time for which it may be enforceable, over the maximum geographical area as to which it may be enforceable, or to the maximum extent in all other respects as to which it may be enforceable, all as determined by such court in such action. As used in this Section 7, the term “Company” shall include the Company and its direct or indirect subsidiaries, if any.
8. Notices. All notices required or permitted under this Agreement shall be in writing and shall be deemed effective upon delivery personally, by facsimile with proof of completed transmission or by overnight mail with proof of receipt, or upon deposit in the United States Post Office, by registered or certified mail, postage prepaid, addressed to the other party at the address shown above, or at such other address or addresses as either party shall designate to the other in accordance with this Section 8.
9. Pronouns. Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular forms of nouns and pronouns shall include the plural, and vice versa.
10. Entire Agreement. This Agreement and the exhibits hereto constitutes the entire agreement between the parties and supersedes all prior agreements and understandings, whether written or oral, relating to the subject matter of this Agreement.
11. Amendment. This Agreement may be amended or modified only by a written instrument executed by both the Company and the Executive.
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12. Governing Law. This Agreement shall be construed, interpreted and enforced in accordance with the laws of the State of New York, without regard to its conflict of laws principles.
13. Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of both parties and their respective successors and assigns, including any corporation with which or into which the Company may be merged or which may succeed to its assets or business, provided, however, that the obligations of the Executive are personal and shall not be assigned by the Executive.
14. Arbitration. The parties agree that any controversy, claim, or dispute arising out of or relating to this Agreement, or the breath thereof, or arising out of or relating to the employment of the Executive, or the termination thereof, including any claims under federal, state, or local law, shall be resolved by arbitration in New York, New York, in accordance with the Employment Dispute Resolution Rules of the American Arbitration Association. The parties agree that any award rendered by the arbitrator shall be final and binding, and that judgment upon the award may be entered in any court having jurisdiction thereof. EACH OF THE PARTIES HERETO HEREBY VOLUNTARILY AND IRREVOCABLY WAIVES TRIAL BY JURY IN ANY ACTION OR OTHER PROCEEDING BROUGHT IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY.
15. Indemnification. The Company shall indemnify and save harmless the Executive for any liability incurred by reason of any act or omission performed by the Executive while acting in good faith on behalf of the Company and within the scope of the authority of the Executive pursuant to this Agreement and to the fullest extent provided under the Bylaws, the Certificate of Incorporation and the General Corporation Law of the State of Delaware, except that the Executive must have in good faith believed that such action was 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 that such conduct was unlawful.
16. Cooperation with the Company after Termination of Employment. Following termination of Executive’s employment for any reason, Executive shall fully cooperate with the Company in all matters relating to the winding up of the Executive’s pending work on behalf of the Company including, but not limited to, any litigation in which the Company is involved, and the orderly transfer of any such pending work to other employees of the Company as may be designated by the Company. Following any notice of termination of employment by either the Company or the Executive, the Company shall be entitled to such full time or part time services of Executive as the Company may reasonably require during all or any part of the fifteen (15)-day period following any notice of termination, provided that Executive shall be compensated for such services at the same rate as in effect immediately before the notice of termination.
17. Miscellaneous.
17.1 No delay or omission by either party in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by a party on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of any right on any other occasion.
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17.2 The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope or substance of any section of this Agreement.
17.3 In case any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceability of the remaining provisions shall in no way be affected or impaired thereby.
17.4 This Agreement is effective as of the date of execution of this Agreement, will survive Executive’s employment with the Company, and does not in any way restrict Executive’s right or the right of the Company to terminate Executive’s employment.
17.5 Each party certifies and acknowledges that he or it has carefully read all of the provisions of this Agreement and that he or it understands and will fully and faithfully comply with its provisions.
17.6 The Company shall be entitled to withhold from any amounts payable under this Agreement any federal, state, local or foreign withholding or other taxes or charges which the Company is required to withhold. The Company shall be entitled to rely on an opinion of counsel if any questions as to the amount or requirement of withholding shall arise.
17.7 Section 409A. The parties acknowledge and agree that, to the extent applicable, this Agreement shall be interpreted in accordance with, and the parties agree to use their best efforts to achieve timely compliance with, Section 409A, including without limitation any such regulations or other guidance that may be issued after the Commencement Date. Notwithstanding any provision of this Agreement to the contrary, in the event that the Company determines that any compensation or benefits payable or provided hereunder may be subject to Section 409A, the Company reserves the right (without any obligation to do so or to indemnify the Executive for failure to do so) to adopt such limited amendments to this Agreement and appropriate policies and procedures, including amendments and policies with retroactive effect, that the Company reasonably determines are necessary or appropriate to (a) exempt the compensation and benefits payable under this Agreement from Section 409A and/or preserve the intended tax treatment of the compensation and benefits provided with respect to this Agreement or (b) comply with the requirements of Section 409A
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year set forth above.
MICROLIN BIO, INC. | ||
By: | /s/ Joseph Hernandez |
EXECUTIVE: | |
/s/ Joseph Hernandez | |
Joseph Hernandez |
[Signature Page to Employment Agreement]
Annex A
1. Bota-Nik, LLC
2. VitaBar, LLC
3. Mariel Advisors, LLC
4. Prolias Technologies, INC
Annex B
Incentive Units Agreement
MICROLIN BIO, INC.
Scientific Advisory Board Agreement
This Scientific Advisory Board Agreement (the “Agreement”) is made and entered into as of September 18, 2013 (the “Effective Date”), by and between MicroLin Bio, Inc., a Delaware company, having its principal place of business at 302A W. 12th Street, NY, NY 10014 (the “Company”), and Dr. Philip Tsichlis, an individual with an address at 25 Jefferson Road, Winchester MA, 01890 (the “Advisor”). The Company and the Advisor may be referred to herein individually as “Party” or collectively, as “Parties.”
Recital
As part of its ongoing program of research and development, the Company desires to retain distinguished scientists and other qualified individuals to advise the Company with respect to its technology strategy and to assist it in the research, development and analysis of the Company’s technology and products. In furtherance thereof, the Company desires to retain Advisor as a member of its Scientific Advisory Board as described below, and the Company and Advisor desire to enter into this Agreement to effect such retention.
Agreement
In consideration of the mutual covenants set forth below, the Parties hereby agree as follows:
1. Scientific Advisory Board and Consulting Services. Commencing as of the Effective Date, the Company hereby retains Advisor, and Advisor hereby agrees to serve, as a member of the Company’s Scientific Advisory Board (the “SAB”) and as a consultant to the Company. As member of the SAB and consultant, Advisor agrees to provide the services as follows: (a) attending meetings of the Company’s SAB; (b) performing the duties of an SAB member at such meetings, as established from time to time by the mutual agreement of the Company and the SAB members, including without limitation meeting with Company employees, consultants and other SAB members, reviewing goals of the Company and assisting in developing strategies for achieving such goals, and providing advice, support, theories, techniques and improvements in the Company’s scientific research and product development activities; and (c) providing consulting services to the Company at its request, including a reasonable amount of informal consultation over the telephone or otherwise as requested by the Company. The services to be provided by Advisor hereunder are referred to collectively herein as the “Services.” Advisor shall provide at least four (4) full days of Services to the Company, and such additional days as requested by the Company each annual period, but not to exceed ten (10) full days of Services per year unless otherwise agreed. Advisor’s consultation with the Company will involve services as scientific, technical and business advisor for company and senior team as needed with respect to the field of microRNA diagnostics and therapeutics (the “Field”) and requires the application of unique, special and extraordinary skills and knowledge that Advisor possesses in the Field.
2. Compensation.
As compensation for performing the Services, the Company shall pay Advisor two hundred dollars ($200) hourly, payable quarterly (within ten (10) days of the end of the applicable quarter) up to the maximum of eighty (80) hours total per year, unless otherwise agreed. The Company will also reimburse Advisor for reasonable out-of-pocket expenses incurred by Advisor subject to the submission of reasonable documentation.
3. Independent Contractor. The Parties understand and agree that Advisor is an independent contractor and not an employee of the Company. Advisor has no authority to obligate the Company by contract or otherwise. Advisor will not be eligible for any employee benefits, nor will the Company make deductions from Advisor’s fees for taxes (except as otherwise required by applicable law or regulation). Any taxes imposed on Advisor due to activities performed hereunder will be the sole responsibility of Advisor.
4. Institutional Affiliations.
4.1. The Company acknowledges that Advisor is a Professor at the Tufts University School of Medicine. He is also the Director of the Molecular Oncology Research Institute at Tufts Medical Center (the “Institute”) and is subject to the Institute’s policies, including policies concerning consulting, conflicts of interest and intellectual property. The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor’s obligations under the Institute’s policies take priority over the obligations Advisor has by reason of this Agreement. The Company further acknowledges and agrees that nothing in this Agreement shall affect Advisor’s obligations to, or research on behalf of, the Institute. Advisor agrees to use reasonable efforts to avoid or minimize any such conflict. Advisor agrees that he will use best efforts to avoid using any facilities or resources of the Institute in performing the Services hereunder.
4.2. Advisor agrees to provide to the Company copies of Institute’s policies or guidelines relating to Advisor’s obligations to the Institute and consulting services, if any, promptly upon request by the Company. If Advisor is required by the Institute, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services being provided by Advisor hereunder or is that contrary to the terms of this Agreement, Advisor will promptly notify the Company of such obligation, specifying the nature of such disclosure or action and identifying the applicable guideline or policy under which disclosure or action is required, prior to making such disclosure or taking such action.
5. Recognition of Company’s Rights; Nondisclosure. Advisor recognizes that the Company is engaged in a continuous program of research and development respecting its present and future business activities. Advisor agrees as follows:
5.1. At all times during the term of Advisor’s association with the Company and thereafter, Advisor will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except to the extent such disclosure, use or publication may be required in direct connection with Advisor’s performing requested Services for the Company, is expressly authorized in writing by an officer of the Company, or is required by law.
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5.2. The term “Proprietary Information” shall mean any and all trade secrets, confidential knowledge, know-how, data or other proprietary information or materials of the Company. By way of illustration but not limitation, Proprietary Information includes: (i) inventions, ideas, samples, prototypes, devices, hardware, software, electronic components and materials, and procedures for producing any such items, as well as data, know-how, improvements, inventions, discoveries, developments, designs and techniques; (ii) information regarding plans for research, development, new products, marketing and selling activities, business models, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (iii) information regarding the skills and compensation of employees or other consultants of the Company. The preceding obligations of Advisor of nondisclosure and the limitation upon the right to use the Proprietary Information shall not apply to the extent that Advisor can demonstrate by suitable physical evidence that the Proprietary Information: (a) was in the possession or control of Advisor prior to the time of disclosure hereunder; or (b) was independently developed by employees of Advisor or its affiliated companies, who had no knowledge of the Information; or (c) at the time of disclosure was, or thereafter becomes, public knowledge through no fault or omission of Advisor; or (d) was lawfully obtained by Advisor from a third party under no obligation of confidentiality to Company.
5.3. In addition, Advisor understands that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of Advisor’s association and thereafter, Advisor will hold Third Party Information in the strictest confidence and will not disclose or use Third Party Information, except in connection with Advisor’s performing requested Services for the Company, as expressly authorized in writing by an officer of the Company, or is required by law.
6. Intellectual Property Rights.
6.1. Advisor agrees that any and all ideas, inventions, technologies, discoveries, improvements, know-how and techniques that the Advisor conceives, reduces to practice or develops during the term of the Agreement, alone or in conjunction with others, but only in the course of and directly related to the Advisor’s performing the Services for the Company under this Agreement (collectively, the “Inventions”) shall be the sole and exclusive property of the Company.
6.2. Advisor hereby assigns to the Company his entire right, title and interest in and to all Inventions. Advisor hereby designates the Company as his agent for, and grants to the Company a power of attorney, which power of attorney shall be deemed coupled with an interest, solely for the purpose of effecting the foregoing assignment from the Advisor to the Company. Advisor will perform other activities necessary to effect the intent of this Section 6.2.
6.3. Advisor further agrees to reasonably cooperate and provide reasonable assistance to the Company to obtain and from time to time enforce United States and foreign patents, copyrights, and other rights and protections claiming, covering or relating to the Inventions in any and all countries, all at the Company’s expense.
6.4. Advisor agrees to submit to the Company any proposed publication that contains any discussion relating to the Company, Proprietary Information, Inventions or work performed by Advisor for the Company hereunder. Advisor further agrees that no such publication shall be made without the prior written consent of the Company, which consent shall not be unreasonably withheld or delayed.
6.5. Notwithstanding anything herein, Company shall not obtain any right in or respecting any intellectual property, information, data, advice, methods, solutions, inventions, technologies, results or any other work products, in any form whatsoever, which: (a) received direct or indirect financial support from Tufts Medical Center, Inc. (“Tufts MC”), Tufts Medical Center Physicians Organization, Inc. (“PO”) or any of their affiliates (Tufts MC, PO and their affiliates are collectively referred to herein as the “Institution”). including funding from any outside source awarded to or administered by the Institution, or (b) made use of any space, facilities, materials or other resources of the Institution including resources provided in-kind by outside sources.
6.6. Advisor acknowledges and agrees that he is entering into this Agreement in his individual capacity and not as employee or agent of Institution and that it is his sole responsibility to ensure that the Services do not employ any proprietary information of Institution or make use of Institution’s time or resources in violation of Institution’s rules and policies. For the avoidance of doubt, in providing Services under this arrangement Advisor will not use the time or services of any other Institution employee nor will Advisor use any Institution facilities, space, equipment, materials, information or other resources, provided that he may use the library and his office.
6.7. Neither the name of Advisor nor that of Institution, nor any variation thereon nor adaptation thereof may be used for any purpose without the prior written approval of the party whose name is to be used.
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7. Noncompetition and Nonsolicitation of Employees.
7.1. During the term of this Agreement, Advisor will not, without the prior consent of the Company’s Board of Directors, engage in any commercial business activity that competes in any way with any business then being conducted by the Company in the Field, except that Advisor may continue the affiliations set forth in Exhibit A. In addition, but without limiting the generality of the foregoing, Advisor covenants and agrees during the term of this Agreement and for one (1) year thereafter not to enter into any consulting relationship in the Field with any third party commercial entity. The foregoing shall not prevent Advisor from engaging in his work at the Institute or conducting any academic research, teaching or related non-commercial activity or any non-related commercial activity.
7.2. During the term of this Agreement and for one (1) year after its termination, Advisor will not personally or through others recruit, solicit or induce any employee of the Company to terminate his or her employment with the Company.
7.3. If any restriction set forth in Sections 7.1 and 7.2 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable.
8. No Conflicting Obligation.
8.1. Advisor represents that Advisor’s performance of all of the terms of this Agreement and the performing of the Services for the Company do not and will not breach or conflict with any agreement with a third party, except as contemplated by Section 4.1, including an agreement to keep in confidence any proprietary information of another entity acquired by Advisor in confidence or in trust prior to the date of this Agreement.
8.2. Advisor hereby agrees not to enter into any agreement that conflicts with this Agreement during the term.
9. No Improper Use of Materials. Advisor agrees not to bring to the Company or to use in the performance of Services for the Company any materials or documents of a present or former employer of Advisor, or any materials or documents obtained by Advisor from a third party under a binder of confidentiality, unless such materials or documents are generally available to the public or Advisor has authorization from such present or former employer or third party for the possession and unrestricted use of such materials. Advisor understands that Advisor is not to breach any obligation of confidentiality that Advisor has to present or former employers or clients, and agrees to fulfill all such obligations during the term of this Agreement.
10. Term and Termination.
10.1. This Agreement, and Advisor’s Services hereunder, shall commence on the Effective Date and shall continue for an initial term of one (1) year after the Effective Date, unless earlier terminated as provided below. At the end of such initial term, the Agreement will automatically be extended for an additional period or periods of one (1) year each, unless the Advisor or the Company shall have given to the other written notice to the contrary at least thirty (30) days prior to the commencement of such additional period.
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10.2. Advisor or the Company may terminate the Agreement at any time by giving no less than thirty (30) days prior written notice to the other Party.
10.3. The obligations set forth in Articles 2, 5, 6, 7 and 10 through 16 will survive any termination or expiration of this Agreement. Upon termination of this Agreement, Advisor will promptly deliver to the Company all documents and other materials of any nature pertaining to the Services, together with all documents and other items containing or pertaining to any Proprietary Information.
11. Assignment. The rights and liabilities of the Parties hereto shall bind and inure to the benefit of their respective successors, heirs, executors and administrators, as the case may be; provided that, as the Company has specifically contracted for Advisor’s Services, Advisor may not assign or delegate Advisor’s obligations under this Agreement either in whole or in part without the prior written consent of the Company. The Company may assign its rights and obligations hereunder to any person or entity that succeeds to all or substantially all of the Company’s business. Any assignment not in accordance with this Section 11 shall be void.
12. Legal and Equitable Remedies. Because Advisor’s Services are personal and unique and because Advisor may have access to and become acquainted with the Proprietary Information of the Company, the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.
13. Governing Law; Severability. This Agreement shall be governed by and construed according to the laws of the State of Delaware, without regards to conflicts of laws rules. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, that provision shall be severed and the remainder of this Agreement shall continue in full force and effect. The parties agree that the State and federal courts located within the First Department (for State courts) and the Southern District of New York (for federal courts) shall be the venue for the initiation of any legal proceedings by a party with respect to this Agreement.
14. Complete Understanding; Modification. This Agreement, and the Exhibit mentioned herein, constitute the final, exclusive and complete understanding and agreement of the Parties hereto and supersedes all prior understandings and agreements. Any waiver, modification or amendment of any provision of this Agreement shall be effective only if in writing and signed by the Parties hereto.
15. Notices. Any notices required or permitted hereunder shall be given to the appropriate Party at the address listed on the first page of the Agreement, or such other address as the Party shall specify in writing pursuant to this notice provision. Such notice shall be deemed given upon personal delivery to the appropriate address or three days after the date of delivery if sent by certified or registered mail, return receipt requested; or three days after the date of delivery if sent by an overnight delivery service with verified delivery.
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16. Counterparts. This Agreement may be executed in one or more counterparts each of which will be deemed an original, but all of which together shall constitute one and the same instrument.
17. Indemnification. The Company shall indemnify and defend the Advisor from any and all third party claims against Advisor and any costs, losses or expenses related thereto, including any reasonable legal fees and expenses, arising out of his services or status as an Advisor hereunder, except to the extent such claims arise out of Advisor’s deliberate and material misconduct. The Company shall reimburse the Advisor for any reasonable legal fees and expenses incurred by the Advisor in order to enforce the provisions of this paragraph.
In Witness Whereof, the Parties hereto have executed this Agreement as of the date first written above.
Microlin Bio, Inc. | Dr. Philip Tsichlis | |
/s/ Joe Hernandez | /s/ Philip Tsichilis | |
By: Joe Hernandez | ||
Title: Chairman & CEO |
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Exhibit A
Affiliations
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MICROLIN BIO, INC.
Scientific Advisory Board Agreement
This Scientific Advisory Board Agreement (the “Agreement”) is made and entered into as of September 20, 2013 (the “Effective Date”), by and between MicroLin Bio, Inc., a Delaware company, having its principal place of business at 302A W. 12th Street, NY, NY 10014 (the “Company”), and Dr. Robert Lee, an individual with an address at 2300 Green Island Dr., Columbus, OH 43228 (the “Advisor”). The Company and the Advisor may be referred to herein individually as “Party” or collectively, as “Parties.”
Recital
As part of its ongoing program of research and development, the Company desires to retain distinguished scientists and other qualified individuals to advise the Company with respect to its technology strategy and to assist it in the research, development and analysis of the Company’s technology and products. In furtherance thereof, the Company desires to retain Advisor as a member of its Scientific Advisory Board as described below, and the Company and Advisor desire to enter into this Agreement to effect such retention.
Agreement
In consideration of the mutual covenants set forth below, the Parties hereby agree as follows:
1. Scientific Advisory Board and Consulting Services. Commencing as of the Effective Date, the Company hereby retains Advisor, and Advisor hereby agrees to serve, as a member of the Company’s Scientific Advisory Board (the “SAB”) and as a consultant to the Company. As member of the SAB and consultant, Advisor agrees to provide the services as follows: (a) attending meetings of the Company’s SAB; (b) performing the duties of an SAB member at such meetings, as established from time to time by the mutual agreement of the Company and the SAB members, including without limitation meeting with Company employees, consultants and other SAB members, reviewing goals of the Company and assisting in developing strategies for achieving such goals, and providing advice, support, theories, techniques and improvements in the Company’s scientific research and product development activities; and (c) providing consulting services to the Company at its request, including a reasonable amount of informal consultation over the telephone or otherwise as requested by the Company. The services to be provided by Advisor hereunder are referred to collectively herein as the “Services.” Advisor shall provide at least ten (10) full days of Services to the Company, and such additional days as requested by the Company each annual period, but not to exceed twenty (20) full days of Services per year unless otherwise agreed. Advisor’s consultation with the Company will involve services as scientific, technical and business advisor for company and senior team as needed with respect to the field of microRNA diagnostics and therapeutics related to prostate, colorectal, ovarian, and lung cancers (the “Field”) and requires the application of unique, special and extraordinary skills and knowledge that Advisor possesses in the Field.
2. Compensation.
As compensation for performing the Services, the Company shall pay Advisor three hundred fifty dollars ($350) hourly, payable quarterly (within fifteen (15) days of the end of the applicable quarter) up to the maximum of one hundred sixty (160) hours total per year, unless otherwise agreed. The Company will also reimburse Advisor for reasonable out-of-pocket expenses incurred by Advisor subject to the submission of reasonable documentation.
3. Independent Contractor. The Parties understand and agree that Advisor is an independent contractor and not an employee of the Company. Advisor has no authority to obligate the Company by contract or otherwise. Advisor will not be eligible for any employee benefits, nor will the Company make deductions from Advisor’s fees for taxes (except as otherwise required by applicable law or regulation). Any taxes imposed on Advisor due to activities performed hereunder will be the sole responsibility of Advisor.
4. Institutional Affiliations.
4.1. The Company acknowledges that Advisor is a Professor at The Ohio State University (the “Institute”) and is subject to the Institute’s policies, including policies concerning consulting, conflicts of interest and intellectual property. The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor’s obligations under the Institute’s policies take priority over the obligations Advisor has by reason of this Agreement. The Company further acknowledges and agrees that nothing in this Agreement shall affect Advisor’s obligations to, or research on behalf of, the Institute. Advisor agrees to use reasonable efforts to avoid or minimize any such conflict. Advisor agrees that he will use best efforts to avoid using any facilities or resources of the Institute in performing the Services hereunder.
4.2. Advisor agrees to provide to the Company copies of Institute’s policies or guidelines relating to Advisor’s obligations to the Institute and consulting services, if any, promptly upon request by the Company. If Advisor is required by the Institute, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services being provided by Advisor hereunder or is that contrary to the terms of this Agreement, Advisor will promptly notify the Company of such obligation, specifying the nature of such disclosure or action and identifying the applicable guideline or policy under which disclosure or action is required, prior to making such disclosure or taking such action.
5. Recognition of Company’s Rights; Nondisclosure. Advisor recognizes that the Company is engaged in a continuous program of research and development respecting its present and future business activities. Advisor agrees as follows:
5.1. At all times during the term of Advisor’s association with the Company and thereafter, Advisor will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except to the extent such disclosure, use or publication may be required in direct connection with Advisor’s performing requested Services for the Company, is expressly authorized in writing by an officer of the Company, or is required by law.
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5.2. The term “Proprietary Information” shall mean any and all trade secrets, confidential knowledge, know-how, data or other proprietary information or materials of the Company. By way of illustration but not limitation, Proprietary Information includes: (i) inventions, ideas, samples, prototypes, devices, hardware, software, electronic components and materials, and procedures for producing any such items, as well as data, know-how, improvements, inventions, discoveries, developments, designs and techniques; (ii) information regarding plans for research, development, new products, marketing and selling activities, business models, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (iii) information regarding the skills and compensation of employees or other consultants of the Company.
5.3. In addition, Advisor understands that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of Advisor’s association and thereafter, Advisor will hold Third Party Information in the strictest confidence and will not disclose or use Third Party Information, except in connection with Advisor’s performing requested Services for the Company, as expressly authorized in writing by an officer of the Company, or is required by law.
6. Intellectual Property Rights.
6.1. Advisor agrees that any and all ideas, inventions, technologies, discoveries, improvements, know-how and techniques that the Advisor conceives, reduces to practice or develops during the term of the Agreement, alone or in conjunction with others, but only in the course of and directly related to the Advisor’s performing the Services for the Company under this Agreement (collectively, the “Inventions”) shall be the sole and exclusive property of the Company.
6.2. Advisor hereby assigns to the Company his entire right, title and interest in and to all Inventions. Advisor hereby designates the Company as his agent for, and grants to the Company a power of attorney, which power of attorney shall be deemed coupled with an interest, solely for the purpose of effecting the foregoing assignment from the Advisor to the Company. Advisor will perform other activities necessary to effect the intent of this Section 6.2.
6.3. Advisor further agrees to reasonably cooperate and provide reasonable assistance to the Company to obtain and from time to time enforce United States and foreign patents, copyrights, and other rights and protections claiming, covering or relating to the Inventions in any and all countries, all at the Company’s expense.
6.4. Advisor agrees to submit to the Company any proposed publication that contains any discussion relating to the Company, Proprietary Information, Inventions or work performed by Advisor for the Company hereunder. Advisor further agrees that no such publication shall be made without the prior written consent of the Company, which consent shall not be unreasonably withheld or delayed.
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7. Noncompetition and Nonsolicitation of Employees.
7.1. During the term of this Agreement, Advisor will not, without the prior consent of the Company’s Board of Directors, engage in any commercial business activity that competes in any way with any business then being conducted by the Company in the Field. In addition, but without limiting the generality of the foregoing, Advisor covenants and agrees during the term of this Agreement and for one year thereafter not to enter into any consulting relationship in the Field with any third party commercial entity. The foregoing shall not prevent Advisor from engaging in his work at the Institute or conducting any academic research, teaching or related non-commercial activity or any non-related commercial activity, which may include therapeutic delivery of antisense oligonucleotides, siRNA, and microRNA related therapeutics outside the specified indications of prostate, colorectal, ovarian and lung cancers.
7.2. During the term of this Agreement and for one (1) year after its termination, Advisor will not personally or through others recruit, solicit or induce any employee of the Company to terminate his or her employment with the Company.
7.3. If any restriction set forth in Sections 7.1 and 7.2 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable.
8. No Conflicting Obligation.
8.1. Advisor represents that Advisor’s performance of all of the terms of this Agreement and the performing of the Services for the Company do not and will not breach or conflict with any agreement with a third party, except as contemplated by Section 4.1, including an agreement to keep in confidence any proprietary information of another entity acquired by Advisor in confidence or in trust prior to the date of this Agreement.
8.2. Advisor hereby agrees not to enter into any agreement that conflicts with this Agreement.
9. No Improper Use of Materials. Advisor agrees not to bring to the Company or to use in the performance of Services for the Company any materials or documents of a present or former employer of Advisor, or any materials or documents obtained by Advisor from a third party under a binder of confidentiality, unless such materials or documents are generally available to the public or Advisor has authorization from such present or former employer or third party for the possession and unrestricted use of such materials. Advisor understands that Advisor is not to breach any obligation of confidentiality that Advisor has to present or former employers or clients, and agrees to fulfill all such obligations during the term of this Agreement.
10. Term and Termination.
10.1. This Agreement, and Advisor’s Services hereunder, shall commence on the Effective Date and shall continue for an initial term of two (2) year after the Effective Date, unless earlier terminated as provided below. At the end of such initial term, the Agreement will automatically be extended for an additional period or periods of one (1) year each, unless the Advisor or the Company shall have given to the other written notice to the contrary at least thirty (30) days prior to the commencement of such additional period.
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10.2. Advisor or the Company may terminate the Agreement at any time by giving no less than thirty (30) days prior written notice to the other Party.
10.3. The obligations set forth in Articles 2, 5, 6, 7 and 10 through 16 will survive any termination or expiration of this Agreement. Upon termination of this Agreement, Advisor will promptly deliver to the Company all documents and other materials of any nature pertaining to the Services, together with all documents and other items containing or pertaining to any Proprietary Information.
11. Assignment. The rights and liabilities of the Parties hereto shall bind and inure to the benefit of their respective successors, heirs, executors and administrators, as the case may be; provided that, as the Company has specifically contracted for Advisor’s Services, Advisor may not assign or delegate Advisor’s obligations under this Agreement either in whole or in part without the prior written consent of the Company. The Company may assign its rights and obligations hereunder to any person or entity that succeeds to all or substantially all of the Company’s business. Any assignment not in accordance with this Section 11 shall be void.
12. Legal and Equitable Remedies. Because Advisor’s Services are personal and unique and because Advisor may have access to and become acquainted with the Proprietary Information of the Company, the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.
13. Governing Law; Severability. This Agreement shall be governed by and construed according to the laws of the State of Delaware, without regards to conflicts of laws rules. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, that provision shall be severed and the remainder of this Agreement shall continue in full force and effect. The parties agree that the State and federal courts located within the First Department (for State courts) and the Southern District of New York (for federal courts) shall be the venue for the initiation of any legal proceedings by a party with respect to this Agreement.
14. Complete Understanding; Modification. This Agreement constitutes the final, exclusive and complete understanding and agreement of the Parties hereto and supersedes all prior understandings and agreements. Any waiver, modification or amendment of any provision of this Agreement shall be effective only if in writing and signed by the Parties hereto.
15. Notices. Any notices required or permitted hereunder shall be given to the appropriate Party at the address listed on the first page of the Agreement, or such other address as the Party shall specify in writing pursuant to this notice provision. Such notice shall be deemed given upon personal delivery to the appropriate address or three days after the date of delivery if sent by certified or registered mail, return receipt requested; or three days after the date of delivery if sent by an overnight delivery service with verified delivery.
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16. Counterparts. This Agreement may be executed in one or more counterparts each of which will be deemed an original, but all of which together shall constitute one and the same instrument.
17. Indemnification. The Company shall indemnify and defend the Advisor from any and all third party claims against Advisor and any costs, losses or expenses related thereto, including any reasonable legal fees and expenses, arising out of his services or status as an Advisor hereunder, except to the extent such claims arise out of Advisor’s deliberate and material misconduct. The Company shall reimburse the Advisor for any reasonable legal fees and expenses incurred by the Advisor in order to enforce the provisions of this paragraph.
In Witness Whereof, the Parties hereto have executed this Agreement as of the date first written above.
Microlin Bio, Inc. | Dr. Robert Lee | |
/s/ Joe Hernandez | /s/ Robert Lee | |
By: Joe Hernandez | ||
Title: Chairman & CEO |
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MICROLIN BIO, INC.
Scientific Advisory Board Agreement
This Scientific Advisory Board Agreement (the “Agreement”) is made and entered into as of December 18, 2013 (the “Effective Date”), by and between Microlin Bio, Inc., a Delaware company, having its principal place of business at 302A W. 12th Street, NY, NY 10014 (the “Company”), and Dr. George Calin, an individual with an address at 1515 Holcombe Blvd., Unit 1950, Houston, TX 77030-4009 (the “Advisor”). The Company and the Advisor may be referred to herein individually as “Party” or collectively, as “Parties.”
Recital
As part of its ongoing program of research and development, the Company desires to retain distinguished scientists and other qualified individuals to advise the Company with respect to its technology strategy and to assist it in the research, development and analysis of the Company’s technology and products. In furtherance thereof, the Company desires to retain Advisor as a member of its Scientific Advisory Board as described below, and the Company and Advisor desire to enter into this Agreement to effect such retention.
Agreement
In consideration of the mutual covenants set forth below, the Parties hereby agree as follows:
1. Scientific Advisory Board and Consulting Services.
1.1. Commencing as of the Effective Date, the Company hereby retains Advisor, and Advisor hereby agrees to serve, as a member of the Company’s Scientific Advisory Board (the “SAB”) and as a consultant to the Company. As member of the SAB and consultant, Advisor agrees to provide the services as follows: (a) attending meetings of the Company’s SAB; (b) performing the duties of an SAB member at such meetings, as established from time to time by the mutual agreement of the Company and the SAB members, including without limitation meeting with Company employees, consultants and other SAB members, reviewing goals of the Company and assisting in developing strategies for achieving such goals, and providing advice, support, theories, techniques and improvements in the Company’s scientific research and product development activities; and (c) providing consulting services to the Company at its request, including a reasonable amount of informal consultation over the telephone or otherwise as requested by the Company. The services to be provided by Advisor hereunder are referred to collectively herein as the “Services.” Advisor shall provide at least ten (10) full days of Services to the Company, and such additional days as requested by the Company each annual period, but not to exceed twenty (20) full days of Services per year unless otherwise agreed. Advisor’s consultation with the Company will involve services as scientific, technical and business advisor for company and senior team as needed with respect to the field of microRNA diagnostics and therapeutics (the “Field”) and requires the application of unique, special and extraordinary skills and knowledge that Advisor possesses in the Field.
1.2. Advisor agrees that all Services will be performed by Advisor on his own time and without the support of The University of Texas (“U. T.”) System or any U. T. System institution, including, without limitation, the U. T. M. D. Anderson Cancer Center (“M. D. Anderson”) or the use of their respective facilities or resources. Advisor acknowledges and agrees that the neither the Services nor the subject matter to which the Services relate are within the scope of Advisor’s employment by M. D. Anderson. Advisor agrees to use his best efforts to obtain (a) an acknowledgement by M. D. Anderson that the Services to be performed hereunder are not within the scope of Advisor’s employment by M. D. Anderson and (b) a waiver by M. D. Anderson of any and all rights to the Inventions (as defined below).
2. Compensation.
As compensation for performing the Services, the Company shall pay Advisor two hundred dollars ($200) hourly, payable quarterly (within fifteen (15) days of the end of the applicable quarter) up to the maximum of seventy five (75) hours total or fifteen thousand ($15,000) per year, unless otherwise agreed. The Company will also reimburse Advisor for reasonable out-of-pocket expenses incurred by Advisor subject to the submission of reasonable documentation.
3. Independent Contractor. The Parties understand and agree that Advisor is an independent contractor and not an employee of the Company. Advisor has no authority to obligate the Company by contract or otherwise. Advisor will not be eligible for any employee benefits, nor will the Company make deductions from Advisor’s fees for taxes (except as otherwise required by applicable law or regulation). Any taxes imposed on Advisor due to activities performed hereunder will be the sole responsibility of Advisor.
4. Institutional Affiliations.
4.1. The Company acknowledges that Advisor is a Professor at the ___________ (the “Institute”) and is subject to the Institute’s policies, including policies concerning consulting, conflicts of interest and intellectual property. The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor’s obligations under the Institute’s policies take priority over the obligations Advisor has by reason of this Agreement. The Company further acknowledges and agrees that nothing in this Agreement shall affect Advisor’s obligations to, or research on behalf of, the Institute. Advisor agrees to use reasonable efforts to avoid or minimize any such conflict. Advisor agrees that he will use best efforts to avoid using any facilities or resources of the Institute in performing the Services hereunder.
4.2. Advisor agrees to provide to the Company copies of Institute’s policies or guidelines relating to Advisor’s obligations to the Institute and consulting services, if any, promptly upon request by the Company. If Advisor is required by the Institute, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services being provided by Advisor hereunder or is that contrary to the terms of this Agreement, Advisor will promptly notify the Company of such obligation, specifying the nature of such disclosure or action and identifying the applicable guideline or policy under which disclosure or action is required, prior to making such disclosure or taking such action.
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5. Recognition of Company’s Rights; Nondisclosure. Advisor recognizes that the Company is engaged in a continuous program of research and development respecting its present and future business activities. Advisor agrees as follows:
5.1. At all times during the term of Advisor’s association with the Company and thereafter, Advisor will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except to the extent such disclosure, use or publication may be required in direct connection with Advisor’s performing requested Services for the Company, is expressly authorized in writing by an officer of the Company, or is required by law.
5.2. The term “Proprietary Information” shall mean any and all trade secrets, confidential knowledge, know-how, data or other proprietary information or materials of the Company. By way of illustration but not limitation, Proprietary Information includes: (i) inventions, ideas, samples, prototypes, devices, hardware, software, electronic components and materials, and procedures for producing any such items, as well as data, know-how, improvements, inventions, discoveries, developments, designs and techniques; (ii) information regarding plans for research, development, new products, marketing and selling activities, business models, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (iii) information regarding the skills and compensation of employees or other consultants of the Company.
5.3. In addition, Advisor understands that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of Advisor’s association and thereafter, Advisor will hold Third Party Information in the strictest confidence and will not disclose or use Third Party Information, except in connection with Advisor’s performing requested Services for the Company, as expressly authorized in writing by an officer of the Company, or is required by law.
6. Intellectual Property Rights.
6.1. Advisor agrees that any and all ideas, inventions, technologies, discoveries, improvements, know-how and techniques that the Advisor conceives, reduces to practice or develops during the term of the Agreement, alone or in conjunction with others, but only in the course of and directly related to the Advisor’s performing the Services for the Company under this Agreement (collectively, the “Inventions”) shall be the sole and exclusive property of the Company.
6.2. Advisor hereby assigns to the Company his entire right, title and interest in and to all Inventions. Advisor hereby designates the Company as his agent for, and grants to the Company a power of attorney, which power of attorney shall be deemed coupled with an interest, solely for the purpose of effecting the foregoing assignment from the Advisor to the Company. Advisor will perform other activities necessary to effect the intent of this Section 6.2.
6.3. Advisor further agrees to reasonably cooperate and provide reasonable assistance to the Company to obtain and from time to time enforce United States and foreign patents, copyrights, and other rights and protections claiming, covering or relating to the Inventions in any and all countries, all at the Company’s expense.
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6.4. Advisor agrees to submit to the Company any proposed publication that contains any discussion relating to the Company, Proprietary Information, Inventions or work performed by Advisor for the Company hereunder. Advisor further agrees that no such publication shall be made without the prior written consent of the Company, which consent shall not be unreasonably withheld or delayed.
6.5. Notwithstanding any of the other terms of this Agreement, the Parties acknowledge and agree that Advisor is an employee of The University of Texas M. D. Anderson Cancer Center and therefore Advisor executes this Agreement subject to the Rules and Regulations of The Board of Regents of The University of Texas System (the “Rules and Regulations”) and all terms and conditions therein that apply to Advisor. Advisor has no right, power, or authority to assign or enter into any other agreement with respect to intellectual property, confidential or other proprietary information owned by The Board of Regents of The University of Texas System that is inconsistent with the Rules and Regulations. A complete copy of the Rules and Regulations of may be found at https://www.utsystem.edu/bor/rules/.
7. Noncompetition and Nonsolicitation of Employees.
7.1. During the term of this Agreement, Advisor will not, without the prior consent of the Company’s Board of Directors, engage in any commercial business activity that competes in any way with any business then being conducted by the Company in the Field, except that Advisor may continue the affiliations set forth in Exhibit A. In addition, but without limiting the generality of the foregoing, Advisor covenants and agrees during the term of this Agreement and for one year thereafter not to enter into any consulting relationship in the Field with any third party commercial entity. The foregoing shall not prevent Advisor from engaging in his work at the Institute or conducting any academic research, teaching or related non-commercial activity or any non-related commercial activity.
7.2. During the term of this Agreement and for three (3) year after its termination, Advisor will not personally or through others recruit, solicit or induce any employee of the Company to terminate his or her employment with the Company.
7.3. If any restriction set forth in Sections 7.1 and 7.2 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable.
8. No Conflicting Obligation.
8.1. Advisor represents that Advisor’s performance of all of the terms of this Agreement and the performing of the Services for the Company do not and will not breach or conflict with any agreement with a third party, except as contemplated by Section 4.1, including an agreement to keep in confidence any proprietary information of another entity acquired by Advisor in confidence or in trust prior to the date of this Agreement.
8.2. Advisor hereby agrees not to enter into any agreement that conflicts with this Agreement.
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9. No Improper Use of Materials. Advisor agrees not to bring to the Company or to use in the performance of Services for the Company any materials or documents of a present or former employer of Advisor, or any materials or documents obtained by Advisor from a third party under a binder of confidentiality, unless such materials or documents are generally available to the public or Advisor has authorization from such present or former employer or third party for the possession and unrestricted use of such materials. Advisor understands that Advisor is not to breach any obligation of confidentiality that Advisor has to present or former employers or clients, and agrees to fulfill all such obligations during the term of this Agreement.
10. Term and Termination.
10.1. This Agreement, and Advisor’s Services hereunder, shall commence on the Effective Date and shall continue for an initial term of two (2) year after the Effective Date, unless earlier terminated as provided below. At the end of such initial term, the Agreement will automatically be extended for an additional period or periods of one (1) year each, unless the Advisor or the Company shall have given to the other written notice to the contrary at least thirty (30) days prior to the commencement of such additional period.
10.2. Advisor or the Company may terminate the Agreement at any time by giving no less than thirty (30) days prior written notice to the other Party.
10.3. The obligations set forth in Articles 2, 5, 6, 7 and 10 through 16 will survive any termination or expiration of this Agreement. Upon termination of this Agreement, Advisor will promptly deliver to the Company all documents and other materials of any nature pertaining to the Services, together with all documents and other items containing or pertaining to any Proprietary Information.
11. Assignment. The rights and liabilities of the Parties hereto shall bind and inure to the benefit of their respective successors, heirs, executors and administrators, as the case may be; provided that, as the Company has specifically contracted for Advisor’s Services, Advisor may not assign or delegate Advisor’s obligations under this Agreement either in whole or in part without the prior written consent of the Company. The Company may assign its rights and obligations hereunder to any person or entity that succeeds to all or substantially all of the Company’s business. Any assignment not in accordance with this Section 11 shall be void.
12. Legal and Equitable Remedies. Because Advisor’s Services are personal and unique and because Advisor may have access to and become acquainted with the Proprietary Information of the Company, the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.
13. Governing Law; Severability. This Agreement shall be governed by and construed according to the laws of the State of Delaware, without regards to conflicts of laws rules. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, that provision shall be severed and the remainder of this Agreement shall continue in full force and effect. The parties agree that the State and federal courts located within the First Department (for State courts) and the Southern District of New York (for federal courts) shall be the venue for the initiation of any legal proceedings by a party with respect to this Agreement.
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14. Complete Understanding; Modification. This Agreement, and the Exhibit mentioned herein, constitute the final, exclusive and complete understanding and agreement of the Parties hereto and supersedes all prior understandings and agreements. Any waiver, modification or amendment of any provision of this Agreement shall be effective only if in writing and signed by the Parties hereto.
15. Notices. Any notices required or permitted hereunder shall be given to the appropriate Party at the address listed on the first page of the Agreement, or such other address as the Party shall specify in writing pursuant to this notice provision. Such notice shall be deemed given upon personal delivery to the appropriate address or three days after the date of delivery if sent by certified or registered mail, return receipt requested; or three days after the date of delivery if sent by an overnight delivery service with verified delivery.
16. Counterparts. This Agreement may be executed in one or more counterparts each of which will be deemed an original, but all of which together shall constitute one and the same instrument.
17. Indemnification. The Company shall indemnify and defend the Advisor from any and all third party claims against Advisor and any costs, losses or expenses related thereto, including any reasonable legal fees and expenses, arising out of his services or status as an Advisor hereunder, except to the extent such claims arise out of Advisor’s deliberate and material misconduct. The Company shall reimburse the Advisor for any reasonable legal fees and expenses incurred by the Advisor in order to enforce the provisions of this paragraph.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first written above.
Microlin Bio, Inc. | Dr. George Calin | |
/s/ Joe Hernandez | /s/ George Calin | |
By: Joe Hernandez | ||
Title: Chairman & CEO |
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Exhibit A
Affiliations
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MICROLIN BIO, INC.
Scientific Advisory Board Agreement
This Scientific Advisory Board Agreement (the “Agreement”) is made and entered into as of December 19, 2013 (the “Effective Date”), by and between MicroLin Bio, Inc., a Delaware company, having its principal place of business at 302A W. 12th Street, NY, NY 10014 (the “Company”), and Dr. Sakari Kauppinen, an individual with an address at Norskekrogen 12, DK-2765 Smoerum, Denmark (the “Advisor”). The Company and the Advisor may be referred to herein individually as “Party” or collectively, as “Parties.”
Recital
As part of its ongoing program of research and development, the Company desires to retain distinguished scientists and other qualified individuals to advise the Company with respect to its research and development and business strategy and to assist it in the research, development and analysis of the Company’s technology and products. In furtherance thereof, the Company desires to retain Advisor as a member of its Scientific Advisory Board as described below, and the Company and Advisor desire to enter into this Agreement to effect such retention.
Agreement
In consideration of the mutual covenants set forth below, the Parties hereby agree as follows:
1. Scientific Advisory Board and Consulting Services. Commencing as of the Effective Date, the Company hereby retains the Advisor, and the Advisor hereby agrees to serve, as a member of the Company’s Scientific Advisory Board (the “SAB”) and as a consultant to the Company. As member of the SAB, Advisor agrees to provide the services as follows: (a) attending meetings of the Company’s SAB; (b) performing the duties of an SAB member at such meetings, as established from time to time by the mutual agreement of the Company and the SAB members. As a consultant to the Company, the Advisor will meet with Company employees, consultants and other SAB members, review goals of the Company and assist in developing strategies for achieving such goals, and provide advice, support, theories, techniques and improvements in the Company’s scientific research and product development activities; and (c) provide consulting services to the Company at its request, including a reasonable amount of informal consultation over the telephone or otherwise as requested by the Company. These services to be provided by Advisor hereunder are referred to collectively herein as the “Services.” Advisor shall annually provide ten (10) full days of Services to the Company, pursuant to a mutually agreed schedule, as requested by the Company for each annual period and agreed to by the Advisor. Advisor’s consultation with the Company will involve Services with respect to the field of microRNA diagnostics and therapeutics (the “Field”) and requires the application of unique, special and extraordinary skills and knowledge that Advisor possesses in the Field. Notwithstanding the foregoing appointments, it is agreed and understood that the Company will not use the Advisors’s name or identify his institutional and non-institutional affiliations in any advertising, promotional or sale literature, or other publicity without the prior written consent of the Advisor.
2. Compensation.
As compensation for performing the Services, the Company shall pay Advisor two hundred and fifty dollars ($250) hourly, payable quarterly (within ten (10) days of the end of the applicable quarter) up to the maximum of eighty (80) hours total per year, unless otherwise agreed. The Company will also reimburse Advisor for reasonable out-of-pocket expenses incurred by Advisor subject to the submission of reasonable documentation.
3. Independent Contractor. The Parties understand and agree that the Advisor is an independent contractor and not an employee of the Company. Advisor has no authority to obligate the Company by contract or otherwise. Advisor will not be eligible for any employee benefits, nor will the Company make deductions from Advisor’s fees for taxes (except as otherwise required by applicable law or regulation). Any taxes imposed on Advisor due to activities performed hereunder will be the sole responsibility of Advisor.
4. Institutional Affiliations.
4.1. The Company acknowledges that the Advisor is a Professor at the Department of Haematology, Aalborg University Hospital (the “Institute”) and is subject to the Institute’s policies, including policies concerning consulting, conflicts of interest and intellectual property. The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor’s obligations under the Institute’s policies take priority and control over the obligations that Advisor has by reason of this Agreement. The Company further acknowledges and agrees that nothing in this Agreement shall affect Advisor’s obligations to, or research on behalf of, the Institute. Advisor agrees to use reasonable efforts to avoid or minimize any such conflict. Advisor agrees that he will use best efforts to avoid using any facilities or resources of the Institute in performing the Services hereunder.
4.2. Advisor agrees to provide to the Company copies of Institute’s policies or guidelines relating to Advisor’s obligations to the Institute and consulting services, if any, promptly upon request by the Company. If Advisor is required by the Institute, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services being provided by Advisor hereunder or is that contrary to the terms of this Agreement, Advisor will promptly notify the Company of such obligation, specifying the nature of such disclosure or action and identifying the applicable guideline or policy under which disclosure or action is required, prior to making such disclosure or taking such action.
4.3. It is agreed and understood that nothing in this AGREEMENT shall be construed to restrict or limit the duties Advisor is performing or may perform in the course of, or incidental to, Advisor's employment at the Institute, including but not limited to research sponsored by a third party commercial entity nor shall anything in the Agreement be construed to restrict or limit Advisor's right to serve as an advisor to any hospital, or to any governmental or non-profit organization.
5. Recognition of Company’s Rights; Nondisclosure. Advisor recognizes that the Company is engaged in a continuous program of research and development respecting its present and future business activities. Advisor agrees as follows:
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5.1. At all times during the term of Advisor’s association with the Company and thereafter, Advisor will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information (defined below), except to the extent such disclosure, use or publication may be required in direct connection with Advisor’s performing requested Services for the Company, is expressly authorized in writing by an officer of the Company, or is required by law.
5.2. The term “Proprietary Information” shall mean any and all trade secrets, confidential knowledge, know-how, data or other proprietary information or materials of the Company. By way of illustration but not limitation, Proprietary Information includes: (i) inventions, ideas, samples, prototypes, devices, hardware, software, electronic components and materials, and procedures for producing any such items, as well as data, know-how, improvements, inventions, discoveries, developments, designs and techniques; (ii) information regarding plans for research, development, new products, marketing and selling activities, business models, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (iii) information regarding the skills and compensation of employees or other consultants of the Company.
5.3. In addition, Advisor understands that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of Advisor’s association and thereafter, Advisor will hold Third Party Information in the strictest confidence and will not disclose or use Third Party Information, except in connection with Advisor’s performing requested Services for the Company, as expressly authorized in writing by an officer of the Company, or is required by law.
5.4. It is agreed and understood that nothing in this Agreement shall limit or be construed to limit the right of the Advisor to use or publish information which: (a) is or becomes available to the public through no breach of the Agreement by Advisor, (b) was known to Advisor before the Services were performed, (c) is acquired by Advisor from a third party that has the legal right to disclose the information to the Advisor or (d) Advisor is required to disclose by law, government regulation, court order, or the Institute policies. In addition, information generated by Advisor pursuant to the Agreement shall be proprietary to the Company only if: (a) such information is generated as a direct result of the performance of the Services under the Agreement and (b) is not generated in the course of the Advisor’s activities as an Institute employee.
6. Intellectual Property Rights.
6.1. Advisor agrees that any and all ideas, inventions, technologies, discoveries, improvements, know-how and techniques that the Advisor conceives, reduces to practice or develops during the term of the Agreement, alone or in conjunction with others, but only in the course of and directly related to the Advisor’s performing the Services for the Company under this Agreement (collectively, the “Inventions”) shall be the sole and exclusive property of the Company.
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6.2. Advisor hereby assigns to the Company his entire right, title and interest in and to all Inventions. Advisor hereby designates the Company as his agent for, and grants to the Company a power of attorney, which power of attorney shall be deemed coupled with an interest, solely for the purpose of effecting the foregoing assignment from the Advisor to the Company. Advisor will perform other activities necessary to effect the intent of this Section 6.2.
6.3. Advisor further agrees to reasonably cooperate and provide reasonable assistance to the Company to obtain and from time to time enforce United States and foreign patents, copyrights, and other rights and protections claiming, covering or relating to the Inventions in any and all countries, all at the Company’s expense.
6.4. Advisor agrees to submit to the Company any proposed publication that contains any discussion relating to the Company, Proprietary Information, Inventions or work performed by Advisor for the Company hereunder. Advisor further agrees that no such publication shall be made without the prior written consent of the Company, which consent shall not be unreasonably withheld or delayed.
6.5. Notwithstanding anything to the contrary herein contained, the Company agrees and understands that the Advisor has a pre-existing obligation to assign to the Institute all of his rights, title and interest in and to all intellectual property which arise or are derived from Advisor’s employment at the Institute. The Company has no rights by reason of this Agreement in any publication, invention, discovery, improvement or other intellectual property, whether or not publishable, patentable or copyrightable that is subject to Advisor’s obligations to the Institute. Company also acknowledges and agrees that it will enjoy no priority or advantage as a result of the consultancy created hereunder in gaining access, whether by license or otherwise, to any proprietary information or intellectual property of the Institute. Other than the Inventions properly assigned to Company pursuant to this Article 6, Company shall have no rights, title or interest in any other inventions, discoveries or developments owned by or assignable to the Institute.
7. Noncompetition and Nonsolicitation of Employees.
7.1. During the term of this Agreement, Advisor will not, without the prior consent of the Company’s Board of Directors, engage in any commercial business activity that competes in any way with any business then being conducted by the Company in the Field, except that Advisor may continue the affiliations set forth in Exhibit A. In addition, but without limiting the generality of the foregoing, Advisor covenants and agrees during the term of this Agreement and for one year thereafter not to enter into any consulting relationship in the Field with any third party commercial entity. The foregoing shall not prevent Advisor from engaging in his work at the Institute or conducting any academic research, teaching or related non-commercial activity or any non-related commercial activity.
7.2. During the term of this Agreement and for two (2) year after its termination, Advisor will not personally or through others recruit, solicit or induce any employee of the Company to terminate his or her employment with the Company.
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7.3. If any restriction set forth in Sections 7.1 and 7.2 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable.
8. No Conflicting Obligation.
8.1. Advisor represents that Advisor’s performance of all of the terms of this Agreement and the performing of the Services for the Company do not and will not breach or conflict with any agreement with a third party, except as contemplated by Section 4.1, including an agreement to keep in confidence any proprietary information of another entity acquired by Advisor in confidence or in trust prior to the date of this Agreement.
8.2. Advisor hereby agrees not to enter into any agreement that conflicts with this Agreement.
9. No Improper Use of Materials. Advisor agrees not to bring to the Company or to use in the performance of Services for the Company any materials or documents of a present or former employer of Advisor, or any materials or documents obtained by Advisor from a third party under a binder of confidentiality, unless such materials or documents are generally available to the public or Advisor has authorization from such present or former employer or third party for the possession and unrestricted use of such materials. Advisor understands that Advisor is not to breach any obligation of confidentiality that Advisor has to present or former employers or clients, and agrees to fulfill all such obligations during the term of this Agreement.
10. Term and Termination.
10.1. This Agreement, and Advisor’s Services hereunder, shall commence on the Effective Date and shall continue for an initial term of one (2) year after the Effective Date, unless earlier terminated as provided below. At the end of such initial term, the Agreement will automatically be extended for an additional period or periods of one (1) year each, unless the Advisor or the Company shall have given to the other written notice to the contrary at least thirty (30) days prior to the commencement of such additional period.
10.2. Advisor or the Company may terminate the Agreement at any time by giving no less than fifteen (15) days prior written notice to the other Party.
10.3. The obligations set forth in Articles 2, 5, 6, 7 and 10 through 16 will survive any termination or expiration of this Agreement. Upon termination of this Agreement, Advisor will promptly deliver to the Company all documents and other materials of any nature pertaining to the Services, together with all documents and other items containing or pertaining to any Proprietary Information.
11. Assignment. The rights and liabilities of the Parties hereto shall bind and inure to the benefit of their respective successors, heirs, executors and administrators, as the case may be; provided that, as the Company has specifically contracted for Advisor’s Services, Advisor may not assign or delegate Advisor’s obligations under this Agreement either in whole or in part without the prior written consent of the Company. The Company may assign its rights and obligations hereunder to any person or entity that succeeds to all or substantially all of the Company’s business. Any assignment not in accordance with this Section 11 shall be void.
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12. Legal and Equitable Remedies. Because Advisor’s Services are personal and unique and because Advisor may have access to and become acquainted with the Proprietary Information of the Company, the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.
13. Governing Law; Severability. This Agreement shall be governed by and construed according to the laws of the State of Delaware, without regards to conflicts of laws rules. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, that provision shall be severed and the remainder of this Agreement shall continue in full force and effect. The parties agree that the State and federal courts located within the First Department (for State courts) and the Southern District of New York (for federal courts) shall be the venue for the initiation of any legal proceedings by a party with respect to this Agreement.
14. Complete Understanding; Modification. This Agreement, and the Exhibit mentioned herein, constitute the final, exclusive and complete understanding and agreement of the Parties hereto and supersedes all prior understandings and agreements. Any waiver, modification or amendment of any provision of this Agreement shall be effective only if in writing and signed by the Parties hereto.
15. Notices. Any notices required or permitted hereunder shall be given to the appropriate Party at the address listed on the first page of the Agreement, or such other address as the Party shall specify in writing pursuant to this notice provision. Such notice shall be deemed given upon personal delivery to the appropriate address or three days after the date of delivery if sent by certified or registered mail, return receipt requested; or three days after the date of delivery if sent by an overnight delivery service with verified delivery.
16. Counterparts. This Agreement may be executed in one or more counterparts each of which will be deemed an original, but all of which together shall constitute one and the same instrument.
17. Indemnification. The Company shall indemnify, defend and hold harmless the Advisor from and against any and all third party claims against Advisor and any costs, losses or expenses related thereto, including any reasonable legal fees and expenses, arising out of his services or status as an Advisor hereunder, except to the extent such claims arise out of Advisor’s deliberate and material misconduct. The Company shall reimburse the Advisor for any legal fees and all other expenses incurred by the Advisor in order to enforce the provisions of this paragraph.
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In Witness Whereof, the Parties hereto have executed this Agreement as of the date first written above.
Microlin Bio, Inc. | Dr. Sakari Kauppinen | |
/s/ Joe Hernandez | /s/ Sakari Kauppinen | |
By: Joe Hernandez | By: Sakari Kauppinen | |
Title: Chairman & CEO | Title: Professor |
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Exhibit A
Affiliations
1. | Professor, Department of Haematology, Aalborg University Hospital |
2. | Senior Consultant, SK Pharma Consulting |
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CONSULTING AGREEMENT
THIS CONSULTING AGREEMENT (the "Agreement") is made and entered into this day of May 21, 2015, (the "Effective Date") by and between Microlin Bio, Inc., a Delaware corporation duly organized under law and having an usual place of business at 302A W. 12 Street, Suite 114, New York, NY 10014 (hereinafter referred to as the "Company") and Bruce C. Galton (hereinafter referred to as the "Consultant") residing at 8 Holden Lane Madison, NJ 07940
WHEREAS, the Company wishes to engage the Consultant to provide the services described herein and Consultant agrees to provide the services for the compensation and otherwise in accordance with the terms and conditions contained in this Agreement,
NOW THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, accepted and agreed to, the Company and the Consultant, intending to be legally bound, agree to the terms set forth below.
1. TERM. Commencing as of the Effective Date, and continuing for a period of one (1) year (the "Term"), unless earlier terminated pursuant to Article 4 hereof, the Consultant agrees that he/she will serve as a consultant to the Company. This Agreement may be renewed or extended for any period as may be agreed by the parties.
2. DUTIES AND SERVICES.
(a) Consultant's duties and responsibilities shall be to provide business, operations, strategic, scientific and technical advice and support to the company and its Chairman in the company's preclinical development efforts, including scientific planning, experimentation design, data analysis and vendor selection and management. In addition, the consultant shall assist in document preparation, including business plans, corporate presentation, S-1 document, financial model and other related material and work as requested by the Company, the Executive management personnel or Board of Directors. The Consultant shall act as the Interim Chief Operating Officer and report directly to the Chairman (collectively, the "Duties"or "Services").
(b) The Consultant represents and warrants to the Company that he/she is under no contractual or other restrictions or obligations which are inconsistent with the execution of this Agreement, or which will interfere with the performance of his/her Duties. Consultant represents and warrants that the execution and performance of this Agreement will not violate any policies or procedures of any other person or entity for which he/she performs Services concurrently with those performed herein.
(c) In performing the Services, Consultant shall comply, to the best of his/her knowledge, with all business conduct, regulatory and health and safety guidelines established by the Company for any governmental authority with respect to the Company's business.
3. CONSULTING FEE.
(a) Subject to the provisions hereof, the Company shall pay Consultant a hourly consulting fee of $187.50 per hour, paid monthly (the "Consulting Fee"). The Consultant agrees to devote a minimum of twenty (20) hours per month for services to the company. The Consultant shall submit a brief summary report to the Company of her activities for the month just ended during the Term of this Agreement. Additionally, the company will issue the option to purchase 20,000 of the company's outstanding shares at the time of this agreement. These options shall vest over a four (4) year period as follows; twenty five percent (25%) of the shares shall vest on the first anniversary of this agreement and the remaining shares shall vest on a monthly basis over the remaining three-year period on a pro-rata basis. The Consultant acknowledges that this is the only form of compensation provide for his/her services.
(b) Consultant shall be entitled to prompt reimbursement for all pre-approved expenses incurred in the performance of his/her Duties, upon submission and approval of written statements and receipts in accordance with the then regular procedures of the Company.
(c) The Consultant agrees that all Services will be rendered by him/her as an independent contractor and that this Agreement does not create an employer-employee relationship between the Consultant and the Company. The Consultant shall have no right to receive any employee benefits including, but not limited to, health and accident insurance, life insurance, sick leave and/or vacation. Consultant agrees to pay all taxes including, self-employment taxes due in respect of the Consulting Fee and to indemnify the Company in the event the Company is required to pay any such taxes on behalf of the Consultant.
4. EARLY TERMINATION OF THE TERM.
(a) If the Consultant voluntarily ceases performing his/her Duties, becomes physically or mentally unable to perform his/her Duties, or is terminated for cause, then, in each instance, the Consulting Fee shall cease and terminate as of such date. Any termination "For Cause" shall be made in good faith.
(b) This Agreement may be terminated without cause by either party upon not less than fifteen (15) days prior written notice by either party to the other.
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(c) Upon termination under Sections 4(a) or 4(b), neither party shall have any further obligations under this Agreement, except for the obligations which by their terms survive this termination as noted in Section 16 hereof. Upon termination and, in any case, upon the Company's request, the Consultant shall return immediately to the Company all Confidential Information, as hereinafter defined, and copies thereof.
5. RESTRICTED ACTIVITIES. During the Term and for a period of five (5) year thereafter, Consultant will not, directly or indirectly:
(i) solicit or request any employee of or consultant to the Company to leave the employ of or cease consulting for the Company;
(ii) solicit or request any employee of or consultant to the Company to join the employ of, or begin consulting for, any individual or entity that researches, develops, markets or sells products that compete with those of the Company. However, Company is aware that Consultant is consulting with TK Biotech, Inc., a development stage oncology company whose sole technology is currently focused on monoclonal antibodies to TK-1. Company agrees that Consultant's work with TK Biotech is not in conflict with that of the Company;
(iii) solicit or request any individual or entity that researches, develops, markets or sells products that compete with those of the Company, to employ or retain as a consultant any employee or consultant of the Company; or
(iv) induce or attempt to induce any supplier or vendor of the Company to terminate or breach any written or oral agreement or understanding with the Company.
6. PROPRIETARY RIGHTS.
(a) Definitions. For the purposes of this Article 6, the terms set forth below shall have the following meanings:
(i) Concept and Ideas. Those concepts and ideas disclosed by the Company to Consultant or which are first developed by Consultant during the course of the performance of Services hereunder and which relate to the Company' present, past or prospective business activities, services, and products, all of which shall remain the sole and exclusive property of the Company. The Consultant shall have no publication rights and all of the same shall belong exclusively to the Company.
(ii) Confidential Information. For the purposes of this Agreement, Confidential Information shall mean and collectively include: all information relating to the business, plans and/or technology of the Company including, but not limited to technical information including inventions, methods, plans, processes, specifications, characteristics, assays, raw data, scientific preclinical or clinical data, records, databases, formulations, clinical protocols, equipment design, know-how, experience, and trade secrets; developmental, marketing, sales, customer, supplier, consulting relationship information, operating, performance, and cost information; computer programming techniques whether in tangible or intangible form, and all record bearing media containing or disclosing the foregoing information and techniques including, written business plans, patents and patent applications, grant applications, notes, and memoranda, whether in writing or presented, stored or maintained in or by electronic, magnetic, or other means.
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Notwithstanding the foregoing, the term "Confidential Information" shall not include any information which: (a) can be demonstrated to have been in the public domain or was publicly known or available prior to the date of the disclosure to Consultant; (b) can be demonstrated in writing to have been rightfully in the possession of Consultant prior to the disclosure of such information to Consultant by the Company; (c) becomes part of the public domain or publicly known or available by publication or otherwise, not due to any unauthorized act or omission on the part of Consultant; or (d) is supplied to Consultant by a third party without binder of secrecy, so long as that such third party has no obligation to the Company or any of its affiliated companies to maintain such information in confidence.
(b) Non-Disclosure to Third Parties. Except as required by Consultant's Duties, Consultant shall not, at any time now or in the future, directly or indirectly, use, publish, disseminate or otherwise disclose any Confidential Information, Concepts, or Ideas to any third party without the prior written consent of the Company which consent may be denied in each instance and all of the same, together with publication rights, shall belong exclusively to the Company.
(c) Documents, etc. All documents, diskettes, tapes, procedural manuals, guides, specifications, plans, drawings, designs and similar materials, lists of present, past or prospective customers, customer proposals, invitations to submit proposals, price lists and data relating to the pricing of the Company' products and services, records, notebooks and all other materials containing Confidential Information or information about Concepts or Ideas (including all copies and reproductions thereof), that come into Consultant's possession or control by reason of Consultant's performance of the relationship, whether prepared by Consultant or others: (a) are the property of the Company, (b) will not be used by Consultant in any way other than in connection with the performance of his/her Duties, (c) will not be provided or shown to any third party by Consultant, (d) will not be removed from the Company's or Consultant's premises (except as Consultant's Duties require), and (e) at the termination (for whatever reason), of Consultant's relationship with the Company, will be left with, or forthwith returned by Consultant to the Company.
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(d) Patents. etc. The Consultant agrees that the Company is and shall remain the exclusive owner of the Confidential Information and Concepts and Ideas. Any interest in patents, patent applications, inventions, technological innovations, trade names, trademarks, service marks, copyrights, copyrightable works, developments, discoveries, designs, processes, formulas, know-how, data and analysis, whether registrable or not ("Developments"), which Consultant, as a result of rendering Services to the Company under this Agreement, may conceive or develop, shall: (i) forthwith be brought to the attention of the Company by Consultant and (ii) belong exclusively to the Company. No license or conveyance of any such rights to the Consultant is granted or implied under this Agreement
(e) Assignment. The Consultant hereby assigns and, to the extent any such assignment cannot be made at present, hereby agrees to assign to the Company, without further compensation, all of his/her right, title and interest in and to all Concepts, Ideas, and Developments. The Consultant will execute all documents and perform all lawful acts which the Company considers necessary or advisable to secure its rights hereunder and to carry out the intent of this Agreement.
7. EQUITABLE RELIEF. Consultant agrees that any breach of Articles 5 and 6 above by him/her would cause irreparable damage to the Company and that, in the event of such breach, the Company shall have, in addition to any and all remedies of law, the right to an injunction, specific performance or other equitable relief to prevent the violation or threatened violation of Consultant's obligations hereunder.
8. WAIVER. Any waiver by the Company of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach of the same or any other provision hereof. All waivers by the Company shall be in writing.
9. SEVERABILITY; REFORMATION. In case any one or more of the provisions or parts of a provision contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; and this Agreement shall, to the fullest extent lawful, be reformed and construed as if such invalid or illegal or unenforceable provision, or part of a provision, had never been contained herein, and such provision or part reformed so that it would be valid, legal and enforceable to the maximum extent possible. Without limiting the foregoing, if any provision (or part of provision) contained in this Agreement shall for any reason be held to be excessively broad as to duration, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the fullest extent compatible with then existing applicable law.
10. ASSIGNMENT. The Company shall have the right to assign its rights and obligations under this Agreement to a party which assumes the Company' obligations hereunder. Consultant shall not have the right to assign his/her rights or obligations under this Agreement without the prior written consent of the Company. This Agreement shall be binding upon and inure to the benefit of the Consultant's heirs and legal representatives in the event of his/her death or disability.
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11. HEADINGS. Headings and subheadings are for convenience only and shall not be deemed to be a part of this Agreement.
12. AMENDMENTS. This Agreement may be amended or modified, in whole or in part, only by an instrument in writing signed by all parties hereto.
13. NOTICES. Any notices or other communications required hereunder shall be in writing and shall be deemed given when delivered in person or when mailed, by certified or registered first class mail, postage prepaid, return receipt requested, addressed to the parties at their addresses specified in the preamble to this Agreement or to such other addresses of which a party shall have notified the others in accordance with the provisions of this Section 13.
14. COUNTERPART S. This Agreement may be executed in two or more counterparts, each of which shall constitute an original and all of which shall be deemed a single agreement.
15. GOVERNING LAW. This Agreement shall be construed in accordance with and governed for all purposes by the laws of the state of New York applicable to contracts executed and wholly performed within such jurisdiction. Any dispute arising hereunder shall be referred to and heard in only a court located in New York.
16. SURVIVAL. The provisions of Sections 5 to 9 and 15 to 16 of this Agreement shall survive the expiration of the Term or the termination of this Agreement. This Agreement supersedes all prior agreements, written or oral, between the Company and the Consultant relating to the subject matter of this Agreement.
EXECUTED, under seal, effective as of the Effective Date.
MICROLIN BIO, INC.
By: /s/ Joe Hernandez Joe Hernandez Executive Chairman Hereunto Duly Authorized |
CONSULTANT
/s/ Bruce C. Galton Bruce C. Galton |
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CONSULTING AGREEMENT
THIS CONSULTING AGREEMENT (the "Agreement") is made and entered into this day of May 29, 2015, (the "Effective Date") by and between Microlin Bio, Inc., a Delaware corporation duly organized under law and having an usual place of business at 302A W. 12 Street, Suite 114, New York, NY 10014 (hereinafter referred to as the "Company") and Richard Dondero (hereinafter referred to as the "Consultant") residing at 37 Hillside Avenue, Riverdale, NJ 07457.
WHEREAS, the Company wishes to engage the Consultant to provide the services described herein and Consultant agrees to provide the services for the compensation and otherwise in accordance with the terms and conditions contained in this Agreement,
NOW THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, accepted and agreed to, the Company and the Consultant, intending to be legally bound, agree to the terms set forth below.
1. TERM. Commencing as of the Effective Date, and continuing for a period of one (1) year (the "Term"), unless earlier terminated pursuant to Article 4 hereof, the Consultant agrees that he/she will serve as a consultant to the Company. This Agreement may be renewed or extended for any period as may be agreed by the parties.
2. DUTIES AND SERVICES.
(a) Consultant's duties and responsibilities shall be to provide business, operations, strategic, scientific and technical advice and support to the company and its Chairman in the company's preclinical development efforts, including scientific planning, experimentation design, data analysis and vendor selection and management. In addition, the consultant shall assist in document preparation, including business plans, corporate presentation, S-1 document, financial model and other related material and work as requested by the Company, the Executive management personnel or Board of Directors. The Consultant shall act as the Interim Vice President of Preclinical and Clinical Development and report directly to the Chairman (collectively, the "Duties"or "Services").
(b) The Consultant represents and warrants to the Company that he/she is under no contractual or other restrictions or obligations which are inconsistent with the execution of this Agreement, or which will interfere with the performance of his/her Duties. Consultant represents and warrants that the execution and performance of this Agreement will not violate any policies or procedures of any other person or entity for which he/she performs Services concurrently with those performed herein.
(c) In performing the Services, Consultant shall comply, to the best of his/her knowledge, with all business conduct, regulatory and health and safety guidelines established by the Company for any governmental authority with respect to the Company's business.
3. CONSULTING FEE.
(a) Subject to the provisions hereof, the Company shall pay Consultant a hourly consulting fee of $150 per hour, paid monthly (the "Consulting Fee"). The Consultant agrees to devote a minimum of twenty (20) hours per month for services to the company. The Consultant shall submit a brief summary report to the Company of her activities for the month just ended during the Term of this Agreement. Additionally, the company will issue the option to purchase 20,000 of the company's outstanding shares at the time of this agreement. These options shall vest over a four (4) year period as follows; twenty five percent (25%) of the shares shall vest on the first anniversary of this agreement and the remaining shares shall vest on a monthly basis over the remaining three-year period on a pro-rata basis. The Consultant acknowledges that this is the only form of compensation provide for his/her services.
(b) Consultant shall be entitled to prompt reimbursement for all pre-approved expenses incurred in the performance of his/her Duties, upon submission and approval of written statements and receipts in accordance with the then regular procedures of the Company.
(c) The Consultant agrees that all Services will be rendered by him/her as an independent contractor and that this Agreement does not create an employer-employee relationship between the Consultant and the Company. The Consultant shall have no right to receive any employee benefits including, but not limited to, health and accident insurance, life insurance, sick leave and/or vacation. Consultant agrees to pay all taxes including, self-employment taxes due in respect of the Consulting Fee and to indemnify the Company in the event the Company is required to pay any such taxes on behalf of the Consultant.
4. EARLY TERMINATION OF THE TERM.
(a) If the Consultant voluntarily ceases performing his/her Duties, becomes physically or mentally unable to perform his/her Duties, or is terminated for cause, then, in each instance, the Consulting Fee shall cease and terminate as of such date. Any termination "For Cause" shall be made in good faith.
(b) This Agreement may be terminated without cause by either party upon not less than fifteen (15) days prior written notice by either party to the other.
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(c) Upon termination under Sections 4(a) or 4(b), neither party shall have any further obligations under this Agreement, except for the obligations which by their terms survive this termination as noted in Section 16 hereof. Upon termination and, in any case, upon the Company's request, the Consultant shall return immediately to the Company all Confidential Information, as hereinafter defined, and copies thereof.
5. RESTRICTED ACTIVITIES. During the Term and for a period of five (5) year thereafter, Consultant will not, directly or indirectly:
(i) solicit or request any employee of or consultant to the Company to leave the employ of or cease consulting for the Company;
(ii) solicit or request any employee of or consultant to the Company to join the employ of, or begin consulting for, any individual or entity that researches, develops, markets or sells products that compete with those of the Company. However, Company is aware that Consultant is consulting with TK Biotech, Inc., a development stage oncology company whose sole technology is currently focused on monoclonal antibodies to TK-1. Company agrees that Consultant's work with TK Biotech is not in conflict with that of the Company;
(iii) solicit or request any individual or entity that researches, develops, markets or sells products that compete with those of the Company, to employ or retain as a consultant any employee or consultant of the Company; or
(iv) induce or attempt to induce any supplier or vendor of the Company to terminate or breach any written or oral agreement or understanding with the Company.
6. PROPRIETARY RIGHTS.
(a) Definitions. For the purposes of this Article 6, the terms set forth below shall have the following meanings:
(i) Concept and Ideas. Those concepts and ideas disclosed by the Company to Consultant or which are first developed by Consultant during the course of the performance of Services hereunder and which relate to the Company' present, past or prospective business activities, services, and products, all of which shall remain the sole and exclusive property of the Company. The Consultant shall have no publication rights and all of the same shall belong exclusively to the Company.
(ii) Confidential Information. For the purposes of this Agreement, Confidential Information shall mean and collectively include: all information relating to the business, plans and/or technology of the Company including, but not limited to technical information including inventions, methods, plans, processes, specifications, characteristics, assays, raw data, scientific preclinical or clinical data, records, databases, formulations, clinical protocols, equipment design, know-how, experience, and trade secrets; developmental, marketing, sales, customer, supplier, consulting relationship information, operating, performance, and cost information; computer programming techniques whether in tangible or intangible form, and all record bearing media containing or disclosing the foregoing information and techniques including, written business plans, patents and patent applications, grant applications, notes, and memoranda, whether in writing or presented, stored or maintained in or by electronic, magnetic, or other means.
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Notwithstanding the foregoing, the term "Confidential Information" shall not include any information which: (a) can be demonstrated to have been in the public domain or was publicly known or available prior to the date of the disclosure to Consultant; (b) can be demonstrated in writing to have been rightfully in the possession of Consultant prior to the disclosure of such information to Consultant by the Company; (c) becomes part of the public domain or publicly known or available by publication or otherwise, not due to any unauthorized act or omission on the part of Consultant; or (d) is supplied to Consultant by a third party without binder of secrecy, so long as that such third party has no obligation to the Company or any of its affiliated companies to maintain such information in confidence.
(b) Non-Disclosure to Third Parties. Except as required by Consultant's Duties, Consultant shall not, at any time now or in the future, directly or indirectly, use, publish, disseminate or otherwise disclose any Confidential Information, Concepts, or Ideas to any third party without the prior written consent of the Company which consent may be denied in each instance and all of the same, together with publication rights, shall belong exclusively to the Company.
(c) Documents, etc. All documents, diskettes, tapes, procedural manuals, guides, specifications, plans, drawings, designs and similar materials, lists of present, past or prospective customers, customer proposals, invitations to submit proposals, price lists and data relating to the pricing of the Company' products and services, records, notebooks and all other materials containing Confidential Information or information about Concepts or Ideas (including all copies and reproductions thereof), that come into Consultant's possession or control by reason of Consultant's performance of the relationship, whether prepared by Consultant or others: (a) are the property of the Company, (b) will not be used by Consultant in any way other than in connection with the performance of his/her Duties, (c) will not be provided or shown to any third party by Consultant, (d) will not be removed from the Company's or Consultant's premises (except as Consultant's Duties require), and (e) at the termination (for whatever reason), of Consultant's relationship with the Company, will be left with, or forthwith returned by Consultant to the Company.
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(d) Patents. etc. The Consultant agrees that the Company is and shall remain the exclusive owner of the Confidential Information and Concepts and Ideas. Any interest in patents, patent applications, inventions, technological innovations, trade names, trademarks, service marks, copyrights, copyrightable works, developments, discoveries, designs, processes, formulas, know-how, data and analysis, whether registrable or not ("Developments"), which Consultant, as a result of rendering Services to the Company under this Agreement, may conceive or develop, shall: (i) forthwith be brought to the attention of the Company by Consultant and (ii) belong exclusively to the Company. No license or conveyance of any such rights to the Consultant is granted or implied under this Agreement
(e) Assignment. The Consultant hereby assigns and, to the extent any such assignment cannot be made at present, hereby agrees to assign to the Company, without further compensation, all of his/her right, title and interest in and to all Concepts, Ideas, and Developments. The Consultant will execute all documents and perform all lawful acts which the Company considers necessary or advisable to secure its rights hereunder and to carry out the intent of this Agreement.
7. EQUITABLE RELIEF. Consultant agrees that any breach of Articles 5 and 6 above by him/her would cause irreparable damage to the Company and that, in the event of such breach, the Company shall have, in addition to any and all remedies of law, the right to an injunction, specific performance or other equitable relief to prevent the violation or threatened violation of Consultant's obligations hereunder.
8. WAIVER. Any waiver by the Company of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach of the same or any other provision hereof. All waivers by the Company shall be in writing.
9. SEVERABILITY; REFORMATION. In case any one or more of the provisions or parts of a provision contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; and this Agreement shall, to the fullest extent lawful, be reformed and construed as if such invalid or illegal or unenforceable provision, or part of a provision, had never been contained herein, and such provision or part reformed so that it would be valid, legal and enforceable to the maximum extent possible. Without limiting the foregoing, if any provision (or part of provision) contained in this Agreement shall for any reason be held to be excessively broad as to duration, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the fullest extent compatible with then existing applicable law.
10. ASSIGNMENT. The Company shall have the right to assign its rights and obligations under this Agreement to a party which assumes the Company' obligations hereunder. Consultant shall not have the right to assign his/her rights or obligations under this Agreement without the prior written consent of the Company. This Agreement shall be binding upon and inure to the benefit of the Consultant's heirs and legal representatives in the event of his/her death or disability.
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11. HEADINGS. Headings and subheadings are for convenience only and shall not be deemed to be a part of this Agreement.
12. AMENDMENTS. This Agreement may be amended or modified, in whole or in part, only by an instrument in writing signed by all parties hereto.
13. NOTICES. Any notices or other communications required hereunder shall be in writing and shall be deemed given when delivered in person or when mailed, by certified or registered first class mail, postage prepaid, return receipt requested, addressed to the parties at their addresses specified in the preamble to this Agreement or to such other addresses of which a party shall have notified the others in accordance with the provisions of this Section 13.
14. COUNTERPART S. This Agreement may be executed in two or more counterparts, each of which shall constitute an original and all of which shall be deemed a single agreement.
15. GOVERNING LAW. This Agreement shall be construed in accordance with and governed for all purposes by the laws of the state of New York applicable to contracts executed and wholly performed within such jurisdiction. Any dispute arising hereunder shall be referred to and heard in only a court located in New York.
16. SURVIVAL. The provisions of Sections 5 to 9 and 15 to 16 of this Agreement shall survive the expiration of the Term or the termination of this Agreement. This Agreement supersedes all prior agreements, written or oral, between the Company and the Consultant relating to the subject matter of this Agreement.
EXECUTED, under seal, effective as of the Effective Date.
MICROLIN BIO, INC.
By: /s/ Joe Hernandez Joe Hernandez Executive Chairman Hereunto Duly Authorized |
CONSULTANT
/s/ Richard Dondero Richard Dondero |
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CONSULTING AGREEMENT
THIS CONSULTING AGREEMENT (the "Agreement") is made and entered into this day of June 8, 2015, (the "Effective Date") by and between Microlin Bio, Inc., a Delaware corporation duly organized under law and having an usual place of business at 302A W. 12th Street, Suite 114, New York, NY 10014 (hereinafter referred to as the “Company") and Sonya Zabludoff Palmer (hereinafter referred to as the "Consultant") residing at 4310 Trias St San Diego, CA 92103.
WHEREAS, the Company wishes to engage the Consultant to provide the services described herein and Consultant agrees to provide the services for the compensation and otherwise in accordance with the terms and conditions contained in this Agreement,
NOW THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, accepted and agreed to, the Company and the Consultant, intending to be legally bound, agree to the terms set forth below.
1. TERM. Commencing as of the Effective Date, and continuing for a period of one
(1) year (the “Term”), unless earlier terminated pursuant to Article 4 hereof, the Consultant agrees that he/she will serve as a consultant to the Company. This Agreement may be renewed or extended for any period as may be agreed by the parties.
2. | DUTIES AND SERVICES. |
(a) Consultant's duties and responsibilities shall be to provide strategic, scientific and technical advice and support to the company and its CEO in the company’s preclinical development efforts, including scientific planning, experimentation design, data analysis and vendor selection and management. In addition, the consultant shall assist in document preparation, including business plans, corporate presentation, S-1 document, financial model and other related material and work as requested by the Company, the Executive management personnel or Board of Directors. The Consultant shall report directly to the Chairman (collectively, the “Duties” or “Services”).
(b) The Consultant represents and warrants to the Company that he/she is under no contractual or other restrictions or obligations which are inconsistent with the execution of this Agreement, or which will interfere with the performance of his/her Duties. Consultant represents and warrants that the execution and performance of this Agreement will not violate any policies or procedures of any other person or entity for which he/she performs Services concurrently with those performed herein.
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(c) In performing the Services, Consultant shall comply, to the best of his/her knowledge, with all business conduct, regulatory and health and safety guidelines established by the Company for any governmental authority with respect to the Company’s business.
3. | CONSULTING FEE. |
(a) Subject to the provisions hereof, the Company shall pay Consultant a hourly consulting fee of $225 per hour, paid monthly (the "Consulting Fee"). The Consultant agrees to devote a minimum of twenty (20) hours per month for services to the company. The Consultant shall submit a brief summary report to the Company of her activities for the month just ended during the Term of this Agreement. Additionally, the company will issue the option to purchase 10,000 of the company’s outstanding shares at the time of this agreement. These options shall vest over a four (4) year period as follows; twenty five percent (25%) of the shares shall vest on the first anniversary of this agreement and the remaining shares shall vest on a monthly basis over the remaining three-year period on a pro-rata basis. The Consultant acknowledges that this is the only form of compensation provide for his/her services.
(b) Consultant shall be entitled to prompt reimbursement for all pre-approved expenses incurred in the performance of his/her Duties, upon submission and approval of written statements and receipts in accordance with the then regular procedures of the Company.
(c) The Consultant agrees that all Services will be rendered by him/her as an independent contractor and that this Agreement does not create an employer-employee relationship between the Consultant and the Company. The Consultant shall have no right to receive any employee benefits including, but not limited to, health and accident insurance, life insurance, sick leave and/or vacation. Consultant agrees to pay all taxes including, self-employment taxes due in respect of the Consulting Fee and to indemnify the Company in the event the Company is required to pay any such taxes on behalf of the Consultant.
4. | EARLY TERMINATION OF THE TERM. |
(a) If the Consultant voluntarily ceases performing his/her Duties, becomes physically or mentally unable to perform his/her Duties, or is terminated for cause, then, in each instance, the Consulting Fee shall cease and terminate as of such date. Any termination “For Cause” shall be made in good faith.
(b) This Agreement may be terminated without cause by either party upon not less than fifteen (15) days prior written notice by either party to the other.
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(c) Upon termination under Sections 4(a) or 4(b), neither party shall have any further obligations under this Agreement, except for the obligations which by their terms survive this termination as noted in Section 16 hereof. Upon termination and, in any case, upon the Company’s request, the Consultant shall return immediately to the Company all Confidential Information, as hereinafter defined, and copies thereof.
5. RESTRICTED ACTIVITIES. During the Term and for a period of five (5) year thereafter, Consultant will not, directly or indirectly:
(i) solicit or request any employee of or consultant to the Company to leave the employ of or cease consulting for the Company;
(ii) solicit or request any employee of or consultant to the Company to join the employ of, or begin consulting for, any individual or entity that researches, develops, markets or sells products that compete with those of the Company;
(iii) solicit or request any individual or entity that researches, develops, markets or sells products that compete with those of the Company, to employ or retain as a consultant any employee or consultant of the Company; or
(iv) induce or attempt to induce any supplier or vendor of the Company to terminate or breach any written or oral agreement or understanding with the Company.
6. | PROPRIETARY RIGHTS. |
(a) Definitions. For the purposes of this Article 6, the terms set forth below shall have the following meanings:
(i) Concept and Ideas. Those concepts and ideas disclosed by the Company to Consultant or which are first developed by Consultant during the course of the performance of Services hereunder and which relate to the Company' present, past or prospective business activities, services, and products, all of which shall remain the sole and exclusive property of the Company. The Consultant shall have no publication rights and all of the same shall belong exclusively to the Company.
(ii) Confidential Information. For the purposes of this Agreement, Confidential Information shall mean and collectively include: all information relating to the business, plans and/or technology of the Company including, but not limited to technical information including inventions, methods, plans, processes, specifications, characteristics, assays, raw data, scientific preclinical or clinical data, records, databases, formulations, clinical protocols, equipment design, know-how, experience, and trade secrets; developmental, marketing, sales, customer, supplier, consulting relationship information, operating, performance, and cost information; computer programming techniques whether in tangible or intangible form, and all record bearing media containing or disclosing the foregoing information and techniques including, written business plans, patents and patent applications, grant applications, notes, and memoranda, whether in writing or presented, stored or maintained in or by electronic, magnetic, or other means.
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Notwithstanding the foregoing, the term “Confidential Information” shall not include any information which: (a) can be demonstrated to have been in the public domain or was publicly known or available prior to the date of the disclosure to Consultant; (b) can be demonstrated in writing to have been rightfully in the possession of Consultant prior to the disclosure of such information to Consultant by the Company; (c) becomes part of the public domain or publicly known or available by publication or otherwise, not due to any unauthorized act or omission on the part of Consultant; or (d) is supplied to Consultant by a third party without binder of secrecy, so long as that such third party has no obligation to the Company or any of its affiliated companies to maintain such information in confidence.
(b) Non-Disclosure to Third Parties. Except as required by Consultant's Duties, Consultant shall not, at any time now or in the future, directly or indirectly, use, publish, disseminate or otherwise disclose any Confidential Information, Concepts, or Ideas to any third party without the prior written consent of the Company which consent may be denied in each instance and all of the same, together with publication rights, shall belong exclusively to the Company.
(c) Documents, etc. All documents, diskettes, tapes, procedural manuals, guides, specifications, plans, drawings, designs and similar materials, lists of present, past or prospective customers, customer proposals, invitations to submit proposals, price lists and data relating to the pricing of the Company' products and services, records, notebooks and all other materials containing Confidential Information or information about Concepts or Ideas (including all copies and reproductions thereof), that come into Consultant's possession or control by reason of Consultant's performance of the relationship, whether prepared by Consultant or others: (a) are the property of the Company, (b) will not be used by Consultant in any way other than in connection with the performance of his/her Duties, (c) will not be provided or shown to any third party by Consultant, (d) will not be removed from the Company's or Consultant’s premises (except as Consultant's Duties require), and (e) at the termination (for whatever reason), of Consultant's relationship with the Company, will be left with, or forthwith returned by Consultant to the Company.
(d) Patents, etc. The Consultant agrees that the Company is and shall remain the exclusive owner of the Confidential Information and Concepts and Ideas. Any interest in patents, patent applications, inventions, technological innovations, trade
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names, trademarks, service marks, copyrights, copyrightable works, developments, discoveries, designs, processes, formulas, know-how, data and analysis, whether registrable or not ("Developments"), which Consultant, as a result of rendering Services to the Company under this Agreement, may conceive or develop, shall: (i) forthwith be brought to the attention of the Company by Consultant and (ii) belong exclusively to the Company. No license or conveyance of any such rights to the Consultant is granted or implied under this Agreement.
(e) Assignment. The Consultant hereby assigns and, to the extent any such assignment cannot be made at present, hereby agrees to assign to the Company, without further compensation, all of his/her right, title and interest in and to all Concepts, Ideas, and Developments. The Consultant will execute all documents and perform all lawful acts which the Company considers necessary or advisable to secure its rights hereunder and to carry out the intent of this Agreement.
7. EQUITABLE RELIEF. Consultant agrees that any breach of Articles 5 and 6 above by him/her would cause irreparable damage to the Company and that, in the event of such breach, the Company shall have, in addition to any and all remedies of law, the right to an injunction, specific performance or other equitable relief to prevent the violation or threatened violation of Consultant's obligations hereunder.
8. WAIVER. Any waiver by the Company of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach of the same or any other provision hereof. All waivers by the Company shall be in writing.
9. SEVERABILITY; REFORMATION. In case any one or more of the provisions or parts of a provision contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; and this Agreement shall, to the fullest extent lawful, be reformed and construed as if such invalid or illegal or unenforceable provision, or part of a provision, had never been contained herein, and such provision or part reformed so that it would be valid, legal and enforceable to the maximum extent possible. Without limiting the foregoing, if any provision (or part of provision) contained in this Agreement shall for any reason be held to be excessively broad as to duration, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the fullest extent compatible with then existing applicable law.
10. ASSIGNMENT. The Company shall have the right to assign its rights and obligations under this Agreement to a party which assumes the Company' obligations hereunder. Consultant shall not have the right to assign his/her rights or obligations under this Agreement without the prior written consent of the Company. This Agreement shall be binding upon and inure to the benefit of the Consultant's heirs and legal representatives in the event of his/her death or disability.
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11. HEADINGS. Headings and subheadings are for convenience only and shall not be deemed to be a part of this Agreement.
12. AMENDMENTS. This Agreement may be amended or modified, in whole or in part, only by an instrument in writing signed by all parties hereto.
13. NOTICES. Any notices or other communications required hereunder shall be in writing and shall be deemed given when delivered in person or when mailed, by certified or registered first class mail, postage prepaid, return receipt requested, addressed to the parties at their addresses specified in the preamble to this Agreement or to such other addresses of which a party shall have notified the others in accordance with the provisions of this Section 13.
14. COUNTERPART S. This Agreement may be executed in two or more counterparts, each of which shall constitute an original and all of which shall be deemed a single agreement.
15. GOVERNING LAW. This Agreement shall be construed in accordance with and governed for all purposes by the laws of the state of New York applicable to contracts executed and wholly performed within such jurisdiction. Any dispute arising hereunder shall be referred to and heard in only a court located in New York.
16. SURVIVAL. The provisions of Sections 5 to 9 and 15 to 16 of this Agreement shall survive the expiration of the Term or the termination of this Agreement. This Agreement supersedes all prior agreements, written or oral, between the Company and the Consultant relating to the subject matter of this Agreement.
EXECUTED, under seal, effective as of the Effective Date.
MICROLIN BIO, INC.
By: /s/ Joe Hernandez Joe Hernandez Executive Chairman Hereunto Duly Authorized |
CONSULTANT
/s/ Sonya Zabludoff Palmer Sonya Zabludoff Palmer |
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MICROLIN BIO INC.
NONQUALIFIED STOCK OPTION AGREEMENT
Notice of Stock Option Grant
MicroLin Bio Inc., a Delaware corporation (the "Company"), grants to the Grantee named below, in accordance with the terms of the Microlin Bio Inc. Equity Incentive Plan (the "Plan") and this Nonqualified Stock Option Agreement (this "Agreement"), an option (the "Stock Option") to purchase the number of Shares at the exercise price per share ("Exercise Price") as follows:
Name of Grantee: | John N. Bonfiglio |
Number of Shares: | 10,000 |
Exercise Price: | $12.65 per Share |
Date of Grant: | December 31, 2013 |
Vesting Dates: | First anniversary of the Date of Grant and the first day of each month between the first and fourth anniversaries of the Date of Grant |
Terms of Agreement
1. Grant of Stock Option. Subject to and upon the terms, conditions and restrictions set forth in this Agreement and in the Plan, the Company hereby grants to the Grantee as of the Date of Grant this Stock Option to purchase the number of Shares at the Exercise Price as set forth above. This Stock Option is intended to be a nonqualified stock option and shall not be treated as an "incentive stock option" within the meaning of that term under Section 422 of the Code.
2. Vesting of Stock Option.
(a) Unless and until terminated as hereinafter provided, the Stock Option shall vest and become exercisable as follows:
(i) With respect to twenty-five percent (25%) of the Shares subject to the Stock Option, on the first anniversary of the Date of Grant, provided that the Grantee shall have remained in the continuous employment or other service of the Company or a Subsidiary through such Vesting Date; and
(ii) With respect to seventy-five percent (75%) of the Shares subject to the Stock Option, ratably, on the first day of each month between the first anniversary of the Date of Grant and the fourth anniversary of the Date of Grant, provided that the Grantee shall have remained in the continuous employment or other service of the Company or a Subsidiary through each such Vesting Date.
(b) Notwithstanding the provisions of Section 2(a), the Stock Option will become immediately vested and exercisable in full if, prior to the applicable Vesting Date: (i) the Grantee's employment or service with the Company and its Subsidiaries terminates by reason of the Grantee's death or "Disability" (defined as permanent and total disability within the meaning of Section 22(e)(3) of the Code); or (ii) the Grantee's employment or service is terminated within two years after a Change in Control: (A) by the Company and its Subsidiaries without Cause and not as a result of Disability; or (B) by the Grantee for Good Reason (defined as in Section 2(c) of this Agreement).
(c) For purposes of this Agreement, "Good Reason" shall mean the occurrence of any of the following without the Grantee's consent: (i) a material reduction of the Grantee's annual base salary; (ii) a material reduction in the Grantee's title, authority, responsibilities or reporting relationship as in effect immediately prior to the Change in Control; or (iii) the Company's requirement that in order to perform his obligations to the Company, the Grantee must relocate his residence to a location more than fifty (50) miles from the Grantee's principal office location immediately prior to a Change in Control. A termination of the Grantee's employment or service by the Grantee shall not be deemed to be for Good Reason unless (x) the Grantee gives notice to the Company of the existence of the event or condition constituting Good Reason within 60 calendar days after such event or condition initially occurs or exists, and (y) the Company fails to cure such event or condition within 30 calendar days after receiving such notice.
(d) For purposes of this Agreement, the continuous employment or service of the Grantee with the Company and its Subsidiaries shall not be deemed to have been interrupted, and the Grantee shall not be deemed to have ceased to be an employee of, or service provider to, the Company and its Subsidiaries, by reason of the transfer of his employment or service among the Company and its Subsidiaries or a leave of absence approved by the Board.
3. Forfeiture of Stock Option.
(a) To the extent that the Stock Option has not yet vested pursuant to Section 2 above, it shall be forfeited automatically without further action or notice if the Grantee ceases to be employed by, or to provide services to, the Company and its Subsidiaries prior to the applicable Vesting Date other than as provided in Section 2(b).
(b) The provisions of Section 17 of the Plan regarding forfeiture of Awards shall apply to the Stock Option and any Shares delivered hereunder. This Section 3(b) shall survive and continue in full force in accordance with its terms notwithstanding any termination of the Grantee's employment or service or the exercise of the Stock Option as provided herein.
4. Exercise of Stock Option.
(a) To the extent that the Stock Option has become vested and exercisable in accordance with this Agreement, it may be exercised in whole or in part from time to time by written notice to the Company stating the number of whole Shares for which the Stock Option is being exercised, the intended manner of payment, and such other provisions as may be required by the Company. The Stock Option may be exercised, during the lifetime of the Grantee, only by the Grantee, or in the event of his legal incapacity, by his guardian or legal representative acting on behalf of the Grantee in a fiduciary capacity under state law and/or court supervision. If the Grantee dies before the expiration of the Stock Option, all or part of this Stock Option may be exercised (prior to expiration) by the personal representative of the Grantee or by any person who has acquired this Stock Option directly from the Grantee by will, bequest or inheritance, but only to the extent that the Stock Option was vested and exercisable upon the Grantee's death.
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(b) The Exercise Price is payable in cash or by certified or cashier's check or other cash equivalent acceptable to the Board payable to the order of the Company.
5. Term of Stock Option. Subject to Section 3(b) hereof, the Stock Option will terminate on the earliest of the following dates (the "Expiration Date"):
(a) Twelve (12) months after the termination of the Grantee's employment or service as a result of death or Disability;
(b) Immediately upon termination of the Grantee's employment or service by the Company for Cause;
(c) Ninety (90) days after the termination of the Grantee 's employment or service for any other reason; or
(d) Midnight on the day immediately preceding the tenth anniversary of the Date of Grant.
6. Delivery of Shares. Subject to the terms and conditions of this Agreement and the Plan, Shares shall be issuable to the Grantee as soon as administratively practicable following the date the Grantee (a) exercises the Stock Option in accordance with Section 4 hereof, (b) makes full payment to the Company of the Exercise Price and (c) makes arrangements satisfactory to the Company (or any Subsidiary, if applicable) for the payment of any required withholding taxes related to the exercise of the Stock Option. The Grantee shall not possess any incidents of ownership (including, without limitation, dividend or voting rights) in the Shares until such Shares have been issued to the Grantee in accordance with this Section 6.
7. Transferability. The Stock Option may not be sold, exchanged, assigned, transferred, pledged, encumbered or otherwise disposed of by the Grantee; provided that the Grantee's rights with respect to such Stock Option may be transferred by will or pursuant to the laws of descent and distribution. Any purported transfer or encumbrance in violation of the provisions of this Section 7 shall be void, and the other party to any such purported transaction shall not obtain any rights to or interest in such Stock Option.
8. Restrictions on Resale. Unless and until registered under the Securities Act of 1933, as amended (the "Securities Act"), any Shares purchased pursuant to the Stock Option will be illiquid and will be deemed to be "restricted securities" for purposes of the Securities Act. Accordingly, any such Shares may be sold only in compliance with the registration requirements of the Securities Act or an exemption therefrom and may need to be held indefinitely. Unless and until the Shares have been registered under the Securities Act, each certificate evidencing any of the Shares shall bear a restrictive legend specified by the Company.
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9. Company's Right to Repurchase Shares.
(a) The Company shall have the right (the "Repurchase Right") to repurchase all, but not less than all, of the Shares purchased by the Grantee pursuant to the Stock Option, upon written notice to the Grantee within ninety (90) days after the termination of the Grantee's employment or service with the Company and its Subsidiaries, voluntarily or involuntarily, for any reason whatsoever other than by the Company for Cause, including as a result of death or Disability. The Repurchase Right shall be exercised by the Company by giving the holder of the Shares written notice of its intention to exercise the Repurchase Right, and, together with such notice, tendering to the holder an amount equal to the Fair Market Value of the Shares. Upon timely exercise of the Repurchase Right in the manner provided in this Section 9(a), the holder of the Shares shall deliver to the Company any stock certificate or certificates representing the Shares being repurchased, duly endorsed and free and clear of any and all liens, charges and encumbrances. If Shares are not repurchased under the Repurchase Right, the Grantee and his successor in interest, if any, will continue to hold the Shares subject to all of the provisions of this Agreement and the Plan.
(b) In the event that the Company or a Subsidiary terminates the Grantee's employment or service for Cause, the Company's rights with respect to any Shares purchased by the Grantee pursuant to the Stock Option shall be governed by Section 3(b) of this Agreement and Section 17 of the Plan.
10. No Right to Continued Employment or Service. Nothing contained in this Agreement shall confer upon the Grantee any right with respect to continuance of employment by or service with the Company and its Subsidiaries, nor limit or affect in any manner the right of the Company and its Subsidiaries to terminate the employment or service of the Grantee or adjust the Grantee's compensation.
11. Relation to Other Benefits. Any economic or other benefit to the Grantee under this Agreement or the Plan shall not be taken into account in determining any benefits to which the Grantee may be entitled under any profit-sharing, retirement or other benefit or compensation plan or arrangement maintained by the Company or a Subsidiary.
12. Taxes and Withholding. The Grantee shall pay to the Company, or make arrangements satisfactory to the Company for payment of, any federal, state, local or other taxes that the Company or any Subsidiary is required to withhold in connection with the delivery of Shares under this Agreement. The obligation of the Company to deliver Shares under this Agreement shall be conditioned on such payment or arrangements, and the Company and its Subsidiaries shall, to the extent permitted by Applicable Law, have the right to deduct any such taxes from any payment otherwise due to the Grantee.
13. Compliance with Applicable Law. The Company shall make reasonable efforts to comply with Applicable Law (including applicable federal and state securities laws) with respect to the Stock Option; provided that, notwithstanding any other provision of this Agreement, and only to the extent permitted under Section 409A of the Code, the Company shall not be obligated to deliver any Shares pursuant to this Agreement if the delivery thereof would result in a violation of Applicable Law.
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14. Adjustments. The Exercise Price and the number and kind of shares of stock covered by this Agreement shall be subject to adjustment as provided in Section 13 of the Plan.
15. Amendments. Subject to the terms of the Plan, the Board may modify this Agreement upon written notice to the Grantee. Any amendment to the Plan shall be deemed to be an amendment to this Agreement to the extent that the amendment is applicable hereto. Notwithstanding the foregoing, no amendment of the Plan or this Agreement shall adversely affect the rights of the Grantee under this Agreement in a material way without the Grantee's consent, except as otherwise may be provided in the Plan.
16. Severability. In the event that one or more of the provisions of this Agreement shall be invalidated for any reason by a court of competent jurisdiction, any provision so invalidated shall be deemed to be separable from the other provisions hereof, and the remaining provisions hereof shall continue to be valid and fully enforceable.
17. Relation to Plan. This Agreement is subject to the terms and conditions of the Plan, including the forfeiture provisions of Section 17 of the Plan. This Agreement and the Plan contain the entire agreement and understanding of the parties with respect to the subject matter contained in this Agreement, and supersede all prior written or oral communications, representations and negotiations in respect thereto . In the event of any inconsistency between the provisions of this Agreement and the Plan, the Plan shall govern. Capitalized terms used herein without definition shall have the meanings assigned to them in the Plan. The Board shall have the right to determine any questions which arise in connection with the grant of the Stock Option.
18. Successors and Assigns. Without limiting Section 7 hereof, the provisions of this Agreement shall inure to the benefit of, and be binding upon, the successors, administrators, heirs, legal representatives and assigns of the Grantee, and the successors and assigns of the Company.
19. Governing Law. The interpretation, performance, and enforcement of this Agreement shall be governed by the laws of the State of Delaware, excluding any conflicts or choice of law rule or principle that might otherwise refer interpretation or enforcement of the Agreement to the substantive law of another jurisdiction.
20. Use of Grantee's Information. Information about the Grantee and the Grantee's participation in the Plan may be collected, recorded and held, used and disclosed for any purpose related to the administration of the Plan. The Grantee understands that such processing of this information may need to be carried out by the Company and its Subsidiaries and by third party administrators whether such persons are located within the Grantee's country or elsewhere, including the United States of America . The Grantee consents to the processing of information relating to the Grantee and the Grantee's participation in the Plan in any one or more of the ways referred to above.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the Company has caused this Agreement to be executed on its behalf by its duly authorized officer and the Grantee has also executed this Agreement, as of the Date of Grant.
MICROLIN BIO INC.
By: /s/ Joseph Hernandez
Joseph Hernandez
Executive Chairman
The undersigned Grantee hereby acknowledges receipt of a copy of the Plan. The Grantee represents that he is familiar with the terms and provisions of the Plan, has had an opportunity to obtain the advice of counsel prior to executing this Agreement, and hereby accepts the Stock Option on the terms and conditions set forth herein and in the Plan.
GRANTEE
/s/ John N. Bonfiglio
John N. Bonfiglio
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Financial Statements | Page |
Balance sheets as of September 30, 2015 and September 30, 2014 | 3 |
Statements of operations for the years ended September 30, 2015, and September 30, 2014 | 4 |
Statements of stockholders' deficiency for the years ended September 30, 2015, and September 30, 2014 | 5 |
Statements of cash flows for the years ended September 30, 2015, and September 30, 2014 | 6 |
Notes to financial statements | 6 - 17 |
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2580 Anthem Village Drive Henderson, NV 89052 (917) 229-4600 www.rbsmllp.com |
REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Microlin Bio, Inc.
New York, NY
We have audited the accompanying balance sheets of Microlin Bio, Inc. as of September 30, 2015 and 2014, and the related statements of operations, stockholders’ deficit, and cash flows for each of the two years in the period ended September 30, 2015. These financial statements are the responsibility of the entity’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes 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.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Microlin Bio, Inc. as of September 30, 2015 and 2014, and the results of its operations and its cash flows for each of the two years in the period ended September 30, 2015, in conformity with accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the entity will continue as a going concern. As discussed in Note B to the financial statements, the entity has suffered recurring losses from operations and has a net capital deficiency that raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note B. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ RBSM LLP
RBSM, LLP |
December 15, 2015 |
Henderson, Nevada |
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Microlin Bio, Inc |
Balance Sheet
September 30, | September 30, | ||||||
2015 | 2014 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash | $ | 1 | $ | 1 | |||
Prepaid expense | — | 2,149 | |||||
Total Current Assets | 1 | 2,150 | |||||
SECURITY DEPOSIT | 8,000 | 8,000 | |||||
TOTAL ASSETS | $ | 8,001 | $ | 10,150 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIENCY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable | $ | 1,652,183 | 1,471,057 | ||||
Accrued expenses | 4,377,727 | 2,875,066 | |||||
Notes payable - Ohio State Innovation Foundation | 2,446,213 | 2,446,213 | |||||
Loans made by Founder | 430,379 | 419,314 | |||||
Derivative anti-dilution liability | 752,700 | 752,700 | |||||
Total Current Liabilities | 9,659,202 | 7,965,350 | |||||
COMMITMENTS AND CONTINGENCIES | |||||||
STOCKHOLDERS' DEFICIT | |||||||
Preferred stock, $0.000001 par value; 5,000,000 shares authorized, | |||||||
0 shares issued and outstanding | — | — | |||||
Common stock, $0.000001 par value; 50,000,000 shares authorized, | |||||||
4,030,258 shares issued and outstanding | 4 | 4 | |||||
Additional paid-in capital | 2,638,164 | 2,369,534 | |||||
Accumulated Deficit | (12,289,369 | ) | (10,358,738 | ) | |||
Total Stockholders' Deficit | (9,651,201 | ) | (7,954,200 | ) | |||
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ | 8,001 | $ | 10,150 |
The accompanying notes are an integral part of these financial statements.
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Microlin Bio, Inc |
Statements of Operations
Year
Ended September 30, 2015 | Year
Ended September 30, 2014 | ||||||
REVENUES | $ | — | $ | — | |||
OPERATING EXPENSES | |||||||
Research and development- principally costs to obtain patent portfolio | 894,529 | 1,631,234 | |||||
General and administrative | 985,485 | 2,753,233 | |||||
Total Operating Expenses | 1,880,014 | 4,384,467 | |||||
Net Loss from Operation | (1,880,014 | ) | (4,384,467 | ) | |||
OTHER EXPENSE | |||||||
Interest expense | 85,617 | 84,769 | |||||
Total Other Expenses | 85,617 | 84,769 | |||||
NET LOSS | $ | (1,965,631 | ) | $ | (4,469,236 | ) | |
BASIC AND DILUTED LOSS PER SHARE | $ | (0.49 | ) | $ | (1.11 | ) | |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | 4,030,258 | 4,021,968 |
The accompanying notes are an integral part of these financial statements.
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Microlin Bio, Inc |
Statements of Stockholders’ Deficiency
Additional | Total | |||||||||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders' | |||||||||||||||||
(Number of Shares) | (Amount) | Capital | Deficit | Deficiency | ||||||||||||||||
Balance – July 30, 2013 (inception) | — | $ | — | $ | — | $ | — | $ | — | |||||||||||
Issuance of common stock to founder | 3,720,000 | 4 | (4 | ) | — | — | ||||||||||||||
Issuance of stock for license of patents - Ohio State Innovation Foundation | 280,000 | — | 1,771,000 | — | 1,771,000 | |||||||||||||||
Stock based compensation charge | — | — | 26,354 | — | 26,354 | |||||||||||||||
Net loss | — | — | — | (5,854,502 | ) | (5,854,502 | ) | |||||||||||||
Balance – September 30, 2013 | 4,000,000 | 4 | 1,797,350 | (5,854,502 | ) | (4,057,148 | ) | |||||||||||||
Stock based compensation charge | — | — | 380,802 | — | 380,802 | |||||||||||||||
Issuance of stock pursuant to anti-dilution provisions | 30,258 | — | 191,382 | — | 191,382 | |||||||||||||||
Net loss | — | — | — | (4,469,236 | ) | (4,469,236 | ) | |||||||||||||
Balance – September 30, 2014 | 4,030,258 | $ | 4 | $ | 2,369,534 | $ | (10,323,738 | ) | $ | (7,954,200 | ) | |||||||||
Stock based compensation charge | — | — | 268,630 | — | 268,630 | |||||||||||||||
Net loss | — | — | — | (1,965,631 | ) | (1,965,631 | ) | |||||||||||||
Balance – September 30, 2015 | 4,030,258 | $ | 4 | $ | 2,638,164 | $ | (12,289,369 | ) | $ | (9,651,201 | ) |
The accompanying notes are an integral part of these financial statements.
5 |
Microlin Bio, Inc |
Statements of Cash Flows
Year ended | Year ended | ||||||
September 30, 2015 | September 30, 2014 | ||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss | $ | (1,965,631 | ) | $ | (4,469,236 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Issuance of common stock in exchange for obtaining patent portfolio | — | 191,382 | |||||
Stock based compensation expense | 268,630 | 380,802 | |||||
Changes in operating assets and liabilities | |||||||
Security deposit | — | 8,000 | |||||
Prepaid expense | 2,149 | (2,149 | ) | ||||
Accounts payable | 181,126 | 1,471,057 | |||||
Accrued expenses | 1,502,661 | 2,041,395 | |||||
Net Cash Provided by (Used in) Operating Activities | (11,065 | ) | (394,749 | ) | |||
CASH FLOWS FROM FINANCING ACTIVITIES | — | — | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
Advances made by Founder | 11,065 | 394,750 | |||||
Net Cash Provided by (Used in) Financing Activities | 11,065 | 386,750 | |||||
NET CHANGE IN CASH | — | 1 | |||||
CASH AT BEGINNING OF PERIOD | 1 | — | |||||
CASH AT END OF PERIOD | $ | 1 | $ | 1 | |||
Supplemental disclosure of cash paid | |||||||
Interest | $ | — | $ | — | |||
Taxes | $ | — | $ | — |
The accompanying notes are an integral part of these financial statements.
6 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note A – Company Information
Microlin Bio, Inc. (the “Company”) is a development stage biopharmaceutical company with a focus on identifying and developing novel pharmaceutical and diagnostic products for the diagnosis and treatment of cancer. The Company focuses on a class of targets termed microRNAs. The Company was founded on July 30, 2013 and entered into the Patent and License agreements with Ohio State Innovation Foundation (“OSIF”), an affiliate of The Ohio State University, on September 6, 2013 (Note D). The Company’s fiscal year end is September 30.
The Company's operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's products, the Company's ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company's ability to raise capital.
From its inception, the Company has devoted substantially all of its efforts to business planning and licensing its portfolio of assets. The Company is currently arranging for outsourced providers to continue clinical development. Accordingly, the Company is considered to be in the development stage.
Note B – Liquidity And Plan Of Operation
The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern.
The Company does not expect to receive FDA approval for its therapeutics products for several years. The Company also expects that its research and development expenses will continue to increase as the Company advances to pre-clinical and clinical trials and pursues FDA approval. As a result, the Company expects to continue to incur substantial losses for the foreseeable future, and these losses will be increasing. The Company is uncertain when or if the Company will be able to achieve or sustain profitability. If the Company achieved profitability in the future, the Company may not be able to sustain profitability in subsequent periods. Failure to become and remain profitable would impair its ability to sustain operations and adversely affect the fair value of its common stock and its ability to raise capital.
Through September 30, 2015, the Company has an accumulated deficit of approximately $12,539,000 and has not raised any significant funds to date. In addition, the Company has not made the payments as required under the term note with OSIF (Note D (4)). The Company’s lack of sufficient capital to execute the development plan for its products raises substantial doubt about its ability to continue as a going concern, and as a result, the Company’s independent registered public accounting firm included an explanatory paragraph in its report on the Company’s financial statements for the years ended September 30, 2015 and 2014 with respect to this uncertainty.
7 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note C – Summary Of Significant Accounting Policies
[1] | Use of estimates: |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the valuation of the Company's equity-based instruments. Actual results could differ from those estimates.
[2] Loss per common share:
Basic loss per share is calculated by dividing the Company’s net loss applicable to common stockholders by the weighted average number of common shares during the period. Diluted loss per share is calculated by dividing the Company’s net loss available to common stockholders by the diluted weighted average number of shares outstanding during the year, and is the same as basic net loss per share because the Company incurred a net loss in all periods presented and the potentially dilutive securities from the assumed issuance of shares under the anti-dilution option held by OSIF or exercise of outstanding stock options (287,000 shares at September 30, 2015 and 2014) would have an anti-dilutive effect.
Year ended September 30, 2015 | Year ended September 30, 2014 | ||||||
Net Loss (numerator) | $ | (1,965,631 | ) | $ | (4,384,236 | ) | |
Common Shares (denominator) | 4,030,258 | 4,021,968 | |||||
Net loss per share amount | $ | (0.49 | ) | $ | (1.11 | ) |
[3] Equity-based compensation:
The Company recognizes compensation expense for all equity-based payments. Stock based compensation issued to employees is accounted for under Accounting Standard Codification (“ASC”) ASC 718-10, Compensation— Share Compensation” (“ASC 718-10”). The Company utilizes the Black- Scholes valuation method to recognize compensation expense over the vesting period. Certain assumptions need to be made with respect to utilizing the Black-Scholes valuation model, including the expected life, volatility, risk-free interest rate and anticipated forfeiture of the stock options.
The Company accounts for stock-based transactions with non-employees in which services are received in exchange for the equity instruments based upon the fair value of the equity instruments issued, in accordance with Accounting Standards Codification (“ASC”) 718-10 and ASC 505-50, Equity-Based Payments to Non-Employees. The value of such options, computed utilizing the Black-Scholes valuation model, is remeasured at the end of each period for any change in fair value from the previous valuation until the award vests. The Company begins expensing the awards to non-employees at the service commencement date.
Accounting for share-based compensation granted by the Company requires fair value estimates of the equity instrument granted. If the Company’s estimate of the fair value of stock-based compensation is too high or too low, it will have the effect of overstating or understating expenses. When stock-based grants are granted in exchange for the receipt of goods or services, the Company estimates the value of the stock-based compensation based upon the value of its common stock.
8 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note C – Summary Of Significant Accounting Policies (Continued)
[4] Derivative Instrument:
The Company accounts for its derivative instruments in accordance with ASC 815-10, “Derivatives and Hedging”. ASC 815-10 establishes accounting and reporting standards requiring that derivative instruments, including derivative instruments embedded in other contracts, be recorded on the balance sheet as either an asset or liability measured at its fair value. ASC 815-10 also requires that changes in the fair value of derivative instruments be recognized currently in results of operations unless specific hedge accounting criteria are met. The Company has not entered into hedging activities to date but has entered into a derivative (Note D).
[5] Revenue recognition:
The Company will develop an appropriate revenue recognition policy when planned principal operations commence.
[6] Research and development:
One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. The Company makes this judgment based on whether the technology has alternative future uses, as defined in ASC 730, “Research and Development.” The Company’s patent portfolio consists of a large number of compounds and methodologies, substantially all of which are in the very early stage of development, and there is significant uncertainty as to future use and ability to make required payments to the licensor. Based on this consideration, the Company expensed payments made to in-license such patent portfolio. These costs are reflected in research and development expense in the statement of operations.
[7] Income taxes:
Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates.
The Company adopted the provisions of ASC 740-10 and has analyzed its filing positions in 2015 in jurisdictions where it may be obligated to file returns. The Company has not had any income tax return filings to date. Therefore, no reserves for uncertain income tax positions have been recorded. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties as of September 30, 2015 or September 30, 2014. In addition, future changes in unrecognized tax benefits will have no impact on the effective tax rate due to the existence of the valuation.
[8] Fair Value Estimate:
The Company is required to estimate the fair value of the common stock underlying stock-based awards when performing the fair value calculations with the Black-Scholes option-pricing model. The fair value of the common stock underlying stock-based awards was determined on each grant date by the Company’s board of directors. All options to purchase shares of common stock are intended to be granted with an exercise price per share no less than the fair value per share of common stock underlying those options on the date of grant, based on the information known on the date of grant.
9 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note C – Summary Of Significant Accounting Policies (Continued)
[8] Fair Value Estimate (continued):
The Company is privately held with no active public market for its common stock. Therefore, the board of directors have for financial reporting purposes periodically determined the estimated per share fair value of the Company’s common stock at various dates using contemporaneous valuations consistent with the American Institute of Certified Public Accountants Practice Aid, “Valuation of Privately-Held Company Equity Securities Issued as Compensation,” also known as the Practice Aid. These valuations were performed with the assistance of a third-party valuation specialist. The Company performed these contemporaneous valuations as of September 30, 2015 and determined the fair value of common stock to be $6.33. In conducting these contemporaneous valuations, the board of directors considered all objective and subjective factors that it believed to be relevant in each valuation conducted, including the board of directors’ best estimate of the Company’s business condition, prospects and operating performance at each valuation date. Within the contemporaneous valuations performed, a range of factors, assumptions and methodologies were used. The significant factors included external market conditions affecting the biotechnology industry, trends within the biotechnology industry, the results of operations, financial position, status of research and development efforts, stage of development and business strategy, the lack of an active public market for the common stock, and the likelihood of achieving a liquidity event such as an initial public offering (“IPO”).
The Company determined that a market-based approach to value that employs the probability-weighted expected returns method (“PWERM”) would provide the most appropriate paradigm for estimating the fair market value of the Company. The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the Company, as well as the economic and control rights of each share class. Under the PWERM approach, the Company used point estimates for values and dates, since the Company is a relatively small and early-stage company.
Under the PWERM approach, six scenarios were evaluated, both in terms of company value and probability of each scenario. The probability identified was the likeliness that the scenario occurs within the next year, or by the end of 2016. The scenarios ranged from achieving commercialization of both diagnostic and therapeutic products to company dissolution by 2016. The discount rate applied to the future proceeds are based on an estimate of our cost of capital, which is based on the Capital Asset Pricing Model. In the scenarios in which the Company does not become a public company and remain privately held, and thus have illiquid shares, the value of the shares and thus the company were discounted for lack of marketability.
The dates of the Company’s contemporaneous valuations have not always coincided with the dates of its stock-based compensation grants. In such instances, board of directors’ estimates have been based on the most recent contemporaneous valuation of the Company’s shares of common stock and its assessment of additional objective and subjective factors the board of directors believed were relevant and which may have changed from the date of the most recent contemporaneous valuation through the date of the grant. Management believes there were no substantial changes from the date of the valuation (September 30, 2013) through September 30, 2015 noted in valuing the Company’s stock based awards.
[9] Fair Value of Financial Instruments
ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
10 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note C – Summary Of Significant Accounting Policies (Continued)
[9] Fair Value of Financial Instruments (continued)
The three levels of the fair value hierarchy are as follows:
• Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.
• Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace
• Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
The carrying amounts reported in the balance sheet for cash, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. The Company recognizes all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss. See Note D(3) regarding changes to the value of the derivative anti-dilution liability.
[10] Deferred issuance costs
Deferred public offering costs, which primarily consist of direct, incremental legal and accounting fees relating to the company’s initial public offering, are capitalized within deferred issuance costs. The deferred issuance costs will be offset against IPO proceeds upon the consummation of the offering. In the event the offering is terminated, deferred offering costs will be expensed. The Company has incurred approximately $1,151,000 in initial public offering costs as of September 30, 2014 and full amount was expensed due to the offering was terminated.
[11] Recent accounting pronouncements
In June 2014, the FASB issued ASU 2014-10, “Development State Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, including an amendment to Variable Interest Entities Guidance in Topic 810 Consolidation”, which eliminated the definition of a Development State Entity and the related reporting requirements. ASU 2014-10 is effective for annual reporting periods beginning after December 15, 2014, with early adoption allowed. The Company adopted ASU 2014-10, effective in its financial statements for the years ended September 30, 2015 and 2014.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern, which states management should evaluate whether there are conditions of events, considered in the aggregate, that raise a substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Management’ evaluation should be based on relevant conditions and events that are known and likely to occur at the date that the financial statements are issued. The standard update will be effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter, however, early application is permitted. The Company is evaluating the effect that adoption will have on its financial statements and related disclosures.
11 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note D - License Agreements
On September 6, 2013, the Company entered into five license agreements with OSIF pursuant to which OSIF grants the Company the rights to a world-wide license to discover, develop, make, have made, use, import, lease, sell and offer for sale licensed products. In consideration of the licenses:
1. | The Company paid OSIF a total non-refundable license initiation fee of $25,000 ($5,000 for each of the five licensing agreements) and is required to pay an additional fee of $500,000 ($95,000 for each of the four licensing agreements and $120,000 for one of the five licensing agreements) in year 2; |
2. | The Company issued 280,000 shares of common stock which have been assigned amounts equivalent to the estimated fair value of the securities issued during the year ended September 30, 2013. Such issuances resulted in charges to research and development expense of $0 for the years ended September 30, 2015 and 2014; |
3. | OSIF received anti-dilution rights equal to 7% of the Company’s issued and outstanding share capital of the Company on a fully diluted basis. In January 2014, the Company issued an additional 30,258 common shares to OSIF pursuant to anti-dilution provisions in our licensing agreements with OSIF. The right shall lapse following a raise of at least $10,000,000 in a single transaction or a series of transactions of equity financing. The anti-dilution provision was determined to be a derivative liability, as the timing and number of shares which may be issuable are not determinable at September 6, 2013 (date of the OSIF agreements). The maximum liability of the instrument of $752,700 was charged to research and development expense during the year ended September 30, 2013. This liability is based upon the estimated value of shares potentially required to be issued under such agreements and is considered a level 3 measurement. |
4. | The Company executed a term note with OSIF in the amount of approximately $2,363,000. The terms of the note require four payments of principal and interest in fixed installments of $100,000 beginning October 31, 2013 through December 31, 2014, and eight payments of principal and interest in fixed installments of approximately $273,000 beginning June 30, 2015 through March 31, 2017. The entire amount becomes immediately due in the event that the Company receives external funding of at least $10,000,000. Interest is charged at a 3.5% interest rate. In the event the Company does not make note payments as required, the agreements are technically in default with the patent portfolio reverting back to OSIF. In January 2014, the Company executed an amendment to one of their license agreements which increases the number of patents that the Company has exclusive licensing rights. As consideration for the additional patents, the Company has agreed to pay additional upfront licensing costs of $25,000 (Note D(1)) and has agreed to increase the term note from approximately $2,363,000 to $2,446,000. Such amounts have not yet been paid. The execution of the note payable resulted in charges to research and development expense of approximately $83,000 for the year ended September 30, 2013. At September 30, 2015 and 2014, the Company has not made the payments as required under the license agreement. Although OSIF has informally accepted the deferral of the payments currently due until consummation of external funding by the Company, the Company has recorded the entire amount as current as of September 30, 2015 and 2014 due to the technical default. Interest expense on this note was $85,617 and $84,769, respectively, for the years ended September 30, 2015 and 2014. Accrued interest at September 30, 2015 and September 30, 2014 was $175,895 and $90,278, respectively and is included in accrued expenses. |
12 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note D - License Agreements (Continued)
Future commitments under the OSIF License Agreements are as follows:
5. | The Company will pay OSIF annual license maintenance fees of $95,000 (in contract year 3), $35,000 (in contract year 4), $60,000 (in contract year 5) and $10,000 (each contract year thereafter); |
6. | The Company may be required to make future milestone payments upon the achievement of various milestones relating to regulatory approval or commercial events under the five licensing agreements plus additional occurrence specific costs which will depend on international and commercial growth; and |
7. | The Company will be required to pay OSIF a varying low single digit royalty rate of net sales relating to the licensed products. The license agreements also require annual minimum royalties, as defined in the agreements, beginning in the contract year ending December 31, 2015 and continuing in all contract years thereafter (minimum royalty payments will escalate annually through contract year December 31, 2019). |
Under the terms of the license agreements, the Company is allowed to grant sublicenses or assign the license agreements to third parties. If the grant of a sublicense occurs, then the Company will be obligated to pay OSIF a varying percentage of all payments received from the sublicensees. If an assignment of any of the license agreements occur, the Company will be obligated to pay the greater of a specified amount or percentage, as defined in the agreements, of the gross consideration of the total transaction for contract years beginning December 31, 2014 and continiuing in all contract years thereafter. The term of each agreement continues until the last to expire of the applicable patent rights licensed thereunder. The Company may terminate the agreements at any time upon 90 days' prior written notice. Four of the agreements require the Company to pay a termination penalty of $2,500,000 if the agreement is terminated by the Company in the first two years of the contract.
As result of the license agreements, the Company recorded $105,000 and $40,000 annual license maintenance fees for the years ended September 30, 2015 and 2014, respectively. The Company also recorded $0 and $25,000 milestone extensions and fees for the years ended September 30, 2015 and 2014, respectively. The Company has agreed to reimburse OSIF the related patent costs which amounted to approximately $783,500 and $1,203,000 for the years ended September 30, 2015 and 2014, respectively. Such amounts have not yet been paid and recorded as additional research and development expenses.
Note E – Related Party Transactions
As of September 30, 2015 and September 30, 2014, the Company has borrowed approximately $430,400 and $419,300, respectively, from its founder and Executive Chairman and Chief Executive Officer, who is also the principal shareholder. These loans are short term, non-collateralized and non-interest bearing. See Note D for description of equity and licensing transactions with OSIF.
Note F - Commitments and Contingencies
[1] Compensation of Scientific Advisory Board members and Board of Directors:
Each of the members of the Company's Scientific Advisory Board (“SAB”) have entered into a scientific advisory board agreement with the Company, terminable upon 30 days' written notice by either party, which specifies the services to be provided by each member and compensation payable to each member.
13 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note F - Commitments and Contingencies (Continued)
[2] Minimum Lease Commitments
In November 2013, the Company entered into a non-cancellable operating lease for office space expiring in November 2014. The premises were occupied in November 2013. However, this lease was assigned to a related company, owned by its founder and Executive Chairman and Chief Executive Officer, effective May 1, 2014.
In March 2014, the Company entered into a non-cancellable operating lease for office space effective May 1, 2014 and expiring in June 2016. Monthly rent payments under the agreement total $8,000. Future minimum annual rental payments are approximately $96,000.
[3] Employment Agreements
The Company entered into an employment agreement with its Executive Chairman and Chief Executive Officer which has an effective date of July 2013. The agreement specifies the compensation payable to, and the services to be provided by, the executive. If the agreement should be terminated by the Company for other than cause, as defined, the Company will be required to pay 24 months annual salary in a lump sum within 60 days of the date of termination. No payments have been made through September 30, 2015 and $1,153,500 and $622,731 has been accrued at September 30, 2015 and 2014, respectively as a result of the agreement.
Note G – Accrued Expenses
Accrued expenses are comprised of the following as of September 30, 2013 and September 30, 2014:
September 30, 2015 | September 30, 2014 | ||||||
License Initiation Fee to OSIF (Note D) | $ | 620,000 | $ | 515,000 | |||
Accrued Salaries and benefits (primarily founder) | 1,153,500 | 622,731 | |||||
Due to OSIF for patent expenses | 2,226,932 | 1,443,432 | |||||
Professional fees | 201,400 | 203,625 | |||||
Accrued interests | 175,895 | 90,278 | |||||
$ | 4,377,727 | $ | 2,875,066 |
Note H – Equity
[1] Stock Issued to Founder
On August 1, 2013, the founder and principal stockholder was issued 3,720,000 shares of the Company’s common stock. The date of issuance was prior to the execution of the OSIF agreements and therefore the Company had no business assets or liabilities at that time. Accordingly, minimal value was assigned to the founder shares.
14 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note H – Equity (Continued)
[2] Stock Options
The Company reserved 500,000 shares of Common Stock for issuance to officers, directors, employees and consultants pursuant to the Microlin Bio, Inc. Equity Incentive Plan. The awards under this plan must be approved by the Board of Directors and may include stock options, restricted stock or other types of awards, and are subject to compliance with Internal Revenue Code regulations. In certain cases, the Company may include in its awards, a right to repurchase shares exercised/vested by the grantee at its then fair value. During the years ended September 30, 2015 and 2014, the Company issued 0 and 302,000 options under the stock option plan, respectively, of which 60,000 and 60,000 options were forfeited during the years ended September 30, 2015 and 2014, respectively, and there are 198,000 options available for future issuance as of December 30, 2015. During the period ended September 30, 2013, the Company also issued 100,000 options outside of the stock option plan, of which 100,000 options were forfeited during the year ended September 30, 2014.
A summary of stock option activity for the years ended September 30, 2015 and 2014 is summarized as follows:
Weighted Average | ||||||||||
Number of Options | Exercisable Price | |||||||||
Options outstanding at September 30, 2013 | 100,000 | $ | 0.0000005 | |||||||
Granted | 302,000 | 6.325 | ||||||||
Exercised | — | — | ||||||||
Forfeited | (160,000 | ) | 2.37 | |||||||
Options outstanding at September 30, 2014 | 242,000 | $ | 6.325 |
Granted | — | $ | — | |||||||
Exercised | — | — | ||||||||
Forfeited | (60,000 | ) | 6.325 | |||||||
Options outstanding at September 30, 2015 | 182,000 | $ | 6.325 |
The following is a summary of the status of stock options outstanding at September 30, 2015:
Outstanding Options | Exercisable Options | ||
Exercise Price | Number | Weighted
Average Contractual Life |
Number |
$6.33 | 182,000 | 8.25 years | 81,583 |
15 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note H– Equity (Continued)
[2] Stock Options (Continued)
The fair value of each option award was estimated on the grant date using the Black Scholes option-pricing model and will be expensed under the straight-line method. The following assumptions were used:
Year
ended September 30, 2014 | ||||
Exercise price | $ | 6.33 | ||
Fair value underlying common stock | $ | 6.33 | ||
Risk free interest rate | 2.22 | % | ||
Calculated dividend rate | 0 | |||
Expected life of the option in years | 7 | |||
Expected volatility | 80.20 | % | ||
Fair value of option | $ | 4.64 |
The expected life of the stock options was calculated using the method allowed by the provisions of ASC 718-10. The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the options. Estimates of pre-vesting option forfeitures are based on the Company’s experience. The Company will adjust its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods.
Total stock compensation expense recognized amounted to approximately $269,000 and $381,000 for the years ended September 30, 2015 and 2014, respectively. As of September 30, 2015, the total remaining unrecognized compensation cost related to unvested stock options was approximately $475,000, which will be recognized over a period of approximately 2.25 years.
[3] Forward Stock Split
All share and per share amounts have been adjusted to reflect a 2-for-1 forward stock split of the Company’s common stock to be effected upon the consummation of the Company’s initial public offering.
[4] Increase in number of shares
In December 2013, the Company increased the number of authorized shares of common stock from 4,000,000 to 50,000,000 and authorized 5,000,000 shares of preferred stock at $0.000001 par value per share.
16 |
Microlin Bio, Inc
Notes to Financial Statements
|
Note I - Subsequent Events
The Company evaluated subsequent events through December 15, 2015, which is the date the financial statements were available to be issued.
17 |
Microlin Bio, Inc
Notes to Financial Statements
|
American Boarding Company
Unaudited Pro Forma Balance Sheets
September 30, 2015
American
Boarding Company For the Year Ended | Microlin
Bio, Inc. For the Year Ended | Pro Forma | Consolidated | ||||||||||||
September 30, 2015 | September 30, 2015 | Adjustments | Pro Forma | ||||||||||||
ASSETS | |||||||||||||||
CURRENT ASSETS | |||||||||||||||
Cash and cash equivalents | $ | 97 | $ | 1 | $ | — | $ | 98 | |||||||
Prepaid expense | — | — | — | — | |||||||||||
Total Current Assets | 97 | 1 | — | 98 | |||||||||||
SECURITY DEPOSIT | — | 8,000 | — | 8,000 | |||||||||||
TOTAL ASSETS | $ | 97 | $ | 8,001 | $ | — | $ | 8,098 | |||||||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||||||||||
CURRENT LIABILITIES | |||||||||||||||
Accounts payable and accrued expenses | $ | 5,231 | $ | 6,029,910 | $ | — | $ | 6,035,141 | |||||||
Notes payable - Ohio State Innovation Foundation | — | 2,446,213 | — | 2,446,213 | |||||||||||
Convertible note payable - related party | 18,868 | — | — | 18,868 | |||||||||||
Due to officer | 8,438 | — | — | 8,438 | |||||||||||
Loans made by Founder | — | 430,379 | — | 430,379 | |||||||||||
Convertible notes payable, net of discount | 23,423 | — | — | 23,423 | |||||||||||
Derivative anti-dilution liability | — | 752,700 | — | 752,700 | |||||||||||
Total Current Liabilities | 55,960 | 9,659,202 | — | 9,715,162 | |||||||||||
STOCKHOLDERS' DEFICIT | |||||||||||||||
Preferred stock, $0.001 par value; | |||||||||||||||
10,000,000 shares authorized, | |||||||||||||||
0 shares issued and outstanding | — | — | — | — | |||||||||||
Common stock, $0.001 par value; | |||||||||||||||
90,000,000 shares authorized, | |||||||||||||||
20,000,000 shares issued and outstanding | 9,100 | 4 | 19,000 | (a) | 20,000 | ||||||||||
(8,100 | )(b) | ||||||||||||||
(4 | )(c) | ||||||||||||||
Stock Payable | 32,100 | — | (32,100 | )(d) | — | ||||||||||
Additional paid-in capital | 269,737 | 2,638,164 | (19,000 | )(a) | 2,562,305 | ||||||||||
8,100 | (b) | ||||||||||||||
4 | (c) | ||||||||||||||
32,100 | (d) | ||||||||||||||
(366,800 | )(e) | ||||||||||||||
Accumulated Deficit | (366,800 | ) | (12,289,369 | ) | 366,800 | (e) | (12,289,369 | ) | |||||||
Total Stockholders' Deficit | (55,863 | ) | (9,651,201 | ) | — | (9,707,064 | ) | ||||||||
TOTAL LIABILITIES AND | |||||||||||||||
STOCKHOLDERS' DEFICIT | $ | 97 | $ | 8,001 | $ | — | $ | 8,098 |
The accompanying notes are an integral part of these financial statements.
1 |
American Boarding Company
Unaudited Pro Forma Statements of Operations
September 30, 2015
American Boarding Company For the Nine Months Ended | Microlin Bio, Inc. For the Year Ended | Pro Forma | Consolidated | |||||||||||||
September 30, 2015 | September 30, 2015 | Adjustments | Pro Forma | |||||||||||||
REVENUES | $ | 1,800 | $ | — | $ | — | $ | 1,800 | ||||||||
OPERATING EXPENSES | ||||||||||||||||
Research and development- principally costs to obtain patent portfolio | — | 894,529 | — | 894,529 | ||||||||||||
Licenses and fees | 2,122 | — | — | 2,122 | ||||||||||||
Professional fees | 12,980 | — | — | 12,980 | ||||||||||||
General and administrative | 885 | 985,485 | — | 986,370 | ||||||||||||
Total Operating Expenses | 15,987 | 1,880,014 | — | 1,896,001 | ||||||||||||
Net Loss from Operation | (14,187 | ) | (1,880,014 | ) | — | (1,894,201 | ) | |||||||||
OTHER EXPENSE | ||||||||||||||||
Interest expense | 10,313 | 85,617 | 95,930 | |||||||||||||
Total Other Expenses | 10,313 | 85,617 | — | 95,930 | ||||||||||||
Net Loss Before Provision of Income Taxes | (24,500 | ) | (1,965,631 | ) | — | (1,990,131 | ) | |||||||||
Income taxes | — | — | ||||||||||||||
NET LOSS | $ | (24,500 | ) | $ | (1,965,631 | ) | $ | — | $ | (1,990,131 | ) | |||||
BASIC AND DILUTED | ||||||||||||||||
NET LOSS PER SHARE | $ | (0.00 | ) | $ | (0.49 | ) | $ | (0.10 | ) | |||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | 9,100,000 | 4,030,258 | 20,000,000 |
The accompanying notes are an integral part of these financial statements.
2 |
American Boarding Company
Notes to Pro Forma Financial Statements
(Unaudited)
Note 1 - INTRODUCTION
Merger
On December __, 2015, American Boarding Company (“Boarding”) entered into a Share Exchange and Conversion Agreement (the “Exchange Agreement”) by and among Boarding and a holder of a majority of Boarding’s issued and outstanding capital stock (the “Majority Shareholder”), on the one hand, and Microlin Bio, Inc., a Delaware corporation (“Microlin”) and the shareholders of Microlin (“Microlin Stockholders”).
Pursuant to the share exchange, Boarding shall issue 19,000,000 restricted shares of its common stock, $0.001 par value per share, to the Microlin Stockholders in the aggregate, in exchange for 4,030,258 shares of Microlin common stock held by them, representing 100% of the then issued and outstanding share capital of Microlin (the “Share Exchange”).
The completion of the Share Exchange resulted in a change of control. The Share Exchange was accounted for as a reverse merger and recapitalization. Microlin was the acquirer for financial reporting purposes and Boarding was the acquired company.
Consequently, the assets and liabilities and the operations reflected in the historical financial statements prior to the Share Exchange were those of Microlin and was recorded at its historical cost basis; and the consolidated financial statements after completion of the Share Exchange included the assets and liabilities of Microlin and Boarding, the historical operations of Microlin .
Note 2 - PRO FORMA PRESENTATION
General
The following unaudited pro forma combined balance sheets and income statements are based on historical financial statements of Boarding as if the transaction had occurred during the period ended September 30, 2015, the date of accounting acquirer’s most recent period end.
The unaudited pro forma combined financial statements are provided for information purposes only. The pro forma financial statements are not necessarily indicative of what the financial position or results of operations actually would have been had the acquisition been completed at the dates indicated below. In addition, the unaudited pro forma combined financial statements do not purport to project the future financial position or operating results of the combined company. The unaudited pro forma combined financial information has been prepared in accordance with the rules and regulations of the Securities and Exchange Commission.
For pro forma purposes:
· | The unaudited Pro Forma Combined Balance Sheets as of September 30, 2015 of the companies give effect to the transaction as if it had occurred on September 30, 2015 ; and |
· | The unaudited Pro Forma Combined Statements of Operations for the period ended September 30, 2015 combines the income statements of the companies for the indicated periods, giving effect to the transaction as if it had occurred on October 1, 2014. |
Pro forma adjustments:
The unaudited pro forma balance sheet and statements of operations reflect the following adjustments associated with the Share Exchange between Boarding and Microlin:
(a) | In connection with the Share Exchange Agreement, 4,030,258 shares of Microlin common stock were exchanged for 19,000,000 newly issued shares of Boarding common stock, and 8,100,000 shares of Boarding common stock were cancelled; |
(b) | 8,100,000 shares of Boarding common stock were cancelled; |
(c) | Pro forma elimination of Microlin’s existing common stock; |
(d) | Stock payable of $32,100 were written off; |
(e) | Pro forma elimination of Boarding’s remaining holding deficit against Microlin’s accumulated paid in capital. |
These unaudited pro forma combined financial statements and accompanying notes should be read in conjunction with the separate audited financial statements of Boarding and Microlin as of and for the period ended September 30, 2015.
3 |
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